US Codex
Pub. L.
Notes

Division FF — Health and Human Services

117th Congress · Approved Dec 29, 2022 · 136 Stat. 4459

DIVISION FF Health and Human Services

SEC. 1. Short Title.

This division may be cited as the “Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022”.

SEC. 2. Table of Contents.

The table of contents for this division is as follows:

DIVISION FF— HEALTH AND HUMAN SERVICES

Sec. 1. Short title.

Sec. 2. Table of contents.

TITLE I— RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING

Sec. 1001. Short title.

Subtitle A— Mental Health and Crisis Care Needs

Chapter 1— Crisis Care Services and 9–8–8 Implementation

Sec. 1101. Behavioral Health Crisis Coordinating Office.

Sec. 1102. Crisis response continuum of care.

Sec. 1103. Suicide Prevention Lifeline Improvement.

Chapter 2— Into the Light for Maternal Mental Health and Substance Use Disorders

Sec. 1111. Screening and treatment for maternal mental health and substance use disorders.

Sec. 1112. Maternal mental health hotline.

Sec. 1113. Task force on maternal mental health.

Sec. 1114. Residential treatment program for pregnant and postpartum women pilot program reauthorization.

Chapter 3— Reaching Improved Mental Health Outcomes for Patients

Sec. 1121. Innovation for mental health.

Sec. 1122. Crisis care coordination.

Sec. 1123. Treatment of serious mental illness.

Sec. 1124. Study on the costs of serious mental illness.

Chapter 4— Anna Westin Legacy

Sec. 1131. Maintaining education and training on eating disorders.

Chapter 5— Community Mental Health Services Block Grant Reauthorization

Sec. 1141. Reauthorization of block grants for community mental health services.

Chapter 6— Peer-Supported Mental Health Services

Sec. 1151. Peer-supported mental health services.

Subtitle B— Substance Use Disorder Prevention, Treatment, and Recovery Services

Chapter 1— Native Behavioral Health Resources

Sec. 1201. Behavioral health and substance use disorder resources for Native Americans.

Chapter 2— Summer Barrow Prevention, Treatment, and Recovery

Sec. 1211. Grants for the benefit of homeless individuals.

Sec. 1212. Priority substance use disorder treatment needs of regional and national significance.

Sec. 1213. Evidence-based prescription opioid and heroin treatment and interventions demonstration.

Sec. 1214. Priority substance use disorder prevention needs of regional and national significance.

Sec. 1215. Sober Truth on Preventing (STOP) Underage Drinking Reauthorization.

Sec. 1216. Grants for jail diversion programs.

Sec. 1217. Formula grants to States.

Sec. 1218. Projects for Assistance in Transition From Homelessness.

Sec. 1219. Grants for reducing overdose deaths.

Sec. 1220. Opioid overdose reversal medication access and education grant programs.

Sec. 1221. Emergency department alternatives to opioids.

Chapter 3— Excellence in Recovery Housing

Sec. 1231. Clarifying the role of SAMHSA in promoting the availability of high-quality recovery housing.

Sec. 1232. Developing guidelines for States to promote the availability of high-quality recovery housing.

Sec. 1233. Coordination of Federal activities to promote the availability of recovery housing.

Sec. 1234. National Academies of Sciences, Engineering, and Medicine study and report.

Sec. 1235. Grants for States to promote the availability of recovery housing and services.

Sec. 1236. Funding.

Sec. 1237. Technical correction.

Chapter 4— Substance Use Prevention, Treatment, and Recovery Services Block Grant

Sec. 1241. Eliminating stigmatizing language relating to substance use.

Sec. 1242. Authorized activities.

Sec. 1243. State plan requirements.

Sec. 1244. Updating certain language relating to Tribes.

Sec. 1245. Block grants for substance use prevention, treatment, and recovery services.

Sec. 1246. Requirement of reports and audits by States.

Sec. 1247. Study on assessment for use of State resources.

Chapter 5— Timely Treatment for Opioid Use Disorder

Sec. 1251. Study on exemptions for treatment of opioid use disorder through opioid treatment programs during the COVID–19 public health emergency.

Sec. 1252. Changes to Federal opioid treatment standards.

Chapter 6— Additional Provisions Relating to Addiction Treatment

Sec. 1261. Prohibition.

Sec. 1262. Eliminating additional requirements for dispensing narcotic drugs in schedule III, IV, and V for maintenance or detoxification treatment.

Sec. 1263. Requiring prescribers of controlled substances to complete training.

Sec. 1264. Increase in number of days before which certain controlled substances must be administered.

Chapter 7— Opioid Crisis Response

Sec. 1271. Opioid prescription verification.

Sec. 1272. Synthetic opioid and emerging drug misuse danger awareness.

Sec. 1273. Grant program for State and Tribal response to opioid use disorders.

Subtitle C— Access to Mental Health Care and Coverage

Chapter 1— Improving Uptake and Patient Access to Integrated Care Services

Sec. 1301. Improving uptake and patient access to integrated care services.

Chapter 2— Helping Enable Access to Lifesaving Services

Sec. 1311. Reauthorization and provision of certain programs to strengthen the health care workforce.

Sec. 1312. Reauthorization of minority fellowship program.

Chapter 3— Eliminating the Opt-Out for Nonfederal Governmental Health Plans

Sec. 1321. Eliminating the opt-out for nonfederal governmental health plans.

Chapter 4— Mental Health and Substance Use Disorder Parity Implementation

Sec. 1331. Grants to support mental health and substance use disorder parity implementation.

Subtitle D— Children and Youth

Chapter 1— Supporting Children’s Mental Health Care Access

Sec. 1401. Technical assistance for school-based health centers.

Sec. 1402. Infant and early childhood mental health promotion, intervention, and treatment.

Sec. 1403. Co-occurring chronic conditions and mental health in youth study.

Sec. 1404. Best practices for behavioral and mental health intervention teams.

Chapter 2— Continuing Systems of Care for Children

Sec. 1411. Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances.

Sec. 1412. Substance Use Disorder Treatment and Early Intervention Services for Children and Adolescents.

Chapter 3— Garrett Lee Smith Memorial Reauthorization

Sec. 1421. Suicide prevention technical assistance center.

Sec. 1422. Youth suicide early intervention and prevention strategies.

Sec. 1423. Mental health and substance use disorder services for students in higher education.

Sec. 1424. Mental and behavioral health outreach and education at institutions of higher education.

Chapter 4— Media and Mental Health

Sec. 1431. Study on the effects of smartphone and social media use on adolescents.

Sec. 1432. Research on the health and development effects of media and related technology on infants, children, and adolescents.

Subtitle E— Miscellaneous Provisions

Sec. 1501. Limitations on authority.

TITLE II— PREPARING FOR AND RESPONDING TO EXISTING VIRUSES, EMERGING NEW THREATS, AND PANDEMICS

Sec. 2001. Short title.

Subtitle A— Strengthening Federal and State Preparedness

Chapter 1— Federal Leadership and Accountability

Sec. 2101. Appointment and authority of the Director of the Centers for Disease Control and Prevention.

Sec. 2102. Advisory committee to the director of the centers for disease control and prevention.

Sec. 2103. Public health and medical preparedness and response coordination.

Sec. 2104. Office of Pandemic Preparedness and Response Policy.

Chapter 2— State and Local Readiness

Sec. 2111. Improving State and local public health security.

Sec. 2112. Supporting access to mental health and substance use disorder services during public health emergencies.

Sec. 2113. Trauma care reauthorization.

Sec. 2114. Assessment of containment and mitigation of infectious diseases.

Sec. 2115. Consideration of unique challenges in noncontiguous States and territories.

Subtitle B— Improving Public Health Preparedness and Response Capacity

Chapter 1— Improving Public Health Emergency Responses

Sec. 2201. Addressing factors related to improving health outcomes.

Chapter 2— Improving State, Local, and Tribal Public Health Data

Sec. 2211. Modernizing State, local, and Tribal biosurveillance capabilities and infectious disease data.

Sec. 2212. Genomic sequencing, analytics, and public health surveillance of pathogens.

Sec. 2213. Supporting State, local, and Tribal public health data.

Sec. 2214. Epidemic forecasting and outbreak analytics.

Sec. 2215. Public health data transparency.

Sec. 2216. GAO report on public health preparedness, response, and recovery data capabilities.

Chapter 3— Revitalizing the Public Health Workforce

Sec. 2221. Improving recruitment and retention of the frontline public health workforce.

Sec. 2222. Awards to support community health workers and community health.

Sec. 2223. Improving public health emergency response capacity.

Sec. 2224. Increasing educational opportunities for allied health professions.

Sec. 2225. Public Health Service Corps annual and sick leave.

Sec. 2226. Leadership exchange pilot for public health and medical preparedness and response positions at the Department of Health and Human Services.

Sec. 2227. Continuing educational support for health professionals serving in rural and underserved communities.

Chapter 4— Enhancing Public Health Preparedness and Response

Sec. 2231. Centers for public health preparedness and response.

Sec. 2232. Vaccine distribution plans.

Sec. 2233. Coordination and collaboration regarding blood supply.

Sec. 2234. Supporting laboratory capacity and international collaboration to address antimicrobial resistance.

Sec. 2235. One Health framework.

Sec. 2236. Supporting children during public health emergencies.

Subtitle C— Accelerating Research and Countermeasure Discovery

Chapter 1— Fostering Research and Development and Improving Coordination

Sec. 2301. Research centers for pathogens of pandemic concern.

Sec. 2302. Improving medical countermeasure research coordination.

Sec. 2303. Accessing specimen samples and diagnostic tests.

Sec. 2304. National Academies of Sciences, Engineering, and Medicine study on natural immunity in relation to the COVID–19 pandemic.

Chapter 2— Improving Biosafety and Biosecurity

Sec. 2311. Improving control and oversight of select biological agents and toxins.

Sec. 2312. Strategy for Federal high-containment laboratories.

Sec. 2313. National Science Advisory Board for Biosecurity.

Sec. 2314. Research to improve biosafety.

Sec. 2315. Federally-funded research with enhanced pathogens of pandemic potential.

Chapter 3— Preventing Undue Foreign Influence in Biomedical Research

Sec. 2321. Foreign talent recruitment programs.

Sec. 2322. Securing identifiable, sensitive information and addressing other national security risks related to research.

Sec. 2323. Duties of the Director.

Sec. 2324. Protecting America’s biomedical research enterprise.

Sec. 2325. GAO Study.

Sec. 2326. Report on progress to address undue foreign influence.

Chapter 4— Advanced Research Projects Agency–Health

Sec. 2331. Advanced Research Projects Agency–Health.

Subtitle D— Modernizing and Strengthening the Supply Chain for Vital Medical Products

Sec. 2401. Warm base manufacturing capacity for medical countermeasures.

Sec. 2402. Supply chain considerations for the Strategic National Stockpile.

Sec. 2403. Strategic National Stockpile equipment maintenance.

Sec. 2404. Improving transparency and predictability of processes of the Strategic National Stockpile.

Sec. 2405. Improving supply chain flexibility for the Strategic National Stockpile.

Sec. 2406. Reimbursement for certain supplies.

Sec. 2407. Action reporting on stockpile depletion.

Sec. 2408. Provision of medical countermeasures to Indian programs and facilities.

Sec. 2409. Grants for State strategic stockpiles.

Sec. 2410. Study on incentives for domestic production of generic medicines.

Sec. 2411. Increased manufacturing capacity for certain critical antibiotic drugs.

Subtitle E— Enhancing Development and Combating Shortages of Medical Products

Chapter 1— Development and Review

Sec. 2501. Accelerating countermeasure development and review.

Sec. 2502. Third party test evaluation during emergencies.

Sec. 2503. Platform technologies.

Sec. 2504. Increasing EUA decision transparency.

Sec. 2505. Improving FDA guidance and communication.

Chapter 2— Mitigating Shortages

Sec. 2511. Ensuring registration of foreign drug and device manufacturers.

Sec. 2512. Extending expiration dates for certain drugs.

Sec. 2513. Combating counterfeit devices.

Sec. 2514. Preventing medical device shortages.

Sec. 2515. Technical corrections.

TITLE III— FOOD AND DRUG ADMINISTRATION

Sec. 3001. Short title.

Sec. 3002. Definition.

Subtitle A— Reauthorizations

Sec. 3101. Reauthorization of the critical path public-private partnership.

Sec. 3102. Reauthorization of the best pharmaceuticals for children program.

Sec. 3103. Reauthorization of the humanitarian device exemption incentive.

Sec. 3104. Reauthorization of the pediatric device consortia program.

Sec. 3105. Reauthorization of provision pertaining to drugs containing single enantiomers.

Sec. 3106. Reauthorization of certain device inspections.

Sec. 3107. Reauthorization of orphan drug grants.

Sec. 3108. Reauthorization of reporting requirements related to pending generic drug applications and priority review applications.

Sec. 3109. Reauthorization of third-party review program.

Subtitle B— Drugs and Biologics

Chapter 1— Research, Development, and Competition Improvements

Sec. 3201. Prompt reports of marketing status by holders of approved applications for biological products.

Sec. 3202. Improving the treatment of rare diseases and conditions.

Sec. 3203. Emerging technology program.

Sec. 3204. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

Sec. 3205. Public workshop on cell therapies.

Sec. 3206. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products.

Sec. 3207. GAO report on nonprofit pharmaceutical organizations.

Sec. 3208. Rare disease endpoint advancement pilot program.

Sec. 3209. Animal testing alternatives.

Sec. 3210. Modernizing accelerated approval.

Sec. 3211. Antifungal research and development.

Sec. 3212. Advancing qualified infectious disease product innovation.

Sec. 3213. Advanced manufacturing technologies designation program.

Chapter 2— Transparency, Program Integrity, and Regulatory Improvements

Sec. 3221. Safer disposal of opioids.

Sec. 3222. Therapeutic equivalence evaluations.

Sec. 3223. Public docket on proposed changes to third-party vendors.

Sec. 3224. Enhancing access to affordable medicines.

Subtitle C— Medical Devices

Sec. 3301. Dual submission for certain devices.

Sec. 3302. Medical Devices Advisory Committee meetings.

Sec. 3303. GAO report on third-party review.

Sec. 3304. Certificates to foreign governments.

Sec. 3305. Ensuring cybersecurity of medical devices.

Sec. 3306. Bans of devices for one or more intended uses.

Sec. 3307. Third party data transparency.

Sec. 3308. Predetermined change control plans for devices.

Sec. 3309. Small business fee waiver.

Subtitle D— Infant Formula

Sec. 3401. Protecting infants and improving formula supply.

Subtitle E— Cosmetics

Sec. 3501. Short title.

Sec. 3502. Amendments to cosmetic requirements.

Sec. 3503. Enforcement and conforming amendments.

Sec. 3504. Records inspection.

Sec. 3505. Talc-containing cosmetics.

Sec. 3506. PFAS in cosmetics.

Sec. 3507. Sense of the Congress on animal testing.

Sec. 3508. Funding.

Subtitle F— Cross-Cutting Provisions

Chapter 1— Clinical Trial Diversity and Modernization

Sec. 3601. Diversity action plans for clinical studies.

Sec. 3602. Guidance on diversity action plans for clinical studies.

Sec. 3603. Public workshops to enhance clinical study diversity.

Sec. 3604. Annual summary report on progress to increase diversity in clinical studies.

Sec. 3605. Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic.

Sec. 3606. Decentralized clinical studies.

Sec. 3607. Modernizing clinical trials.

Chapter 2— Inspections

Sec. 3611. Device inspections.

Sec. 3612. Bioresearch monitoring inspections.

Sec. 3613. Improving Food and Drug Administration inspections.

Sec. 3614. GAO report on inspections of foreign establishments manufacturing drugs.

Sec. 3615. Unannounced foreign facility inspections pilot program.

Sec. 3616. Enhancing coordination and transparency on inspections.

Sec. 3617. Enhancing transparency of drug facility inspection timelines.

Chapter 3— Miscellaneous

Sec. 3621. Regulation of certain products as drugs.

Sec. 3622. Women’s Health Research Roadmap.

Sec. 3623. Strategic workforce plan and report.

Sec. 3624. Enhancing Food and Drug Administration hiring authority for scientific, technical, and professional personnel.

Sec. 3625. Facilities management.

Sec. 3626. User fee program transparency and accountability.

Sec. 3627. Improving information technology systems of the Food and Drug Administration.

Sec. 3628. Reporting on mailroom and Office of the Executive Secretariat of the Food and Drug Administration.

Sec. 3629. Facilitating the use of real world evidence.

Sec. 3630. Facilitating exchange of product information prior to approval.

Sec. 3631. Streamlining blood donor input.

TITLE IV— MEDICARE PROVISIONS

Subtitle A— Medicare Extenders

Sec. 4101. Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals.

Sec. 4102. Extension of the Medicare-Dependent Hospital program.

Sec. 4103. Extension of add-on payments for ambulance services.

Subtitle B— Other Expiring Medicare Provisions

Sec. 4111. Extending incentive payments for participation in eligible alternative payment models.

Sec. 4112. Extension of support for physicians and other professionals in adjusting to Medicare payment changes.

Sec. 4113. Advancing telehealth Beyond COVID–19.

Sec. 4114. Revised phase-in of Medicare clinical laboratory test payment changes.

Subtitle C— Medicare Mental Health Provisions

Sec. 4121. Coverage of marriage and family therapist services and mental health counselor services under part B of the Medicare program.

Sec. 4122. Additional residency positions.

Sec. 4123. Improving mobile crisis care in Medicare.

Sec. 4124. Ensuring adequate coverage of outpatient mental health services under the Medicare program.

Sec. 4125. Improvements to Medicare prospective payment system for psychiatric hospitals and psychiatric units.

Sec. 4126. Exception for physician wellness programs.

Sec. 4127. Consideration of safe harbor under the anti-kickback statute for certain contingency management interventions.

Sec. 4128. Provider outreach and reporting on certain behavioral health integration services.

Sec. 4129. Outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs.

Sec. 4130. GAO study and report comparing coverage of mental health and substance use disorder benefits and non-mental health and substance use disorder benefits.

Subtitle D— Other Medicare Provisions

Sec. 4131. Temporary inclusion of authorized oral antiviral drugs as covered part D drug.

Sec. 4132. Restoration of CBO access to certain part D payment data.

Sec. 4133. Medicare coverage of certain lymphedema compression treatment items.

Sec. 4134. Permanent in-home benefit for IVIG services.

Sec. 4135. Access to non-opioid treatments for pain relief.

Sec. 4136. Technical amendments to Medicare separate payment for disposable negative pressure wound therapy devices.

Sec. 4137. Extension of certain home health rural add-on payments.

Sec. 4138. Remedying election revocations relating to administration of COVID–19 vaccines.

Sec. 4139. Payment rates for durable medical equipment under the Medicare Program.

Sec. 4140. Extending Acute Hospital Care at Home waivers and flexibilities.

Sec. 4141. Extension of pass-through status under the Medicare program for certain devices impacted by COVID–19.

Sec. 4142. Increasing transparency for home health payments under the Medicare program.

Sec. 4143. Waiver of cap on annual payments for nursing and allied health education payments.

Subtitle E— Health Care Tax Provisions

Sec. 4151. Extension of safe harbor for absence of deductible for telehealth.

Subtitle F— Offsets

Sec. 4161. Reduction of Medicare Improvement Fund.

Sec. 4162. Extension of adjustment to calculation of hospice cap amount under Medicare.

Sec. 4163. Medicare direct spending reductions.

TITLE V— MEDICAID AND CHIP PROVISIONS

Subtitle A— Territories

Sec. 5101. Medicaid adjustments for the territories.

Subtitle B— Medicaid and CHIP Coverage

Sec. 5111. Funding extension of the Children’s Health Insurance Program and related provisions.

Sec. 5112. Continuous eligibility for children under Medicaid and CHIP.

Sec. 5113. Modifications to postpartum coverage under Medicaid and CHIP.

Sec. 5114. Extension of Money Follows the Person Rebalancing demonstration.

Sec. 5115. Extension of Medicaid protections against spousal impoverishment for recipients of home and community-based services.

Subtitle C— Medicaid and CHIP Mental Health

Sec. 5121. Medicaid and CHIP requirements for health screenings, referrals, and case management services for eligible juveniles in public institutions.

Sec. 5122. Removal of limitations on Federal financial participation for inmates who are eligible juveniles pending disposition of charges.

Sec. 5123. Requiring accurate, updated, and searchable provider directories.

Sec. 5124. Supporting access to a continuum of crisis response services under Medicaid and CHIP.

Subtitle D— Transitioning From Medicaid FMAP Increase Requirements

Sec. 5131. Transitioning from Medicaid FMAP increase requirements.

Subtitle E— Medicaid Improvement Fund

Sec. 5141. Medicaid improvement fund.

TITLE VI— HUMAN SERVICES

Sec. 6101. Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022.

Sec. 6102. Extension of Temporary Assistance for Needy Families Program.

Sec. 6103. 1-year extension of child and family services programs.

TITLE I Restoring Hope for Mental Health and Well-Being

SEC. 1001. Short Title.

This title may be cited as the “Restoring Hope for Mental Health and Well-Being Act of 2022”.

Subtitle A Mental Health and Crisis Care Needs

CHAPTER 1 Crisis Care Services and 9–8–8 Implementation

SEC. 1101. Behavioral Health Crisis Coordinating Office.

Part A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended by inserting after section 501A (42 U.S.C. 290aa–0) the following:

“SEC. 501B. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE.

“(a) In General.—The Secretary shall establish, within the Substance Abuse and Mental Health Services Administration, an office to coordinate work relating to behavioral health crisis care across the operating divisions and agencies of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration, and external stakeholders.

“(b) Duty.—The office established under subsection (a) shall—

“(1) convene Federal, State, Tribal, local, and private partners;

“(2) launch and manage Federal workgroups charged with making recommendations regarding issues related to mental health and substance use disorder crises, including with respect to health care best practices, workforce development, health disparities, data collection, technology, program oversight, public awareness, and engagement; and

“(3) support technical assistance, data analysis, and evaluation functions in order to assist States, localities, Territories, Indian Tribes, and Tribal organizations in developing crisis care systems and identifying best practices with the objective of expanding the capacity of, and access to, local crisis call centers, mobile crisis care, crisis stabilization, psychiatric emergency services, and rapid post-crisis follow-up care provided by—

“(A) the National Suicide Prevention and Mental Health Crisis Hotline and Response System;

“(B) the Veterans Crisis Line;

“(C) community mental health centers (as defined in section 1861(ff)(3)(B) of the Social Security Act);

“(D) certified community behavioral health clinics, as described in section 223 of the Protecting Access to Medicare Act of 2014; and

“(E) other community mental health and substance use disorder providers.

“(c) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2023 through 2027.”

SEC. 1102. Crisis Response Continuum of Care.

(a)
In General.— The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, shall facilitate the identification and publication of best practices for a crisis response continuum of care related to mental health and substance use disorders for use by health care providers, crisis services administrators, and crisis services providers in responding to individuals (including children and adolescents) experiencing mental health crises, substance-related crises, and crises arising from co-occurring disorders.
(b)
Best Practices.—
(1)
In general.— The best practices published under subsection (a) shall, as appropriate, address best practices related to crisis response services for the range of entities that furnish such services, taking into consideration such services that—
(A)
do not require prior authorization from an insurance provider or group health plan nor a referral from a health care provider prior to the delivery of services;
(B)
provide for serving all individuals regardless of age or ability to pay;
(C)
provide for operating 24 hours a day, 7 days a week;
(D)
provide for care and support through resources described in paragraph (2)(A) until the individual has been stabilized or transferred to the next level of crisis care; and
(E)
address psychiatric stabilization, including for—
(i)
individuals screened over the phone, text, and chat; and
(ii)
individuals stabilized on the scene by mobile teams.
(2)
Identification of functions.— The best practices published under subsection (a) shall consider the functions of the range of services in the crisis response continuum, including the following:
(A)
Identification of resources for referral and enrollment in continuing mental health, substance use, or other human services relevant for the individual in crisis where necessary.
(B)
A description of access and entry points to services within the crisis response continuum.
(C)
Identification, as appropriate and consistent with State laws, of any protocols and agreements for the transfer and receipt of individuals to and from other segments of the crisis response continuum segments as needed, and from outside referrals, including health care providers, first responders (including law enforcement, paramedics, and firefighters), education institutions, and community-based organizations.
(D)
Description of the qualifications of the range of crisis services staff, including roles for physicians, licensed clinicians, case managers, and peers (in accordance with State licensing requirements or requirements applicable to Tribal health professionals).
(E)
The convening of collaborative meetings of relevant crisis response system partners, such as crisis response service providers, first responders (including law enforcement, paramedics, and firefighters), and community partners (including the National Suicide Prevention Lifeline or 9–8–8 call centers, 9–1–1 public service answering points, and local mental health and substance use disorder treatment providers), operating in a common region for the discussion of case management, best practices, and general performance improvement.
(3)
Service capacity and quality best practices.— The best practices under subsection (a) may include recommendations on—
(A)
the volume of services to meet population need;
(B)
appropriate timely response; and
(C)
capacity to meet the needs of different patient populations that may experience a mental health or substance use crisis, including children, families, and all age groups, racial and ethnic minorities, veterans, individuals with co-occurring mental health and substance use disorders, individuals with disabilities, and individuals with chronic illness.
(4)
Implementation timeframe.— The Secretary shall—
(A)
not later than 1 year after the date of enactment of this section, publish and maintain the best practices required by subsection (a); and
(B)
after 3 years, facilitate the identification of any updates to such best practices, as appropriate.
(5)
Evaluations.— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an assessment of relevant programs related to mental health and substance use disorder crises authorized under title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) in order to assess the extent to which such programs meet objectives and performance metrics, as determined by the Secretary. Such evaluation may, as appropriate, include data on—
(A)
the type and variety of services provided when responding to mental health and substance use-related crises;
(B)
the impact on emergency department facility use and length of stay, including for patients who require further psychiatric care;
(C)
the impact on access to crisis care centers and crisis bed services;
(D)
the impact on linkage to appropriate post-crisis care; and
(E)
the use of best practices and recommendations identified under this section.

SEC. 1103. Suicide Prevention Lifeline Improvement.

(a)
Suicide Prevention Lifeline.—
(1)
Activities.— Section 520E–3(b) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)) is amended—
(A)
in paragraph (1)—
(i)
by inserting “ supporting and” before “ coordinating”; and
(ii)
by striking “ crisis intervention services” and inserting “ mental health crisis intervention services, including appropriate follow-up services,”;
(B)
in paragraph (2), by striking “ and” at the end;
(C)
in paragraph (3), by striking the period at the end and inserting a semicolon; and
(D)
by adding at the end the following:

“(4) improving awareness of the program for suicide prevention and mental health crisis intervention services, including by conducting an awareness initiative and ongoing outreach to the public; and

“(5) improving the collection and analysis of demographic information, in a manner that protects personal privacy, consistent with applicable Federal and State privacy laws, in order to understand disparities in access to the program among individuals who are seeking help.”

(2)
Plan.— Section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c) is further amended—
(A)
by redesignating subsection (c) as subsection (f); and
(B)
by inserting after subsection (b) the following:

“(c) Plan.—

“(1) In general.—For purposes of supporting the crisis centers under subsection (b)(1) and maintaining the suicide prevention hotline under subsection (b)(2), the Secretary shall develop and implement a plan to ensure the provision of high-quality services.

“(2) Contents.—The plan required by paragraph (1) shall include the following:

“(A) Program evaluation, including performance measures to assess progress toward the goals and objectives of the program and to improve the responsiveness and performance of the hotline, including at all backup call centers.

“(B) Requirements that crisis centers and backup centers must meet—

“(i) to participate in the network under subsection (b)(1); and

“(ii) to ensure that each telephone call and applicable other communication received by the hotline, including at backup call centers, is answered in a timely manner, consistent with evidence-based guidance or other guidance or best practices, as appropriate.

“(C) Specific recommendations and strategies for implementing evidence-based practices, including with respect to followup and communicating the availability of resources in the community for individuals in need.

“(D) Criteria for carrying out periodic testing of the hotline during each fiscal year, including at crisis centers and backup centers, to identify and address any problems in a timely manner.

“(3) Consultation.—In developing requirements under paragraph (2)(B), the Secretary shall consult with State departments of health, local governments, Indian Tribes, and Tribal organizations.

“(4) Initial plan; updates.—The Secretary shall—

“(A) not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, complete development of the initial plan under paragraph (1) and make such plan publicly available; and

“(B) periodically thereafter, update such plan and make the updated plan publicly available.”

(3)
Transmission of data to cdc and to assist state and local agencies.— Section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c) is amended by inserting after subsection (c), as added by paragraph (2), the following:

“(d) Improving Epidemiological Data.—The Secretary shall, as appropriate, formalize and strengthen agreements between the Suicide Prevention Lifeline program and the Centers for Disease Control and Prevention with respect to the secure sharing of de-identified epidemiological data. Such agreements shall include appropriate privacy and security protections that meet the requirements of applicable Federal law, at a minimum.

“(e) Data to Assist State and Local Suicide Prevention Activities.—The Secretary shall ensure that the aggregated information collected and any applicable analyses conducted under subsection (b)(5), including from local call centers, as applicable, are made available in a usable format to State and local agencies in order to inform suicide prevention activities.”

(4)
Authorization of appropriations.— Subsection (f) of section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c), as redesignated by paragraph (2), is amended to read as follows:

“(f) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated $101,621,000 for each of fiscal years 2023 through 2027.”

(b)
Pilot Program on Innovative Technologies.—
(1)
In general.— The Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall, as appropriate, carry out a pilot program to research, analyze, and employ various technologies and platforms of communication (including social media platforms, texting platforms, and email platforms) for suicide prevention in addition to the telephone and online chat service provided by the Suicide Prevention Lifeline.
(2)
Report.— Not later than 24 months after the date on which the pilot program under paragraph (1) commences, the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall submit to the Congress a report on the pilot program. With respect to each platform of communication employed pursuant to the pilot program, the report shall include—
(A)
a full description of the program;
(B)
the number of individuals served by the program;
(C)
the average wait time for each individual to receive a response;
(D)
the cost of the program, including the cost per individual served; and
(E)
any other information the Secretary determines appropriate.
(c)
HHS Study and Report.— Not later than 2 years after the Secretary of Health and Human Services completes development of the plan under section 520E–3(c) of the Public Health Service Act, as added by subsection (a)(2)(B), the Secretary shall—
(1)
complete a study on—
(A)
the implementation of such plan, including the progress towards meeting the goals and objectives identified pursuant to paragraph (2)(A) of such section 520E–3(c); and
(B)
in consultation with the Director of the Centers for Disease Control and Prevention, options to improve data regarding usage of the Suicide Prevention Lifeline, such as repeat calls, consistent with applicable Federal and State privacy laws; and
(2)
submit a report to Congress on the progress made on meeting the goals and objectives identified pursuant to paragraph (2)(A) of such section 520E–3(c) and recommendations on improving the program, including improvements to enhance data collection and usage.
(d)
GAO Study and Report.—
(1)
In general.— Not later than 2 years after the Secretary of Health and Human Services begins implementation of the plan required by section 520E–3(c) of the Public Health Service Act, as added by subsection (a)(2)(B), the Comptroller General of the United States shall—
(A)
complete a study on the Suicide Prevention Lifeline; and
(B)
submit a report to the Congress on the results of such study.
(2)
Content.— The study required by paragraph (1) shall include what is known about—
(A)
the feasibility of routing calls to the Suicide Prevention Lifeline to the nearest crisis center based on the physical location of the contact;
(B)
capacity of the Suicide Prevention Lifeline;
(C)
State and regional variation with respect to access to crisis centers described in section 520E–3(b)(1) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)(1)), including wait times, answer times, hours of operation, and funding sources;
(D)
the implementation of the plan under section 520E–3(c) of the Public Health Service Act, as added by subsection (a)(2)(B), including the progress toward meeting the goals and objectives in such plan; and
(E)
the capacity of the Suicide Prevention Lifeline to handle calls from individuals with limited English proficiency.
(3)
Recommendations.— The report required by paragraph (1) shall include recommendations for improving the Suicide Prevention Lifeline, including recommendations for administrative actions.
(e)
Definition.— In this section, the term “Suicide Prevention Lifeline” means the suicide prevention hotline maintained pursuant to section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c).

CHAPTER 2 Into the Light for Maternal Mental Health and Substance Use Disorders

SEC. 1111. Screening and Treatment for Maternal Mental Health and Substance Use Disorders.

(a)
In General.— Section 317L–1 of the Public Health Service Act (42 U.S.C. 247b–13a) is amended—
(1)
in the section heading, by striking “ maternal depression” and inserting “ maternal mental health and substance use disorders”; and
(2)
in subsection (a)—
(A)
by inserting “ , Indian Tribes and Tribal organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act)” after “ States”; and
(B)
by striking “ for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression” and inserting “ for women who are postpartum, pregnant, or have given birth within the preceding 12 months, for maternal mental health and substance use disorders”.
(b)
Application.— Subsection (b) of section 317L–1 of the Public Health Service Act (42 U.S.C. 247b–13a) is amended—
(1)
by striking “ a State shall submit” and inserting “ an entity listed in subsection (a) shall submit”; and
(2)
in paragraphs (1) and (2), by striking “ maternal depression” each place it appears and inserting “ maternal mental health and substance use disorders”.
(c)
Priority.— Subsection (c) of section 317L–1 of the Public Health Service Act (42 U.S.C. 247b–13a) is amended—
(1)
by striking “ may give priority to States proposing to improve or enhance access to screening” and inserting the following:

“(1) are proposing to create, improve, or enhance screening, prevention, and treatment”

(2)
by striking “ maternal depression” and inserting “ maternal mental health and substance use disorders”;
(3)
by striking the period at the end of paragraph (1), as so designated, and inserting a semicolon; and
(4)
by inserting after such paragraph (1) the following:

“(2) are currently partnered with, or will partner with, one or more community-based organizations to address maternal mental health and substance use disorders;

“(3) are located in, or provide services under this section in, an area with disproportionately high rates of maternal mental health or substance use disorders or other related disparities; and

“(4) operate in a health professional shortage area designated under section 332, including maternity care health professional target areas.”

(d)
Use of Funds.— Subsection (d) of section 317L–1 of the Public Health Service Act (42 U.S.C. 247b–13a) is amended—
(1)
in paragraph (1)—
(A)
in subparagraph (A), by striking “ to health care providers; and” and inserting “ on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers), and referrals for treatment to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals;”;
(B)
in subparagraph (B), by striking “ to health care providers, including information on maternal depression screening, treatment, and followup support services, and linkages to community-based resources; and” and inserting “ on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers) and referrals for treatment, follow-up support services, and linkages to community-based resources to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals; and”; and
(C)
by adding at the end the following:

“(C) to the extent practicable and appropriate, enabling health care providers (such as obstetrician-gynecologists, nurse practitioners, nurse midwives, pediatricians, psychiatrists, mental and other behavioral health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in-person or remotely), including through the use of technology-enabled collaborative learning and capacity building models (as defined in section 330N), to aid in the treatment of pregnant and postpartum women; and”

; and

(2)
in paragraph (2)—
(A)
by striking subparagraph (A);
(B)
by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively;
(C)
in subparagraph (A), as so redesignated, by striking “ and” at the end;
(D)
in subparagraph (B), as so redesignated—
(i)
by inserting “ , including” before “ for rural areas”; and
(ii)
by striking the period at the end and inserting a semicolon; and
(E)
by inserting after subparagraph (B), as so redesignated, the following:

“(C) providing assistance to pregnant and postpartum women to receive maternal mental health and substance use disorder treatment, including patient consultation, care coordination, and navigation for such treatment;

“(D) coordinating, as appropriate, with maternal and child health programs of State, local, and Tribal governments, including child psychiatric access programs;

“(E) conducting public outreach and awareness regarding grants under subsection (a);

“(F) creating multistate consortia to carry out the activities required or authorized under this subsection; and

“(G) training health care providers in the primary care setting and relevant health paraprofessionals on trauma-informed care, culturally and linguistically appropriate services, and best practices related to training to improve the provision of maternal mental health and substance use disorder care for racial and ethnic minority populations and reduce related disparities in the delivery of such care.”

(e)
Additional Provisions.— Section 317L–1 of the Public Health Service Act (42 U.S.C. 247b–13a) is amended—
(1)
by redesignating subsection (e) as subsection (h); and
(2)
by inserting after subsection (d) the following:

“(e) Technical Assistance.—The Secretary shall provide technical assistance to grantees and entities listed in subsection (a) for carrying out activities pursuant to this section.

“(f) Dissemination of Best Practices.—The Secretary, based on evaluation of the activities funded pursuant to this section, shall identify and disseminate evidence-based or evidence-informed practices for screening, assessment, treatment, and referral to treatment services for maternal mental health and substance use disorders, including culturally and linguistically appropriate services, for women during pregnancy and 12 months following pregnancy.

“(g) Matching Requirement.—The Federal share of the cost of the activities for which a grant is made to an entity under subsection (a) shall not exceed 90 percent of the total cost of such activities.”

(f)
Authorization of Appropriations.— Subsection (h) of section 317L–1 (42 U.S.C. 247b–13a) of the Public Health Service Act, as redesignated by subsection (e), is amended—
(1)
by striking “ $5,000,000” and inserting “ $24,000,000”; and
(2)
by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

SEC. 1112. Maternal Mental Health Hotline.

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

“SEC. 399V–7. MATERNAL MENTAL HEALTH HOTLINE.

“(a) In General.—The Secretary shall maintain, by grant or contract, a national maternal mental health hotline to provide emotional support, information, brief intervention, and mental health and substance use disorder resources to pregnant and postpartum women at risk of, or affected by, maternal mental health and substance use disorders, and to their families or household members.

“(b) Requirements for Hotline.—The hotline under subsection (a) shall—

“(1) be a 24/7 real-time hotline;

“(2) provide voice and text support;

“(3) be staffed by certified peer specialists, licensed health care professionals, or licensed mental health professionals who are trained on—

“(A) maternal mental health and substance use disorder prevention, identification, and intervention; and

“(B) providing culturally and linguistically appropriate support; and

“(4) provide maternal mental health and substance use disorder assistance and referral services to meet the needs of underserved populations, individuals with disabilities, and family and household members of pregnant or postpartum women at risk of experiencing maternal mental health and substance use disorders.

“(c) Additional Requirements.—In maintaining the hotline under subsection (a), the Secretary shall—

“(1) consult with the Domestic Violence Hotline, National Suicide Prevention Lifeline, and Veterans Crisis Line to ensure that pregnant and postpartum women are connected in real-time to the appropriate specialized hotline service, when applicable;

“(2) conduct a public awareness campaign for the hotline;

“(3) consult with Federal departments and agencies, including the Substance Abuse and Mental Health Services Administration and the Department of Veterans Affairs, to increase awareness regarding the hotline; and

“(4) consult with appropriate State, local, and Tribal public health officials, including officials who administer programs that serve low-income pregnant and postpartum individuals.

“(d) Annual Report.—The Secretary shall submit an annual report to the Congress on the hotline under subsection (a) and implementation of this section, including—

“(1) an evaluation of the effectiveness of activities conducted or supported under subsection (a);

“(2) a directory of entities or organizations to which staff maintaining the hotline funded under this section may make referrals; and

“(3) such additional information as the Secretary determines appropriate.

“(e) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2023 through 2027.”

SEC. 1113. Task Force on Maternal Mental Health.

(a)
Establishment.— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, for purposes of identifying, evaluating, and making recommendations to coordinate and improve Federal activities related to addressing maternal mental health conditions, shall—
(1)
establish a task force to be known as the Task Force on Maternal Mental Health (in this section referred to as the “Task Force”); or
(2)
incorporate the duties, public meetings, and reports specified in subsections (c) through (f) into existing relevant Federal committees or working groups, such as the Maternal Health Interagency Policy Committee and the Maternal Health Working Group, as appropriate.
(b)
Membership.—
(1)
Composition.— The Task Force shall be composed of—
(A)
the Federal members under paragraph (2); and
(B)
the non-Federal members under paragraph (3).
(2)
Federal members.— The Federal members of the Task Force shall consist of the following heads of Federal departments and agencies (or their designees):
(A)
The Assistant Secretary for Health of the Department of Health and Human Services and the Assistant Secretary for Mental Health and Substance Use, who shall serve as co-chairs.
(B)
The Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services.
(C)
The Assistant Secretary of the Administration for Children and Families.
(D)
The Director of the Centers for Disease Control and Prevention.
(E)
The Administrator of the Centers for Medicare & Medicaid Services.
(F)
The Administrator of the Health Resources and Services Administration.
(G)
The Director of the Indian Health Service.
(H)
Such other Federal departments and agencies as the Secretary determines appropriate that serve individuals with maternal mental health conditions.
(3)
Non-federal members.— The non-Federal members of the Task Force shall—
(A)
compose not more than one-half, and not less than one-third, of the total membership of the Task Force;
(B)
be appointed by the Secretary; and
(C)
include—
(i)
representatives of professional medical societies, professional nursing societies, and relevant health paraprofessional societies with expertise in maternal or mental health;
(ii)
representatives of nonprofit organizations with expertise in maternal or mental health;
(iii)
relevant industry representatives; and
(iv)
other representatives, as appropriate.
(4)
Deadline for designating designees.— If the Assistant Secretary for Health, the Assistant Secretary for Mental Health and Substance Use, or the head of a Federal department or agency serving as a member of the Task Force under paragraph (2), chooses to be represented on the Task Force by a designee, the Assistant Secretary for Health, the Assistant Secretary for Mental Health and Substance Use, or department or agency head shall designate such designee not later than 90 days after the date of the enactment of this section.
(c)
Duties.— The Task Force shall—
(1)
prepare and regularly update a report that analyzes and evaluates the state of maternal mental health programs at the Federal level, and identifies best practices with respect to maternal mental health (which may include co-occurring substance use disorders), including—
(A)
a set of evidence-based, evidence-informed, and promising practices with respect to—
(i)
prevention strategies for maternal mental health conditions, including strategies and recommendations to reduce racial, ethnic, geographic, and other health disparities;
(ii)
the identification, screening, diagnosis, intervention, and treatment of maternal mental health conditions and affected families;
(iii)
the timely referral to supports, and implementation of practices, that prevent and mitigate the effects of a maternal mental health condition, including strategies and recommendations to eliminate racial and ethnic disparities that exist in maternal mental health; and
(iv)
community-based or multigenerational practices that provide support related to maternal mental health conditions, including support for affected families; and
(B)
Federal and State programs and activities that support prevention, screening, diagnosis, intervention, and treatment of maternal mental health conditions;
(2)
develop and regularly update a national strategy for maternal mental health, taking into consideration the findings of the report under paragraph (1), on how the Task Force and Federal departments and agencies represented on the Task Force may prioritize options for, and may improve coordination with respect to, addressing maternal mental health conditions, including by—
(A)
increasing prevention, screening, diagnosis, intervention, treatment, and access to maternal mental health care, including clinical and nonclinical care such as peer-support and community health workers, through the public and private sectors;
(B)
providing support relating to the prevention, screening, diagnosis, intervention, and treatment of maternal mental health conditions, including families, as appropriate;
(C)
reducing racial, ethnic, geographic, and other health disparities related to prevention, diagnosis, intervention, treatment, and access to maternal mental health care;
(D)
identifying opportunities to modify, strengthen, and better coordinate existing Federal infant and maternal health programs in order to improve screening, diagnosis, research, prevention, identification, intervention, and treatment with respect to maternal mental health; and
(E)
improving planning, coordination, and collaboration across Federal departments, agencies, offices, and programs;
(3)
solicit public comments, as appropriate, from stakeholders for the report under paragraph (1) and the national strategy under paragraph (2) in order to inform the activities and reports of the Task Force; and
(4)
consider the latest research related to maternal mental health in developing the strategy, including, as applicable and appropriate, data and information disaggregated by relevant factors, such as race, ethnicity, geographical location, age, socioeconomic level, and others, as appropriate.
(d)
Meetings.— The Task Force shall—
(1)
meet not less than two times each year; and
(2)
convene public meetings, as appropriate, to fulfill its duties under this section.
(e)
Reports to Public and Federal Leaders.— The Task Force shall make publicly available and submit to the heads of relevant Federal departments and agencies, the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and other relevant congressional committees, the following:
(1)
Not later than 1 year after the first meeting of the Task Force, an initial report under subsection (c)(1).
(2)
Not later than 2 years after the first meeting of the Task Force, an initial national strategy under subsection (c)(2).
(3)
Each year thereafter—
(A)
an updated report under subsection (c)(1);
(B)
an updated national strategy under subsection (c)(2); or
(C)
if no update is made under subsection (c)(1) or (c)(2), a report summarizing the activities of the Task Force.
(f)
Reports to Governors.— Upon finalizing the initial national strategy under subsection (c)(2), and upon making relevant updates to such strategy, the Task Force shall submit a report to the Governors of all States describing any opportunities for local- and State-level partnerships identified under subsection (c)(2).
(g)
Sunset.— The Task Force shall terminate on September 30, 2027.
(h)
Nonduplication of Federal Efforts.— The Secretary may relieve the Task Force, in carrying out subsections (c) through (f), from responsibility for carrying out such activities as may be specified by the Secretary as duplicative of other activities carried out by the Department of Health and Human Services.

SEC. 1114. Residential Treatment Program for Pregnant and Postpartum Women Pilot Program Reauthorization.

Section 508(r) of the Public Health Service Act (42 U.S.C. 290bb–1(r)) is amended—
(1)
by striking paragraph (4);
(2)
by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; and
(3)
in paragraph (4)(B), as so redesignated—
(A)
in the matter preceding clause (i), by striking “ The Director” and inserting “ Not later than September 30, 2026, the Director”; and
(B)
by striking “ the relevant committees of jurisdiction of the House of Representatives and the Senate” and inserting “ the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives”.

CHAPTER 3 Reaching Improved Mental Health Outcomes for Patients

SEC. 1121. Innovation for Mental Health.

(a)
National Mental Health and Substance Use Policy Laboratory.— Section 501A of the Public Health Service Act (42 U.S.C. 290aa–0) is amended—
(1)
in subsection (e)(1), by striking “ Indian tribes or tribal organizations” and inserting “ Indian Tribes or Tribal organizations”;
(2)
by striking subsection (e)(3); and
(3)
by adding at the end the following:

“(f) Authorization of Appropriations.—To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2023 through 2027.”

(b)
GAO Study.— Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare a report on the work of the National Mental Health and Substance Use Policy Laboratory established under section 501A of the Public Health Service Act (42 U.S.C. 290aa–0), including—
(1)
the extent to which such Laboratory is meeting its responsibilities as set forth in such section 501A; and
(2)
any recommendations for improvement, including methods to expand the use of evidence-based practices across programs, recommendations to improve program evaluations for effectiveness, and dissemination of resources to stakeholders and the public.
(c)
Interdepartmental Serious Mental Illness Coordinating Committee.—
(1)
In general.— Part A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section 1101, is further amended by inserting after section 501B, as added by such section 1101, the following:

“SEC. 501C. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING COMMITTEE.

“(a) Establishment.—

“(1) In general.—The Secretary, or the designee of the Secretary, shall establish a committee to be known as the Interdepartmental Serious Mental Illness Coordinating Committee (in this section referred to as the ‘Committee’).

“(2) Federal advisory committee act.—Except as provided in this section, the provisions of the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee.

“(b) Meetings.—The Committee shall meet not fewer than 2 times each year.

“(c) Responsibilities.—Not later than each of 1 year and 5 years after the date of enactment of this section, the Committee shall submit to Congress and any other relevant Federal department or agency a report including—

“(1) a summary of advances in serious mental illness and serious emotional disturbance research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of serious mental illnesses, serious emotional disturbances, and advances in access to services and support for adults with a serious mental illness or children with a serious emotional disturbance;

“(2) an evaluation of the effect Federal programs related to serious mental illness have on public health, including outcomes such as—

“(A) rates of suicide, suicide attempts, incidence and prevalence of serious mental illnesses, serious emotional disturbances, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency department boarding, preventable emergency department visits, interaction with the criminal justice system, homelessness, and unemployment;

“(B) increased rates of employment and enrollment in educational and vocational programs;

“(C) quality of mental and substance use disorders treatment services; or

“(D) any other criteria as may be determined by the Secretary; and

“(3) specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with a serious mental illness or children with a serious emotional disturbance.

“(d) Membership.—

“(1) Federal members.—The Committee shall be composed of the following Federal representatives, or the designees of such representatives—

“(A) the Secretary of Health and Human Services, who shall serve as the Chair of the Committee;

“(B) the Assistant Secretary for Mental Health and Substance Use;

“(C) the Attorney General;

“(D) the Secretary of Veterans Affairs;

“(E) the Secretary of Defense;

“(F) the Secretary of Housing and Urban Development;

“(G) the Secretary of Education;

“(H) the Secretary of Labor;

“(I) the Administrator of the Centers for Medicare & Medicaid Services;

“(J) the Administrator of the Administration for Community Living; and

“(K) the Commissioner of Social Security.

“(2) Non-federal members.—The Committee shall also include not less than 14 non-Federal public members appointed by the Secretary of Health and Human Services, of which—

“(A) at least 2 members shall be an individual who has received treatment for a diagnosis of a serious mental illness;

“(B) at least 1 member shall be a parent or legal guardian of an adult with a history of a serious mental illness or a child with a history of a serious emotional disturbance;

“(C) at least 1 member shall be a representative of a leading research, advocacy, or service organization for adults with a serious mental illness;

“(D) at least 2 members shall be—

“(i) a licensed psychiatrist with experience in treating serious mental illnesses;

“(ii) a licensed psychologist with experience in treating serious mental illnesses or serious emotional disturbances;

“(iii) a licensed clinical social worker with experience treating serious mental illnesses or serious emotional disturbances; or

“(iv) a licensed psychiatric nurse, nurse practitioner, or physician assistant with experience in treating serious mental illnesses or serious emotional disturbances;

“(E) at least 1 member shall be a licensed mental health professional with a specialty in treating children and adolescents with a serious emotional disturbance;

“(F) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with minorities;

“(G) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with medically underserved populations;

“(H) at least 1 member shall be a State certified mental health peer support specialist;

“(I) at least 1 member shall be a judge with experience in adjudicating cases related to criminal justice or serious mental illness;

“(J) at least 1 member shall be a law enforcement officer or corrections officer with extensive experience in interfacing with adults with a serious mental illness, children with a serious emotional disturbance, or individuals in a mental health crisis; and

“(K) at least 1 member shall have experience providing services for homeless individuals and working with adults with a serious mental illness, children with a serious emotional disturbance, or individuals in a mental health crisis.

“(3) Terms.—A member of the Committee appointed under paragraph (2) shall serve for a term of 3 years, and may be reappointed for 1 or more additional 3-year terms. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has been appointed.

“(e) Working Groups.—In carrying out its functions, the Committee may establish working groups. Such working groups shall be composed of Committee members, or their designees, and may hold such meetings as are necessary.

“(f) Sunset.—The Committee shall terminate on September 30, 2027.”

(2)
Conforming amendments.—
(A)
Section 501(l)(2) of the Public Health Service Act (42 U.S.C. 290aa(l)(2)) is amended by striking “ section 6031 of such Act” and inserting “ section 501C”.
(B)
The Helping Families in Mental Health Crisis Reform Act of 2016 (Division B of Public Law 114–255) is amended—
(i)
by repealing section 6031; and
(ii)
by conforming the item relating to such section in the table of contents in section 1(b) of Public Law 114–255.
(d)
Priority Mental Health Needs of Regional and National Significance.— Section 520A of the Public Health Service Act (42 U.S.C. 290bb–32) is amended—
(1)
in subsection (a), by striking “ Indian tribes or tribal organizations” and inserting “ Indian Tribes or Tribal organizations”; and
(2)
in subsection (f), by striking “ $394,550,000 for each of fiscal years 2018 through 2022” and inserting “ $599,036,000 for each of fiscal years 2023 through 2027”.

SEC. 1122. Crisis Care Coordination.

(a)
Strengthening Community Crisis Response Systems.— Section 520F of the Public Health Service Act (42 U.S.C. 290bb–37) is amended to read as follows:

“SEC. 520F. MENTAL HEALTH CRISIS RESPONSE PARTNERSHIP PILOT PROGRAM.

“(a) In General.—The Secretary shall establish a pilot program under which the Secretary will award competitive grants to States, localities, territories, Indian Tribes, and Tribal organizations to establish new, or enhance existing, mobile crisis response teams that divert the response for mental health and substance use disorder crises from law enforcement to mobile crisis teams, as described in subsection (b).

“(b) Mobile Crisis Teams Described.—A mobile crisis team, for purposes of this section, is a team of individuals—

“(1) that is available to respond to individuals in mental health and substance use disorder crises and provide immediate stabilization, referrals to community-based mental health and substance use disorder services and supports, and triage to a higher level of care if medically necessary;

“(2) which may include licensed counselors, clinical social workers, physicians, paramedics, crisis workers, peer support specialists, or other qualified individuals; and

“(3) which may provide support to divert mental health and substance use disorder crisis calls from the 9–1–1 system to the 9–8–8 system.

“(c) Priority.—In awarding grants under this section, the Secretary shall prioritize applications which account for the specific needs of the communities to be served, including children and families, veterans, rural and underserved populations, and other groups at increased risk of death from suicide or overdose.

“(d) Report.—

“(1) Initial report.—Not later than September 30, 2024, the Secretary shall submit to Congress a report on steps taken by States, localities, territories, Indian Tribes, and Tribal organizations prior to the date of enactment of this section to strengthen the partnerships among mental health providers, substance use disorder treatment providers, primary care physicians, mental health and substance use disorder crisis teams, paramedics, law enforcement officers, and other first responders.

“(2) Progress reports.—Not later than one year after the date on which the first grant is awarded to carry out this section, and for each year thereafter, the Secretary shall submit to Congress a report on the grants made during the year covered by the report, which shall include—

“(A) impact data on the teams and people served by such programs, including demographic information of individuals served, volume, and types of service utilization;

“(B) outcomes of the number of linkages made to community-based resources or short-term crisis receiving and stabilization facilities, as applicable, and diversion from law enforcement or hospital emergency department settings;

“(C) data consistent with the State block grant requirements for continuous evaluation and quality improvement, and other relevant data as determined by the Secretary;

“(D) identification and, where appropriate, recommendations of best practices from States and localities providing mobile crisis response and stabilization services for youth and adults; and

“(E) identification of any opportunities for improvements to the program established under this section.

“(e) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2023 through 2027.”

(b)
Mental Health Awareness Training Grants.—
(1)
In general.— Section 520J(b) of the Public Health Service Act (42 U.S.C. 290bb–41(b)) is amended—
(A)
in paragraph (1), by striking “ Indian tribes, tribal organizations” and inserting “ Indian Tribes, Tribal organizations”;
(B)
in paragraph (4), by striking “ Indian tribe, tribal organization” and inserting “ Indian Tribe, Tribal organization”;
(C)
in paragraph (5)—
(i)
by striking “ Indian tribe, tribal organization” and inserting “ Indian Tribe, Tribal organization”;
(ii)
in subparagraph (A), by striking “ and” at the end;
(iii)
in subparagraph (B)(ii), by striking the period at the end and inserting “ ; and”; and
(iv)
by adding at the end the following:

“(C) suicide intervention and prevention.”

(D)
in paragraph (6), by striking “ Indian tribe, tribal organization” and inserting “ Indian Tribe, Tribal organization”;
(E)
by redesignating paragraph (7) as paragraph (8);
(F)
by inserting after paragraph (6) the following:

“(7) Technical assistance.—The Secretary may provide technical assistance to grantees in carrying out this section, which may include assistance with—

“(A) program evaluation and related activities, including related data collection and reporting;

“(B) implementing and disseminating evidence-based practices and programs; and

“(C) facilitating collaboration among grantees.”

; and

(G)
in paragraph (8), as so redesignated, by striking “ $14,693,000 for each of fiscal years 2018 through 2022” and inserting “ $24,963,000 for each of fiscal years 2023 through 2027”.
(2)
Technical corrections.— Section 520J(b) of the Public Health Service Act (42 U.S.C. 290bb–41(b)) is amended—
(A)
in the heading of paragraph (2), by striking “ Emergency Services Personnel” and inserting “ Emergency services personnel”; and
(B)
in the heading of paragraph (3), by striking “ Distribution of Awards” and inserting “ Distribution of awards”.
(c)
Adult Suicide Prevention.— Section 520L of the Public Health Service Act (42 U.S.C. 290bb–43) is amended—
(1)
in subsection (a)—
(A)
in paragraph (1)—
(i)
by striking “ individuals who are 25 years of age or older” and inserting “ adult individuals”; and
(ii)
by inserting “ prevention” after “ raise awareness of suicide”; and
(B)
in paragraph (2)—
(i)
by striking “ Indian tribe” each place it appears and inserting “ Indian Tribe”; and
(ii)
by striking “ tribal organization” each place it appears and inserting “ Tribal organization”; and
(C)
by amending paragraph (3)(C) to read as follows:

“(C) Raising awareness of suicide prevention resources and promoting help seeking among those at risk for suicide.”

(2)
in subsection (b)—
(A)
in paragraph (1), by striking “ ; and” and inserting a semicolon;
(B)
in paragraph (2), by striking the period at the end and inserting “ ; and”; and
(C)
by adding at the end the following:

“(3) identify best practices, as applicable, to improve the identification, assessment, treatment, and timely transition, as appropriate, to additional or follow-up care for individuals in emergency departments who are at risk for suicide and enhance the coordination of care for such individuals during and after discharge, in support of activities under subsection (a).”

; and

(3)
in subsection (d), by striking “ $30,000,000 for the period of fiscal years 2018 through 2022” and inserting “ $30,000,000 for each of fiscal years 2023 through 2027”.

SEC. 1123. Treatment of Serious Mental Illness.

(a)
Assertive Community Treatment Grant Program.—
(1)
Technical amendment.— Section 520M(b) of the Public Health Service Act (42 U.S.C. 290bb–44(b)) is amended by striking “ Indian tribe or tribal organization” and inserting “ Indian Tribe or Tribal organization”.
(2)
Report to congress.— Section 520M(d)(1) of the Public Health Service Act (42 U.S.C. 290bb–44(d)(1)) is amended—
(A)
by striking “ not later than the end of fiscal year 2021” and inserting “ not later than the end of fiscal year 2026”; and
(B)
by striking “ appropriate congressional committees” and inserting “ Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives”.
(3)
Authorization of appropriations.— Section 520M(e)(1) of the Public Health Service Act (42 U.S.C. 290bb–44(d)(1)) is amended by striking “ $5,000,000 for the period of fiscal years 2018 through 2022” and inserting “ $9,000,000 for each of fiscal years 2023 through 2027”.
(b)
Assisted Outpatient Treatment.—
(1)
In general.— Section 224 of the Protecting Access to Medicare Act of 2014 (Public Law 113–93; 42 U.S.C. 290aa note) is amended—
(A)
in subsection (a), by striking “ 4-year pilot”;
(B)
in subsection (e), in the matter preceding paragraph (1)—
(i)
by striking “ each of fiscal years 2016, 2017, 2018, 2019, 2020, 2021, and 2022” and inserting “ fiscal year 2023, and biennially thereafter”; and
(ii)
by striking “ appropriate congressional committees” and inserting “ Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives”;
(C)
in subsection (e), by inserting after paragraph (4) the following:

“(5) Demographic information regarding participation of those served by the grant compared to demographic information in the population of the grant recipient.”

; and

(D)
in subsection (g)—
(i)
in paragraph (1), by striking “ 2015 through 2022” and inserting “ 2023 through 2027”; and
(ii)
by amending paragraph (2) to read as follows:

“(2) Authorization of appropriations.—There is authorized to be appropriated to carry out this section $22,000,000 for each of fiscal years 2023 through 2027.”

(2)
GAO report.— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the efficacy of assisted outpatient treatment programs that received funding under section 224 of the Protecting Access to Medicare Act of 2014 (Public Law 113– 93; 42 U.S.C. 290aa note) in improving health outcomes and treatment adherence, reducing rates of incarceration, and reducing rates of homelessness. Such report shall include—
(A)
a comparison of health outcomes, treatment compliance, program participant feedback, reduced rates of incarceration, and reduced rates of homelessness as compared to other evidence- and community-based outpatient treatment programs and services, including information on geographic differences in program efficacy, as applicable; and
(B)
identification of best practices used, as applicable, in the implementation of assisted outpatient treatment programs to ensure program participants are receiving treatment in the least restrictive environment that is clinically appropriate consistent with Federal and State law, as applicable.

SEC. 1124. Study on the Costs of Serious Mental Illness.

(a)
In General.— The Secretary of Health and Human Services, in consultation with the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary for Planning and Evaluation, the Attorney General of the United States, the Secretary of Labor, and the Secretary of Housing and Urban Development, shall conduct a study on the direct and indirect costs of serious mental illness with respect to—
(1)
nongovernmental entities; and
(2)
the Federal Government and State, local, and Tribal governments.
(b)
Content.— The study under subsection (a) shall consider each of the following:
(1)
The costs to the health care system for health services, including with respect to—
(A)
office-based physician visits;
(B)
residential and inpatient treatment programs;
(C)
outpatient treatment programs;
(D)
emergency department visits;
(E)
crisis stabilization programs;
(F)
home health care;
(G)
skilled nursing and long-term care facilities;
(H)
prescription drugs and digital therapeutics; and
(I)
any other relevant health services.
(2)
The costs of homelessness, including with respect to—
(A)
homeless shelters;
(B)
street outreach activities;
(C)
crisis response center visits; and
(D)
other supportive services.
(3)
The costs of structured residential facilities and other supportive housing for residential and custodial care services.
(4)
The costs of law enforcement encounters and encounters with the criminal justice system, including with respect to—
(A)
encounters that do and do not result in an arrest;
(B)
criminal and judicial proceedings;
(C)
services provided by law enforcement and judicial staff (including public defenders, prosecutors, and private attorneys); and
(D)
incarceration.
(5)
The costs of serious mental illness on employment.
(6)
With respect to family members and caregivers, the costs of caring for an individual with a serious mental illness.
(7)
Any other relevant costs for programs and services administered by the Federal Government or State, Tribal, or local governments.
(c)
Data Disaggregation.— In conducting the study under subsection (a), the Secretary of Health and Human Services shall (to the extent feasible)—
(1)
disaggregate data by—
(A)
costs to nongovernmental entities, the Federal Government, and State, local, and Tribal governments;
(B)
types of serious mental illnesses and medical chronic diseases common in patients with a serious mental illness; and
(C)
demographic characteristics, including race, ethnicity, sex, age (including pediatric subgroups), and other characteristics determined by the Secretary; and
(2)
include an estimate of—
(A)
the total number of individuals with a serious mental illness in the United States, including in traditional and nontraditional housing; and
(B)
the percentage of such individuals in—
(i)
homeless shelters;
(ii)
penal facilities, including Federal prisons, State prisons, and county and municipal jails; and
(iii)
nursing facilities.
(d)
Report.— Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall—
(1)
submit to the Congress a report containing the results of the study conducted under this section; and
(2)
make such report publicly available.

CHAPTER 4 Anna Westin Legacy

SEC. 1131. Maintaining Education and Training on Eating Disorders.

Subpart 3 of part B of title V of the Public Health Service Act (42 U.S.C. 290bb–31 et seq.) is amended by adding at the end the following:

“SEC. 520N. CENTER OF EXCELLENCE FOR EATING DISORDERS FOR EDUCATION AND TRAINING ON EATING DISORDERS.

“(a) In General.—The Secretary, acting through the Assistant Secretary, shall maintain, by competitive grant or contract, a Center of Excellence for Eating Disorders (referred to in this section as the ‘Center’) to improve the identification of, interventions for, and treatment of eating disorders in a manner that is developmentally, culturally, and linguistically appropriate.

“(b) Subgrants and Subcontracts.—The Center shall coordinate and implement the activities under subsection (c), in whole or in part, which may include by awarding competitive subgrants or subcontracts—

“(1) across geographical regions; and

“(2) in a manner that is not duplicative.

“(c) Activities.—The Center—

“(1) shall—

“(A) provide training and technical assistance, including for—

“(i) primary care and mental health providers to carry out screening, brief intervention, and referral to treatment for individuals experiencing, or at risk for, eating disorders; and

“(ii) other paraprofessionals and relevant individuals providing nonclinical community services to identify and support individuals with, or at disproportionate risk for, eating disorders;

“(B) facilitate the development of, and provide training materials to, health care providers (including primary care and mental health professionals) regarding the effective treatment and ongoing support of individuals with eating disorders, including children and marginalized populations at disproportionate risk for eating disorders;

“(C) collaborate and coordinate, as appropriate, with other centers of excellence, technical assistance centers, and psychiatric consultation lines of the Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration regarding eating disorders;

“(D) coordinate with the Director of the Centers for Disease Control and Prevention and the Administrator of the Health Resources and Services Administration, and other Federal agencies, as appropriate, to disseminate training to primary care and mental health care providers; and

“(E) support other activities, as determined appropriate by the Secretary; and

“(2) may—

“(A) support the integration of protocols pertaining to screening, brief intervention, and referral to treatment for individuals experiencing, or at risk for, eating disorders, with health information technology systems;

“(B) develop and provide training materials to health care providers, including primary care and mental health providers, to provide screening, brief intervention, and referral to treatment for members of the military and veterans experiencing, or at risk for, eating disorders; and

“(C) consult, as appropriate, with the Secretary of Defense and the Secretary of Veterans Affairs on prevention, identification, intervention for, and treatment of eating disorders.

“(d) Authorization of Appropriations.—To carry out this section, there is authorized to be appropriated $1,000,000 for each of fiscal years 2023 through 2027.”

CHAPTER 5 Community Mental Health Services Block Grant Reauthorization

SEC. 1141. Reauthorization of Block Grants for Community Mental Health Services.

(a)
Funding.— Section 1920(a) of the Public Health Service Act (42 U.S.C. 300x–9(a)) is amended by striking “ $532,571,000 for each of fiscal years 2018 through 2022” and inserting “ $857,571,000 for each of fiscal years 2023 through 2027”.
(b)
Set-Aside for Evidence-based Crisis Care Services.— Section 1920 of the Public Health Service Act (42 U.S.C. 300x–9) is amended by adding at the end the following:

“(d) Crisis Care.—

“(1) In general.—Except as provided in paragraph (3), a State shall expend at least 5 percent of the amount the State receives pursuant to section 1911 for each fiscal year to support evidenced-based programs that address the crisis care needs of individuals with serious mental illnesses and children with serious emotional disturbances, which may include individuals (including children and adolescents) experiencing mental health crises demonstrating serious mental illness or serious emotional disturbance, as applicable.

“(2) Core elements.—At the discretion of the single State agency responsible for the administration of the program of the State under a grant under section 1911, funds expended pursuant to paragraph (1) may be used to fund some or all of the core crisis care service components, as applicable and appropriate, including the following:

“(A) Crisis call centers.

“(B) 24/7 mobile crisis services.

“(C) Crisis stabilization programs offering acute care or subacute care in a hospital or appropriately licensed facility, as determined by such State, with referrals to inpatient or outpatient care.

“(3) State flexibility.—In lieu of expending 5 percent of the amount the State receives pursuant to section 1911 for a fiscal year to support evidence-based programs as required by paragraph (1), a State may elect to expend not less than 10 percent of such amount to support such programs by the end of two consecutive fiscal years.

“(4) Rule of construction.—Section 1912(b)(1)(A)(vi) shall not be construed as limiting the provision of crisis care services pursuant to paragraph (1).”

(c)
Report to Congress.— Not later than September 30, 2025, and biennially thereafter, the Secretary shall provide a report to the Congress on the crisis care strategies and programs pursued by States pursuant to subsection (d) of section 1920 of the Public Health Service Act (42 U.S.C. 300x–9), as added by subsection (b). Such report shall include—
(1)
a description of each State’s crisis care activities;
(2)
the population served, including information on demographics, including age;
(3)
the outcomes of such activities, including—
(A)
how such activities reduced hospitalizations and hospital stays;
(B)
how such activities reduced incidents of suicidal ideation and behaviors; and
(C)
how such activities reduced the severity of onset of serious mental illness and serious emotional disturbance, as applicable; and
(4)
any other relevant information the Secretary determines is necessary.

CHAPTER 6 Peer-Supported Mental Health Services

SEC. 1151. Peer-Supported Mental Health Services.

Subpart 3 of part B of title V of the Public Health Service Act (42 U.S.C. 290bb—31 et seq.) is amended by inserting after section 520G (42 U.S.C. 290bb—38) the following:

“SEC. 520H. PEER-SUPPORTED MENTAL HEALTH SERVICES.

“(a) Grants Authorized.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, shall award grants to eligible entities to enable such entities to develop, expand, and enhance access to mental health peer-delivered services.

“(b) Use of Funds.—Grants awarded under subsection (a) shall be used to develop, expand, and enhance national, statewide, or community-focused programs, including virtual peer-support services and technology-related capabilities, including by—

“(1) carrying out workforce development, recruitment, and retention activities, to train, recruit, and retain peer-support providers;

“(2) building connections between mental health treatment programs, including between community organizations and peer-support networks, including virtual peer-support networks, and with other mental health support services;

“(3) reducing stigma associated with mental health disorders;

“(4) expanding and improving virtual peer mental health support services, including through the adoption of technologies and capabilities to expand access to virtual peer mental health support services, such as by acquiring equipment and software necessary to efficiently run virtual peer-support services; and

“(5) conducting research on issues relating to mental illness and the impact peer-support has on resiliency, including identifying—

“(A) the signs of mental illness;

“(B) the resources available to individuals with mental illness and to their families; and

“(C) the resources available to help support individuals living with mental illness.

“(c) Special Consideration.—In carrying out this section, the Secretary shall give special consideration to the unique needs of rural areas.

“(d) Definition.—In this section, the term ‘eligible entity’ means—

“(1) a consumer-run nonprofit organization that—

“(A) is principally governed by people living with a mental health condition; and

“(B) mobilizes resources within and outside of the mental health community, which may include through peer-support networks, to increase the prevalence and quality of long-term wellness of individuals living with a mental health condition, including those with a co-occurring substance use disorder; or

“(2) an Indian Tribe, Tribal organization, Urban Indian organization, or consortium of Tribes or Tribal organizations.

“(e) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section $13,000,000 for each of fiscal years 2023 through 2027.”

Subtitle B Substance Use Disorder Prevention, Treatment, and Recovery Services

CHAPTER 1 Native Behavioral Health Resources

SEC. 1201. Behavioral Health and Substance Use Disorder Resources for Native Americans.

Section 506A of the Public Health Service Act (42 U.S.C. 290aa–5a) is amended to read as follows:

“SEC. 506A. BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER RESOURCES FOR NATIVE AMERICANS.

“(a) Definitions.—In this section:

“(1) The term ‘eligible entity’ means any health program administered directly by the Indian Health Service, a Tribal health program, an Indian Tribe, a Tribal organization, an Urban Indian organization, and a Native Hawaiian health organization.

“(2) The terms ‘Indian Tribe’, ‘Tribal health program’, ‘Tribal organization’, and ‘Urban Indian organization’ have the meanings given to the terms ‘Indian tribe’, ‘Tribal health program’, ‘tribal organization’, and ‘Urban Indian organization’ in section 4 of the Indian Health Care Improvement Act.

“(3) The term ‘health program administered directly by the Indian Health Service’ means a ‘health program administered by the Service’ as such term is used in section 4(12)(A) of the Indian Health Care Improvement Act.

“(4) The term ‘Native Hawaiian health organization’ means ‘Papa Ola Lokahi’ as defined in section 12 of the Native Hawaiian Health Care Improvement Act.

“(b) Grant Program.—

“(1) In general.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, and in consultation with the Director of the Indian Health Service, as appropriate, shall award funds to eligible entities, in amounts developed in accordance with paragraph (2), to be used by the eligible entity to provide services for the prevention of, treatment of, and recovery from mental health and substance use disorders among American Indians, Alaska Natives, and Native Hawaiians.

“(2) Formula.—The Secretary, in consultation with the Director of the Indian Health Service, using the process described in subsection (d), shall develop a formula to determine the amount of an award under paragraph (1).

“(3) Delivery of funds.—On request from an Indian Tribe or Tribal organization, the Secretary, acting through the Assistant Secretary for Mental Health and Substance Use and in coordination with the Director of the Indian Health Service, may award funds under this section through a contract or compact under, as applicable, title I or V of the Indian Self-Determination and Education Assistance Act.

“(c) Technical Assistance and Program Evaluation.—

“(1) In general.—The Secretary shall—

“(A) provide technical assistance to applicants and awardees under this section; and

“(B) in consultation with Indian Tribes and Tribal organizations, conference with Urban Indian organizations, and engagement with a Native Hawaiian health organization, identify and establish appropriate mechanisms for Indian Tribes and Tribal organizations, Urban Indian organizations, and a Native Hawaiian health organization to demonstrate outcomes and report data as required for participation in the program under this section.

“(2) Data submission and reporting.—As a condition of receipt of funds under this section, an applicant shall agree to submit program evaluation data and reports consistent with the data submission and reporting requirements developed under this subsection.

“(d) Consultation.—The Secretary shall, using an accountable process, consult with Indian Tribes and Tribal organizations, confer with Urban Indian organizations, and engage with a Native Hawaiian health organization regarding the development of funding allocations pursuant to subsection (b)(2) and program evaluation and reporting requirements pursuant to subsection (c). In establishing such requirements, the Secretary shall seek to minimize administrative burden for eligible entities, as practicable.

“(e) Application.—An entity desiring an award under subsection (b) shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may reasonably require.

“(f) Report.—Not later than 3 years after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report describing the services provided pursuant to this section.

“(g) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section, $80,000,000 for each of fiscal years 2023 through 2027.”

CHAPTER 2 Summer Barrow Prevention, Treatment, and Recovery

SEC. 1211. Grants for the Benefit of Homeless Individuals.

Section 506(e) of the Public Health Service Act (42 U.S.C. 290aa–5(e)) is amended by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

SEC. 1212. Priority Substance Use Disorder Treatment Needs of Regional and National Significance.

Section 509 of the Public Health Service Act (42 U.S.C. 290bb–2) is amended—
(1)
in the section heading, by striking “ abuse” and inserting “ use disorder”;
(2)
in subsection (a)—
(A)
by striking “ tribes and tribal organizations (as the terms ‘Indian tribes’ and ‘tribal organizations’ are defined” and inserting “ Tribes and Tribal organizations (as such terms are defined”; and
(B)
in paragraph (3), by striking “ in substance abuse” and inserting “ in substance use disorders”;
(3)
in subsection (b), in the subsection heading, by striking “ Abuse” and inserting “ Use Disorder”; and
(4)
in subsection (f), by striking “ $333,806,000 for each of fiscal years 2018 through 2022” and inserting “ $521,517,000 for each of fiscal years 2023 through 2027”.

SEC. 1213. Evidence-Based Prescription Opioid and Heroin Treatment and Interventions Demonstration.

Section 514B of the Public Health Service Act (42 U.S.C. 290bb–10) is amended—
(1)
in subsection (a)(1)—
(A)
by striking “ substance abuse” and inserting “ substance use disorder”;
(B)
by striking “ tribes and tribal organizations” and inserting “ Tribes and Tribal organizations”; and
(C)
by striking “ addiction” and inserting “ substance use disorders”;
(2)
in subsection (e)(3), by striking “ tribes and tribal organizations” and inserting “ Tribes and Tribal organizations”; and
(3)
in subsection (f), by striking “ 2017 through 2021” and inserting “ 2023 through 2027”.

SEC. 1214. Priority Substance Use Disorder Prevention Needs of Regional and National Significance.

Section 516 of the Public Health Service Act (42 U.S.C. 290bb–22) is amended—
(1)
in subsection (a)—
(A)
in paragraph (3), by striking “ abuse” and inserting “ use”; and
(B)
in the matter following paragraph (3), by striking “ tribes or tribal organizations” and inserting “ Tribes or Tribal organizations”;
(2)
in subsection (b), in the subsection heading, by striking “ Abuse” and inserting “ Use Disorder”; and
(3)
in subsection (f), by striking “ $211,148,000 for each of fiscal years 2018 through 2022” and inserting “ $218,219,000 for each of fiscal years 2023 through 2027”.

SEC. 1215. Sober Truth on Preventing (stop) Underage Drinking Reauthorization.

Section 519B of the Public Health Service Act (42 U.S.C. 290bb–25b) is amended—
(1)
by amending subsection (a) to read as follows:

“(a) Definitions.—For purposes of this section:

“(1) The term ‘alcohol beverage industry’ means the brewers, vintners, distillers, importers, distributors, and retail or online outlets that sell or serve beer, wine, and distilled spirits.

“(2) The term ‘school-based prevention’ means programs, which are institutionalized, and run by staff members or school-designated persons or organizations in any grade of school, kindergarten through 12th grade.

“(3) The term ‘youth’ means persons under the age of 21.”

; and

(2)
by striking subsections (c) through (g) and inserting the following:

“(c) Interagency Coordinating Committee; Annual Report on State Underage Drinking Prevention and Enforcement Activities.—

“(1) Interagency coordinating committee on the prevention of underage drinking.—

“(A) In general.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall continue to support and enhance the efforts of the interagency coordinating committee, that began operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘Committee’).

“(B) Other agencies.—The officials referred to in subparagraph (A) are the Secretary of Education, the Attorney General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Director of the National Institute on Alcohol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance Use, the Director of the National Institute on Drug Abuse, the Assistant Secretary for Children and Families, the Director of the Office of National Drug Control Policy, the Administrator of the National Highway Traffic Safety Administration, the Administrator of the Office of Juvenile Justice and Delinquency Prevention, the Chairman of the Federal Trade Commission, and such other Federal officials as the Secretary of Health and Human Services determines to be appropriate.

“(C) Chair.—The Secretary of Health and Human Services shall serve as the chair of the Committee.

“(D) Duties.—The Committee shall guide policy and program development across the Federal Government with respect to underage drinking, provided, however, that nothing in this section shall be construed as transferring regulatory or program authority from an agency to the Committee.

“(E) Consultations.—The Committee shall actively seek the input of and shall consult with all appropriate and interested parties, including States, public health research and interest groups, foundations, and alcohol beverage industry trade associations and companies.

“(F) Annual report.—

“(i) In general.—The Secretary, on behalf of the Committee, shall annually submit to the Congress a report that summarizes—

“(I) all programs and policies of Federal agencies designed to prevent and reduce underage drinking, including such programs and policies that support State efforts to prevent or reduce underage drinking;

“(II) the extent of progress in preventing and reducing underage drinking at State and national levels;

“(III) data that the Secretary shall collect with respect to the information specified in clause (ii); and

“(IV) such other information regarding underage drinking as the Secretary determines to be appropriate.

“(ii) Certain information.—The report under clause (i) shall include information on the following:

“(I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not limited to, Monitoring the Future, Youth Risk Behavior Surveillance System, the National Survey on Drug Use and Health, and the Fatality Analysis Reporting System.

“(II) Measures of the availability of alcohol from commercial and non-commercial sources to underage populations.

“(III) Measures of the exposure of underage populations to messages regarding alcohol in advertising, social media, and the entertainment media.

“(IV) Surveillance data, including, to the extent such information is available, information on the onset and prevalence of underage drinking, consumption patterns and beverage preferences, trends related to drinking among different age groups, including between youth and adults, the means of underage access, including trends over time, for these surveillance data, and other data, as appropriate. The Secretary shall develop a plan to improve the collection, measurement, and consistency of reporting Federal underage alcohol data.

“(V) Any additional findings resulting from research conducted or supported under subsection (g).

“(VI) Evidence-based best practices to prevent and reduce underage drinking and provide treatment services to those youth who need such services.

“(2) Annual report on state underage drinking prevention and enforcement activities.—

“(A) In general.—The Secretary shall, with input and collaboration from other appropriate Federal agencies, States, Indian Tribes, territories, and public health, consumer, and alcohol beverage industry groups, annually issue a report on each State’s performance in enacting, enforcing, and creating laws, regulations, programs, and other actions to prevent or reduce underage drinking based on the best practices identified pursuant to paragraph (1)(F)(ii)(VI). For purposes of this paragraph, each such report, with respect to a year, shall be referred to as the ‘State Report’. Each State Report may be used as a resource to inform the identification and implementation of activities to prevent underage drinking, as determined to be appropriate by such State or other applicable entity.

“(B) Contents.—

“(i) Performance measures.—The Secretary shall develop, in consultation with the Committee, a set of measures to be used in preparing the State Report on best practices, including as they relate to State laws, regulations, other actions, and enforcement practices.

“(ii) State report content.—The State Report shall include updates on State laws, regulations, and other actions, including those described in previous reports to Congress, including with respect to the following:

“(I) Whether or not the State has comprehensive anti-underage drinking laws such as for the illegal sale, purchase, attempt to purchase, consumption, or possession of alcohol; illegal use of fraudulent ID; illegal furnishing or obtaining of alcohol for an individual under 21 years; the degree of strictness of the penalties for such offenses; and the prevalence of the enforcement of each of these infractions.

“(II) Whether or not the State has comprehensive liability statutes pertaining to underage access to alcohol such as dram shop, social host, and house party laws, and the prevalence of enforcement of each of these laws.

“(III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage access to alcohol at retail outlets, such as random compliance checks and shoulder tap programs, and the number of compliance checks within alcohol retail outlets measured against the number of total alcohol retail outlets in each State, and the result of such checks.

“(IV) Whether or not the State encourages training on the proper selling and serving of alcohol for all sellers and servers of alcohol as a condition of employment.

“(V) Whether or not the State has policies and regulations with regard to direct sales to consumers and home delivery of alcoholic beverages.

“(VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the number of adults targeted by these programs.

“(VII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.

“(VIII) Whether or not the State has adopted any other policies consistent with evidence-based practices related to the prevention of underage alcohol use, which may include any such practices described in relevant reports issued by the Surgeon General and practices related to youth exposure to alcohol-related products and information.

“(IX) A description of the degree to which the practices of local jurisdictions within the State vary from one another.

“(3) Authorization of appropriations.—There is authorized to be appropriated to carry out this subsection $1,000,000 for each of fiscal years 2023 through 2027.

“(d) National Media Campaign To Prevent Underage Drinking.—

“(1) In general.—The Secretary, in consultation with the National Highway Traffic Safety Administration, shall develop or continue an intensive, multifaceted national media campaign aimed at adults to reduce underage drinking.

“(2) Purpose.—The purpose of the national media campaign described in this section shall be to achieve the following objectives:

“(A) Promote community awareness of, and a commitment to, reducing underage drinking.

“(B) Encourage activities, including activities carried out by adults, that inhibit the illegal use of alcohol by youth.

“(C) Discourage activities, including activities carried out by adults, that promote the illegal use of alcohol by youth.

“(3) Components.—When implementing the national media campaign described in this section, the Secretary shall—

“(A) educate the public about the public health and safety benefits of evidence-based strategies to reduce underage drinking, including existing laws related to the minimum legal drinking age, and engage the public and parents in the implementation of such strategies;

“(B) educate the public about the negative consequences of underage drinking;

“(C) identify specific actions by adults to discourage or inhibit underage drinking;

“(D) discourage adult conduct that tends to facilitate underage drinking;

“(E) establish collaborative relationships with local and national organizations and institutions to further the goals of the campaign and assure that the messages of the campaign are disseminated from a variety of sources;

“(F) conduct the campaign through multi-media sources; and

“(G) take into consideration demographics and other relevant factors to most effectively reach target audiences.

“(4) Consultation requirement.—In developing and implementing the national media campaign described in this section, the Secretary shall review recommendations for reducing underage drinking, including those published by the National Academies of Sciences, Engineering, and Medicine and the Surgeon General. The Secretary shall also consult with interested parties including the alcohol beverage industry, medical, public health, and consumer and parent groups, law enforcement, institutions of higher education, community-based organizations and coalitions, and other relevant stakeholders.

“(5) Annual report.—The Secretary shall produce an annual report on the progress of the development or implementation of the media campaign described in this subsection, including expenses and projected costs, and, as such information is available, report on the effectiveness of such campaign in affecting adult attitudes toward underage drinking and adult willingness to take actions to decrease underage drinking.

“(6) Research on youth-oriented campaign.—The Secretary may, based on the availability of funds, conduct or support research on the potential success of a youth-oriented national media campaign to reduce underage drinking. The Secretary shall report to Congress any such results and any related recommendations.

“(7) Administration.—The Secretary may enter into an agreement with another Federal agency to delegate the authority for execution and administration of the adult-oriented national media campaign.

“(8) Authorization of appropriations.—There is authorized to be appropriated to carry out this section $2,500,000 for each of fiscal years 2023 through 2027.

“(e) Community-Based Coalition Enhancement Grants To Prevent Underage Drinking.—

“(1) Authorization of program.—The Assistant Secretary for Mental Health and Substance Use, in consultation with the Director of the Office of National Drug Control Policy, shall award enhancement grants to eligible entities to design, implement, evaluate, and disseminate comprehensive strategies to maximize the effectiveness of community-wide approaches to preventing and reducing underage drinking. This subsection is subject to the availability of appropriations.

“(2) Purposes.—The purposes of this subsection are to—

“(A) prevent and reduce alcohol use among youth in communities throughout the United States;

“(B) strengthen collaboration among communities, the Federal Government, Tribal Governments, and State and local governments;

“(C) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;

“(D) serve as a catalyst for increased citizen participation and greater collaboration among all sectors and organizations of a community that first demonstrates a long-term commitment to reducing alcohol use among youth;

“(E) implement evidence-based strategies to prevent and reduce underage drinking in communities; and

“(F) enhance, not supplant, effective local community initiatives for preventing and reducing alcohol use among youth.

“(3) Application.—An eligible entity desiring an enhancement grant under this subsection shall submit an application to the Assistant Secretary at such time, and in such manner, and accompanied by such information and assurances, as the Assistant Secretary may require. Each application shall include—

“(A) a complete description of the entity’s current underage alcohol use prevention initiatives and how the grant will appropriately enhance the focus on underage drinking issues; or

“(B) a complete description of the entity’s current initiatives, and how it will use the grant to enhance those initiatives by adding a focus on underage drinking prevention.

“(4) Uses of funds.—Each eligible entity that receives a grant under this subsection shall use the grant funds to carry out the activities described in such entity’s application submitted pursuant to paragraph (3) and obtain specialized training and technical assistance by the entity funded under section 4 of Public Law 107–82, as amended (21 U.S.C. 1521 note). Grants under this subsection shall not exceed $60,000 per year and may not exceed four years.

“(5) Supplement not supplant.—Grant funds provided under this subsection shall be used to supplement, not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.

“(6) Evaluation.—Grants under this subsection shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on recipients of drug-free community grants.

“(7) Definitions.—For purposes of this subsection, the term ‘eligible entity’ means an organization that is currently receiving or has received grant funds under the Drug-Free Communities Act of 1997.

“(8) Administrative expenses.—Not more than 6 percent of a grant under this subsection may be expended for administrative expenses.

“(9) Authorization of appropriations.—There is authorized to be appropriated to carry out this subsection $11,500,000 for each of fiscal years 2023 through 2027.

“(f) Grants to Organizations Representing Pediatric Providers and Other Related Health Professionals To Reduce Underage Drinking Through Screening and Brief Interventions.—

“(1) In general.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, shall make awards to one or more entities representing pediatric providers and other related health professionals with demonstrated ability to increase among the members of such entities effective practices to reduce the prevalence of alcohol use among individuals under the age of 21, including college students.

“(2) Purposes.—Grants under this subsection shall be made to improve—

“(A) screening adolescents for alcohol use;

“(B) offering brief interventions to adolescents to discourage such use;

“(C) educating parents about the dangers of and methods of discouraging such use;

“(D) diagnosing and treating alcohol use disorders; and

“(E) referring patients, when necessary, to other appropriate care.

“(3) Use of funds.—An entity receiving a grant under this section may use the grant funding to promote the practices specified in paragraph (2) among its members by—

“(A) providing training to health care providers;

“(B) disseminating best practices, including culturally and linguistically appropriate best practices, and developing and distributing materials; and

“(C) supporting other activities as determined appropriate by the Assistant Secretary.

“(4) Application.—To be eligible to receive a grant under this subsection, an entity shall submit an application to the Assistant Secretary at such time, and in such manner, and accompanied by such information and assurances as the Secretary may require. Each application shall include—

“(A) a description of the entity;

“(B) a description of the activities to be completed that will promote the practices specified in paragraph (2);

“(C) a description of the entity’s qualifications for performing such activities; and

“(D) a timeline for the completion of such activities.

“(5) Definitions.—For the purpose of this subsection:

“(A) Brief intervention.—The term ‘brief intervention’ means, after screening a patient, providing the patient with brief advice and other brief motivational enhancement techniques designed to increase the insight of the patient regarding the patient’s alcohol use, and any realized or potential consequences of such use to effect the desired related behavioral change.

“(B) Screening.—The term ‘screening’ means using validated patient interview techniques to identify and assess the existence and extent of alcohol use in a patient.

“(6) Authorization of appropriations.—There is authorized to be appropriated to carry out this subsection $3,000,000 for each of fiscal years 2023 through 2027.

“(g) Data Collection and Research.—

“(1) Additional research on underage drinking.—

“(A) In general.—The Secretary shall, subject to the availability of appropriations, support the collection of data, and conduct or support research that is not duplicative of research currently being conducted or supported by the Department of Health and Human Services, on underage drinking, with respect to the following:

“(i) The evaluation, which may include through the development of relevant capabilities of expertise within a State, of the effectiveness of comprehensive community-based programs or strategies and statewide systems to prevent and reduce underage drinking, across the underage years from early childhood to age 21, such as programs funded and implemented by governmental entities, public health interest groups and foundations, and alcohol beverage companies and trade associations.

“(ii) Obtaining and reporting more precise information than is currently collected on the scope of the underage drinking problem and patterns of underage alcohol consumption, including improved knowledge about the problem and progress in preventing, reducing, and treating underage drinking, as well as information on the rate of exposure of youth to advertising and other media messages encouraging and discouraging alcohol consumption.

“(iii) The development and identification of evidence-based or evidence-informed strategies to reduce underage drinking, which may include through translational research.

“(iv) Improving and conducting public health data collection on alcohol use and alcohol-related conditions in States, which may include by increasing the use of surveys, such as the Behavioral Risk Factor Surveillance System, to monitor binge and excessive drinking and related harms among individuals who are at least 18 years of age, but not more than 20 years of age, including harm caused to self or others as a result of alcohol use that is not duplicative of research currently being conducted or supported by the Department of Health and Human Services.

“(B) Authorization of appropriations.—There is authorized to be appropriated to carry out this paragraph $5,000,000 for each of fiscal years 2023 through 2027.

“(2) National academies of sciences, engineering, and medicine study.—

“(A) In general.—Not later than 12 months after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Secretary shall—

“(i) contract with the National Academies of Sciences, Engineering, and Medicine to study developments in research on underage drinking and the implications of these developments; and

“(ii) report to the Congress on the results of such review.

“(B) Authorization of appropriations.—There is authorized to be appropriated to carry out this paragraph $500,000 for fiscal year 2023.”

SEC. 1216. Grants for Jail Diversion Programs.

Section 520G of the Public Health Service Act (42 U.S.C. 290bb–38) is amended—
(1)
in subsection (a)—
(A)
by striking “ up to 125”; and
(B)
by striking “ tribes and tribal organizations” and inserting “ Tribes and Tribal organizations”;
(2)
in subsection (b)(2), by striking “ tribes, and tribal organizations” and inserting “ Tribes, and Tribal organizations”;
(3)
in subsection (c)—
(A)
in paragraph (1), by striking “ Indian tribe or tribal organization” and inserting “ an Indian Tribe or Tribal organization, a health facility or program described in subsection (a), or a public or nonprofit entity referred to in subsection (a)”; and
(B)
in paragraph (2)(A)—
(i)
in clause (i), by inserting “ peer recovery support services,” after “ disorder treatment,”; and
(ii)
in clause (iii), by striking “ tribe, or tribal organization” and inserting “ Tribe, or Tribal organization”;
(4)
in subsection (e)—
(A)
in the matter preceding paragraph (1), by striking “ tribe, or tribal organization” and inserting “ Tribe, or Tribal organization”;
(B)
in paragraph (3), by inserting “ and paraprofessionals” after “ professionals”; and
(C)
in paragraph (5), by striking “ or arrest” and inserting “ , arrest, or release”;
(5)
in subsection (f), by striking “ tribe, or tribal organization” each place it appears and inserting “ Tribe, or Tribal organization”;
(6)
in subsection (h), by striking “ tribe, or tribal organization” and inserting “ Tribe, or Tribal organization”; and
(7)
in subsection (j), by striking “ $4,269,000 for each of fiscal years 2018 through 2022” and inserting “ $14,000,000 for each of fiscal years 2023 through 2027”.

SEC. 1217. Formula Grants to States.

Section 521 of the Public Health Service Act (42 U.S.C. 290cc–21) is amended by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

SEC. 1218. Projects for Assistance in Transition from Homelessness.

Section 535(a) of the Public Health Service Act (42 U.S.C. 290cc–35(a)) is amended by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

SEC. 1219. Grants for Reducing Overdose Deaths.

(a)
Grants.—
(1)
Repeal of maximum grant amount.— Paragraph (2) of section 544(a) of the Public Health Service Act (42 U.S.C. 290dd–3(a)) is hereby repealed.
(2)
Eligible entity; subgrants.— Section 544(a) of the Public Health Service Act (42 U.S.C. 290dd–3(a)) is amended by striking paragraph (3) and inserting the following:

“(2) Eligible entity.—For purposes of this section, the term ‘eligible entity’ means a State, Territory, locality, or Indian Tribe or Tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act).

“(3) Subgrants.—For the purposes for which a grant is awarded under this section, the eligible entity receiving the grant may award subgrants to a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act), an opioid treatment program (as defined in section 8.2 of title 42, Code of Federal Regulations (or any successor regulations)), any practitioner dispensing narcotic drugs pursuant to section 303(g) of the Controlled Substances Act, or any nonprofit organization that the Secretary deems appropriate, which may include Urban Indian organizations (as defined in section 4 of the Indian Health Care Improvement Act).”

(3)
Prescribing.— Section 544(a)(4) of the Public Health Service Act (42 U.S.C. 290dd–3(a)(4)) is amended—
(A)
in subparagraph (A), by inserting “ , including patients prescribed both an opioid and a benzodiazepine” before the semicolon at the end; and
(B)
in subparagraph (D), by striking “ drug overdose” and inserting “ overdose”.
(4)
Use of funds.— Paragraph (5) of section 544(c) of the Public Health Service Act (42 U.S.C. 290dd–3(c)) is amended to read as follows:

“(5) To establish protocols to connect patients who have experienced an overdose with appropriate treatment, including overdose reversal medications, medication assisted treatment, and appropriate counseling and behavioral therapies.”

(5)
Improving access to overdose treatment.— Section 544 of the Public Health Service Act (42 U.S.C. 290dd–3) is amended—
(A)
by redesignating subsections (d) through (f) as subsections (e) through (g), respectively;
(B)
in subsection (f), as so redesignated, by striking “ subsection (d)” and inserting “ subsection (e)”; and
(C)
by inserting after subsection (c) the following:

“(d) Improving Access to Overdose Treatment.—

“(1) Information on best practices.—

“(A) Health and human services.—The Secretary of Health and Human Services may provide information to States, localities, Indian Tribes, Tribal organizations, and Urban Indian organizations on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

“(B) Defense.—The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Defense regarding the provision of information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

“(C) Veterans affairs.—The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Veterans Affairs regarding the provision of information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

“(2) Rule of construction.—Nothing in this subsection shall be construed as establishing or contributing to a medical standard of care.”

(6)
Authorization of appropriations.— Section 544(g) of the Public Health Service Act (42 U.S.C. 290dd–3(g)), as redesignated, is amended by striking “ fiscal years 2017 through 2021” and inserting “ fiscal years 2023 through 2027”.
(7)
Technical amendments.—
(A)
Section 544 of the Public Health Service Act (42 U.S.C. 290dd–3), as amended, is further amended by striking “ approved or cleared” each place it appears and inserting “ approved, cleared, or otherwise legally marketed”.
(B)
Section 107 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198) is amended by striking subsection (b).

SEC. 1220. Opioid Overdose Reversal Medication Access and Education Grant Programs.

(a)
Grants.— Section 545 of the Public Health Service Act (42 U.S.C. 290ee) is amended—
(1)
in the section heading, by striking “ access and education grant programs” and inserting “ access, education, and co-prescribing grant programs”;
(2)
in the heading of subsection (a), by striking “ Grants to States” and inserting “ Grants”;
(3)
in subsection (a), by striking “ shall make grants to States” and inserting “ shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act)”;
(4)
in subsection (a)(1), by striking “ implement strategies for pharmacists to dispense a drug or device” and inserting “ implement strategies that increase access to drugs or devices”;
(5)
by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and
(6)
by inserting after paragraph (2) the following:

“(3) encourage health care providers to co-prescribe, as appropriate, drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose;”

(b)
Grant Period.— Section 545(d)(2) of the Public Health Service Act (42 U.S.C. 290ee(d)(2)) is amended by striking “ 3 years” and inserting “ 5 years”.
(c)
Limitation.— Paragraph (3) of section 545(d) of the Public Health Service Act (42 U.S.C. 290ee(d)) is amended to read as follows:

“(3) Limitations.—A State may—

“(A) use not more than 10 percent of a grant under this section for educating the public pursuant to subsection (a)(5); and

“(B) use not less than 20 percent of a grant under this section to offset cost-sharing for distribution and dispensing of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.”

(d)
Authorization of Appropriations.— Section 545(h)(1) of the Public Health Service Act, is amended by striking “ fiscal years 2017 through 2019” and inserting “ fiscal years 2023 through 2027”.
(e)
Technical Amendment.— Section 545 of the Public Health Service Act (42 U.S.C. 290ee), as amended, is further amended by striking “ approved or cleared” each place it appears and inserting “ approved, cleared, or otherwise legally marketed”.

SEC. 1221. Emergency Department Alternatives to Opioids.

Section 7091 of the SUPPORT for Patients and Communities Act (Public Law 115–271) is amended—
(1)
in the section heading, by striking “ demonstration” (and by conforming the item relating to such section in the table of contents in section 1(b));
(2)
in subsection (a)—
(A)
by amending the subsection heading to read as follows: “ Grant Program”; and
(B)
in paragraph (1), by striking “ demonstration”;
(3)
in subsection (b), in the subsection heading, by striking “ Demonstration”;
(4)
in subsection (d)(4), by striking “ tribal” and inserting “ Tribal”;
(5)
in subsection (f)—
(A)
in the heading, by striking “ Report” and inserting “ Reports”; and
(B)
in the matter preceding paragraph (1), by striking “ Not later than 1 year after completion of the demonstration program under this section, the Secretary shall submit a report to the Congress on the results of the demonstration program” and inserting “ Not later than the end of each of fiscal years 2024 and 2027, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the results of the program”; and
(6)
in subsection (g), by striking “ 2019 through 2021” and inserting “ 2023 through 2027”.

CHAPTER 3 Excellence in Recovery Housing

SEC. 1231. Clarifying the Role of Samhsa in Promoting the Availability of High-Quality Recovery Housing.

Section 501(d) of the Public Health Service Act (42 U.S.C. 290aa) is amended—
(1)
in paragraph (24)(E), by striking “ and” at the end;
(2)
in paragraph (25), by striking the period at the end and inserting “ ; and”; and
(3)
by adding at the end the following:

“(26) collaborate with national accrediting entities, recovery housing providers, organizations or individuals with established expertise in delivery of recovery housing services, States, Federal agencies (including the Department of Health and Human Services, the Department of Housing and Urban Development, and the agencies listed in section 550(e)(2)(B)), and other relevant stakeholders, to promote the availability of high-quality recovery housing and services for individuals with a substance use disorder.”

SEC. 1232. Developing Guidelines for States to Promote the Availability of High-Quality Recovery Housing.

Section 550(a) of the Public Health Service Act (42 U.S.C. 290ee–5(a)) (relating to national recovery housing best practices) is amended—
(1)
by amending paragraph (1) to read as follows:

“(1) In general.—The Secretary, in consultation with the individuals and entities specified in paragraph (2), shall continue activities to identify, facilitate the development of, and periodically update consensus-based best practices, which may include model laws for implementing suggested minimum standards for operating, and promoting the availability of, high-quality recovery housing.”

(2)
in paragraph (2)—
(A)
by striking subparagraphs (A) and (B) and inserting the following:

“(A) officials representing the agencies described in subsection (e)(2);”

(B)
by redesignating subparagraphs (C) through (G) as subparagraphs (B) through (F), respectively;
(C)
in subparagraph (B), as so redesignated, by striking “ tribal” and inserting “ Tribal”; and
(D)
in subparagraph (D), as so redesignated, by striking “ tribes, tribal organizations, and tribally” and inserting “ Tribes, Tribal organizations, and Tribally”; and
(3)
by adding at the end the following:

“(3) Availability.—The best practices referred to in paragraph (1) shall be—

“(A) made publicly available; and

“(B) published on the public website of the Substance Abuse and Mental Health Services Administration.

“(4) Exclusion of guideline on treatment services.—In facilitating the development of best practices under paragraph (1), the Secretary may not include any best practices with respect to substance use disorder treatment services.”

SEC. 1233. Coordination of Federal Activities to Promote the Availability of Recovery Housing.

Section 550 of the Public Health Service Act (42 U.S.C. 290ee–5) (relating to national recovery housing best practices), as amended by section 1232, is further amended—
(1)
by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively;
(2)
in subsection (c)(2), by striking “ Indian tribes, tribal” and inserting “ Indian Tribes, Tribal”;
(3)
in subsection (h)(2), as so redesignated—
(A)
by striking “ Indian tribe” and inserting “ Indian Tribe”; and
(B)
by striking “ tribal organization” and inserting “ Tribal organization”; and
(4)
by inserting after subsection (d) the following:

“(e) Coordination of Federal Activities To Promote the Availability of Housing for Individuals Experiencing Homelessness, Individuals With a Mental Illness, and Individuals With a Substance Use Disorder.—

“(1) In general.—The Secretary, acting through the Assistant Secretary, and the Secretary of Housing and Urban Development shall convene an interagency working group for the following purposes:

“(A) To increase collaboration, cooperation, and consultation among the Department of Health and Human Services, the Department of Housing and Urban Development, and the Federal agencies listed in paragraph (2)(B), with respect to promoting the availability of housing, including high-quality recovery housing, for individuals experiencing homelessness, individuals with mental illnesses, and individuals with substance use disorder.

“(B) To align the efforts of such agencies and avoid duplication of such efforts by such agencies.

“(C) To develop objectives, priorities, and a long-term plan for supporting State, Tribal, and local efforts with respect to the operation of high-quality recovery housing that is consistent with the best practices developed under this section.

“(D) To improve information on the quality of recovery housing.

“(2) Composition.—The interagency working group under paragraph (1) shall be composed of—

“(A) the Secretary, acting through the Assistant Secretary, and the Secretary of Housing and Urban Development, who shall serve as the co-chairs; and

“(B) representatives of each of the following Federal agencies:

“(i) The Centers for Medicare & Medicaid Services.

“(ii) The Substance Abuse and Mental Health Services Administration.

“(iii) The Health Resources and Services Administration.

“(iv) The Office of the Inspector General of the Department of Health and Human Services.

“(v) The Indian Health Service.

“(vi) The Department of Agriculture.

“(vii) The Department of Justice.

“(viii) The Office of National Drug Control Policy.

“(ix) The Bureau of Indian Affairs.

“(x) The Department of Labor.

“(xi) The Department of Veterans Affairs.

“(xii) Any other Federal agency as the co-chairs determine appropriate.

“(3) Meetings.—The working group shall meet on a quarterly basis.

“(4) Reports to congress.—Not later than 4 years after the date of the enactment of this section, the working group shall submit to the Committee on Health, Education, Labor, and Pensions, the Committee on Agriculture, Nutrition, and Forestry, and the Committee on Finance of the Senate and the Committee on Energy and Commerce, the Committee on Ways and Means, the Committee on Agriculture, and the Committee on Financial Services of the House of Representatives a report describing the work of the working group and any recommendations of the working group to improve Federal, State, and local coordination with respect to recovery housing and other housing resources and operations for individuals experiencing homelessness, individuals with a mental illness, and individuals with a substance use disorder.”

SEC. 1234. National Academies of Sciences, Engineering, and Medicine Study and Report.

(a)
In General.— Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall—
(1)
contract with the National Academies of Sciences, Engineering, and Medicine—
(A)
to study the quality and effectiveness of recovery housing in the United States and whether the availability of such housing meets demand; and
(B)
to identify recommendations to promote the availability of high-quality recovery housing; and
(2)
report to the Congress on the results of such review.
(b)
Authorization of Appropriations.— To carry out this section, there is authorized to be appropriated $1,500,000 for fiscal year 2023.

SEC. 1235. Grants for States to Promote the Availability of Recovery Housing and Services.

Section 550 of the Public Health Service Act (42 U.S.C. 290ee–5) (relating to national recovery housing best practices), as amended by sections 1232 and 1233, is further amended by inserting after subsection (e) (as inserted by section 1233) the following:

“(f) Grants for Implementing National Recovery Housing Best Practices.—

“(1) In general.—The Secretary shall award grants to States (and political subdivisions thereof), Indian Tribes, and territories—

“(A) for the provision of technical assistance to implement the guidelines and recommendations developed under subsection (a); and

“(B) to promote—

“(i) the availability of recovery housing for individuals with a substance use disorder; and

“(ii) the maintenance of recovery housing in accordance with best practices developed under this section.

“(2) State promotion plans.—Not later than 90 days after receipt of a grant under paragraph (1), and every 2 years thereafter, each State (or political subdivisions thereof,) Indian Tribe, or territory receiving a grant under paragraph (1) shall submit to the Secretary, and publish on a publicly accessible internet website of the State (or political subdivisions thereof), Indian Tribe, or territory—

“(A) the plan of the State (or political subdivisions thereof), Indian Tribe, or territory, with respect to the promotion of recovery housing for individuals with a substance use disorder located within the jurisdiction of such State (or political subdivisions thereof), Indian Tribe, or territory; and

“(B) a description of how such plan is consistent with the best practices developed under this section.”

SEC. 1236. Funding.

Subsection (i) of section 550 of the Public Health Service Act (42 U.S.C. 290ee–5) (relating to national recovery housing best practices), as redesignated by section 1233, is amended by striking “ $3,000,000 for the period of fiscal years 2019 through 2021” and inserting “ $5,000,000 for the period of fiscal years 2023 through 2027”.

SEC. 1237. Technical Correction.

Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended—
(1)
by redesignating section 550 (relating to Sobriety Treatment and Recovery Teams) (42 U.S.C. 290ee–10), as added by section 8214 of Public Law 115–271, as section 550A; and
(2)
by moving such section so it appears after section 550 (relating to national recovery housing best practices).

CHAPTER 4 Substance Use Prevention, Treatment, and Recovery Services Block Grant

SEC. 1241. Eliminating Stigmatizing Language Relating to Substance Use.

(a)
Block Grants for Prevention and Treatment of Substance Use.— Part B of title XIX of the Public Health Service Act (42 U.S.C. 300x et seq.) is amended—
(1)
in the part heading, by striking “ substance abuse” and inserting “ substance use”;
(2)
in subpart II, by amending the subpart heading to read as follows: “ Block Grants for Substance Use Prevention, Treatment, and Recovery Services”;
(3)
in section 1922(a) (42 U.S.C. 300x–22(a))—
(A)
in paragraph (1), in the matter preceding subparagraph (A), by striking “ substance abuse” and inserting “ substance use disorders”; and
(B)
by striking “ such abuse” each place it appears in paragraphs (1) and (2) and inserting “ such disorders”;
(4)
in section 1923 (42 U.S.C. 300x–23)—
(A)
in the section heading, by striking “ substance abuse” and inserting “ substance use”; and
(B)
in subsection (a), by striking “ drug abuse” and inserting “ substance use disorders”;
(5)
in section 1925(a)(1) (42 U.S.C. 300x–25(a)(1)), by striking “ alcohol or drug abuse” and inserting “ alcohol or other substance use disorders”;
(6)
in section 1926(b)(2)(B) (42 U.S.C. 300x–26(b)(2)(B)), by striking “ substance abuse”;
(7)
in section 1931(b)(2) (42 U.S.C. 300x–31(b)(2)), by striking “ substance abuse” and inserting “ substance use disorders”;
(8)
in section 1933(d)(1) (42 U.S.C. 300x–33(d)), in the matter following subparagraph (B), by striking “ abuse of alcohol and other drugs” and inserting “ use of substances”;
(9)
by amending paragraph (4) of section 1934 (42 U.S.C. 300x–34) to read as follows:

“(4) The term ‘substance use disorder’ means the recurrent use of alcohol or other drugs that causes clinically significant impairment.”

(10)
in section 1935 (42 U.S.C. 300x–35)—
(A)
in subsection (a), by striking “ substance abuse” and inserting “ substance use disorders”; and
(B)
in subsection (b)(1), by striking “ substance abuse” each place it appears and inserting “ substance use disorders”;
(11)
in section 1949 (42 U.S.C. 300x–59), by striking “ substance abuse” each place it appears in subsections (a) and (d) and inserting “ substance use disorders”;
(12)
in section 1954(b)(4) (42 U.S.C. 300x–64(b)(4))—
(A)
by striking “ substance abuse” and inserting “ substance use disorders”; and
(B)
by striking “ such abuse” and inserting “ such disorders”; and
(13)
in section 1956 (42 U.S.C. 300x–66), by striking “ substance abuse” and inserting “ substance use disorders”.
(b)
Certain Programs Regarding Mental Health and Substance Abuse.— Part C of title XIX of the Public Health Service Act (42 U.S.C. 300y et seq.) is amended—
(1)
in the part heading, by striking “ substance abuse” and inserting “ substance use”;
(2)
in section 1971 (42 U.S.C. 300y), by striking “ substance abuse” each place it appears in subsections (a), (b), and (f) and inserting “ substance use”; and
(3)
in section 1976 (42 U.S.C. 300y–11), by striking “ intravenous abuse” each place it appears and inserting “ intravenous use”.

SEC. 1242. Authorized Activities.

Section 1921(b) of the Public Health Service Act (42 U.S.C. 300x–21(b)) is amended by striking “ activities to prevent and treat substance use disorders” and inserting “ activities to prevent, treat, and provide recovery support services for substance use disorders”.

SEC. 1243. State Plan Requirements.

Section 1932(b)(1)(A) of the Public Health Service Act (42 U.S.C. 300x–32(b)(1)(A)) is amended—
(1)
by redesignating clauses (vi) through (ix) as clauses (vii) through (x), respectively;
(2)
by inserting after clause (v) the following:

“(vi) provides a description of—

“(I) the State’s comprehensive statewide recovery support services activities, including the number of individuals being served, target populations, workforce capacity (consistent with clause (viii)), and priority needs; and

“(II) the amount of funds received under this subpart expended on recovery support services, disaggregated by the amount expended for type of service activity;”

; and

(3)
in clause (viii), as so redesignated, by striking “ disorders workforce” and inserting “ disorders workforce, including with respect to prevention, treatment, and recovery,”.

SEC. 1244. Updating Certain Language Relating to Tribes.

Section 1933(d) of the Public Health Service Act (42 U.S.C. 300x–33(d)) is amended—
(1)
in paragraph (1)—
(A)
in subparagraph (A)—
(i)
by striking “ of an Indian tribe or tribal organization” and inserting “ of an Indian Tribe or Tribal organization”; and
(ii)
by striking “ such tribe” and inserting “ such Tribe”;
(B)
in subparagraph (B)—
(i)
by striking “ tribe or tribal organization” and inserting “ Tribe or Tribal organization”; and
(ii)
by striking “ Secretary under this” and inserting “ Secretary under this subpart”; and
(C)
in the matter following subparagraph (B), by striking “ tribe or tribal organization” and inserting “ Tribe or Tribal organization”;
(2)
by amending paragraph (2) to read as follows:

“(2) Indian tribe or tribal organization as grantee.—The amount reserved by the Secretary on the basis of a determination under this subsection shall be granted to the Indian Tribe or Tribal organization serving the individuals for whom such a determination has been made.”

(3)
in paragraph (3), by striking “ tribe or tribal organization” and inserting “ Tribe or Tribal organization”; and
(4)
in paragraph (4)—
(A)
in the paragraph heading, by striking “ Definition” and inserting “ Definitions”; and
(B)
by striking “ The terms” and all that follows through “ given such terms” and inserting the following: “ The terms ‘Indian Tribe’ and ‘Tribal organization’ have the meanings given the terms ‘Indian tribe’ and ‘tribal organization’ ”.

SEC. 1245. Block Grants for Substance Use Prevention, Treatment, and Recovery Services.

(a)
In General.— Section 1935(a) of the Public Health Service Act (42 U.S.C. 300x–35(a)), as amended by section 1241, is further amended by striking “ appropriated” and all that follows through “ 2022..” and inserting the following: “ appropriated $1,908,079,000 for each of fiscal years 2023 through 2027.”.
(b)
Technical Corrections.— Section 1935(b)(1)(B) of the Public Health Service Act (42 U.S.C. 300x–35(b)(1)(B)) is amended by striking “ the collection of data in this paragraph is”.

SEC. 1246. Requirement of Reports and Audits by States.

Section 1942(a) of the Public Health Service Act (42 U.S.C. 300x–52(a)) is amended—
(1)
in paragraph (1), by striking “ and” at the end;
(2)
in paragraph (2), by striking the period at the end and inserting “ ; and”; and
(3)
by adding at the end the following:

“(3) the amount provided to each recipient in the previous fiscal year.”

SEC. 1247. Study on Assessment for Use of State Resources.

(a)
In General.— The Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use (in this section referred to as the “Secretary”), shall, in consultation with States and other local entities providing prevention, treatment, or recovery support services related to substance use, conduct a study on strategies to assess community needs with respect to such services in order to facilitate State use of block grant funding received under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.) to provide services to substance use disorder prevention, treatment, and recovery support. The study shall, where feasible and appropriate, include estimates of resources for community needs strategies respective to prevention, treatment, or recovery support services.
(b)
Report.— Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the results of the study conducted under subsection (a).

CHAPTER 5 Timely Treatment for Opioid Use Disorder

SEC. 1251. Study on Exemptions for Treatment of Opioid Use Disorder Through Opioid Treatment Programs During the Covid–19 Public Health Emergency.

(a)
Study.— The Assistant Secretary for Mental Health and Substance Use shall conduct a study, in consultation with patients and other stakeholders, on activities carried out pursuant to exemptions granted—
(1)
to a State (including the District of Columbia or any territory of the United States) or an opioid treatment program;
(2)
pursuant to section 8.11(h) of title 42, Code of Federal Regulations; and
(3)
during the period—
(A)
beginning on the declaration of the public health emergency for the COVID–19 pandemic under section 319 of the Public Health Service Act (42 U.S.C. 247d); and
(B)
ending on the earlier of—
(i)
the termination of such public health emergency, including extensions thereof pursuant to such section 319; and
(ii)
the end of calendar year 2022.
(b)
Privacy.— The section does not authorize the disclosure by the Department of Health and Human Services of individually identifiable information about patients.
(c)
Feedback.— In conducting the study under subsection (a), the Assistant Secretary for Mental Health and Substance Use shall gather feedback from the States and opioid treatment programs on their experiences in implementing exemptions described in subsection (a).
(d)
Report.— Not later than 180 days after the end of the period described in subsection (a)(3)(B), and subject to subsection (c), the Assistant Secretary for Mental Health and Substance Use shall publish a report on the results of the study under this section.

SEC. 1252. Changes to Federal Opioid Treatment Standards.

(a)
Mobile Medication Units.— Section 302(e) of the Controlled Substances Act (21 U.S.C. 822(e)) is amended by adding at the end the following:

“(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 303(g) narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant’s practice to dispense such narcotics at locations other than the registrant’s principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.”

(b)
Revise Opioid Treatment Program Admission Criteria to Eliminate Requirement That Patients Have an Opioid Use Disorder for at Least 1 Year.— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall revise section 8.12(e)(1) of title 42, Code of Federal Regulations (or successor regulations), to eliminate the requirement that an opioid treatment program only admit an individual for treatment under the program if the individual has been addicted to opioids for at least 1 year before being so admitted for treatment.

CHAPTER 6 Additional Provisions Relating to Addiction Treatment

SEC. 1261. Prohibition.

Notwithstanding any provision of this title and the amendments made by this title, no funds made available to carry out this title or any amendment made by this title shall be used to purchase, procure, or distribute pipes or cylindrical objects intended to be used to smoke or inhale illegal scheduled substances.

SEC. 1262. Eliminating Additional Requirements for Dispensing Narcotic Drugs in Schedule Iii, Iv, and V for Maintenance or Detoxification Treatment.

(a)
In General.— Section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) is amended—
(1)
by striking paragraph (2);
(2)
by striking “ (g)(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment” and inserting “ (g) Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment”;
(3)
by redesignating subparagraphs (A), (B), and (C) as paragraphs (1), (2), and (3), respectively; and
(4)
in paragraph (2), as so redesignated—
(A)
by striking “ (i) security of stocks” and inserting “ (A) security of stocks”; and
(B)
by striking “ (ii) the maintenance of records” and inserting “ (B) the maintenance of records”.
(b)
Conforming Changes.—
(1)
Subsections (a) and (d)(1) of section 304 of the Controlled Substances Act (21 U.S.C. 824) are each amended by striking “ 303(g)(1)” each place it appears and inserting “ 303(g)”.
(2)
Section 309A(a)(2) of the Controlled Substances Act (21 U.S.C. 829a) is amended—
(A)
in the matter preceding subparagraph (A), by striking “ the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2)” and inserting “ the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment”; and
(B)
by striking “ and—” and all that follows through “ is to be administered by injection or implantation;” and inserting “ and is to be administered by injection or implantation;”.
(3)
Section 520E–4(c) of the Public Health Service Act (42 U.S.C. 290bb–36d(c)) is amended by striking “ information on any qualified practitioner that is certified to prescribe medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act” and inserting “ information on any practitioner who prescribes narcotic drugs in schedule III, IV, or V of section 202 of the Controlled Substances Act for the purpose of maintenance or detoxification treatment”.
(4)
Section 544(a)(3) of the Public Health Service Act (42 U.S.C. 290dd–3), as added by section 1219(a)(2), is amended by striking “ any practitioner dispensing narcotic drugs pursuant to section 303(g) of the Controlled Substances Act” and inserting “ any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment”.
(5)
Section 1833(bb)(3)(B) of the Social Security Act (42 U.S.C. 1395l(bb)(3)(B)) is amended by striking “ first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019” and inserting “ first begins prescribing narcotic drugs in schedule III, IV, or V of section 202 of the Controlled Substances Act for the purpose of maintenance or detoxification treatment on or after January 1, 2021”.
(6)
Section 1834(o)(3)(C)(ii) of the Social Security Act (42 U.S.C. 1395m(o)(3)(C)(ii)) is amended by striking “ first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019” and inserting “ first begins prescribing narcotic drugs in schedule III, IV, or V of section 202 of the Controlled Substances Act for the purpose of maintenance or detoxification treatment on or after January 1, 2021”.
(7)
Section 1866F(c)(3) of the Social Security Act (42 U.S.C. 1395cc–6(c)(3)) is amended—
(A)
in subparagraph (A), by adding “ and” at the end;
(B)
in subparagraph (B), by striking “ ; and” and inserting a period; and
(C)
by striking subparagraph (C).
(8)
Section 1903(aa)(2)(C) of the Social Security Act (42 U.S.C. 1396b(aa)(2)(C)) is amended—
(A)
in clause (i), by adding “ and” at the end;
(B)
by striking clause (ii); and
(C)
by redesignating clause (iii) as clause (ii).

SEC. 1263. Requiring Prescribers of Controlled Substances to Complete Training.

(a)
In General.— Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following:

“(l) Required Training for Prescribers.—

“(1) Training required.—As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner, to meet the following:

“(A) If the practitioner is a physician (as defined under section 1861(r) of the Social Security Act) and the practitioner meets one or more of the following conditions:

“(i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.

“(ii) The physician holds a board certification from the American Board of Addiction Medicine.

“(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association.

“(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by—

“(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Commission for Continuing Education Provider Recognition (CCEPR);

“(II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR;

“(III) any organization accredited by the American Osteopathic Association to provide continuing medical education; or

“(IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.

“(v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, dental surgery, or dental medicine in the United States during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental medicine curriculum that included not less than 8 hours of training on—

“(I) treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or

“(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.

“(B) If the practitioner is not a physician (as defined under section 1861(r) of the Social Security Act), the practitioner is legally authorized by the State to dispense controlled substances under schedule II, III, IV, or V and is dispensing such substances within such State in accordance with all applicable State laws, and the practitioner meets one or more of the following conditions:

“(i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of patients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use or the Accreditation Council for Continuing Medical Education.

“(ii) The practitioner has graduated in good standing from an accredited physician assistant school or accredited school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder.

“(2) One-time training.—

“(A) In general.—The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of paragraph (1)(B) more than once.

“(B) Notification.—Not later than 90 days after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Attorney General shall provide to qualified practitioners a single written, electronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B).

“(3) Rule of construction.—Nothing in this subsection shall be construed—

“(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or

“(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.

“(4) Definitions.—In this section:

“(A) First applicable registration.—The term ‘first applicable registration’ means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022.

“(B) Qualified practitioner.—In this subsection, the term ‘qualified practitioner’ means a practitioner who—

“(i) is licensed under State law to prescribe controlled substances; and

“(ii) is not solely a veterinarian.”

(b)
Report.— Not later than 5 years after the date of enactment of this Act, the Secretary, in consultation with the Attorney General, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the impact of the elimination of the waiver program established under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), as amended by the Drug Addiction Treatment Act of 2000.

SEC. 1264. Increase in Number of Days Before Which Certain Controlled Substances Must Be Administered.

Section 309A(a)(5) of the Controlled Substances Act (21 U.S.C. 829a(a)(5)) is amended by striking “ 14 days” and inserting “ 45 days”.

CHAPTER 7 Opioid Crisis Response

SEC. 1271. Opioid Prescription Verification.

(a)
Materials for Training Pharmacists on Certain Circumstances Under Which a Pharmacist May Decline to Fill a Prescription.—
(1)
Updates to materials.— Section 3212(a) of the SUPPORT for Patients and Communities Act (21 U.S.C. 829 note) is amended by striking “ Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate” and inserting “ The Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, and update periodically thereafter”.
(2)
Materials included.— Section 3212(b) of the SUPPORT for Patients and Communities Act (21 U.S.C. 829 note) is amended—
(A)
by redesignating paragraphs (1) and (2) as paragraphs (2) and (3), respectively; and
(B)
by inserting before paragraph (2), as so redesignated, the following new paragraph:

“(1) pharmacists on how to verify the identity of the patient;”

(3)
Materials for training on patient verification .— Section 3212 of the SUPPORT for Patients and Communities Act (21 U.S.C. 829 note) is amended by adding at the end the following new subsection:

“(d) Materials for Training on Verification of Identity.—Not later than 1 year after the date of enactment of this subsection, the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—

“(1) update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of the patient; and

“(2) disseminate, as appropriate, the updated materials.”

(b)
Incentivizing States To Build or Maintain Prescription Drug Monitoring Programs.—
(1)
In general.— Section 392A of the Public Health Service Act (42 U.S.C. 280b–1) is amended—
(A)
by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and
(B)
by inserting after subsection (b) the following new subsection:

“(c) Priority.—In awarding grants to States under subsections (a) and (b), the Director of the Centers for Disease Control and Prevention may give priority to jurisdictions with a disproportionately high rate of drug overdoses or drug overdose deaths, as applicable.”

(2)
Conforming change.— Section 392A of the Public Health Service Act (42 U.S.C. 280b–1) is amended by striking “ Indian tribes” each place it appears and inserting “ Indian Tribes”.

SEC. 1272. Synthetic Opioid and Emerging Drug Misuse Danger Awareness.

(a)
In General.— Not later than one year after the date of enactment of this Act, the Secretary shall provide for the planning and implementation of a public education campaign to raise public awareness of synthetic opioids (including fentanyl and its analogues) and emerging drug use and misuse issues, as appropriate. Such campaign related to synthetic opioids shall include the dissemination of information that—
(1)
promotes awareness about the potency and dangers of fentanyl and its analogues and other synthetic opioids;
(2)
explains services provided by the Substance Abuse and Mental Health Services Administration and the Centers for Disease Control and Prevention (and any entity providing such services under a contract entered into with such agencies) with respect to the use and misuse of opioids (including synthetic opioids) and other emerging drug threats, such as stimulants, as appropriate; and
(3)
relates generally to opioid use and pain management, including information on alternative, nonopioid pain management treatments.

The Secretary shall update such campaign to address emerging drug misuse issues, as appropriate.

(b)
Use of Media.— The campaign under subsection (a) may be implemented through the use of television, radio, internet, in-person public communications, and other commercial marketing venues and may be targeted to specific demographic groups.
(c)
Consideration of Report Findings.— In planning and implementing the public education campaign under subsection (a) related to synthetic opioids, the Secretary shall take into consideration the findings of the report required under section 7001 of the SUPPORT for Patients and Communities Act (Public Law 115–271).
(d)
Consultation.— In coordinating the campaign under subsection (a), the Secretary shall consult with the Assistant Secretary for Mental Health and Substance Use to provide ongoing advice on the effectiveness of information disseminated through the campaign.
(e)
Requirement of Campaign.— The campaign implemented under subsection (a) shall not be duplicative of any other Federal efforts relating to eliminating substance use and misuse.
(f)
Evaluation.—
(1)
In general.— The Secretary shall ensure that the campaign implemented under subsection (a) is subject to an independent evaluation, beginning 2 years after the date of enactment of this Act, and 2 years thereafter.
(2)
Measures and benchmarks.— For purposes of an evaluation conducted pursuant to paragraph (1), the Secretary shall—
(A)
establish baseline measures and benchmarks to quantitatively evaluate the impact of the campaign under this section; and
(B)
conduct qualitative assessments regarding the effectiveness of strategies employed under this section.
(g)
Report.— The Secretary shall, beginning 2 years after the date of enactment of this Act, and 2 years thereafter, submit to Congress a report on the effectiveness of the campaign implemented under subsection (a) towards meeting the measures and benchmarks established under subsection (f)(2).
(h)
Dissemination of Information Through Providers.— The Secretary shall develop and implement a plan for the dissemination of information related to synthetic opioids, to health care providers who participate in Federal programs, including programs administered by the Department of Health and Human Services, the Indian Health Service, the Department of Veterans Affairs, the Department of Defense, and the Health Resources and Services Administration, the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), and the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.).
(i)
Training Guide and Outreach on Synthetic Opioid Exposure Prevention.—
(1)
Training guide.— Not later than 18 months after the date of enactment of this Act, the Secretary shall design, publish, and make publicly available on the internet website of the Department of Health and Human Services, a training guide and webinar for first responders and other individuals who also may be at high risk of exposure to synthetic opioids that details measures to prevent that exposure.
(2)
Outreach.— Not later than 18 months after the date of enactment of this Act, the Secretary shall also conduct outreach about the availability of the training guide and webinar published under paragraph (1) to—
(A)
fire department staff;
(B)
law enforcement officers;
(C)
ambulance transport and other first responders;
(D)
hospital emergency department personnel; and
(E)
other high-risk occupations, as identified by the Secretary.

SEC. 1273. Grant Program for State and Tribal Response to Opioid Use Disorders.

Section 1003 of the 21st Century Cures Act (42 U.S.C. 290ee–3 note) is amended to read as follows:

“SEC. 1003. GRANT PROGRAM FOR STATE AND TRIBAL RESPONSE TO OPIOID USE DISORDERS.

“(a) In General.—The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall carry out the grant program described in subsection (b) for purposes of addressing opioid misuse and use disorders and, as applicable and appropriate, stimulant misuse and use disorders, within States, Indian Tribes, and populations served by Tribal organizations and Urban Indian organizations.

“(b) Grants Program.—

“(1) In general.—Subject to the availability of appropriations, the Secretary shall award grants to the single State agency responsible for administering the substance use prevention, treatment, and recovery services block grant under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.), Indian Tribes, and Tribal organizations for the purpose of addressing opioid misuse and use disorders, and as applicable and appropriate, stimulant misuse and use disorders, within such States, such Indian Tribes, and populations served by such Tribal organizations, in accordance with paragraph (2). Indian Tribes or Tribal organizations may also apply for an award as part of a consortia or may include in an application a partnership with an Urban Indian organization.

“(2) Minimum allocations.—Notwithstanding subsection (i)(3), in determining grant amounts for each recipient of a grant under paragraph (1), the Secretary shall ensure that each State and the District of Columbia receive not less than $4,000,000 and ensure that each Territory receives not less than $250,000.

“(3) Formula methodology.—

“(A) In general.—At least 30 days before publishing a funding opportunity announcement with respect to grants under this section, the Secretary shall—

“(i) develop a formula methodology to be followed in allocating grant funds awarded under this section among grantees, which, where applicable and appropriate based on populations being served by the relevant entity—

“(I) with respect to allocations for States, gives preference to States whose populations have a prevalence of opioid misuse and use disorders or drug overdose deaths that is substantially higher relative to the populations of other States;

“(II) with respect to allocations for Tribes and Tribal organizations, gives preferences to Tribes and Tribal organizations (including those applying in partnership with an Urban Indian organization) serving populations with demonstrated need with respect to opioid misuse and use disorders or drug overdose deaths;

“(III) includes performance assessments for continuation awards; and

“(IV) ensures that the formula avoids a funding cliff between States with similar overdose mortality rates to prevent funding reductions when compared to prior year allocations, as determined by the Secretary; and

“(ii) not later than 30 days after developing the formula methodology under clause (i), submit the formula methodology to—

“(I) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and

“(II) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.

“(B) Report.—Not later than two years after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that—

“(i) assesses how grant funding is allocated to States under this section and how such allocations have changed over time;

“(ii) assesses how any changes in funding under this section have affected the efforts of States to address opioid misuse and use disorders and, as applicable and appropriate, stimulant misuse and use disorders; and

“(iii) assesses the use of funding provided through the grant program under this section and other similar grant programs administered by the Substance Abuse and Mental Health Services Administration.

“(4) Use of funds.—Grants awarded under this subsection shall be used for carrying out activities that supplement activities pertaining to opioid misuse and use disorders and, as applicable and appropriate, stimulant misuse and use disorders (including co-occurring substance misuse and use disorders), undertaken by the entities described in paragraph (1), which may include public health-related activities such as the following:

“(A) Implementing substance use disorder and overdose prevention activities, including primary prevention activities, and evaluating such activities to identify effective strategies to prevent substance use disorders and overdoses, which may include drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act.

“(B) Establishing or improving prescription drug monitoring programs.

“(C) Training for health care practitioners, such as best practices for prescribing opioids, pain management, recognizing potential cases of substance use disorders, referral of patients to treatment programs, preventing diversion of controlled substances, and overdose prevention.

“(D) Supporting access to and the provision of substance use disorder-related health care services, including—

“(i) services provided by federally certified opioid treatment programs;

“(ii) services provided in outpatient and residential substance use disorder treatment programs or facilities, including those that utilize medication-assisted treatment, as appropriate; or

“(iii) services provided by other appropriate health care providers to treat substance use disorders, including crisis services and services provided in integrated health care settings by appropriate health care providers that treat substance use disorders.

“(E) Recovery support services, including—

“(i) community-based services that include education, outreach, and peer supports such as peer support specialists and recovery coaches to help support recovery;

“(ii) mutual aid recovery programs that support medication-assisted treatment;

“(iii) services to address housing needs; or

“(iv) services related to supporting families that include an individual with a substance use disorder.

“(F) Other public health-related activities, as such entity determines appropriate, related to addressing opioid misuse and use disorders and, as applicable and appropriate, stimulant misuse and use disorders, within such entity, including directing resources in accordance with local needs related to substance use disorders.

“(c) Accountability and Oversight.—A State receiving a grant under subsection (b) shall submit to the Secretary a description of—

“(1) the purposes for which the grant funds received by the State under such subsection for the preceding fiscal year were expended and a description of the activities of the State under the grant;

“(2) the ultimate recipients of amounts provided to the State;

“(3) the number of individuals served through the grant; and

“(4) such other information as determined appropriate by the Secretary.

“(d) Limitations.—Any funds made available pursuant to subsection (i) shall not be used for any purpose other than the grant program under subsection (b).

“(e) Indian Tribes and Tribal Organizations.—The Secretary, in consultation with Indian Tribes and Tribal organizations, shall identify and establish appropriate mechanisms for Indian Tribes and Tribal organizations to demonstrate or report the information as required under subsections (b), (c), and (d).

“(f) Report to Congress.—Not later than September 30, 2024, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and the Committees on Appropriations of the House of Representatives and the Senate, a report that includes a summary of the information provided to the Secretary in reports made pursuant to subsections (c) and (d), including—

“(1) the purposes for which grant funds are awarded under this section;

“(2) the activities of the grant recipients; and

“(3) each entity that receives a grant under this section, including the funding level provided to such recipient.

“(g) Technical Assistance.—The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, as applicable, shall provide entities described in subsection (b)(1) with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing substance use disorders.

“(h) Definitions.—In this section:

“(1) Indian tribe.—The term ‘Indian Tribe’ has the meaning given the term ‘Indian tribe’ in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

“(2) Tribal organization.—The term ‘Tribal organization’ has the meaning given the term ‘tribal organization’ in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

“(3) State.—The term ‘State’ has the meaning given such term in section 1954(b) of the Public Health Service Act (42 U.S.C. 300x–64(b)).

“(4) Urban indian organization.—The term ‘Urban Indian organization’ has the meaning given such term in section 4 of the Indian Health Care Improvement Act.

“(i) Authorization of Appropriations.—

“(1) In general.—For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $1,750,000,000 for each of fiscal years 2023 through 2027.

“(2) Federal administrative expenses.—Of the amounts made available for each fiscal year to award grants under subsection (b), the Secretary shall not use more than 2 percent for Federal administrative expenses, training, technical assistance, and evaluation.

“(3) Set aside.—Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, the Secretary shall—

“(A) award not more than 5 percent to Indian Tribes and Tribal organizations; and

“(B) of the amount remaining after application of subparagraph (A), set aside up to 15 percent for awards to States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention.”

Subtitle C Access to Mental Health Care and Coverage

CHAPTER 1 Improving Uptake and Patient Access to Integrated Care Services

SEC. 1301. Improving Uptake and Patient Access to Integrated Care Services.

Section 520K of the Public Health Service Act (42 U.S.C. 290bb–42) is amended to read as follows:

“SEC. 520K. IMPROVING UPTAKE AND PATIENT ACCESS TO INTEGRATED CARE SERVICES.

“(a) Definitions.—In this section:

“(1) Eligible entity.—The term ‘eligible entity’ means a State, or an appropriate State agency, in collaboration with—

“(A) 1 or more qualified community programs as described in section 1913(b)(1); or

“(B) 1 or more health centers (as defined in section 330(a)), rural health clinics (as defined in section 1861(aa) of the Social Security Act), or Federally qualified health centers (as defined in such section), or primary care practices serving adult or pediatric patients or both.

“(2) Integrated care; bidirectional integrated care.—

“(A) The term ‘integrated care’ means collaborative models, including the psychiatric collaborative care model and other evidence-based or evidence-informed models, or practices for coordinating and jointly delivering behavioral and physical health services, which may include practices that share the same space in the same facility.

“(B) The term ‘bidirectional integrated care’ means the integration of behavioral health care and specialty physical health care, and the integration of primary and physical health care within specialty behavioral health settings, including within primary health care settings.

“(3) Psychiatric collaborative care model.—The term ‘psychiatric collaborative care model’ means the evidence-based, integrated behavioral health service delivery method that includes—

“(A) care directed by the primary care team;

“(B) structured care management;

“(C) regular assessments of clinical status using developmentally appropriate, validated tools; and

“(D) modification of treatment as appropriate.

“(4) Special population.—The term ‘special population’ means—

“(A) adults with a serious mental illness or adults who have co-occurring mental illness and physical health conditions or chronic disease;

“(B) children and adolescents with a serious emotional disturbance who have a co-occurring physical health condition or chronic disease;

“(C) individuals with a substance use disorder; or

“(D) individuals with a mental illness who have a co-occurring substance use disorder.

“(b) Grants and Cooperative Agreements.—

“(1) In general.—The Secretary may award grants and cooperative agreements to eligible entities to support the improvement of integrated care for physical and behavioral health care in accordance with paragraph (2).

“(2) Use of funds.—A grant or cooperative agreement awarded under this section shall be used—

“(A) to promote full integration and collaboration in clinical practices between physical and behavioral health care, including for special populations;

“(B) to support the improvement of integrated care models for physical and behavioral health care to improve overall wellness and physical health status, including for special populations;

“(C) to promote the implementation and improvement of bidirectional integrated care services provided at entities described in subsection (a)(1), including evidence-based or evidence-informed screening, assessment, diagnosis, prevention, treatment, and recovery services for mental and substance use disorders, and co-occurring physical health conditions and chronic diseases; and

“(D) in the case of an eligible entity that is collaborating with a primary care practice, to support the implementation of evidence-based or evidence-informed integrated care models, including the psychiatric collaborative care model, including—

“(i) by hiring staff;

“(ii) by identifying and formalizing contractual relationships with other health care providers or other relevant entities offering care management and behavioral health consultation to facilitate the adoption of integrated care, including, as applicable, providers who will function as psychiatric consultants and behavioral health care managers in providing behavioral health integration services through the collaborative care model;

“(iii) by purchasing or upgrading software and other resources, as applicable, needed to appropriately provide behavioral health integration, including resources needed to establish a patient registry and implement measurement-based care; and

“(iv) for such other purposes as the Secretary determines to be applicable and appropriate.

“(c) Applications.—

“(1) In general.—An eligible entity that is seeking a grant or cooperative agreement under this section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may require, including the contents described in paragraph (2).

“(2) Contents for awards.—Any such application of an eligible entity seeking a grant or cooperative agreement under this section shall include, as applicable—

“(A) a description of a plan to achieve fully collaborative agreements to provide bidirectional integrated care to special populations;

“(B) a summary of the policies, if any, that are barriers to the provision of integrated care, and the specific steps, if applicable, that will be taken to address such barriers;

“(C) a description of partnerships or other arrangements with local health care providers to provide services to special populations and, as applicable, in areas with demonstrated need, such as Tribal, rural, or other medically underserved communities, such as those with a workforce shortage of mental health and substance use disorder, pediatric mental health, or other related professionals;

“(D) an agreement and plan to report to the Secretary performance measures necessary to evaluate patient outcomes and facilitate evaluations across participating projects; and

“(E) a description of the plan or progress in implementing the psychiatric collaborative care model, as applicable and appropriate;

“(F) a description of the plan or progress of evidence-based or evidence-informed integrated care models other than the psychiatric collaborative care model implemented by primary care practices, as applicable and appropriate; and

“(G) a plan for sustainability beyond the grant or cooperative agreement period under subsection (e).

“(d) Grant and Cooperative Agreement Amounts.—

“(1) Target amount.—The target amount that an eligible entity may receive for a year through a grant or cooperative agreement under this section shall be no more than $2,000,000.

“(2) Adjustment permitted.—The Secretary, taking into consideration the quality of an eligible entity’s application and the number of eligible entities that received grants under this section prior to the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, may adjust the target amount that an eligible entity may receive for a year through a grant or cooperative agreement under this section.

“(3) Limitation.—An eligible entity that is receiving funding under subsection (b)—

“(A) may not allocate more than 10 percent of the funds awarded to such eligible entity under this section to administrative functions; and

“(B) shall allocate the remainder of such funding to health facilities that provide integrated care.

“(e) Duration.—A grant or cooperative agreement under this section shall be for a period not to exceed 5 years.

“(f) Report on Program Outcomes.—An eligible entity receiving a grant or cooperative agreement under this section shall submit an annual report to the Secretary. Such annual report shall include—

“(1) the progress made to reduce barriers to integrated care as described in the entity’s application under subsection (c);

“(2) a description of outcomes with respect to each special population listed in subsection (a)(4), including outcomes related to education, employment, and housing, or, as applicable and appropriate, outcomes for such populations receiving behavioral health care through the psychiatric collaborative care model in primary care practices; and

“(3) progress in meeting performance metrics and other relevant benchmarks; and

“(4) such other information that the Secretary may require.

“(g) Technical Assistance for Primary-behavioral Health Care Integration.—

“(1) Certain recipients.—The Secretary may provide appropriate information, training, and technical assistance to eligible entities that receive a grant or cooperative agreement under subsection (b)(2), in order to help such entities meet the requirements of this section, including assistance with—

“(A) development and selection of integrated care models;

“(B) dissemination of evidence-based interventions in integrated care;

“(C) establishment of organizational practices to support operational and administrative success; and

“(D) as appropriate, appropriate information, training, and technical assistance in implementing the psychiatric collaborative care model when an eligible entity is collaborating with 1 or more primary care practices for the purposes of implementing the psychiatric collaborative care model.

“(2) Additional dissemination of technical information.—In addition to providing the assistance described in paragraph (1) to recipients of a grant or cooperative agreement under this section, the Secretary may also provide such assistance to other States and political subdivisions of States, Indian Tribes and Tribal organizations, as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act, outpatient mental health and addiction treatment centers, community mental health centers that meet the criteria under section 1913(c), certified community behavioral health clinics described in section 223 of the Protecting Access to Medicare Act of 2014, primary care organizations such as Federally qualified health centers or rural health clinics as defined in section 1861(aa) of the Social Security Act, primary health care practices, the community-based organizations, and other entities engaging in integrated care activities, as the Secretary determines appropriate.

“(h) Report to Congress.—Not later than 18 months after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, and annually thereafter, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives summarizing the information submitted in reports to the Secretary under subsection (f), including progress made in meeting performance metrics and the uptake of integrated care models, any adjustments made to target amounts pursuant to subsection (d)(2), and any other relevant information.

“(i) Funding.—

“(1) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $60,000,000 for each of fiscal years 2023 through 2027.

“(2) Increasing uptake of the psychiatric collaborative care model by primary care practices.—Not less than 10 percent of funds appropriated to carry out this section shall be for the purposes of implementing the psychiatric collaborative care model implemented by primary care practices under subsection (b).

“(3) Funding contingency.—Paragraph (2) shall not apply to a fiscal year unless the amount made available to carry out this section for such fiscal year exceeds the amount appropriated to carry out this section (as in effect before the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022) for fiscal year 2022.”

CHAPTER 2 Helping Enable Access to Lifesaving Services

SEC. 1311. Reauthorization and Provision of Certain Programs to Strengthen the Health Care Workforce.

(a)
Mental and Behavioral Health Education and Training Grants.— Section 756 of the Public Health Service Act (42 U.S.C. 294e–1) is amended—
(1)
in subsection (a)—
(A)
in paragraph (1), by inserting “ (which may include master’s and doctoral level programs)” after “ occupational therapy”; and
(B)
in paragraph (4), by inserting before the period the following: “ , including training to increase skills and capacity to meet the needs of children and adolescents who have experienced trauma”; and
(2)
in subsection (f), by striking “ For each of fiscal years 2019 through 2023” and inserting “ For each of fiscal years 2023 through 2027”.
(b)
Training Demonstration Program.— Section 760 of the Public Health Service Act (42 U.S.C. 294k) is amended—
(1)
by striking “ mental and substance use disorders” each place it appears and inserting “ mental health and substance use disorder”;
(2)
in subsection (a)(2)—
(A)
by inserting “ (including for individuals completing clinical training requirements for licensure)” after “ training”;
(B)
by inserting “ counselors, nurses,” after “ psychologists,”; and
(C)
by striking the semicolon and inserting “ , including such settings that serve pediatric populations;”;
(3)
in subsection (a)(3)(A)—
(A)
by striking “ disorder” (as inserted by paragraph (1)) and inserting “ disorders”; and
(B)
by inserting “ or pediatric populations” after “ addiction”;
(4)
in subsection (b)(2)(A), by inserting “ (including such settings that serve pediatric populations)” after “ settings”;
(5)
in subsection (c)(2)(F)—
(A)
by inserting “ counselors, nurses,” after “ psychologists”; and
(B)
by striking the period and inserting “ , including such entities that serve pediatric populations.”;
(6)
in subsection (d)(1)(A)—
(A)
by inserting “ health service psychologists, nurses” after “ fellows,”; and
(B)
by inserting “ counselors,” after “ physician assistants”;
(7)
in subsection (d)(1)(B)—
(A)
by inserting “ , which may include such settings that serve pediatric populations” after “ settings”;
(B)
by inserting “ health” after “ mental”;
(8)
in subsection (d)(2)(C), inserting “ (which may include trauma-informed care, as appropriate)” after “ care”;
(9)
in subsection (g), by striking “ $10,000,000 for each of fiscal years 2018 through 2022” and inserting “ , and $31,700,000 for each of fiscal years 2023 through 2027”; and
(10)
in subsection (f)(2)(B), by striking “ disorder” (as inserted by paragraph (1)) and inserting “ disorders”.

SEC. 1312. Reauthorization of Minority Fellowship Program.

Section 597(c) of the Public Health Service Act (42 U.S.C. 290ll(c)) is amended by striking “ $12,669,000 for each of fiscal years 2018 through 2022” and inserting “ $25,000,000 for each of fiscal years 2023 through 2027”.

CHAPTER 3 Eliminating the Opt-Out for Nonfederal Governmental Health Plans

SEC. 1321. Eliminating the Opt-Out for Nonfederal Governmental Health Plans.

Section 2722(a)(2) of the Public Health Service Act (42 U.S.C. 300gg–21(a)(2)) is amended by adding at the end the following new subparagraph:

“(F) Sunset of election option.—

“(i) In general.—Notwithstanding the preceding provisions of this paragraph—

“(I) no election described in subparagraph (A) with respect to section 2726 may be made on or after the date of the enactment of this subparagraph; and

“(II) except as provided in clause (ii), no such election with respect to section 2726 expiring on or after the date that is 180 days after the date of such enactment may be renewed.

“(ii) Exception for certain collectively bargained plans.—Notwithstanding clause (i)(II), a plan described in subparagraph (B)(ii) that is subject to multiple agreements described in such subparagraph of varying lengths and that has an election described in subparagraph (A) with respect to section 2726 in effect as of the date of the enactment of this subparagraph that expires on or after the date that is 180 days after the date of such enactment may extend such election until the date on which the term of the last such agreement expires.”

CHAPTER 4 Mental Health and Substance Use Disorder Parity Implementation

SEC. 1331. Grants to Support Mental Health and Substance Use Disorder Parity Implementation.

(a)
In General.— Section 2794(c) of the Public Health Service Act (42 U.S.C. 300gg–94(c)) (as added by section 1003 of the Patient Protection and Affordable Care Act (Public Law 111–148)) is amended by adding at the end the following:

“(3) Parity implementation.—

“(A) In general.—Beginning during the first fiscal year that begins after the date of enactment of this paragraph, the Secretary shall, out of funds made available pursuant to subparagraph (C), award grants to eligible States to enforce and ensure compliance with the mental health and substance use disorder parity provisions of section 2726.

“(B) Eligible state.—A State shall be eligible for a grant awarded under this paragraph only if such State—

“(i) submits to the Secretary an application for such grant at such time, in such manner, and containing such information as specified by the Secretary; and

“(ii) agrees to request and review from health insurance issuers offering group or individual health insurance coverage the comparative analyses and other information required of such health insurance issuers under subsection (a)(8)(A) of section 2726 relating to the design and application of nonquantitative treatment limitations imposed on mental health or substance use disorder benefits.

“(C) Authorization of appropriations.—There are authorized to be appropriated $10,000,000 for each of the first five fiscal years beginning after the date of the enactment of this paragraph, to remain available until expended, for purposes of awarding grants under subparagraph (A).”

(b)
Technical Amendment.— Section 2794 of the Public Health Service Act (42 U.S.C. 300gg–95), as added by section 6603 of the Patient Protection and Affordable Care Act (Public Law 111–148) is redesignated as section 2795.

Subtitle D Children and Youth

CHAPTER 1 Supporting Children’s Mental Health Care Access

SEC. 1401. Technical Assistance for School-Based Health Centers.

Section 399Z–1 of the Public Health Service Act (42 U.S.C. 280h–5) is amended—
(1)
by redesignating subsection (l) as subsection (m); and
(2)
by inserting after subsection (k) the following:

“(l) Technical Assistance.—The Secretary shall provide technical assistance by grants or contracts awarded to private, nonprofit entities with demonstrated expertise related to school-based health centers. Such technical assistance, taking into account local and regional differences among school based health centers, shall support such entities in providing services described in subsection (a)(1) pursuant to this section, including mental health and substance use disorder services, and may include technical assistance relating to program operations and support for the implementation of evidence-based or evidence-informed best practices related to the provision of high quality health care services to children and adolescents.”

SEC. 1402. Infant and Early Childhood Mental Health Promotion, Intervention, and Treatment.

Section 399Z–2 of the Public Health Service Act (42 U.S.C. 280h–6) is amended—
(1)
by redesignating subsection (f) as subsection (g);
(2)
by inserting after subsection (e) the following:

“(f) Technical Assistance.—The Secretary may, directly or by awarding grants or contracts to public and private nonprofit entities, provide training and technical assistance to eligible entities to carry out activities described in subsection (d).”

; and

(3)
in subsection (g) (as redesignated by paragraph (1)), by striking “ $20,000,000 for the period of fiscal years 2018 through 2022” and inserting “ $50,000,000 for the period of fiscal years 2023 through 2027”.

SEC. 1403. Co-Occurring Chronic Conditions and Mental Health in Youth Study.

Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall—
(1)
complete a study on the rates of suicidal behaviors among children and adolescents with chronic illnesses, including substance use disorders, autoimmune disorders, and heritable blood disorders; and
(2)
submit a report to the Congress on the results of such study, including recommendations for early intervention services for such children and adolescents at risk of suicide, the dissemination of best practices to support the emotional and mental health needs of youth, and strategies to lower the rates of suicidal behaviors in children and adolescents described in paragraph (1) to reduce any demographic disparities in such rates.

SEC. 1404. Best Practices for Behavioral and Mental Health Intervention Teams.

The Public Health Service Act is amended by inserting after section 520H of such Act, as added by section 1151 of this Act, the following new section:

“SEC. 520H–1. BEST PRACTICES FOR BEHAVIORAL AND MENTAL HEALTH INTERVENTION TEAMS.

“(a) In General.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, and in consultation with the Secretary of Education, shall submit to the Health Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce Committee of the House of Representatives a report that identifies best practices related to using behavioral and mental health intervention teams, which may be used to assist elementary schools, secondary schools, and institutions of higher education interested in voluntarily establishing and using such teams to support students exhibiting behaviors interfering with learning at school or who are at risk of harm to self or others.

“(b) Elements.—The report under subsection (a) shall assess evidence supporting such best practices and, as appropriate, include consideration of the following:

“(1) How behavioral and mental health intervention teams might operate effectively from an evidence-based, objective perspective while protecting the constitutional and civil rights and privacy of individuals.

“(2) The use of behavioral and mental health intervention teams—

“(A) to identify and support students exhibiting behaviors interfering with learning or posing a risk of harm to self or others; and

“(B) to implement evidence-based interventions to meet the behavioral and mental health needs of such students.

“(3) How behavioral and mental health intervention teams can—

“(A) access evidence-based professional development to support students described in paragraph (2)(A); and

“(B) ensure that such teams—

“(i) are composed of trained, diverse stakeholders with expertise in child and youth development, behavioral and mental health, and disability; and

“(ii) use cross validation by a wide-range of individual perspectives on the team.

“(4) How behavioral and mental health intervention teams can help mitigate inappropriate referral to mental health services or law enforcement by implementing evidence-based interventions that meet student needs.

“(c) Consultation.—In carrying out subsection (a), the Secretary shall consult with—

“(1) the Secretary of Education;

“(2) the Director of the National Threat Assessment Center of the United States Secret Service;

“(3) the Attorney General;

“(4) teachers (which shall include special education teachers), principals and other school leaders, school board members, behavioral and mental health professionals (including school-based mental health professionals), and parents of students;

“(5) local law enforcement agencies and campus law enforcement administrators;

“(6) privacy, disability, and civil rights experts; and

“(7) other education and mental health professionals as the Secretary deems appropriate.

“(d) Publication.—The Secretary shall publish the report under subsection (a) in an accessible format on the internet website of the Department of Health and Human Services.

“(e) Definitions.—In this section:

“(1) The term ‘behavioral and mental health intervention team’ means a multidisciplinary team of trained individuals who—

“(A) are trained to identify and assess the behavioral health needs of children and youth and who are responsible for identifying, supporting, and connecting students exhibiting behaviors interfering with learning at school, or who are at risk of harm to self or others, with appropriate behavioral health services; and

“(B) develop and facilitate implementation of evidence-based interventions to—

“(i) mitigate the threat of harm to self or others posed by a student described in subparagraph (A);

“(ii) meet the mental and behavioral health needs of such students; and

“(iii) support positive, safe, and supportive learning environments.

“(2) The terms ‘elementary school’, ‘parent’, and ‘secondary school’ have the meanings given to such terms in section 8101 of the Elementary and Secondary Education Act of 1965.

“(3) The term ‘institution of higher education’ has the meaning given to such term in section 102 of the Higher Education Act of 1965.”

CHAPTER 2 Continuing Systems of Care for Children

SEC. 1411. Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances.

(a)
Definition.— Section 565(d)(2)(B) of the Public Health Service Act (42 U.S.C. 290ff–4(d)(2)(B)) is amended by striking “ may be)” and inserting “ may be), kinship caregivers of the child,”.
(b)
Authorization of Appropriations.— Paragraph (1) of section 565(f) of the Public Health Service Act (42 U.S.C. 290ff–4(f)) is amended—
(1)
by moving the margin of such paragraph 2 ems to the right; and
(2)
by striking “ $119,026,000 for each of fiscal years 2018 through 2022” and inserting “ $125,000,000 for each of fiscal years 2023 through 2027”.

SEC. 1412. Substance Use Disorder Treatment and Early Intervention Services for Children and Adolescents.

Section 514 of the Public Health Service Act (42 U.S.C. 290bb–7) is amended—
(1)
in subsection (a), by striking “ Indian tribes or tribal organizations” and inserting “ Indian Tribes or Tribal organizations”; and
(2)
in subsection (f), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

CHAPTER 3 Garrett Lee Smith Memorial Reauthorization

SEC. 1421. Suicide Prevention Technical Assistance Center.

(a)
Technical Amendment.— Section 520C of the Public Health Service Act (42 U.S.C. 290bb–34) is amended—
(1)
by striking “ tribes” and inserting “ Tribes”; and
(2)
by striking “ tribal” each place it appears and inserting “ Tribal”.
(b)
Collaboration.— Section 520C(a) of the Public Health Service Act (42 U.S.C. 290bb–34(a)) is amended—
(1)
by striking “ The Secretary” and inserting the following:

“(1) In general.—The Secretary”

; and

(2)
by adding at the end the following:

“(2) Collaboration.—In carrying out this subsection, as applicable with respect to assistance to entities serving members of the Armed Forces and veterans, the Secretary shall, as appropriate, collaborate with the Secretary of Defense and the Secretary of Veterans Affairs.”

(c)
Authorization of Appropriations.— Section 520C(c) of the Public Health Service Act (42 U.S.C. 290bb–34(c)) is amended by striking “ $5,988,000 for each of fiscal years 2018 through 2022” and inserting “ $9,000,000 for each of fiscal years 2023 through 2027”.
(d)
Annual Report.— Section 520C(d) of the Public Health Service Act (42 U.S.C. 290bb–34(d)) is amended by striking “ Not later than 2 years after the date of enactment of this subsection, the Secretary shall submit to Congress” and inserting “ Not later than 2 years after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives”.

SEC. 1422. Youth Suicide Early Intervention and Prevention Strategies.

Section 520E of the Public Health Service Act (42 U.S.C. 290bb–36) is amended—
(1)
by striking “ tribe” and inserting “ Tribe”;
(2)
by striking “ tribal” each place it appears and inserting “ Tribal”;
(3)
in subsection (a)(1), by inserting “ pediatric health programs,” after “ foster care systems,”;
(4)
by amending subsection (b)(1)(B) to read as follows:

“(B) a public organization or private nonprofit organization designated by a State or Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) to develop or direct the State-sponsored statewide or Tribal youth suicide early intervention and prevention strategy; or”

(5)
in subsection (c)—
(A)
in paragraph (1), by inserting “ pediatric health programs,” after “ foster care systems,”;
(B)
in paragraph (7), by inserting “ pediatric health programs,” after “ foster care systems,”;
(C)
in paragraph (9), by inserting “ pediatric health programs,” after “ educational institutions,”;
(D)
in paragraph (13), by striking “ and” at the end;
(E)
in paragraph (14), by striking the period at the end and inserting “ ; and”; and
(F)
by adding at the end the following:

“(15) provide to parents, legal guardians, and family members of youth, supplies to securely store means commonly used in suicide, if applicable, within the household.”

(6)
in subsection (d)—
(A)
in the heading, by striking “ Direct Services” and inserting “ Suicide Prevention Activities”; and
(B)
by striking “ direct services, of which not less than 5 percent shall be used for activities authorized under subsection (a)(3)” and inserting “ suicide prevention activities”;
(7)
in subsection (e)(3)(A), by inserting “ and the Department of Education, as appropriate” after “ agencies and suicide working groups”;
(8)
in subsection (g)—
(A)
in paragraph (1), by striking “ 18” and inserting “ 24”; and
(B)
in paragraph (2), by striking “ 2 years after the date of enactment of Helping Families in Mental Health Crisis Reform Act of 2016” and inserting “ December 31, 2025”;
(9)
in subsection (l)(4), by striking “ between 10 and 24 years of age” and inserting “ up to 24 years of age”; and
(10)
in subsection (m), by striking “ $30,000,000 for each of fiscal years 2018 through 2022” and inserting “ $40,000,000 for each of fiscal years 2023 through 2027”.

SEC. 1423. Mental Health and Substance Use Disorder Services for Students in Higher Education.

Section 520E–2 of the Public Health Service Act (42 U.S.C. 290bb–36b) is amended—
(1)
in the heading, by striking “ on campus” and inserting “ for students in higher education”;
(2)
in subsection (b)—
(A)
in paragraph (1), by striking “ mental and substance use disorders” and inserting “ mental health and substance use disorders and promote resiliency”;
(B)
in paragraph (4), by striking “ mental and substance use disorder services.” and inserting “ mental health and substance use disorder resources and services.”;
(C)
in paragraph (5), by striking “ mental and substance use” and inserting “ mental health and substance use”;
(D)
in paragraph (6), by striking “ staff to respond effectively to students with mental and substance use disorders.” and inserting “ staff to recognize and respond effectively and appropriately to students experiencing mental health and substance use disorders.”;
(E)
in paragraph (7), by striking “ mental and substance use” and inserting “ mental health and substance use”;
(F)
in paragraph (8), by striking “ mental and substance use” and inserting “ mental health and substance use.”;
(G)
in paragraph (9), by striking “ regarding improving the behavioral health of students through clinical services, outreach, prevention, or” and inserting “ to improve the behavioral health of students through clinical services, outreach, prevention, promotion of mental health, or”;
(H)
in paragraph (10), by striking “ mental and behavioral disorders,” and inserting “ mental and behavioral health disorders,”; and
(I)
in paragraph (12), by striking “ best practices.” and inserting “ best practices, and trauma-informed practices.”;
(3)
in subsection (d)—
(A)
in paragraph (1), by striking “ mental and substance use” and inserting “ mental health and substance use”; and
(B)
in paragraph (3), by striking “ promoting access to services,” and inserting “ promoting mental health and access to services,”
(4)
in subsection (f)—
(A)
in the matter preceding paragraph (1), by striking “ the Congress” and inserting “ the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate”;
(B)
in paragraph (2), by striking “ including efforts” and inserting “ including through prevention, early detection, early intervention, and efforts”; and
(C)
by adding at the end the following:

“(3) An assessment of the mental health and substance use disorder needs of the populations served by recipients of grants under this section.”

; and

(5)
in subsection (i), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”;

SEC. 1424. Mental and Behavioral Health Outreach and Education at Institutions of Higher Education.

Section 549 of the Public Health Service Act (42 U.S.C. 290ee–4) is amended—
(1)
in the heading, by striking “ on college campuses” and inserting “ at institutions of higher education”;
(2)
in subsection (c)(2), by inserting “ , including minority-serving institutions as described in section 371(a) of the Higher Education Act of 1965 (20 U.S.C. 1067q) and community colleges” after “ higher education”; and
(3)
in subsection (f), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.

CHAPTER 4 Media and Mental Health

SEC. 1431. Study on the Effects of Smartphone and Social Media Use on Adolescents.

(a)
In General.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services may conduct or support research on—
(1)
smartphone and social media use by adolescents; and
(2)
the effects of such use on—
(A)
emotional, behavioral, and physical health and development; and
(B)
any disparities in the mental health outcomes of rural, minority, and other underserved populations.
(b)
Report.— Not later than 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress, and make publicly available, a report on the findings of research under this section.

SEC. 1432. Research on the Health and Development Effects of Media and Related Technology on Infants, Children, and Adolescents.

(a)
In General.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall, as appropriate, conduct or support research related to the health and developmental effects, including long-term effects, of media and related technology use on infants, children, and adolescents, which may include the effects of exposure to, and use of, media and related technology, such as social media, applications, websites, television, motion pictures, artificial intelligence, mobile devices, computers, video games, virtual and augmented reality, and other content, networks, or platforms disseminated through the internet, broadcasted, or other media technologies, as applicable.
(b)
Activities.— In carrying out subsection (a), the Secretary, acting through the Director of the National Institutes of Health, shall, as appropriate, develop a research agenda to assess the effects of media and related technologies on infants, children, and adolescents, which may include consideration of the following, as appropriate:
(1)
The cognitive development of infants, children, and adolescents, which may include effects related to language development, learning abilities, and other areas of cognitive development.
(2)
The physical health of infants, children, and adolescents, which may include effects related to diet, exercise, sleeping and eating routines, and other areas of physical development.
(3)
The mental health of infants, children, and adolescents, which may include effects related to self-awareness, social awareness, relationship skills, decision-making, violence, bullying, privacy, mental disorders, and other areas related to mental health.
(c)
Consultation.— In developing the research agenda under subsection (b), the Secretary may consult with appropriate national research institutes, academies, and centers, relevant consortia, and non-Federal experts, as appropriate. The Secretary may utilize scientific workshops, symposia, and other activities to assess current knowledge and identify relevant research opportunities and gaps in this area.
(d)
Report to Congress.— Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report—
(1)
on the progress made in improving data and expanding research on the health and developmental effects of media and related technology on infants, children, and adolescents in accordance with this section; and
(2)
that summarizes the grants and research funded under this section for each of the years covered by the report.

Subtitle E Miscellaneous Provisions

SEC. 1501. Limitations on Authority.

In carrying out any program of the Substance Abuse and Mental Health Services Administration whose statutory authorization is enacted or amended by this title, the Secretary of Health and Human Services shall not allocate funding, or require award recipients to prioritize, dedicate, or allocate funding, without consideration of the incidence, prevalence, or determinants of mental health or substance use issues, unless such allocation or requirement is consistent with statute, regulation, or other Federal law.

TITLE II Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics

SEC. 2001. Short Title.

This title may be cited as the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” or the “PREVENT Pandemics Act”.

Subtitle A Strengthening Federal and State Preparedness

CHAPTER 1 Federal Leadership and Accountability

SEC. 2101. Appointment and Authority of the Director of the Centers for Disease Control and Prevention.

(a)
In General.— Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 304 the following:

“SEC. 305. APPOINTMENT AND AUTHORITY OF THE DIRECTOR OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.

“(a) In General.—The Centers for Disease Control and Prevention (referred to in this section as the ‘CDC’) shall be headed by the Director of the Centers for Disease Control and Prevention (referred to in this section as the ‘Director’), who shall be appointed by the President, by and with the advice and consent of the Senate. Such individual shall also serve as the Administrator of the Agency for Toxic Substances and Disease Registry consistent with section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act. The Director shall perform functions provided for in subsection (b) and such other functions as the Secretary may prescribe.

“(b) Functions.—The Secretary, acting through the Director, shall—

“(1) implement and exercise applicable authorities and responsibilities provided for in this Act or other applicable law related to the investigation, detection, identification, prevention, or control of diseases or conditions to preserve and improve public health domestically and globally and address injuries and occupational and environmental hazards, as appropriate;

“(2) be responsible for the overall direction of the CDC and for the establishment and implementation of policies related to the management and operation of programs and activities within the CDC;

“(3) coordinate and oversee the operation of centers, institutes, and offices within the CDC;

“(4) support, in consultation with the heads of such centers, institutes, and offices, program coordination across such centers, institutes, and offices, including through priority setting reviews and the development of strategic plans, to reduce unnecessary duplication and encourage collaboration between programs;

“(5) oversee the development, implementation, and updating of the strategic plan established pursuant to subsection (c);

“(6) ensure that appropriate strategic planning, including the use of performance metrics, is conducted by such centers, institutes, and offices to facilitate and improve CDC programs and activities;

“(7) communicate, including through convening annual meetings, with public and private entities regarding relevant public health programs and activities, and, as applicable, the strategic plan established pursuant to subsection (c).

“(c) Strategic Plan.—

“(1) In general.—Not later than 1 year after the date of enactment of the PREVENT Pandemics Act, and at least every 4 years thereafter, the Director shall develop and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and post on the website of the CDC, a coordinated strategy to provide strategic direction and facilitate collaboration across the centers, institutes, and offices within the CDC. Such strategy shall be known as the ‘CDC Strategic Plan’.

“(2) Requirements.—The CDC Strategic Plan shall—

“(A) identify strategic priorities and objectives related to—

“(i) preventing, reducing, and eliminating the spread of communicable and noncommunicable diseases or conditions, and addressing injuries, and occupational and environmental hazards;

“(ii) supporting the efforts of State, local, and Tribal health departments to prevent and reduce the prevalence of the diseases or conditions under clause (i);

“(iii) containing, mitigating, and ending disease outbreaks;

“(iv) enhancing global and domestic public health capacity, capabilities, and preparedness, including public health data, surveillance, workforce, and laboratory capacity and safety; and

“(v) other priorities, as established by the Director;

“(B) describe the capacity and capabilities necessary to achieve the priorities and objectives under subparagraph (A), and progress towards achieving such capacity and capabilities, as appropriate; and

“(C) include a description of how the CDC Strategic Plan incorporates—

“(i) strategic communications;

“(ii) partnerships with private sector entities, and State, local, and Tribal health departments, and other public sector entities, as appropriate; and

“(iii) coordination with other agencies and offices of the Department of Health and Human Services and other Federal departments and agencies, as appropriate.

“(3) Use of plans.—Strategic plans developed and updated by the centers, institutes, and offices of the CDC shall be prepared regularly and in such a manner that such plans will be informed by the CDC Strategic Plan developed and updated under this subsection.

“(d) Appearances Before Congress.—

“(1) In general.—Each fiscal year, the Director shall appear before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives at hearings on topics such as—

“(A) support for State, local, and Tribal public health preparedness and responses to any recent or ongoing public health emergency, including—

“(i) any objectives, activities, or initiatives that have been carried out, or are planned, by the Director to prepare for, or respond to, the public health emergency, including relevant strategic communications or partnerships and any gaps or challenges identified in such objectives, activities, or initiatives;

“(ii) any objectives and planned activities for the upcoming fiscal year to address gaps in, or otherwise improve, State, local, and Tribal public health preparedness; and

“(iii) other potential all-hazard threats that the Director is preparing to address;

“(B) activities related to public health and functions of the Director described in subsection (b); and

“(C) updates on other relevant activities supported or conducted by the CDC, or in collaboration or coordination with the heads of other Federal departments, agencies, or stakeholders, as appropriate.

“(2) Clarifications.—

“(A) Waiver authority.—The Chair of the Committee on Health, Education, Labor, and Pensions of the Senate or the Chair of the Committee on Energy and Commerce of the House of Representatives may waive the requirements of paragraph (1) for the applicable fiscal year with respect to the applicable Committee.

“(B) Scope of requirements.—The requirements of this subsection shall not be construed to impact the appearance of other Federal officials or the Director at hearings of either Committee described in paragraph (1) at other times and for purposes other than the times and purposes described in paragraph (1).

“(3) Closed hearings.—Information that is not appropriate for disclosure during an open hearing under paragraph (1) in order to protect national security may instead be discussed in a closed hearing that immediately follows the open hearing.

“(e) Other Transactions.—

“(1) In general.—In carrying out activities of the Centers for Disease Control and Prevention, the Director may enter into transactions other than a contract, grant, or cooperative agreement for purposes of infectious disease research, biosurveillance, infectious disease modeling, and public health preparedness and response.

“(2) Written determination.—With respect to a project that is expected to cost the Centers for Disease Control and Prevention more than $40,000,000, the Director may exercise the authority under paragraph (1) only upon a written determination by the Assistant Secretary for Financial Resources of the Department of Health and Human Services, that the use of such authority is essential to promoting the success of the project. The authority of the Assistant Secretary for Financial Resources under this paragraph may not be delegated.

“(3) Guidelines.—The Director, in consultation with the Secretary, shall establish guidelines regarding the use of the authority under paragraph (1). Such guidelines shall include auditing requirements.”

(b)
Effective Date.— The first sentence of section 305(a) of the Public Health Service Act, as added by subsection (a), shall take effect on January 20, 2025.

SEC. 2102. Advisory Committee to the Director of the Centers for Disease Control and Prevention.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 305, as added by section 2101, the following:

“SEC. 305A. ADVISORY COMMITTEE TO THE DIRECTOR.

“(a) In General.—Not later than 60 days after the date of the enactment of the PREVENT Pandemics Act, the Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this section as the ‘Director’), shall maintain or establish an advisory committee within the Centers for Disease Control and Prevention to advise the Director on policy and strategies that enable the agency to fulfill its mission.

“(b) Functions and Activities.—The Advisory Committee may—

“(1) make recommendations to the Director regarding ways to prioritize the activities of the agency in alignment with the CDC Strategic Plan required under section 305(c);

“(2) advise on ways to achieve or improve performance metrics in relation to the CDC Strategic Plan, and other relevant metrics, as appropriate;

“(3) provide advice and recommendations on the development of the CDC Strategic Plan, and any subsequent updates, as appropriate;

“(4) advise on grants, cooperative agreements, contracts, or other transactions, as applicable;

“(5) provide other advice to the Director, as requested, to fulfill duties under sections 301 and 311; and

“(6) appoint subcommittees.

“(c) Membership.—

“(1) In general.—The Advisory Committee shall consist of not more than 15 non-Federal members, including the Chair, to be appointed by the Secretary under paragraph (3).

“(2) Ex officio members.—Any ex officio members of the Advisory Council may consist of—

“(A) the Secretary;

“(B) the Assistant Secretary for Health;

“(C) the Director; and

“(D) such additional officers or employees of the United States as the Secretary determines necessary for the advisory committee to effectively carry out its functions.

“(3) Appointed members.—Individuals shall be appointed to the Advisory Committee under paragraph (1) as follows:

“(A) Twelve of the members shall be appointed by the Director from among the leading representatives of the health disciplines (including public health, global health, health disparities, biomedical research, public health preparedness, and other fields, as applicable) relevant to the activities of the agency or center, as applicable.

“(B) Three of the members may be appointed by the Secretary from the general public and may include leaders in fields of innovation, public policy, public relations, law, economics, or management.

“(4) Compensation.—Ex officio members of the Advisory Council who are officers or employees of the United States shall not receive any compensation for service on the advisory committee. The remaining members of the advisory committee may receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory committee, compensation at rates not to exceed the daily equivalent to the annual rate of basic pay for level III of the Executive Schedule under section 5314 of title 5, United States Code.

“(5) Terms of office.—

“(A) In general.—The term of office of a member of the advisory committee appointed under paragraph (3) shall be 4 years, except that any member appointed to fill a vacancy for an unexpired term shall serve for the remainder of such term. The Secretary shall make appointments to the advisory committee in such a manner as to ensure that the terms of the members not all expire in the same year. A member of the advisory committee may serve after the expiration of such member’s term until a successor has been appointed and taken office.

“(B) Reappointments.—A member who has been appointed to the advisory committee for a term of 4 years may not be reappointed to the advisory committee during the 2-year period beginning on the date on which such 4-year term expired.

“(C) Time for appointment.—If a vacancy occurs in the advisory committee among the members appointed under paragraph (3), the Secretary shall make an appointment to fill such vacancy within 90 days from the date the vacancy occurs.

“(d) Chair.—The Secretary shall select a member of the advisory committee to serve as the Chair of the committee. The Secretary may so select an individual from among the appointed members. The term of office of the chair shall be 2 years.

“(e) Meetings.—The advisory committee shall meet at the call of the Chair or upon request of the Director, but in no event less than 2 times during each fiscal year.

“(f) Executive Secretary and Staff.—The Director shall designate a member of the staff of the agency to serve as the executive secretary of the advisory committee. The Director shall make available to the advisory committee such staff, information, and other assistance as it may require to carry out its functions. The Director shall provide orientation and training for new members of the advisory committee to provide for their effective participation in the functions of the advisory committee.”

SEC. 2103. Public Health and Medical Preparedness and Response Coordination.

(a)
Public Health Emergency Fund.— Section 319(b) of the Public Health Service Act (42 U.S.C. 247d(b)) is amended—
(1)
in paragraph (2)—
(A)
in subparagraph (E), by striking “ and” at the end;
(B)
by redesignating subparagraph (F) as subparagraph (G); and
(C)
by inserting after subparagraph (E), the following:

“(F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and”

; and

(2)
by amending paragraph (3)(A) to read as follows:

“(A) the expenditures made from the Public Health Emergency Fund in such fiscal year, including—

“(i) the amount obligated;

“(ii) the recipient or recipients of such obligated funds;

“(iii) the specific response activities such obligated funds will support; and

“(iv) the declared or potential public health emergency for which such funds were obligated; and”

(b)
Improving Public Health and Medical Preparedness and Response Coordination.—
(1)
Coordination with federal agencies.— Section 2801 of the Public Health Service Act (42 U.S.C. 300hh) is amended by adding at the end the following:

“(c) Coordination With Federal Agencies.—In leading the Federal public health and medical response to a declared or potential public health emergency, consistent with this section, the Secretary shall coordinate with, and may request support from, other Federal departments and agencies, as appropriate in order to carry out necessary activities and leverage the expertise of such departments and agencies, which may include the provision of assistance at the direction of the Secretary related to supporting the public health and medical response for States, localities, and Tribes.”

(2)
ASPR duties.— Section 2811(b) of the Public Health Service Act (42 U.S.C. 300hh–10(b)) is amended—
(A)
in paragraph (1), by inserting “ and, consistent with the National Response Framework and other applicable provisions of law, assist the Secretary in carrying out the functions under section 2801” before the period; and
(B)
in paragraph (4)—
(i)
in subparagraph (E) by striking “ the actions necessary to overcome these obstacles.” and inserting

“(i) improving coordination with relevant Federal officials;

“(ii) partnering with other public or private entities to leverage capabilities maintained by such entities, as appropriate and consistent with this subsection; and

“(iii) coordinating efforts to support or establish new capabilities, as appropriate.”

(ii)
in subparagraph (G)—
(I)
by redesignating clauses (i) and (ii) as subclauses (I) and (II) and adjusting the margins accordingly;
(II)
in the matter preceding subclause (I), as so redesignated—
(aa)
by inserting “ each year, including national-level and State-level full-scale exercises not less than once every 4 years” after “ operational exercises”; and
(bb)
by striking “ exercises based on—” and inserting

“(i) based on”

(III)
by striking the period and inserting a semicolon; and
(IV)
by adding at the end the following:

“(ii) that assess the ability of the Strategic National Stockpile, as appropriate, to provide medical countermeasures, medical products, and other supplies, including ancillary medical supplies, to support the response to a public health emergency or potential public health emergency, including a threat that requires the large-scale and simultaneous deployment of stockpiles and a long-term public health and medical response; and

“(iii) conducted in coordination with State and local health officials.”

; and

(iii)
by adding at the end the following:

“(J) Medical product and supply capacity planning.—Coordinate efforts within the Department of Health and Human Services to support—

“(i) preparedness for medical product and medical supply needs directly related to responding to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and incidents covered by the National Response Framework, including—

“(I) sharing information, including with appropriate stakeholders, related to the anticipated need for, and availability of, such products and supplies during such responses;

“(II) supporting activities, which may include public-private partnerships, to maintain capacity of medical products and medical supplies, as applicable and appropriate; and

“(III) planning for potential surges in medical supply needs for purposes of a response to such a threat; and

“(ii) situational awareness with respect to anticipated need for, and availability of, such medical products and medical supplies within the United States during a response to such a threat.”

(c)
Appearances Before and Reports to Congress.— Section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) is amended by adding at the end the following:

“(g) Appearances Before Congress.—

“(1) In general.—Each fiscal year, the Assistant Secretary for Preparedness and Response shall appear before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives at hearings, on topics such as—

“(A) coordination of Federal activities to prepare for, and respond to, public health emergencies;

“(B) activities and capabilities of the Strategic National Stockpile, including whether, and the degree to which, recommendations made pursuant to section 2811–1(c)(1)(A) have been met;

“(C) support for State, local, and Tribal public health and medical preparedness;

“(D) activities implementing the countermeasures budget plan described under subsection (b)(7), including—

“(i) any challenges in meeting the full range of identified medical countermeasure needs; and

“(ii) progress in supporting advanced research, development, and procurement of medical countermeasures, pursuant to subsection (b)(3);

“(E) the strategic direction of, and activities related to, the sustainment of manufacturing surge capacity and capabilities for medical countermeasures pursuant to section 319L and the distribution and deployment of such countermeasures;

“(F) any additional objectives, activities, or initiatives that have been carried out or are planned by the Assistant Secretary for Preparedness and Response and associated challenges, as appropriate;

“(G) the specific all-hazards threats that the Assistant Secretary for Preparedness and Response is preparing to address, or that are being addressed, through the activities described in subparagraphs (A) through (F); and

“(H) objectives, activities, or initiatives related to the coordination and consultation required under subsections (b)(4)(H) and (b)(4)(I), in a manner consistent with paragraph (3), as appropriate.

“(2) Clarifications.—

“(A) Waiver authority.—The Chair of the Committee on Health, Education, Labor, and Pensions of the Senate or the Chair of the Committee on Energy and Commerce of the House of Representatives may waive the requirements of paragraph (1) for the applicable fiscal year with respect to the applicable Committee.

“(B) Scope of requirements.—The requirements of this subsection shall not be construed to impact the appearance of other Federal officials or the Assistant Secretary at hearings of either Committee described in paragraph (1) at other times and for purposes other than the times and purposes described in paragraph (1)

“(3) Closed hearings.—Information that is not appropriate for disclosure during an open hearing under paragraph (1) in order to protect national security may instead be discussed in a closed hearing that immediately follows such open hearing.”

(d)
Annual Report on Emergency Response and Preparedness.— Section 2801 of the Public Health Service Act (42 U.S.C. 300hh), as amended by subsection (b), is further amended by adding at the end the following:

“(d) Annual Report on Emergency Response and Preparedness.—The Secretary shall submit a written report each fiscal year to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, containing—

“(1) updated information related to an assessment of the response to any public health emergency declared, or otherwise in effect, during the previous fiscal year;

“(2) findings related to drills and operational exercises completed in the previous fiscal year pursuant to section 2811(b)(4)(G);

“(3) the state of public health preparedness and response capabilities for chemical, biological, radiological, and nuclear threats, including emerging infectious diseases; and

“(4) any challenges in preparing for or responding to such threats, as appropriate.”

(e)
GAO Report on Interagency Agreements and Coordination.— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall—
(1)
conduct a review of previous and current interagency agreements established between the Secretary of Health and Human Services and the heads of other relevant Federal departments or agencies pursuant to section 2801(b) of the Public Health Service Act (42 U.S.C. 300hh(b)), including—
(A)
the specific roles and responsibilities of each Federal department or agency that is a party to any such interagency agreement;
(B)
the manner in which specific capabilities of each such Federal department or agency may be utilized under such interagency agreements;
(C)
the frequency with which such interagency agreements have been utilized;
(D)
gaps, if any, in interagency agreements that prevent the Secretary from carrying out the goals under section 2802 of the Public Health Service Act (42 U.S.C. 300hh–1);
(E)
barriers, if any, to establishing or utilizing such interagency agreements; and
(F)
recommendations, if any, on the ways in which such interagency agreements can be improved to address the gaps and barriers identified under subparagraphs (D) and (E);
(2)
conduct a review of the implementation and utilization of the authorities described under section 2801(c) of the Public Health Service Act (42 U.S.C. 300hh(c)); and
(3)
submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the reviews under paragraphs (1) and (2), including related recommendations, as applicable.

SEC. 2104. Office of Pandemic Preparedness and Response Policy.

(a)
In General.— There is established in the Executive Office of the President an Office of Pandemic Preparedness and Response Policy (referred to in this section as the “Office”), which shall be headed by a Director (referred to in this section as the “Director”) appointed by the President and who shall be compensated at the rate provided for level II of the Executive Schedule in section 5313 of title 5, United States Code. The President is authorized to appoint not more than 2 Associate Directors, who shall be compensated at a rate not to exceed that provided for level III of the Executive Schedule in section 5314 of such title. Associate Directors shall perform such functions as the Director may prescribe.
(b)
Functions of the Director.— The primary function of the Director is to provide advice, within the Executive Office of the President, on policy related to preparedness for, and response to, pandemic and other biological threats that may impact national security, and support strategic coordination and communication with respect to relevant activities across the Federal Government. In addition to such other functions and activities as the President may assign, the Director, consistent with applicable laws and the National Response Framework, shall—
(1)
serve as the principal advisor to the President on all matters related to pandemic preparedness and response policy and make recommendations to the President regarding pandemic and other biological threats that may impact national security;
(2)
coordinate Federal activities to prepare for, and respond to, pandemic and other biological threats, by—
(A)
providing strategic direction to the heads of applicable Federal departments, agencies, and offices, including—
(i)
the establishment, implementation, prioritization, and assessment of policy goals and objectives across the Executive Office of the President and such departments, agencies, and offices;
(ii)
supporting the assessment and clarification of roles and responsibilities related to such Federal activities; and
(iii)
supporting the development and implementation of metrics and performance measures to evaluate the extent to which applicable activities meet such goals and objectives;
(B)
providing, in consultation with the Secretary of Health and Human Services and the heads of other relevant Federal departments, agencies, and offices, leadership with respect to the National Biodefense Strategy and related activities pursuant to section 1086 of the National Defense Authorization Act for Fiscal Year 2017 (6 U.S.C. 104) and section 363 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (6 U.S.C. 105);
(C)
facilitating coordination and communication between such Federal departments, agencies, and offices to improve preparedness for, and response to, such threats;
(D)
ensuring that the authorities, capabilities, and expertise of each such department, agency, and office are appropriately leveraged to facilitate the whole-of-Government response to such threats;
(E)
overseeing coordination of Federal efforts to prepare for and support the production, supply, and distribution of relevant medical products and supplies during a response to a pandemic or other biological threat, as applicable and appropriate, including supporting Federal efforts to assess any relevant vulnerabilities in the supply chain of such products and supplies, and identify opportunities for private entities to engage with the Federal Government to address medical product and medical supply needs during such a response;
(F)
overseeing coordination of Federal efforts for the basic and advanced research, development, manufacture, and procurement of medical countermeasures for such threats, including by—
(i)
serving, with the Secretary of Health and Human Services, as co-Chair of the Public Health Emergency Medical Countermeasures Enterprise established pursuant to section 2811–1 of the Public Health Service Act (42 U.S.C. 300hh–10a);
(ii)
promoting coordination between the medical countermeasure research, development, and procurement activities of respective Federal departments and agencies, including to advance the discovery and development of new medical products and technologies;
(G)
convening heads of Federal departments and agencies, as appropriate, on topics related to capabilities to prepare for, and respond to, such threats;
(H)
assessing and advising on international cooperation in preparing for, and responding to, such threats to advance the national security objectives of the United States; and
(I)
overseeing other Federal activities to assess preparedness for, and responses to, such threats, including—
(i)
drills and operational exercises conducted pursuant to applicable provisions of law; and
(ii)
Federal after-action reports developed following such drills and exercises or a response to a pandemic or other biological threat;
(3)
promote and support the development of relevant expertise and capabilities within the Federal Government to ensure that the United States can quickly detect, identify, and respond to such threats, and provide recommendations, as appropriate, to the President;
(4)
consult with the Director of the Office of Management and Budget and other relevant officials within the Executive Office of the President, including the Assistant to the President for National Security Affairs and the Director of the Office of Science and Technology Policy, regarding activities related to preparing for, and responding to, such threats and relevant research and emerging technologies that may advance the biosecurity and preparedness and response goals of the Federal Government;
(5)
identify opportunities to leverage current and emerging technologies, including through public-private partnerships, as appropriate, to address such threats and advance the preparedness and response goals of the Federal Government; and
(6)
ensure that findings of Federal after-action reports conducted pursuant to paragraph (2)(I)(ii) are implemented to the maximum extent feasible within the Federal Government.
(c)
Support From Other Agencies.— Each department, agency, and instrumentality of the executive branch of the Federal Government, including any independent agency, is authorized to support the Director by providing the Director such information as the Director determines necessary to carry out the functions of the Director under this section.
(d)
Preparedness Outlook Report.—
(1)
In general.— Within its first year of operation, the Director, in consultation with the heads of relevant Federal departments and agencies and other officials within the Executive Office of the President, shall through a report submitted to the President and made available to the public, to the extent practicable, identify and describe situations and conditions which warrant special attention within the next 5 years, involving current and emerging problems of national significance related to pandemic or other biological threats, and opportunities for, and the barriers to, the research, development, and procurement of medical countermeasures to adequately respond to such threats.
(2)
Revisions.— The Office shall revise the report under paragraph (1) not less than once every 5 years and work with relevant Federal officials to address the problems, barriers, opportunities, and actions identified under this report through the development of the President’s Budgets and programs.
(e)
Interdepartmental Working Group.— The Director shall lead an interdepartmental working group that will meet on a regular basis to evaluate national biosecurity and pandemic preparedness issues and make recommendations to the heads of applicable Federal departments, agencies and offices. The working group shall consist of representatives from—
(1)
the Office of Pandemic Preparedness and Response Policy, to serve as the chair;
(2)
the Department of Health and Human Services;
(3)
the Department of Homeland Security;
(4)
the Department of Defense;
(5)
the Office of Management and Budget; and
(6)
other Federal Departments and agencies.
(f)
Industry Liaison.—
(1)
In general.— Not later than 10 days after the initiation of a Federal response to a pandemic or other biological threat that may pose a risk to national security, the Director shall appoint an Industry Liaison within the Office of Pandemic Preparedness and Response Policy to serve until the termination of such response.
(2)
Activities.— The Industry Liaison shall—
(A)
not later than 20 days after the initiation of such response, identify affected industries and develop a plan to regularly communicate with, and receive input from, affected industries;
(B)
work with relevant Federal departments and agencies to support information sharing and coordination with industry stakeholders; and
(C)
communicate, and support the provision of technical assistance, as applicable, with private entities interested in supporting such response, which may include entities not historically involved in the public health or medical sectors, as applicable and appropriate.
(g)
Additional Functions of the Director.— The Director, in addition to the other duties and functions set forth in this section—
(1)
shall—
(A)
serve as a member of the Domestic Policy Council and the National Security Council;
(B)
serve as a member of the Intergovernmental Science, Engineering, and Technology Advisory Panel under section 205(b) of the National Science and Technology Policy, Organization, and Priorities Act of 1976 (42 U.S.C. 6614(b)) and the Federal Coordinating Council for Science, Engineering and Technology under section 401 of such Act (42 U.S.C. 6651);
(C)
consult with State, Tribal, local, and territorial governments, industry, academia, professional societies, and other stakeholders, as appropriate;
(D)
use for administrative purposes, on a reimbursable basis, the available services, equipment, personnel, and facilities of Federal, State, and local agencies; and
(E)
at the President’s request, perform such other duties and functions and enter into contracts and other arrangements for studies, analyses, and related services with public or private entities, as applicable and appropriate; and
(2)
may hold such hearings in various parts of the United States as necessary to determine the views of the entities and individuals referred to in paragraph (1) and of the general public, concerning national needs and trends in pandemic preparedness and response.
(h)
Staffing and Detailees.— In carrying out functions under this section, the Director may—
(1)
appoint not more than 25 individuals to serve as employees of the Office as necessary to carry out this section;
(2)
fix the compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code;
(3)
utilize the services of consultants, which may include by obtaining services described under section 3109(b) of title 5, United States Code, at rates not to exceed the rate of basic pay for level IV of the Executive Schedule; and
(4)
direct, with the concurrence of the Secretary of a department or head of an agency, the temporary reassignment within the Federal Government of personnel employed by such department or agency, in order to carry out the functions of the Office.
(i)
Preparedness Review and Report.— The Director, in consultation with the heads of applicable Federal departments, agencies, and offices, shall—
(1)
not later than 1 year after the date of enactment of this Act, conduct a review of applicable Federal strategies, policies, procedures, and after-action reports to identify gaps and inefficiencies related to pandemic preparedness and response;
(2)
not later than 18 months after the date of enactment of this Act, and every 2 years thereafter, submit to the President and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing—
(A)
current and emerging pandemic and other biological threats that pose a significant level of risk to national security;
(B)
the roles and responsibilities of the Federal Government in preparing for, and responding to, such threats;
(C)
the findings of the review conducted under paragraph (1);
(D)
any barriers or limitations related to addressing such findings;
(E)
current and planned activities to update Federal strategies, policies, and procedures to address such findings, consistent with applicable laws and the National Response Framework;
(F)
current and planned activities to support the development of expertise within the Federal Government pursuant to subsection (b)(3); and
(G)
opportunities to improve Federal preparedness and response capacities and capabilities through the use of current and emerging technologies.
(j)
Nonduplication of Effort.— The Director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other Federal departments, agencies, and offices.
(k)
Conforming Amendments.—
(1)
Section 2811–1 of the Public Health Service Act (42 U.S.C. 300hh–10a) is amended—
(A)
in the second sentence of subsection (a), by striking “ shall serve as chair” and inserting “ and the Director of the Office of Pandemic Preparedness and Response Policy shall serve as co-chairs”; and
(B)
in subsection (b)—
(i)
by redesignating paragraph (10) as paragraph (11); and
(ii)
by inserting after paragraph (9) the following:

“(10) The Director of the Office of Pandemic Preparedness and Response Policy.”

(2)
Section 101(c)(1) of the National Security Act of 1947 (50 U.S.C. 3021(c)(1)) is amended by inserting “ the Director of the Office of Pandemic Preparedness and Response Policy” after “ Treasury,”.
(3)
The National Science and Technology Policy, Organization, and Priorities Act of 1976 (42 U.S.C. 6601 et seq.) is amended—
(A)
in section 205(b)(2) (42 U.S.C. 6614(b)(2))—
(i)
by striking “ and (C)” and inserting “ (C)”; and
(ii)
by striking the period at the end and inserting “ ; and (D) the Director of the Office of Pandemic Preparedness and Response Policy.”; and
(B)
in section 401(b) (42 U.S.C. 6651(b)), by inserting “ , the Director of the Office of Pandemic Preparedness and Response Policy,” after “ Technology Policy”.

CHAPTER 2 State and Local Readiness

SEC. 2111. Improving State and Local Public Health Security.

(a)
In General.— Section 319C–1(b)(2) of the Public Health Service Act (42 U.S.C. 247d–3a(b)(2)) is amended—
(1)
in subparagraph (A)—
(A)
in clause (vii), by inserting “ during and” before “ following a public health emergency”;
(B)
by amending clause (viii) to read as follows:

“(viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State education agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965), State child care lead agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990), and other relevant State agencies”

(C)
in clause (xi), by striking “ ; and” and inserting a semicolon;
(D)
by redesignating clause (xii) as clause (xiii); and
(E)
by inserting after clause (xi) the following:

“(xii) a description of how the entity will provide technical assistance to improve public health preparedness and response, as appropriate, to agencies or other entities that operate facilities within the entity’s jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public health emergency declared under section 319, such as residential care facilities, group homes, and other similar settings; and”

(2)
by redesignating subparagraphs (D) through (H) as subparagraphs (E) through (I), respectively; and
(3)
by inserting after subparagraph (C) the following:

“(D) an assurance that the entity will require relevant staff to complete relevant preparedness and response trainings, including trainings related to efficient and effective operation during an incident or event within an Incident Command System;”

(b)
Applicability.— The amendments made by subsection (a) shall not apply with respect to any cooperative agreement entered into prior to the date of enactment of this Act.

SEC. 2112. Supporting Access to Mental Health and Substance Use Disorder Services During Public Health Emergencies.

(a)
Authorities.— Section 501(d) of the Public Health Service Act (42 U.S.C. 290aa(d)) is amended—
(1)
by redesignating paragraphs (24) and (25) as paragraphs (25) and (26), respectively; and
(2)
by inserting after paragraph (23) the following:

“(24) support the continued access to, or availability of, mental health and substance use disorder services during, or in response to, a public health emergency declared under section 319, including in consultation with, as appropriate, the Assistant Secretary for Preparedness and Response, the Director of the Centers for Disease Control and Prevention, and the heads of other relevant agencies, in preparing for, and responding to, a public health emergency;”

(b)
Strategic Plan.— Section 501(l)(4) of the Public Health Service Act (42 U.S.C. 290aa(l)(4)) is amended—
(1)
in subparagraph (E), by striking “ and” at the end;
(2)
in subparagraph (F), by striking the period and inserting “ ; and”; and
(3)
by adding at the end the following:

“(G) specify a strategy to support the continued access to, or availability of, mental health and substance use disorder services, including to at-risk individuals (as defined in section 2802(b)(4)), during, or in response to, public health emergencies declared pursuant to section 319.”

(c)
Biennial Report Concerning Activities and Progress.— Section 501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)) is amended—
(1)
by redesignating paragraphs (4) through (7) as paragraphs (5) through (8), respectively;
(2)
by inserting after paragraph (3) the following:

“(4) a description of the Administration’s activities to support the continued provision of mental health and substance use disorder services, as applicable, in response to public health emergencies declared pursuant to section 319;”

; and

(3)
in paragraph (5), as so redesignated—
(A)
by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and
(B)
by inserting after subparagraph (C) the following:

“(D) relevant preparedness and response activities;”

(d)
Advisory Councils.— Not later than 1 year after the date of enactment of this Act, the Assistant Secretary for Mental Health and Substance Use shall issue a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, reflecting the feedback of the advisory councils for the Center for Substance Abuse Treatment, the Center for Substance Abuse Prevention, and the Center for Mental Health Services, pursuant to section 502 of the Public Health Service Act (42 U.S.C. 290aa–1), with recommendations to improve the continued provision of mental health and substance use disorder services during a public health emergency declared under section 319 of such Act (42 U.S.C. 247d), and the provision of such services as part of the public health and medical response to such an emergency, consistent with title XXVIII of such Act (42 U.S.C. 300hh et seq.), including related to the capacity of the mental health and substance use disorder workforce and flexibilities provided to awardees of mental health and substance use disorder programs.
(e)
GAO Report.— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on programs and activities of the Substance Abuse and Mental Health Services Administration to support the provision of mental health and substance use disorder services and related activities during the COVID–19 pandemic, including the provision of such services as part of the medical and public health response to such pandemic. Such report shall—
(1)
examine the role played by the advisory councils described in section 502 of the Public Health Service Act (42 U.S.C. 290aa–1) and the National Mental Health and Substance Use Policy Laboratory established under section 501A of such Act (42 U.S.C. 290aa–0) in providing technical assistance and recommendations to the Substance Abuse and Mental Health Services Administration to support the response of such agency to the public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19;
(2)
describe the manner in which existing awardees of mental health and substance use disorder programs provided and altered delivery of services during such public health emergency, including information on the populations served by such awardees and any barriers faced in delivering services; and
(3)
describe activities of the Substance Abuse and Mental Health Services Administration to support the response to such public health emergency, including through technical assistance, provision of services, and any flexibilities provided to such existing awardees, and any barriers faced in implementing such activities.

SEC. 2113. Trauma Care Reauthorization.

(a)
In General.— Section 1201 of the Public Health Service Act (42 U.S.C. 300d) is amended—
(1)
in subsection (a)—
(A)
in paragraph (3)—
(i)
by inserting “ analyze,” after “ compile,”; and
(ii)
by inserting “ and medically underserved areas” before the semicolon;
(B)
in paragraph (4), by adding “ and” after the semicolon;
(C)
by striking paragraph (5); and
(D)
by redesignating paragraph (6) as paragraph (5);
(2)
by redesignating subsection (b) as subsection (c); and
(3)
by inserting after subsection (a) the following:

“(b) Trauma Care Readiness and Coordination.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall support the efforts of States and consortia of States to coordinate and improve emergency medical services and trauma care during a public health emergency declared by the Secretary pursuant to section 319 or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act. Such support may include—

“(1) developing, issuing, and updating guidance, as appropriate, to support the coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care;

“(2) disseminating, as appropriate, information on evidence-based or evidence-informed trauma care practices, taking into consideration emergency medical services and trauma care systems, including such practices identified through activities conducted under subsection (a) and which may include the identification and dissemination of performance metrics, as applicable and appropriate; and

“(3) other activities, as appropriate, to optimize a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, and emergency medical systems.”

(b)
Grants to Improve Trauma Care in Rural Areas.— Section 1202 of the Public Health Service Act (42 U.S.C. 300d–3) is amended—
(1)
by amending the section heading to read as follows: “ grants to improve trauma care in rural areas”;
(2)
by amending subsections (a) and (b) to read as follows:

“(a) In General.—The Secretary shall award grants to eligible entities for the purpose of carrying out research and demonstration projects to support the improvement of emergency medical services and trauma care in rural areas through the development of innovative uses of technology, training and education, transportation of seriously injured patients for the purposes of receiving such emergency medical services, access to prehospital care, evaluation of protocols for the purposes of improvement of outcomes and dissemination of any related best practices, activities to facilitate clinical research, as applicable and appropriate, and increasing communication and coordination with applicable State or Tribal trauma systems.

“(b) Eligible Entities.—

“(1) In general.—To be eligible to receive a grant under this section, an entity shall be a public or private entity that provides trauma care in a rural area.

“(2) Priority.—In awarding grants under this section, the Secretary shall give priority to eligible entities that will provide services under the grant in any rural area identified by a State under section 1214(d)(1).”

; and

(3)
by adding at the end the following:

“(d) Reports.—An entity that receives a grant under this section shall submit to the Secretary such reports as the Secretary may require to inform administration of the program under this section.”

(c)
Competitive Grants for Trauma Centers.— Section 1204 of the Public Health Service Act (42 U.S.C. 300d–6) is amended—
(1)
by amending the section heading to read as follows: “ competitive grants for trauma centers”;
(2)
in subsection (a)—
(A)
by striking “ that design, implement, and evaluate” and inserting “ to design, implement, and evaluate new or existing”;
(B)
by striking “ emergency care” and inserting “ emergency medical”; and
(C)
by inserting “ , and improve access to trauma care within such systems” before the period;
(3)
in subsection (b)(1), by striking subparagraphs (A) and (B) and inserting the following:

“(A) a State or consortia of States;

“(B) an Indian Tribe or Tribal organization (as defined in section 4 of the Indian Self-Determination and Education Assistance Act);

“(C) a consortium of level I, II, or III trauma centers designated by applicable State or local agencies within an applicable State or region, and, as applicable, other emergency services providers; or

“(D) a consortium or partnership of nonprofit Indian Health Service, Indian Tribal, and urban Indian trauma centers.”

(4)
in subsection (c)—
(A)
in the matter preceding paragraph (1)—
(i)
by striking “ that proposes a pilot project”;
(ii)
by striking “ an emergency medical and trauma system that—” and inserting “ a new or existing emergency medical and trauma system. Such eligible entity shall use amounts awarded under this subsection to carry out 2 or more of the following activities:”;
(B)
in paragraph (1) —
(i)
by striking “ coordinates” and inserting “ Strengthening coordination and communication”; and
(ii)
by striking “ an approach to emergency medical and trauma system access throughout the region, including 9–1–1 Public Safety Answering Points and emergency medical dispatch;” and inserting “ approaches to improve situational awareness and emergency medical and trauma system access.”;
(C)
in paragraph (2)—
(i)
by striking “ includes” and inserting “ Providing”;
(ii)
by inserting “ support patient movement to” after “ region to”; and
(iii)
by striking the semicolon and inserting a period;
(D)
in paragraph (3)—
(i)
by striking “ allows for” and inserting “ Improving”; and
(ii)
by striking “ ; and” and inserting a period;
(E)
in paragraph (4), by striking “ includes a consistent” and inserting “ Supporting a consistent”; and
(F)
by adding at the end the following:

“(5) Establishing, implementing, and disseminating, or utilizing existing, as applicable, evidence-based or evidence-informed practices across facilities within such emergency medical and trauma system to improve health outcomes, including such practices related to management of injuries, and the ability of such facilities to surge.

“(6) Conducting activities to facilitate clinical research, as applicable and appropriate.”

(5)
in subsection (d)(2)—
(A)
in subparagraph (A)—
(i)
in the matter preceding clause (i), by striking “ the proposed” and inserting “ the applicable emergency medical and trauma system”;
(ii)
in clause (i), by inserting “ or Tribal entity” after “ equivalent State office”; and
(iii)
in clause (vi), by striking “ ; and” and inserting a semicolon;
(B)
by redesignating subparagraph (B) as subparagraph (C); and
(C)
by inserting after subparagraph (A) the following:

“(B) for eligible entities described in subparagraph (C) or (D) of subsection (b)(1), a description of, and evidence of, coordination with the applicable State Office of Emergency Medical Services (or equivalent State Office) or applicable such office for a Tribe or Tribal organization; and”

(6)
in subsection (e), by adding at the end the following:

“(3) Effective date.—The matching requirement described in paragraph (1) shall take effect on October 1, 2025.”

(7)
in subsection (f), by striking “ population in a medically underserved area” and inserting “ medically underserved population”;
(8)
in subsection (g)—
(A)
in the matter preceding paragraph (1), by striking “ described in”;
(B)
in paragraph (2), by striking “ the system characteristics that contribute to” and inserting “ opportunities for improvement, including recommendations for how to improve”;
(C)
by striking paragraph (4);
(D)
by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively;
(E)
in paragraph (4), as so redesignated, by striking “ ; and” and inserting a semicolon;
(F)
in paragraph (5), as so redesignated, by striking the period and inserting “ ; and”; and
(G)
by adding at the end the following:

“(6) any evidence-based or evidence-informed strategies developed or utilized pursuant to subsection (c)(5).”

; and

(9)
by amending subsection (h) to read as follows:

“(h) Dissemination of Findings.—Not later than 1 year after the completion of the final project under subsection (a), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the information contained in each report submitted pursuant to subsection (g) and any additional actions planned by the Secretary related to regionalized emergency care and trauma systems.”

(d)
Program Funding.— Section 1232(a) of the Public Health Service Act (42 U.S.C. 300d–32(a)) is amended by striking “ 2010 through 2014” and inserting “ 2023 through 2027”.

SEC. 2114. Assessment of Containment and Mitigation of Infectious Diseases.

(a)
GAO Study.— The Comptroller General of the United States shall conduct a study that reviews a geographically diverse sample of States and territories that, in response to the COVID–19 pandemic, implemented preparedness and response plans that included isolation and quarantine recommendations or requirements. Such study shall include—
(1)
a review of such State and territorial preparedness and response plans in place during the COVID–19 pandemic, an assessment of the extent to which such plans facilitated or presented challenges to State and territorial responses to such public health emergency, including response activities relating to isolation and quarantine to prevent the spread of COVID–19; and
(2)
a description of the technical assistance provided by the Federal Government to help States and territories facilitate such response activities during responses to relevant public health emergencies declared by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, including the public health emergency with respect to COVID–19, and a review of the degree to which such State and territorial plans were implemented and subsequently revised in response to the COVID–19 pandemic to address any challenges.
(b)
Report.— Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit a report on the study under subsection (a) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

SEC. 2115. Consideration of Unique Challenges in Noncontiguous States and Territories.

During any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the Secretary of Health and Human Services shall conduct quarterly meetings or consultations, as applicable or appropriate, with noncontiguous States and territories with regard to addressing unique public health challenges in such States and territories associated with such public health emergency.

Subtitle B Improving Public Health Preparedness and Response Capacity

CHAPTER 1 Improving Public Health Emergency Responses

SEC. 2201. Addressing Factors Related to Improving Health Outcomes.

(a)
In General.— Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended—
(1)
by inserting after section 317U the following:

“SEC. 317V. ADDRESSING FACTORS RELATED TO IMPROVING HEALTH OUTCOMES.

“(a) In General.—The Secretary may, as appropriate, award grants, contracts, or cooperative agreements to eligible entities for the conduct of evidence-based or evidence-informed projects, which may include the development of networks to improve health outcomes by improving the capacity of such entities to address factors that contribute to negative health outcomes in communities.

“(b) Eligible Entities.—To be eligible to receive an award under this section, an entity shall—

“(1)

(A) be a State, local, or Tribal health department, community-based organization, Indian Tribe or Tribal organization (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), or other public or private entity, as the Secretary determines appropriate; or

“(B) be a consortia of entities described in subparagraph (A) or a public-private partnership, including a community partnership;

“(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary shall require;

“(3) in the case of an entity other than a community-based organization, demonstrate a history of successfully working with an established community-based organization to address health outcomes; and

“(4) submit a plan to conduct activities described in subsection (a) based on a community needs assessment that takes into account community input.

“(c) Use of Funds.—An entity described in subsection (b) shall use funds received under subsection (a), in consultation with State, local, and Tribal health departments, community-based organizations, entities serving medically underserved communities, and other entities, as applicable, for one or more of the following purposes:

“(1) Supporting the implementation, evaluation, and dissemination of strategies, through evidence-informed or evidence-based programs and through the support and use of public health and health care professionals to address factors related to health outcomes.

“(2) Establishing, maintaining, or improving, in consultation with State, local, or Tribal health departments, technology platforms or networks to support, in a manner that is consistent with applicable Federal and State privacy law—

“(A) coordination among appropriate entities, and, as applicable and appropriate, activities to improve such coordination;

“(B) information sharing on health and related social services; and

“(C) technical assistance and related support for entities participating in the platforms or networks.

“(3) Implementing best practices for improving health outcomes and reducing disease among underserved populations.

“(4) Supporting consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, research, and other relevant activities.

“(d) Best Practices and Technical Assistance.—The Secretary, in consultation with the Director of the Office of Minority Health, the National Coordinator for Health Information Technology, and the Administrator of the Administration for Community Living, may award grants, contracts, and cooperative agreements to public or nonprofit private entities, including minority serving institutions (defined, for purposes of this subsection, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institutions described in section 371(a) of such Act of 1965), to—

“(1) identify or facilitate the development of best practices to support improved health outcomes for underserved populations;

“(2) provide technical assistance, training, and evaluation assistance to award recipients under subsection (a);

“(3) disseminate best practices, including to award recipients under subsection (a); and

“(4) leverage, establish, or operate regional centers to develop, evaluate, and disseminate effective strategies on factors related to health outcomes, including supporting research and training related to such strategies.

“(e) Award Periods.—The Secretary shall issue awards under this section for periods of not more than 5 years and may issue extensions of such award periods for an additional period of up to 3 years.

“(f) Report.—Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes information on activities funded under this section. Such report shall include a description of—

“(1) changes in the capacity of public health entities to address factors related to health outcomes in communities, including any applicable platforms or networks developed or utilized to coordinate health and related social services and any changes in workforce capacity or capabilities;

“(2) improvements in health outcomes and in reducing health disparities in medically underserved communities;

“(3) activities conducted to support consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, and other relevant activities;

“(4) communities and populations served by recipients of awards under subsection (a);

“(5) activities supported under subsection (e); and

“(6) other relevant activities and outcomes, as determined by the Secretary.

“(g) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated $35,000,000 for each of fiscal years 2023 through 2027. Of the amounts appropriated under this subsection for a fiscal year, 5 percent shall be reserved for awards under subsection (a) to Indian Tribes and Tribal organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), urban Indian organizations (as defined in section 4 of the Indian Health Care Improvement Act), and Tribal health departments.”

; and

(2)
by striking section 330D (42 U.S.C. 254c–4).
(b)
GAO Study and Report.— Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Energy and Committee on Energy and Commerce of the House of Representatives a report on the program authorized under section 317V of the Public Health Service Act, as added by subsection (a), including a review of the outcomes and effectiveness of the program and coordination with other programs in the Department of Health and Human Services with similar goals to ensure that there was no unnecessary duplication of efforts.

CHAPTER 2 Improving State, Local, and Tribal Public Health Data

SEC. 2211. Modernizing State, Local, and Tribal Biosurveillance Capabilities and Infectious Disease Data.

Section 319D of the Public Health Service Act (42 U.S.C. 247d–4) is amended—
(1)
in subsection (a)(3)—
(A)
in the matter that precedes subparagraph (A), by striking “ . Activities” and all that follows through “ include” and inserting “ , by”; and
(B)
in subparagraph (D), by inserting “ , infectious disease outbreaks,” after “ bioterrorism”;
(2)
in subsection (b)—
(A)
in paragraph (1)—
(i)
in subparagraph (A)—
(I)
by striking “ , and local” and inserting “ , local, and Tribal”; and
(II)
by adding “ and” after the semicolon;
(ii)
in subparagraph (B), by striking “ ; and” and inserting “ ;”; and
(iii)
by striking subparagraph (C); and
(B)
in paragraph (2)—
(i)
by inserting “ , deidentified” before “ information”; and
(ii)
by adding at the end the following: “ The Secretary shall ensure that the activities carried out pursuant to the previous sentence are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and State information privacy or security law, at a minimum.”;
(3)
in subsection (c)—
(A)
in paragraph (1)—
(i)
by inserting “ modernize,” after “ establish,”;
(ii)
by inserting “ that is deidentified, as applicable,” after “ share data and information”;
(iii)
by inserting “ , to the extent practicable” before the period of the second sentence; and
(iv)
by adding at the end the following: “ The Secretary shall ensure that the activities carried out pursuant to this paragraph are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and State information privacy or security law, at a minimum.”;
(B)
in paragraph (3)—
(i)
in subparagraph (A)—
(I)
in clause (iii), by adding “ and” after the semicolon;
(II)
in clause (iv), by striking “ ; and” and inserting a period; and
(III)
by striking clause (v); and
(ii)
in subparagraph (B), by inserting “ , and make recommendations to improve the quality of data collected pursuant to subparagraph (A) to ensure complete, accurate, and timely sharing of such data, as appropriate, across such elements as described in subparagraph (A)” after “ under subparagraph (A)”;
(C)
in paragraph (5)—
(i)
in subparagraph (A)—
(I)
in the matter preceding clause (i), by striking “ and operating” and inserting “ , operating, and updating, as appropriate,”;
(II)
in clause (iii)—
(aa)
by inserting “ that is deidentified, as applicable,” after “ analyses”; and
(bb)
by inserting “ in accordance with applicable Federal and State privacy and security law” before the semicolon at the end;
(III)
in clause (iv), by striking “ and” at the end;
(IV)
in clause (v), by striking the period and inserting “ ; and”; and
(V)
by adding at the end the following:

“(vi) in collaboration with State, local, and Tribal public health officials, integrate and update applicable existing public health data systems and networks of the Department of Health and Human Services to reflect technological advancements, consistent with section 2823, as applicable.”

; and

(ii)
in subparagraph (B)—
(I)
in clause (i), by inserting “ and 180 days after the date of enactment of the PREVENT Pandemics Act,” after “ Innovation Act of 2019,”;
(II)
in clause (ii), by striking “ and other representatives as the Secretary determines appropriate” and inserting “ experts in State-based public health data systems; experts in standards and implementation specifications, including transaction standards; and experts in privacy and data security”; and
(III)
in clause (iii)—
(aa)
in subclause (IV), by inserting “ , including existing public health data systems” before the semicolon;
(bb)
in subclause (V), by striking “ and” at the end;
(cc)
in subclause (VI), by striking the period and inserting a semicolon; and
(dd)
by adding at the end the following:

“(VII) strategies to integrate laboratory and public health data systems and capabilities to support rapid and accurate reporting of laboratory test results and associated relevant data;

“(VIII) strategies to improve the collection, reporting, and dissemination of relevant, aggregated, deidentified demographic data to inform responses to public health emergencies, including identification of at-risk populations and to address potential health disparities; and

“(IX) strategies to improve the electronic exchange of health information, as appropriate, between State and local health departments and health care providers and facilities to improve the detection of, and responses to, potentially catastrophic infectious disease outbreaks.”

(D)
in paragraph (6)(A)—
(i)
in the matter preceding clause (i), by inserting “ and every 5 years thereafter,” after “ Innovation Act of 2019,”
(ii)
in clause (iii)—
(I)
in subclause (III), by striking “ and” at the end; and
(II)
by adding at the end the following:

“(V) improve coordination and collaboration, as appropriate, with other Federal departments to improve the capabilities of the network and reduce administrative burden on State, local, and Tribal entities; and

“(VI) implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities;”

(iii)
in clause (iv), by striking “ and” at the end;
(iv)
in clause (v), by striking the period and inserting “ , including a description of how such steps will further the goals of the network, consistent with paragraph (1); and”; and
(v)
by adding at the end the following:

“(vi) identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of laboratory test results, deidentified as appropriate, during a public health emergency, and improve coordination and collaboration with State, local, and Tribal public health officials, clinical laboratories, and other entities with expertise in public health surveillance.”

; and

(E)
by adding at the end the following:

“(9) Rules of construction.—

“(A) Nothing in this subsection shall be construed to supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to public health surveillance.

“(B) Nothing in this subsection shall be construed to alter the authority of the Secretary with respect to the types of data the Secretary may receive through systems supported or established under this section.”

(4)
in subsection (d)—
(A)
in paragraph (2)—
(i)
in subparagraph (A)—
(I)
by inserting “ deidentified” before “ data, information”; and
(II)
by inserting “ , in consultation with such State or consortium of States” before the semicolon;
(ii)
in subparagraph (C), by inserting “ , including any public-private partnerships or other partnerships entered into to improve such capacity” before the semicolon; and
(B)
by adding at the end the following:

“(6) Non-duplication of effort.—The Secretary shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the Department of Health and Human Services.”

(5)
by striking subsection (e);
(6)
by redesignating subsections (f), (g), (h), (i), and (j), as subsections (e), (f), (g), (h), and (i), respectively;
(7)
by striking subsection (h), as redesignated by paragraph (6), and inserting the following:

“(h) Authorization of Appropriations.—There are authorized to be appropriated—

“(1) to carry out subsection (a), $25,000,000 for each of fiscal years 2022 and 2023; and

“(2) to carry out subsections (b), (c), and (d), $136,800,000 for each of fiscal years 2022 and 2023.”

; and

(8)
by striking “ tribal” each place it appears and inserting “ Tribal”.

SEC. 2212. Genomic Sequencing, Analytics, and Public Health Surveillance of Pathogens.

(a)
Guidance Supporting Genomic Sequencing of Pathogens Collaboration.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), in consultation with the heads of other Federal departments or agencies, as appropriate, shall issue guidance to support collaboration relating to genomic sequencing of pathogens, including the use of new and innovative approaches and technology for the detection, characterization, and sequencing of pathogens, to improve public health surveillance and preparedness and response activities, consistent with section 2824 of the Public Health Service Act, as added by subsection (b). Such guidance shall address the secure sharing, for public health surveillance purposes, of specimens of such pathogens, between appropriate entities and public health authorities, consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), as applicable, and in a manner that protects personal privacy to the extent required by applicable privacy law, at a minimum, and the appropriate use of sequence data derived from such specimens.
(b)
Genomic Sequencing Program.— Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.) is amended by adding at the end the following:

“SEC. 2824. GENOMIC SEQUENCING, ANALYTICS, AND PUBLIC HEALTH SURVEILLANCE OF PATHOGENS PROGRAM.

“(a) Genomic Sequencing, Analytics, and Public Health Surveillance of Pathogens Program.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institutes of Health and heads of other departments and agencies, as appropriate, shall strengthen and expand activities related to genomic sequencing of pathogens, including through new and innovative approaches and technology for the detection, characterization, and sequencing of pathogens, analytics, and public health surveillance, including—

“(1) continuing and expanding activities, which may include existing genomic sequencing activities related to advanced molecular detection, to—

“(A) identify and respond to emerging infectious disease threats; and

“(B) identify the potential use of genomic sequencing technologies, advanced computing, and other advanced technology to inform surveillance activities and incorporate the use of such technologies, as appropriate, into related activities;

“(2) providing technical assistance and guidance to State, Tribal, local, and territorial public health departments to increase the capacity of such departments to perform genomic sequencing of pathogens, including recipients of funding under section 2821;

“(3) carrying out activities to enhance the capabilities of the public health workforce with respect to pathogen genomics, epidemiology, and bioinformatics, including through training; and

“(4) continuing and expanding activities, as applicable, with public and private entities, including relevant departments and agencies, laboratories, academic institutions, and industry.

“(b) Partnerships.—For the purposes of carrying out the activities described in subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative agreements to entities, including academic and other laboratories, with expertise in genomic sequencing for public health purposes, including new and innovative approaches to, and related technology for, the detection, characterization, and sequencing of pathogens.

“(c) Centers of Excellence.—

“(1) In general.—The Secretary shall, as appropriate, award grants, contracts, or cooperative agreements to public health agencies for the establishment or operation of centers of excellence to promote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emergency. Such centers shall, as appropriate—

“(A) identify and evaluate the use of genomics, or other related technologies that may advance public health preparedness and response;

“(B) improve the identification, development, and use of tools for integrating and analyzing genomic and epidemiologic data;

“(C) assist with genomic surveillance of, and response to, infectious diseases, including analysis of pathogen genomic data;

“(D) conduct applied research to improve public health surveillance of, and response to, infectious diseases through innovation in pathogen genomics and molecular epidemiology; and

“(E) develop and provide training materials for experts in the fields of genomics, microbiology, bioinformatics, epidemiology, and other fields, as appropriate.

“(2) Requirements.—To be eligible for an award under paragraph (1), an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will partner, as applicable, with academic institutions or a consortium of academic partners that have relevant expertise, such as microbial genomics, molecular epidemiology, or the application of bioinformatics or statistics.”

(c)
Report to Congress.— Not later than 90 days after the date of enactment of the PREVENT Pandemics Act, and 90 days following expenditure of all funds under section 2402 of the American Rescue Plan Act of 2021 (Public Law 117–2), the Director of the Centers for Disease Control and Prevention shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives outlining how funds awarded under such section 2402 were expended as of the date of such report.

SEC. 2213. Supporting State, Local, and Tribal Public Health Data.

(a)
Designation of Public Health Data Standards.— Section 2823(a)(2) of the Public Health Service Act (42 U.S.C. 300hh–33(a)(2)) is amended—
(1)
by striking “ In carrying out” and inserting the following:

“(A) In general.—In carrying out”

; and

(2)
by striking “ shall, as appropriate and” and inserting “ shall, not later than 2 years after the date of enactment of the PREVENT Pandemics Act,”; and
(3)
by adding at the end the following:

“(B) No duplicative efforts.—

“(i) In general.—In carrying out the requirements of this paragraph, the Secretary, in consultation with the Office of the National Coordinator for Health Information Technology, may use input gathered (including input and recommendations gathered from the Health Information Technology Advisory Committee), and materials developed, prior to the date of enactment of the PREVENT Pandemics Act.

“(ii) Designation of standards.—Consistent with sections 13111 and 13112 of the HITECH Act, the data and technology standards designated pursuant to this paragraph shall align with the standards and implementation specifications previously adopted by the Secretary pursuant to section 3004, as applicable.

“(C) Privacy and security.—Nothing in this paragraph shall be construed as modifying applicable Federal or State information privacy or security law.”

(b)
Study on Laboratory Information Standards.—
(1)
In general.— Not later than 1 year after the date of enactment of this Act, the Office of the National Coordinator for Health Information Technology shall conduct a study to review the use of standards for electronic ordering and reporting of laboratory test results.
(2)
Areas of concentration.— In conducting the study under paragraph (1), the Office of the National Coordinator for Health Information Technology shall—
(A)
determine the extent to which clinical laboratories are using standards for electronic ordering and reporting of laboratory test results;
(B)
assess trends in laboratory compliance with standards for ordering and reporting laboratory test results and the effect of such trends on the interoperability of laboratory data with public health data systems;
(C)
identify challenges related to collection and reporting of demographic and other data elements with respect to laboratory test results;
(D)
identify any challenges associated with using or complying with standards and reporting laboratory test results with data elements identified in standards for electronic ordering and reporting of such results; and
(E)
review other relevant areas determined appropriate by the Office of the National Coordinator for Health Information Technology.
(3)
Report.— Not later than 2 years after the date of enactment of this Act, the Office of the National Coordinator for Health Information Technology shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the findings of the study conducted under paragraph (1).
(c)
Data Use Agreements.—
(1)
Interagency data use agreements within the department of health and human services for public health emergencies.—
(A)
In general.— The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall, as appropriate, facilitate the development of, or updates to, memoranda of understanding, data use agreements, or other applicable interagency agreements regarding appropriate access, exchange, and use of public health data between the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, other relevant agencies or offices within the Department of Health and Human Services, and other relevant Federal agencies, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.
(B)
Requirements.— In carrying out activities pursuant to subparagraph (A), the Secretary shall—
(i)
ensure that the agreements and memoranda of understanding described in such subparagraph—
(I)
address the methods of granting access to data held by one agency or office with another to support the respective missions of such agencies or offices;
(II)
consider minimum necessary principles of data sharing for appropriate use;
(III)
include appropriate privacy and cybersecurity protections; and
(IV)
are subject to regular updates, as appropriate;
(ii)
collaborate with the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, the Office of the Chief Information Officer, and, as appropriate, the Office of the National Coordinator for Health Information Technology, and other entities within the Department of Health and Human Services; and
(iii)
consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agreements, consistent with paragraph (2).
(2)
Data use agreements with external entities.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Assistant Secretary for Preparedness and Response, may update memoranda of understanding, data use agreements, or other applicable agreements and contracts to improve appropriate access, exchange, and use of public health data between the Centers for Disease Control and Prevention and the Office of the Assistant Secretary for Preparedness and Response and external entities, including State, Tribal, and territorial health departments, laboratories, hospitals and other health care providers, electronic health records vendors, and other entities, as applicable and appropriate, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.
(3)
Report.— Not later than 90 days after the date of enactment of this Act, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the status of the agreements under this subsection.
(d)
Improving Information Sharing and Availability of Public Health Data.— Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:

“SEC. 310B. IMPROVING STATE, LOCAL, AND TRIBAL INFORMATION SHARING.

“(a) In General.—The Secretary may, in consultation with State, local, and Tribal public health officials, carry out activities to improve the availability of appropriate and applicable public health data related to communicable diseases, and information sharing between, the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, and such State, local, and Tribal public health officials, which may include such data from—

“(1) health care providers and facilities;

“(2) public health and clinical laboratories;

“(3) health information exchanges and health information networks; and

“(4) State, local, and Tribal health departments.

“(b) Content, Form, and Manner.—The Secretary shall, consistent with the requirements of this section, work with such officials and relevant stakeholders to provide information on the content, form, and manner in which such data, deidentified as applicable, may most effectively support the ability of State, local, and Tribal health departments to respond to such communicable diseases, including related to the collection and reporting of demographic and other relevant data elements. Such form and manner requirements shall align with the standards and implementation specifications adopted by the Secretary under section 3004, as applicable.

“(c) Decreased Burden.—In facilitating the coordination of efforts under subsection (a), the Secretary shall make reasonable efforts to limit reported public health data to the minimum necessary information needed to accomplish the intended public health purpose.

“(d) Exemption of Certain Public Health Data From Disclosure.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may exempt from disclosure under section 552(b)(3) of title 5, United States Code, public health data that are gathered under this section if—

“(1) an individual is identified through such data; or

“(2) there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, the request, and other available data sources or the application of technology could be used to deduce the identity of an individual.”

(e)
Improving State, Local, and Tribal Public Health Data.—
(1)
In general.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall award grants, contracts, or cooperative agreements to eligible entities for purposes of identifying, developing, or disseminating best practices in electronic health information and the use of designated data standards and implementation specifications, including privacy standards, to improve the quality and completeness of data, including demographic data used for public health purposes.
(2)
Eligible entities.— To be eligible to receive an award under this subsection an entity shall—
(A)
be a health care provider, academic medical center, community-based organization, State, local governmental entity, Indian Tribe or Tribal organization (as such terms are defined in section 4 of the Indian Self Determination and Education Assistance Act (25 U.S.C. 5304)), urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)), or other appropriate public or private nonprofit entity, or a consortia of any such entities; and
(B)
submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(3)
Activities.— Entities receiving awards under this subsection shall use such award to develop and test best practices for training health care providers to use standards and implementation specifications that assist in the capture, access, exchange, and use of electronic health information, deidentified as applicable, such as demographic information, disability status, veteran status, and functional status. Such activities shall include, at a minimum—
(A)
improving, understanding, and using data standards and implementation specifications;
(B)
developing or identifying methods to improve communication with patients in a culturally- and linguistically-appropriate manner, including to better capture information related to demographics of such individuals;
(C)
developing methods for accurately categorizing and recording patient responses using available data standards;
(D)
educating providers regarding the utility of such information for public health purposes and the importance of accurate collection and recording of such data; and
(E)
providing information regarding how data will be deidentified if used for such public health purposes, as applicable and appropriate.
(4)
Reporting.—
(A)
Reporting by award recipients.— Each recipient of an award under this subsection shall submit to the Secretary a report on the results of best practices identified, developed, or disseminated through such award.
(B)
Report to congress.— Not later than 1 year after the completion of the program under this subsection, the Secretary shall submit a report to Congress on the success of best practices developed under such program, opportunities for further dissemination of such best practices, and recommendations for improving the capture, access, exchange, and use of information to improve public health and reduce health disparities.
(5)
Non-duplication of efforts.— The Secretary shall ensure that the activities and programs carried out under this subsection are free of unnecessary duplication of effort.
(f)
Rules of Construction.— Nothing in this section shall be construed to—
(1)
supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to public health surveillance, as applicable;
(2)
alter the authority of the Secretary with respect to the types of data the Secretary may receive through systems supported or established in this section or other laws; or
(3)
modify applicable Federal or State information privacy or security law.

SEC. 2214. Epidemic Forecasting and Outbreak Analytics.

Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.), as amended by section 2212, is further amended by adding at the end the following:

“SEC. 2825. EPIDEMIC FORECASTING AND OUTBREAK ANALYTICS.

“(a) In General.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall continue activities related to the development of infectious disease outbreak analysis capabilities to enhance the prediction, modeling, and forecasting of potential public health emergencies and other infectious disease outbreaks, which may include activities to support preparedness for, and response to, such emergencies and outbreaks. In carrying out this subsection, the Secretary shall identify strategies to include and leverage, as appropriate, the capabilities to public and private entities, which may include conducting such activities through collaborative partnerships with public and private entities, including academic institutions, and other Federal agencies, consistent with section 319D, as applicable.

“(b) Considerations.—In carrying out subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may consider public health data and, as appropriate, other data sources related to preparedness for, or response to, public health emergencies and infectious disease outbreaks.

“(c) Annual Reports.—Not later than 1 year after the date of enactment of this section, and annually thereafter for each of the subsequent 4 years, the Secretary shall prepare and submit a report, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, regarding an update on progress on activities conducted under this section to develop infectious disease outbreak analysis capabilities and any additional information relevant to such efforts.”

SEC. 2215. Public Health Data Transparency.

(a)
Report.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report assessing practices, objectives, and associated progress and challenges in achieving such objectives, of the Centers of Disease Control and Prevention with respect to the collection and dissemination of public health data related to a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d) or a potential public health emergency.
(b)
Plan.— Not later than 180 days following the issuance of the report pursuant to paragraph (1), the Director of the Centers for Disease Control and Prevention shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a plan that shall include—
(1)
steps to improve the timely reporting and dissemination of deidentified public health data related to a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d) or a potential public health emergency that is collected by the Centers for Disease Control and Prevention, including any associated barriers;
(2)
recommendations to Congress regarding gaps in such practices and objectives described in subsection (a); and
(3)
considerations regarding the requirements and limitations of data use agreements for such purposes, as applicable, and any efforts undertaken to address those requirements and limitations.

SEC. 2216. Gao Report on Public Health Preparedness, Response, and Recovery Data Capabilities.

(a)
Study.— The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study on the efforts of the Department of Health and Human Services to ensure that public health preparedness, response, and recovery data capabilities related to pandemic and other biological threats are not unnecessarily duplicative, overlapping, or fragmented. Such study shall include—
(1)
a comprehensive list of all public health preparedness, response, and recovery data collection, such as incidence and prevalence of disease tracking, hospitalizations, critical care capacity, and testing programs, at the Department of Health and Human Services, as identified by the department and its component agencies;
(2)
an analysis of any duplication, overlap, or fragmentation of the programs identified in paragraph (1);
(3)
identification of any efforts of the Department of Health and Human Services to reduce unnecessary duplication and improve coordination, efficiency, and effectiveness of such programs and any associated challenges;
(4)
any practices that threaten individual privacy and recommendations to improve the protection of individual, identifiable data; and
(5)
a description of the funding and other resources dedicated to the operation of each such program identified in paragraph (1).
(b)
Reporting.—
(1)
In general.— Based on the study conducted under subsection (a), the Comptroller General shall—
(A)
not later than 6 months after the date of enactment of this Act, provide a briefing to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and
(B)
not later than 18 months after the date of enactment of this Act, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a complete report on such study.
(2)
Recommendations.— The report under paragraph (1)(B) shall include recommendations, as appropriate, with respect to public health preparedness, response, and recovery data programs at the Department of Health and Human Services, to—
(A)
streamline data collection and reduce fragmentation and address any associated challenges;
(B)
reduce duplication in such programs; and
(C)
improve information-sharing across programs.

CHAPTER 3 Revitalizing the Public Health Workforce

SEC. 2221. Improving Recruitment and Retention of the Frontline Public Health Workforce.

(a)
In General.— Section 776 of the Public Health Service Act (42 U.S.C. 295f–1) is amended—
(1)
in subsection (a)—
(A)
by striking “ supply of” and inserting “ supply of, and encourage recruitment and retention of,”; and
(B)
by striking “ Federal,”;
(2)
in subsection (b)—
(A)
by amending paragraph (1)(A) to read as follows:

“(1)

(A)

(i) be accepted for enrollment, or be enrolled, as a student in an accredited institution of higher education or school of public health in the final semester (or equivalent) of a program leading to a certificate or degree, including a master’s or doctoral degree, in public health, epidemiology, laboratory sciences, data systems, data science, data analytics, informatics, statistics, or another subject matter related to public health; and

“(ii) be employed by, or have accepted employment with, a State, local, or Tribal public health agency, or a related training fellowship at such State, local, or Tribal public health agency, as recognized by the Secretary, to commence upon graduation; or”

; and

(B)
in paragraph (1)(B)—
(i)
in clause (i)—
(I)
by striking “ accredited educational institution in a State or territory” and inserting “ accredited institution of higher education or school of public health”; and
(II)
by striking “ a public health or health professions degree or certificate” and inserting “ a certificate or degree, including a master’s or doctoral degree, in public health, epidemiology, laboratory sciences, data systems, data science, data analytics, informatics, statistics, or another subject matter related to public health”; and
(ii)
in clause (ii)—
(I)
by striking “ Federal,”; and
(II)
by striking “ fellowship,” and inserting “ fellowship at such State, local, or Tribal public health agency,”;
(3)
in subsection (c)(2)—
(A)
by striking “ Federal,”; and
(B)
by striking “ equal to the greater of—” and all that follows through the end of subparagraph (B) and inserting “ of at least 3 consecutive years;”;
(4)
in subsection (d)—
(A)
by amending paragraph (1) to read as follows:

“(1) In general.—A loan repayment provided for an individual under a written contract under the Program shall consist of payment, in accordance with paragraph (2), for the individual toward the outstanding principal and interest on education loans incurred by the individual in the pursuit of the relevant degree or certificate described in subsection (b)(1) in accordance with the terms of the contract.”

; and

(B)
in paragraph (2)—
(i)
by striking “ For each year” and inserting the following:

“(A) In general.—For each year”

(ii)
by striking “ $35,000” and inserting “ $50,000”;
(iii)
by striking “ $105,000” and inserting “ $150,000”; and
(iv)
by adding at the end the following:

“(B) Considerations.—The Secretary may take action in making awards under this section to ensure that—

“(i) an appropriate proportion of contracts are awarded to individuals who are eligible to participate in the program pursuant to subsection (b)(1)(A); and

“(ii) contracts awarded under this section are equitably distributed among—

“(I) the geographical regions of the United States;

“(II) local, State, and Tribal public health departments; and

“(III) such public health departments under subclause (II) serving rural and urban areas.”

(5)
in subsection (e), by striking “ receiving a degree or certificate from a health professions or other related school” and inserting “ with a contract to serve under subsection (c)”;
(6)
in subsection (f), by adding at the end the following: “ In the event that a participant fails to either begin or complete the obligated service requirement of the loan repayment contract under this section, the Secretary may waive or suspend either the unfulfilled service or the assessed damages as provided for under section 338E(d), as appropriate.”;
(7)
by redesignating subsection (g) as subsection (i);
(8)
by inserting after subsection (f) the following:

“(g) Eligible Loans.—The loans eligible for repayment under this section are each of the following:

“(1) Any loan for education or training for employment by a health department.

“(2) Any loan under part E of title VIII (relating to nursing student loans).

“(3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).

“(4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.

“(5) Any other Federal loan, as the Secretary determines appropriate.

“(h) Pilot Program.—

“(1) In general.—The Secretary shall, as appropriate, establish a pilot program, to be known as the Bio-Preparedness Workforce Pilot Program, to provide for loan repayment for health professionals with expertise in infectious diseases and emergency preparedness and response activities to ensure an adequate supply of such professionals. Such program shall be administered consistent with the requirements of this section, except that, to be eligible to participate in the pilot program, an individual shall—

“(A)

(i) be accepted for enrollment, or be enrolled, as a student in an accredited institution of higher education in the final semester (or equivalent) of a program leading to a health professions degree or certificate program relevant to such program; or

“(ii) have graduated, during the preceding 10-year period, from an accredited institution of higher education with a health professions degree or certificate program relevant to such program; and

“(B) be employed by, or have accepted employment with—

“(i) a Federal health care facility;

“(ii) a nonprofit health care facility that is located in a health professional shortage area (as defined in section 332), a frontier health professional shortage area (as defined in section 799B), or a medically underserved community (as defined in section 799B);

“(iii) an entity receiving assistance under title XXVI for the provision of clinical services;

“(iv) a health program, or a facility, operated by an Indian Tribe or Tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act) or by an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act); or

“(v) another relevant entity determined appropriate by the Secretary, as a health professional with expertise in infectious diseases or emergency preparedness and response.

“(2) Non-duplication of effort.—The Secretary shall ensure that the pilot program established under paragraph (1) does not unnecessarily duplicate the National Health Service Corps Loan Repayment Program, or any other loan repayment program operated by the Department of Health and Human Services.

“(3) Evaluation and report to congress.—

“(A) In general.—The Secretary shall evaluate the pilot program at the conclusion of the first cycle of recipients funded by the pilot program.

“(B) Report.—

“(i) In general.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the evaluation under subparagraph (A). The report shall include, at a minimum, outcomes information from the pilot program, including any impact on recruitment and retention of health professionals with expertise in infectious diseases and emergency preparedness and response activities.

“(ii) Recommendation.—The report under this subparagraph shall include a recommendation by the Secretary as to whether the pilot program under this subsection should be extended.”

(9)
in subsection (i), as so redesignated, by striking “ $195,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2015” and inserting “ $100,000,000 for each of fiscal years 2023 through 2025”; and
(10)
by striking “ tribal” each place such term appears and inserting “ Tribal”.
(b)
GAO Study on Public Health Workforce.— Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall—
(1)
conduct an evaluation of what is known about the public health workforce in the United States, which shall address—
(A)
existing gaps in the Federal, State, local, Tribal, and territorial public health workforce, including positions that may be required to prepare for, and respond to, a public health emergency such as COVID–19;
(B)
challenges associated with the hiring, recruitment, and retention of the Federal, State, local, Tribal, and territorial public health workforce; and
(C)
Federal efforts to improve hiring, recruitment, and retention of the public health workforce; and
(2)
submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review.

SEC. 2222. Awards to Support Community Health Workers and Community Health.

(a)
In General.— Section 399V of the Public Health Service Act (42 U.S.C. 280g–11) is amended—
(1)
by amending the section heading to read as follows: “ awards to support community health workers and community health”;
(2)
by amending subsection (a) to read as follows:

“(a) In General.—The Secretary shall award grants, contracts, or cooperative agreements to eligible entities to promote positive health behaviors and outcomes for populations in medically underserved communities by leveraging community health workers, including by addressing ongoing and longer-term community health needs, and by building the capacity of the community health worker workforce. Such grants, contracts, and cooperative agreements shall be awarded in alignment and coordination with existing funding arrangements supporting community health workers.”

(3)
in subsection (b)—
(A)
in the matter preceding paragraph (1)—
(i)
by striking “ Grants awarded” and inserting “ Subject to any requirements for the scope of licensure, registration, or certification of a community health worker under applicable State law, grants, contracts, and cooperative agreements awarded”; and
(ii)
by striking “ support community health workers”;
(B)
by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively;
(C)
by striking paragraphs (1) and (2) and inserting the following:

“(1) recruit, hire, train, and retain community health workers that reflect the needs of the community;

“(2) support community health workers in providing education and outreach, in a community setting, regarding—

“(A) health conditions prevalent in—

“(i) medically underserved communities (as defined in section 799B), particularly racial and ethnic minority populations; and

“(ii) other such at-risk populations or geographic areas that may require additional support during public health emergencies, which may include counties identified by the Secretary using applicable measures developed by the Centers for Disease Control and Prevention or other Federal agencies; and

“(B) addressing health disparities, including by—

“(i) promoting awareness of services and resources to increase access to health care, mental health and substance use disorder services, child services, technology, housing services, educational services, nutrition services, employment services, and other services; and

“(ii) assisting in conducting individual and community needs assessments;

“(3) educate community members, including regarding effective strategies to promote healthy behaviors;”

(D)
in paragraph (4), as so redesignated, by striking “ to educate” and inserting “ educate”;
(E)
in paragraph (5), as so redesignated—
(i)
by striking “ to identify” and inserting “ identify”;
(ii)
by striking “ healthcare agencies” and inserting “ health care agencies”; and
(iii)
by striking “ healthcare services and to eliminate duplicative care; or” and inserting “ health care services and to streamline care, including serving as a liaison between communities and health care agencies; and”; and
(F)
in paragraph (6), as so redesignated—
(i)
by striking “ to educate, guide, and provide” and inserting “ support community health workers in educating, guiding, or providing”; and
(ii)
by striking “ maternal health and prenatal care” and inserting “ chronic diseases, maternal health, prenatal, and postpartum care in order to improve maternal and infant health outcomes”;
(4)
in subsection (c), by striking “ Each eligible entity” and all that follows through “ accompanied by” and inserting “ To be eligible to receive an award under subsection (a), an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing”;
(5)
in subsection (d)—
(A)
in the matter preceding paragraph (1), by striking “ awarding grants” and inserting “ making awards”;
(B)
by amending paragraph (1) to read as follows:

“(1) propose to serve—

“(A) areas with populations that have a high rate of chronic disease, infant mortality, or maternal morbidity and mortality;

“(B) low-income populations, including medically underserved populations (as defined in section 330(b)(3));

“(C) populations residing in health professional shortage areas (as defined in section 332(a));

“(D) populations residing in maternity care health professional target areas identified under section 332(k); or

“(E) rural or traditionally underserved populations, including racial and ethnic minority populations or low-income populations;”

(C)
in paragraph (2), by striking “ ; and” and inserting “ , including rural populations and racial and ethnic minority populations;”;
(D)
in paragraph (3), by striking “ with community health workers.” and inserting “ and established relationships with community health workers in the communities expected to be served by the program;” and
(E)
by adding at the end the following:

“(4) develop a plan for providing services to the extent practicable, in the language and cultural context most appropriate to individuals expected to be served by the program; and

“(5) propose to use evidence-informed or evidence-based practices, as applicable and appropriate.”

(6)
in subsection (e)—
(A)
by striking “ community health worker programs” and inserting “ eligible entities”; and
(B)
by striking “ and one-stop delivery systems under section 121(e)” and inserting “ , health professions schools, minority-serving institutions (defined, for purposes of this subsection, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institutions described in section 371(a) of such Act), area health education centers under section 751 of this Act, and one-stop delivery systems under section 121”;
(7)
by striking subsections (f), (g), (h), (i), and (j) and inserting the following:

“(f) Technical Assistance.—The Secretary may provide to eligible entities that receive awards under subsection (a) technical assistance with respect to planning, development, and operation of community health worker programs authorized or supported under this section.

“(g) Dissemination of Best Practices.—Not later than 4 years after the date of enactment of the PREVENT Pandemics Act, the Secretary shall, based on activities carried out under this section and in consultation with relevant stakeholders, identify and disseminate evidence-based or evidence-informed practices regarding recruitment and retention of community health workers and paraprofessionals to address ongoing public health and community health needs, and to prepare for, and respond to, future public health emergencies.

“(h) Report to Congress.—Not later than 4 years after the date of enactment of the PREVENT Pandemics Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report concerning the effectiveness of the program under this section in addressing ongoing public health and community health needs. Such report shall include recommendations regarding any improvements to such program, including recommendations for how to improve recruitment, training, and retention of the community health workforce.

“(i) Authorization of Appropriations.—For purposes of carrying out this section, there are authorized to be appropriated $50,000,000 for each of fiscal years 2023 through 2027.”

(8)
by redesignating subsection (k) as subsection (j); and
(9)
in subsection (j), as so redesignated—
(A)
by striking paragraphs (1), (2), and (4);
(B)
by redesignating paragraph (3) as paragraph (1);
(C)
in paragraph (1), as so redesignated—
(i)
by striking “ entity (including a State or public subdivision of a State” and inserting “ entity, including a State or political subdivision of a State, an Indian Tribe or Tribal organization, an urban Indian organization, a community-based organization”; and
(ii)
by striking “ as defined in section 1861(aa) of the Social Security Act))” and inserting “ (as defined in section 1861(aa)(4) of the Social Security Act)”; and
(D)
by adding at the end the following:

“(2) Indian tribe; tribal organization.—The terms ‘Indian Tribe’ and ‘Tribal organization’ have the meanings given the terms ‘Indian tribe’ and ‘tribal organization’, respectively, in section 4 of the Indian Self-Determination and Education Assistance Act.

“(3) Urban indian organization.—The term ‘urban Indian organization’ has the meaning given such term in section 4 of the Indian Health Care Improvement Act.”

(b)
GAO Study and Report.— Not later than 1 year after the date of submission of the report under subsection (h) of section 399V of the Public Health Service Act (42 U.S.C. 280g–11), as amended by subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the program authorized under such section 399V, including a review of the efforts of the Secretary of Health and Human Services to coordinate such program with applicable programs of the Health Resources and Services Administration to ensure there is no unnecessary duplication of efforts among such programs, and identification of any areas of duplication.

SEC. 2223. Improving Public Health Emergency Response Capacity.

(a)
Certain Appointments to Support Public Health Emergency Responses.— Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following:

“(g) Certain Appointments to Support Public Health Emergency Responses.—

“(1) In general.—In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, United States Code, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to—

“(A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or

“(B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section.

“(2) Number of appointments.—Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—

“(A) 400 individuals under paragraph (1)(A); and

“(B) 100 individuals under paragraph (1)(B).

“(3) Compensation.—The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with chapter 51 and subchapter III of chapter 53 of title 5, United States Code.

“(4) Reporting.—The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—

“(A) the number of positions filled through such authority;

“(B) the types of appointments of such positions;

“(C) the titles, occupational series, and grades of such positions;

“(D) the number of positions publicly noticed to be filled under such authority;

“(E) the number of qualified applicants who apply for such positions;

“(F) the qualification criteria for such positions; and

“(G) the demographic information of individuals appointed to such positions.

“(5) Notification to congress.—In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include—

“(A) information on each such appointment within such fiscal year;

“(B) a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and

“(C) the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.

“(6) Reports to congress.—Not later than September 30, 2023, and annually thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph (A) or (B) of paragraph (1).

“(7) Sunset.—The authority under this subsection shall expire on September 30, 2028.”

(b)
GAO Report.— Not later than 1 year after the issuance of the initial report under subsection (g)(6) of section 319 of the Public Health Service Act (42 U.S.C. 247d), as added by subsection (a), and again 180 days after the date on which the authority provided under section 319(g) of such Act expires pursuant to paragraph (7) of such section, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the use of the authority provided under such section. Such report shall, in a manner that protects personal privacy, at a minimum, include information on—
(1)
the number of positions publicly noticed and filled under the authority of each of subparagraphs (A) and (B) of such section 319(g)(1);
(2)
the occupational series, grades, and types of appointments of such positions;
(3)
how such positions related to addressing a need or shortage described in subparagraph (A) or (B) of such section;
(4)
how the Secretary of Health and Human Services made appointment decisions under each of subparagraphs (A) and (B) of such section;
(5)
sources used to identify candidates for filling such positions;
(6)
the number of individuals appointed under each such subparagraph;
(7)
aggregated demographic information related to individuals appointed under each such subparagraph; and
(8)
any challenges, limitations, or gaps related to the use of the authority under each such subparagraph and any related recommendations to address such challenges, limitations, or gaps.

SEC. 2224. Increasing Educational Opportunities for Allied Health Professions.

Section 755(b) of the Public Health Service Act (42 U.S.C. 294e(b)) is amended by adding at the end the following:

“(4) Increasing educational opportunities in physical therapy, occupational therapy, respiratory therapy, audiology, and speech-language pathology professions, which may include offering scholarships or stipends and carrying out other activities to improve retention, for individuals from disadvantaged backgrounds or individuals who are underrepresented in such professions.”

SEC. 2225. Public Health Service Corps Annual and Sick Leave.

(a)
In General.— Section 219 of the Public Health Service Act (42 U.S.C. 210–1) is amended—
(1)
in subsection (a)—
(A)
by striking “ Reserve Corps” and inserting “ Ready Reserve Corps”; and
(B)
by striking “ : Provided, That such regulations shall not authorize annual leave to be accumulated in excess of sixty days”;
(2)
by inserting after subsection (a) the following:

“(b) The regulations described in subsection (a) may authorize accumulated annual leave of not more than 120 days for any commissioned officer of the Regular Corps or officer of the Ready Reserve Corps on active duty.”

; and

(3)
by redesignating subsection (d) as subsection (c).
(b)
Application.— The amendments made by subsection (a) shall apply with respect to accumulated annual leave (as defined in section 219 of the Public Health Service Act (42 U.S.C. 210–1)) that a commissioned officer of the Regular Corps or officer of the Ready Reserve Corps on active duty would, but for the regulations described in such section, lose at the end of fiscal year 2022 or a subsequent fiscal year.

SEC. 2226. Leadership Exchange Pilot for Public Health and Medical Preparedness and Response Positions at the Department of Health and Human Services.

Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.), as amended by section 2214, is further amended by adding at the end the following:

“SEC. 2826. LEADERSHIP EXCHANGE PILOT FOR PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE POSITIONS AT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.

“(a) In General.—The Secretary may, not later than 1 year after the date of enactment of the PREVENT Pandemics Act, establish a voluntary program to provide additional training to individuals in eligible positions, as described in subsection (c), to support the continuous professional development of such individuals.

“(b) Criteria.—

“(1) Duration.—The program under subsection (a) shall provide for fellowships, details, or other relevant placements with Federal agencies or departments, or State or local health departments, pursuant to the guidance issued under paragraph (2), for a maximum period of 2 years.

“(2) Guidance.—The Secretary shall issue guidance establishing criteria for identifying placements that demonstrate ongoing sufficient mastery of knowledge, skills, and abilities to satisfy the field experience criteria under the program established under subsection (a), including assignments and experiences that develop public health and medical preparedness and response expertise.

“(c) Eligible Position.—For purposes of subsection (a), the term ‘eligible position’ means any position at the Department of Health and Human Services at or above grade GS–13 of the General Schedule, or the equivalent, for which not less than 50 percent of the time of such position is spent on activities related to public health preparedness or response.

“(d) Pilot Period and Final Report.—The pilot program authorized under this section shall not exceed 5 years. Not later than 90 days after the end of the program, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—

“(1) the number of individuals who participated in such pilot, as applicable;

“(2) a description of the professional growth experience in which individuals participated; and

“(3) an assessment of the outcomes of such program, including a recommendation on whether such program should be continued.”

SEC. 2227. Continuing Educational Support for Health Professionals Serving in Rural and Underserved Communities.

Section 752 of the Public Health Service Act (42 U.S.C. 294b) is amended—
(1)
in the section heading, by inserting “ rural and” after “ serving in”;
(2)
in subsection (a)—
(A)
by striking “ shall make grants to, and enter into contracts with, eligible entities” and inserting “ , as appropriate, shall make grants to, and enter into contracts with, eligible entities to support access to accredited continuing medical education for primary care physicians and health care providers at community health centers or rural health clinics to improve and increase access to care for patients in rural and medically underserved areas. Such grants or contracts may be used”;
(B)
by striking “ faculty members” and inserting “ health care providers”; and
(C)
by inserting “ increase primary care physician and health care provider knowledge,” after “ practice environment,”;
(3)
in subsection (b), by inserting “ , such as a community health center or rural health clinic” before the period;
(4)
in subsection (c), by striking “ by require.” and inserting the following:

“(1) a description of how participation in activities funded under this section will help improve access to, and quality of, health care services and training needs of primary care physicians and health care providers; and

“(2) a plan for providing peer-to-peer training, as appropriate.”

(5)
by amending subsection (d) to read as follows:

“(d) Use of Funds.—

“(1) In general.—An eligible entity shall use amounts awarded under a grant or contract under this section to provide innovative supportive activities to enhance education for primary care physicians and health care providers described in subsection (a) through distance learning, continuing educational activities, collaborative conferences, and electronic and telelearning activities, with priority for primary care providers who are seeking additional education in specialty fields such as infectious disease, endocrinology, pediatrics, mental health and substance use disorders, pain management, geriatrics, and other areas, as appropriate, in order to—

“(A) improve retention of primary care physicians and health care providers and increase access to specialty health care services for patients; and

“(B) support access to the integration of specialty care through existing service delivery locations and care across settings.

“(2) Clarification.—Entities may use amounts awarded under a grant or contract under this section for continuing educational activities that include a clinical training component, including in-person patient care, in the respective community health center or rural health clinic, with the primary care physician or health care provider at such site and the clinical specialist from whom such additional training is being provided.”

(6)
by redesignating subsection (e) as subsection (g);
(7)
by inserting after subsection (d) the following:

“(e) Administrative Expenses.—An entity that revives a grant or contract under this section shall use not more than 5 percent of the amounts received under the grant or contract under this section for administrative expenses.

“(f) Non-duplication of Effort.—The Secretary shall ensure that activities under this section do not unnecessarily duplicate efforts of other programs overseen by the Health Resources and Services Administration, including activities described in section 330N.”

; and

(8)
in subsection (g), as so redesignated, by striking “ the fiscal years 2010 through 2014, and such sums as may be necessary for each subsequent fiscal year” and inserting “ fiscal years 2023 through 2025”.

CHAPTER 4 Enhancing Public Health Preparedness and Response

SEC. 2231. Centers for Public Health Preparedness and Response.

(a)
In General.— Section 319F of the Public Health Service Act (42 U.S.C. 247d–6) is amended—
(1)
by striking subsection (d) and inserting the following:

“(d) Centers for Public Health Preparedness and Response.—

“(1) In general.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative agreements to institutions of higher education, including accredited schools of public health, or other nonprofit private entities to establish or maintain a network of Centers for Public Health Preparedness and Response (referred to in this subsection as ‘Centers’).

“(2) Eligibility.—To be eligible to receive an award under this subsection, an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will—

“(A) coordinate relevant activities with applicable State, local, and Tribal health departments and officials, health care facilities, and health care coalitions to improve public health preparedness and response, as informed by the public health preparedness and response needs of the community, or communities, involved;

“(B) prioritize efforts to implement evidence-informed or evidence-based practices to improve public health preparedness and response, including by helping to reduce the transmission of emerging infectious diseases; and

“(C) use funds awarded under this subsection, including by carrying out any activities described in paragraph (3).

“(3) Use of funds.—The Centers established or maintained under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include—

“(A) identifying, translating, and disseminating promising research findings or strategies into evidence-informed or evidence-based practices to inform preparedness for, and responses to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and other public health emergencies, which may include conducting research related to public health preparedness and response systems;

“(B) improving awareness of such evidence-informed or evidence-based practices and other relevant scientific or public health information among health care professionals, public health professionals, other stakeholders, and the public, including through the development, evaluation, and dissemination of trainings and training materials, consistent with section 2802(b)(2), as applicable and appropriate, and with consideration given to existing training materials, to support preparedness for, and responses to, such threats;

“(C) utilizing and expanding relevant technological and analytical capabilities to inform public health and medical preparedness and response efforts;

“(D) expanding activities, including through public-private partnerships, related to public health preparedness and response, including participation in drills and exercises and training public health experts, as appropriate; and

“(E) providing technical assistance and expertise that relies on evidence-based practices, as applicable, related to responses to public health emergencies, as appropriate, to State, local, and Tribal health departments and other entities pursuant to paragraph (2)(A).

“(4) Distribution of awards.—In awarding grants, contracts, or cooperative agreements under this subsection, the Secretary shall support not fewer than 10 Centers, subject to the availability of appropriations, and ensure that such awards are equitably distributed among the geographical regions of the United States.”

; and

(2)
in subsection (f)(1)(C), by striking “ , of which $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection”.
(b)
Repeal.— Section 319G of the Public Health Service Act (42 U.S.C. 247d–7) is repealed.

SEC. 2232. Vaccine Distribution Plans.

Section 319A of the Public Health Service Act (42 U.S.C. 247d–1) is amended—
(1)
in subsection (a)—
(A)
by inserting “ , or other federally purchased vaccine to address another pandemic” before the period at the end of the first sentence; and
(B)
by inserting “ or other pandemic” before the period at the end of the second sentence; and
(2)
in subsection (d), by inserting “ or other pandemics” after “ influenza pandemics”.

SEC. 2233. Coordination and Collaboration Regarding Blood Supply.

The Secretary of Health and Human Services, or the Secretary’s designee, shall—
(1)
ensure coordination and collaboration between relevant Federal departments and agencies related to the safety and availability of the blood supply, including—
(A)
the Department of Health and Human Services, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration;
(B)
the Department of Defense; and
(C)
the Department of Veterans Affairs; and
(2)
consult and communicate with private stakeholders, including blood collection establishments, health care providers, accreditation organizations, researchers, and patients, regarding issues related to the safety and availability of the blood supply.

SEC. 2234. Supporting Laboratory Capacity and International Collaboration to Address Antimicrobial Resistance.

Section 319E of the Public Health Service Act (42 U.S.C. 247d–5) is amended—
(1)
by redesignating subsections (k), (l), and (m) as subsections (m), (n), and (o), respectively; and
(2)
by inserting after subsection (j), the following:

“(k) Network of Antibiotic Resistance Regional Laboratories.—

“(1) In general.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate, maintain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capabilities, within existing laboratory capacity maintained or supported by the Centers for Disease Control and Prevention, to—

“(A) identify and monitor the emergence and changes in the patterns of antimicrobial-resistant pathogens;

“(B) detect, identify, confirm, and isolate such resistant pathogens, including, as appropriate, performing such activities upon the request of another laboratory and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and

“(C) perform activities to support the diagnosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.

“(2) Geographic distribution.—The Secretary shall ensure that such capacity and capabilities are appropriately distributed among the geographical regions of the United States.

“(3) Partnerships and nonduplication of current domestic capacity.—Activities supported under this subsection may be based in an academic center, a State health department, or other facility operated by a public or private entity that carries out relevant laboratory or public health surveillance activities.

“(l) International Collaboration.—

“(1) In general.—The Secretary, in coordination with heads of other relevant Federal departments and agencies, shall support activities related to addressing antimicrobial resistance internationally, including by—

“(A) supporting basic, translational, epidemiological, and clinical research related to antimicrobial-resistant pathogens, including such pathogens that have not yet been detected in the United States, and improving related public health surveillance systems, and laboratory and other response capacity; and

“(B) providing technical assistance related to antimicrobial resistant infection and control activities.

“(2) Awards.—In carrying out paragraph (1), the Secretary may award grants, contracts, or cooperative agreements to public and private entities, including nongovernmental organizations, with applicable expertise, for purposes of supporting new and innovative approaches to the prevention, detection, and mitigation of antimicrobial-resistant pathogens.”

SEC. 2235. One Health Framework.

(a)
One Health Framework.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the Centers for Disease Control and Prevention, shall develop, or update as appropriate, in coordination with other Federal departments and agencies, as appropriate, a One Health framework to address zoonotic diseases and advance public health preparedness.
(b)
One Health Coordination.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall coordinate with the Secretary of Agriculture and the Secretary of the Interior to develop a One Health coordination mechanism at the Federal level to strengthen One Health collaboration related to prevention, detection, control, and response for zoonotic diseases and related One Health work across the Federal Government.
(c)
Reporting.— Not later than 1 year after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report providing an update on the activities under subsections (a) and (b).

SEC. 2236. Supporting Children During Public Health Emergencies.

Section 2811A of the Public Health Service Act (42 U.S.C. 300hh–10b) is amended—
(1)
in subsection (b)—
(A)
in paragraph (2)—
(i)
by striking “ and behavioral” and inserting “ , behavioral, developmental”; and
(ii)
by striking “ ; and” and inserting a semicolon;
(B)
in paragraph (3), by striking the period and inserting “ ; and”; and
(C)
by adding at the end the following:

“(4) provide advice and consultation with respect to continuity of care and education for all children and supporting parents and caregivers during all-hazards emergencies.”

(2)
in subsection (d)(2)—
(A)
in subparagraph (C), by striking “ care; and” and inserting “ care;”;
(B)
by redesignating subparagraph (D) as subparagraph (E);
(C)
by inserting after subparagraph (C) the following:

“(D) at least 4 non-Federal members representing child care settings, State or local educational agencies, individuals with expertise in children with disabilities, and parents; and”

; and

(D)
in subparagraph (E), as so redesignated—
(i)
by striking clause (ii); and
(ii)
by redesignating clauses (iii) and (iv) as clauses (ii) and (iii), respectively.

Subtitle C Accelerating Research and Countermeasure Discovery

CHAPTER 1 Fostering Research and Development and Improving Coordination

SEC. 2301. Research Centers for Pathogens of Pandemic Concern.

Subpart 6 of part C of title IV of the Public Health Service Act is amended by inserting after section 447C (42 U.S.C. 285f–4) the following:

“SEC. 447D. RESEARCH CENTERS FOR PATHOGENS OF PANDEMIC CONCERN.

“(a) In General.—The Director of the Institute, in collaboration, as appropriate, with the directors of applicable institutes, centers, and divisions of the National Institutes of Health, the Assistant Secretary for Preparedness and Response, and the Director of the Biomedical Advanced Research and Development Authority, shall establish or continue a multidisciplinary research program to advance the discovery and preclinical development of medical products for priority virus families and other viral pathogens with a significant potential to cause a pandemic, through support for research centers.

“(b) Uses of Funds.—The Director of the Institute shall award funding through grants, contracts, or cooperative agreements to public or private entities to provide support for research centers described in subsection (a) for the purpose of—

“(1) conducting basic research through preclinical development of new medical products or technologies, including platform technologies, to address pathogens of pandemic concern;

“(2) identifying potential targets for therapeutic candidates, including antivirals, to treat such pathogens;

“(3) identifying existing medical products with the potential to address such pathogens, including candidates that could be used in outpatient settings; and

“(4) carrying out or supporting other research related to medical products to address such pathogens, as determined appropriate by the Director.

“(c) Coordination.—The Director of the Institute shall, as appropriate, provide for the coordination of activities among the centers described in subsection (a), including through—

“(1) facilitating the exchange of information and regular communication among the centers, as appropriate; and

“(2) requiring the periodic preparation and submission to the Director of reports on the activities of each center.

“(d) Priority.—In awarding funding through grants, contracts, or cooperative agreements under subsection (a), the Director of the Institute shall, as appropriate, give priority to applicants with existing frameworks and partnerships, as applicable, to support the advancement of such research.

“(e) Collaboration.—The Director of the Institute shall—

“(1) collaborate with the heads of other appropriate Federal departments, agencies, and offices with respect to the identification of additional priority virus families and other viral pathogens with a significant potential to cause a pandemic; and

“(2) collaborate with the Director of the Biomedical Advanced Research and Development Authority with respect to the research conducted by centers described in subsection (a), including, as appropriate, providing any updates on the research advancements made by such centers, identifying any advanced research and development needs for such countermeasures, consistent with section 319L(a)(6), and taking into consideration existing manufacturing capacity and future capacity needs for such medical products or technologies, including platform technologies, supported by the centers described in subsection (a).

“(f) Supplement, Not Supplant.—Any support received by a center described in subsection (a) under this section shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported.”

SEC. 2302. Improving Medical Countermeasure Research Coordination.

Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)) is amended—
(1)
in paragraph (24), by striking “ and” at the end;
(2)
in paragraph (25), by striking the period and inserting a semicolon; and
(3)
by inserting after paragraph (25) the following:

“(26) shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;”

SEC. 2303. Accessing Specimen Samples and Diagnostic Tests.

(a)
Improving Research and Development of Medical Countermeasures for Novel Pathogens.—
(1)
Sample access.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall make publicly available policies and procedures related to public and private entities accessing specimens of, or specimens containing, pathogens or suitable surrogates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases. Such policies and procedures shall take into account, as appropriate, any applicable existing Federal resources.
(2)
Guidance.— The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including—
(A)
the method for requesting such samples;
(B)
considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including applicable safeguard and security measures; and
(C)
information required to be provided in order to receive such samples or suitable surrogates or alternatives.
(b)
Earlier Development of Diagnostic Tests.— Title III of the Public Health Service Act is amended by inserting after section 319A (42 U.S.C. 247d–1) the following:

“SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.

“The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency.”

SEC. 2304. National Academies of Sciences, Engineering, and Medicine Study on Natural Immunity in Relation to the Covid–19 Pandemic.

(a)
In General.— Not later than 45 days after the date of enactment of this Act, the Secretary of Health and Human Services shall seek to enter into a contract with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the “National Academies”) to conduct a study related to the current scientific evidence on the durability of immunity to COVID–19.
(b)
Inclusions.— The study pursuant to the contract under subsection (a) shall include—
(1)
an assessment of scientific evidence related to the durability of immunity resulting from SARS–CoV–2 infection, COVID–19 vaccination, or both, including any differences between population groups;
(2)
an assessment of the extent to which the Federal Government makes publicly available the scientific evidence used by relevant Federal departments and agencies to inform public health recommendations related to immunity resulting from SARS–CoV–2 infection and COVID–19 vaccination; and
(3)
a summary of scientific studies and evidence related to SARS–CoV–2 infection-acquired immunity from a sample of other countries or multilateral organizations.
(c)
Report.— Not later than 18 months after the date of enactment of this Act, the National Academies shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the study pursuant to subsection (a).

CHAPTER 2 Improving Biosafety and Biosecurity

SEC. 2311. Improving Control and Oversight of Select Biological Agents and Toxins.

Section 351A of the Public Health Service Act (42 U.S.C. 262a) is amended—
(1)
in subsection (b)(1), by amending subparagraph (A) to read as follows:

“(A) proper training, including with respect to notification requirements under this section, of—

“(i) individuals who are involved in the handling and use of such agents and toxins, including appropriate skills to handle such agents and toxins;

“(ii) individuals whose responsibilities routinely place them in close proximity to laboratory facilities in which such agents and toxins are being transferred, possessed, or used; and

“(iii) individuals who perform administrative or oversight functions of the facility related to the transfer, possession, or use of such agents and toxins on behalf of registered persons;”

(2)
in subsection (e)(1), by striking “ (including the risk of use in domestic or international terrorism)” and inserting “ (including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism)”;
(3)
in subsection (k)—
(A)
by redesignating paragraphs (1) and (2) as paragraphs (2) and (3), respectively;
(B)
by inserting before paragraph (2), as so redesignated, the following:

“(1) Notification with respect to federal facilities.—In the event of the release, loss, or theft of an agent or toxin listed by the Secretary pursuant to subsection (a)(1), or by the Secretary of Agriculture pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002, from or within a laboratory facility owned or operated by the Department of Health and Human Services, or other Federal laboratory facility subject to the requirements of this section, the Secretary, in a manner that does not compromise national security, shall—

“(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives of such event, including—

“(i) the Federal laboratory facility in which such release, loss, or theft occurred; and

“(ii) the circumstances of such release, loss, or theft; and

“(B) not later than 14 days after such notification, update such Committees on—

“(i) any actions taken or planned by the Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and

“(ii) any actions taken or planned by the Secretary to review the circumstances of such release, loss, or theft, and prevent similar events.”

; and

(C)
by amending paragraph (2), as so redesignated, to read as follows:

“(2) Annual report.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on an annual basis a report—

“(A) summarizing the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases), during the preceding fiscal year;

“(B) describing actions taken by the Secretary to address such incidents, such as any corrective action plans required and steps taken to promote adherence to, and compliance with, safety and security best practices, standards, and regulations; and

“(C) describing any gaps, challenges, or limitations with respect to ensuring that such safety and security practices are consistently applied and adhered to, and actions taken to address such gaps, challenges, or limitations.”

; and

(4)
in subsection (m), by striking “ fiscal years 2002 through 2007” and inserting “ fiscal years 2023 through 2027”.

SEC. 2312. Strategy for Federal High-Containment Laboratories.

(a)
Strategy for Federal High-containment Laboratories.— Not later than 1 year after the date of enactment of this Act, the Director of the Office of Science and Technology Policy, in consultation with relevant Federal departments and agencies, shall establish a strategy for the management, maintenance, and oversight of federally-owned laboratory facilities operating at Biosafety Level 3 or 4, including equivalent classification levels and facilities with Biosafety Level 4 capabilities. Such strategy shall include—
(1)
a description of the roles and responsibilities of relevant Federal departments and agencies with respect to the management, maintenance, and oversight of Biosafety Level 3 or 4 laboratory facilities;
(2)
an assessment of the needs of the Federal Government with respect to Biosafety Level 3 or 4 laboratory facilities;
(3)
a summary of existing federally-owned Biosafety Level 3 or 4 laboratory facility capacity;
(4)
a summary of other Biosafety Level 3 or 4 laboratory facility capacity established through Federal funds;
(5)
a description of how the capacity described in paragraphs (3) and (4) addresses the needs of the Federal Government, including—
(A)
how relevant Federal departments and agencies coordinate to provide access to appropriate laboratory facilities to reduce unnecessary duplication; and
(B)
any gaps in such capacity related to such needs;
(6)
a summary of plans that are in place for the maintenance of such capacity within each relevant Federal department or agency, as applicable and appropriate, including processes for determining whether to maintain or expand such capacity, and a description of how the Federal Government will address rapid changes in the need for such capacity within each relevant Federal department or agency during a public health emergency; and
(7)
a description of how the heads of relevant Federal departments and agencies will coordinate to ensure appropriate oversight of federally-owned laboratory facility capacity and leverage such capacity within each relevant Federal department, as appropriate, to fulfill the needs of each Federal department and agency in order to reduce unnecessary duplication and improve collaboration within the Federal Government.
(b)
Clarification.— The strategy under subsection (a) shall not be construed to supersede the authorities of each relevant Federal department or agency with respect to the management, maintenance, and oversight of the Federally-owned laboratory facilities operated by any such Federal department or agency.

SEC. 2313. National Science Advisory Board for Biosecurity.

(a)
In General.— Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

“SEC. 404O. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

“(a) Establishment.—The Secretary, acting through the Director of NIH, shall establish an advisory committee, to be known as the ‘National Science Advisory Board for Biosecurity’ (referred to in this section as the ‘Board’).

“(b) Duties.—

“(1) In general.—The National Science Advisory Board for Biosecurity referred to in section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417) (referred to in this section as the ‘Board’) shall provide technical advice, guidance, or recommendations, to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research, including—

“(A) oversight of federally-conducted or federally-supported dual use biomedical research, such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research, taking into consideration national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration; and

“(B) continuing to carry out the activities required under section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417).

“(c) Considerations.—In carrying out the duties under subsection (b), the Board may consider strategies to improve the safety and security of biomedical research, including through—

“(1) leveraging or using new technologies and scientific advancements to reduce safety and security risks associated with such research and improve containment of pathogens; and

“(2) outreach to, and education and training of, researchers, laboratory personnel, and other appropriate individuals with respect to safety and security risks associated with such research and mitigation of such risks.

“(d) Membership.—The Board shall be composed of the following:

“(1) Non-voting, ex officio members, including the following:

“(A) At least one representative of each of the following:

“(i) The Department of Health and Human Services.

“(ii) The Department of Defense.

“(iii) The Department of Agriculture.

“(iv) The Department of Homeland Security.

“(v) The Department of Energy.

“(vi) The Department of State.

“(vii) The Office of Science and Technology Policy.

“(viii) The Office of the Director of National Intelligence.

“(B) Representatives of such other Federal departments or agencies as the Secretary determines appropriate to carry out the requirements of this section.

“(2) Individuals, appointed by the Secretary, with expertise in biology, infectious diseases, public health, ethics, national security, and other fields, as the Secretary determines appropriate, who shall serve as voting members.”

(b)
Orderly Transition.— The Secretary of Health and Human Services shall take such steps as are necessary to provide for the orderly transition to the authority of the National Science Advisory Board for Biosecurity established under section 404O of the Public Health Service Act, as added by subsection (a), from any authority of the Board described in section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417), as in effect on the day before the date of enactment of this Act.
(c)
Application.— The requirements under section 404O of the Public Health Service Act, as added by subsection (a), related to the mission, activities, or functions of the National Science Advisory Board for Biosecurity shall not apply until the completion of any work undertaken by such Board before the date of enactment of this Act.

SEC. 2314. Research to Improve Biosafety.

(a)
In General.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, as appropriate, conduct or support research to improve the safe conduct of biomedical research activities involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).
(b)
Report.— Not later than 5 years after the date of enactment of this Act, the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of any research conducted or supported under this section, any relevant findings, and steps the Secretary is taking to disseminate any such findings to support the reduction of risks associated with biomedical research involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).

SEC. 2315. Federally-Funded Research with Enhanced Pathogens of Pandemic Potential.

(a)
Review and Oversight of Enhanced Pathogens of Pandemic Potential.—
(1)
In general.— The Director of the Office of Science and Technology Policy (referred to in this section as the “Director”), in consultation with the heads of relevant Federal departments and agencies, shall—
(A)
not later than 1 year after the date of enactment of this Act—
(i)
continue or conduct a review of existing Federal policies related to research proposed for Federal funding that may be reasonably anticipated to involve the creation, transfer, or use of enhanced pathogens of pandemic potential; and
(ii)
establish or update a Federal policy for the consistent review and oversight of such proposed research that appropriately considers the risks associated with, and potential benefits of, such research; and
(B)
not less than every 4 years thereafter, review and update such policy, as necessary and appropriate, to ensure that such policy fully accounts for relevant research that may be reasonably anticipated to involve the creation, transfer, or use of enhanced pathogens of pandemic potential, takes into consideration the benefits of such research, and supports the mitigation of related risks.
(2)
Requirements.— The policy established pursuant to paragraph (1) shall include—
(A)
a clear scope to support the consistent identification of research proposals subject to such policy by relevant Federal departments and agencies;
(B)
a framework for such reviews that accounts for safety, security, and ethical considerations related to the creation, transfer, or use of enhanced pathogens of pandemic potential;
(C)
measures to enhance the transparency and public availability of information related to such research activities in a manner that does not compromise national security, the safety and security of such research activities, or any identifiable, sensitive information of relevant individuals; and
(D)
consistent procedures across relevant Federal department and agencies to ensure that—
(i)
proposed research that has been determined to have scientific and technical merit and may be subject to such policy is identified and referred for review;
(ii)
subjected research activities conducted under an award, including activities undertaken by any subrecipients of such award, are monitored regularly throughout the project period to ensure compliance with such policy and the terms and conditions of such award; and
(iii)
in the event that federally-funded research activities not subject to such policy produce unanticipated results related to the creation, transfer, or use of enhanced pathogens of pandemic potential, such research activities are identified and appropriately reviewed under such policy.
(3)
Clarification.— Reviews required pursuant to this section shall be in addition to any applicable requirements for research project applications required under the Public Health Service Act, including reviews required under section 492 of such Act (42 U.S.C. 289a), as applicable, or other applicable laws.
(b)
Implementation.—
(1)
In general.— The Director shall direct all heads of relevant Federal departments and agencies to update, modernize, or promulgate applicable implementing guidance to implement the requirements of this section.
(2)
Updates.— Consistent with the requirements under subsection (a)(1)(B), the Director shall require all heads of relevant Federal departments and agencies to update such policies consistent with any changes to the policy established pursuant to subsection (a)(1).
(c)
Limitations on Countries of Concern Conducting Certain Research.—
(1)
In general.— Beginning not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall not fund research conducted by a foreign entity at a facility located in a country of concern, in the estimation of the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Secretary of Health and Human Services, involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).
(2)
Conditions for lifting or suspending prohibition.— The Secretary of Health and Human Services may lift or suspend the prohibition of funding under paragraph (1)—
(A)
only after the review required under subsection (a)(1)(A)(i) is complete; and
(B)
only if the Secretary notifies Congress not less than 15 days before such prohibition is lifted or suspended.

CHAPTER 3 Preventing Undue Foreign Influence in Biomedical Research

SEC. 2321. Foreign Talent Recruitment Programs.

(a)
Intramural Research.—
(1)
In general.— Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this chapter as the “Secretary”) shall prohibit personnel of the National Institutes of Health engaged in intramural research from participation in foreign talent recruitment programs.
(2)
Exemption.— Paragraph (1) shall not apply to participation in international conferences or other international exchanges, partnerships, or programs, for which such participation has been approved by the National Institutes of Health. In such circumstances, the National Institutes of Health shall ensure appropriate training is provided to the participant on how to respond to overtures from individuals associated with foreign talent recruitment programs.
(b)
Extramural Research.— The Secretary shall require disclosure of participation in foreign talent recruitment programs, including the provision of copies of all grants, contracts, or other agreements related to such programs, and other supporting documentation related to such programs, as a condition of receipt of Federal extramural biomedical research funding awarded through the Department of Health and Human Services.
(c)
Consistency.— The Secretary shall ensure that the policies developed, updated, or issued pursuant to subsections (a) and (b) are, to the greatest extent practicable, consistent with the requirements of subtitle D of title VI of division B of Public Law 117–167 (42 U.S.C. 19231 et seq.) related to foreign talent recruitment programs.

SEC. 2322. Securing Identifiable, Sensitive Information and Addressing Other National Security Risks Related to Research.

(a)
In General.— The Secretary of Health and Human Services, in consultation with the Director of National Intelligence, the Secretary of State, the Secretary of Defense, and other national security experts, as appropriate, shall ensure that biomedical research conducted or supported by the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services is conducted or supported in a manner that appropriately considers national security risks, including national security implications related to research involving the sequencing of human genomic information, and collection, analysis, or storage of identifiable, sensitive information, as defined in section 301(d)(4) of the Public Health Service Act (42 U.S.C. 241(d)(4)), and the potential misuse of such data. Not later than 2 years after the date of enactment of this Act, the Secretary shall ensure that the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services, in consultation with the heads of agencies and national security experts, including the Office of the National Security within the Department of Health and Human Services—
(1)
develop a comprehensive framework and policies for assessing and managing such national security risks that includes, or review and update, as appropriate, the current (as of the date of review) such framework and policies to include—
(A)
criteria for how and when to conduct risk assessments for projects that may have national security implications;
(B)
security controls and training for researchers or entities, including peer reviewers, that manage or have access to such data that may present national security risks; and
(C)
methods to incorporate risk mitigation in the process for funding such projects that may have national security implications and monitor associated research activities following issuance of an award, including changes in the terms and conditions related to the use of such funds, as appropriate;
(2)
not later than 1 year after the framework and policies are developed or reviewed and updated, as applicable, under paragraph (1), develop and implement controls to ensure that—
(A)
researchers or entities involved in projects reviewed under the framework and relevant policies, including such projects that manage or have access to sensitive, identifiable information, have complied with the requirements of paragraph (1) and ongoing requirements with such paragraph;
(B)
consideration of funding for projects that may have national security implications takes into account the extent to which the country in which the proposed research will be conducted or supported poses a risk to the integrity of the United States biomedical research enterprise; and
(C)
data access committees reviewing data access requests for projects that may have national security risks, as appropriate, include members with expertise in current and emerging national security threats, in order to make appropriate decisions, including related to access to such identifiable, sensitive information; and
(3)
not later than 2 years after the framework and relevant policies are developed or reviewed and updated, as applicable, under paragraph (1), update data access and sharing policies related to human genomic data, as applicable, based on current and emerging national security threats.
(b)
Congressional Briefing.— Not later than 1 year after the date of enactment of this Act, the Secretary shall provide a briefing to the Committee on Health, Education, Labor, and Pensions and the Select Committee on Intelligence of the Senate and the Committee on Energy and Commerce and the Permanent Select Committee on Intelligence of the House of Representatives on the activities required under subsection (a).

SEC. 2323. Duties of the Director.

Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)), as amended by section 2302, is further amended by inserting after paragraph (26) (as added by section 2302) the following:

“(27) shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security;

“(28) shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and

“(29) shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.”

SEC. 2324. Protecting America’s Biomedical Research Enterprise.

(a)
In General.— The Secretary, in consultation with the Assistant to the President for National Security Affairs, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other relevant departments and agencies, and in consultation with research institutions and research advocacy organizations or other relevant experts, as appropriate, shall—
(1)
identify ways to improve the protection of intellectual property and other proprietary information, as well as identifiable, sensitive information of participants in biomedical research and development, from national security risks and other applicable threats, including the identification of gaps in policies and procedures in such areas related to biomedical research and development supported by the Department of Health and Human Services, and make recommendations to institutions of higher education or other entities that have traditionally received Federal funding for biomedical research to protect such information;
(2)
identify or develop strategies to prevent, mitigate, and address national security risks and threats in biomedical research and development supported by the Federal Government, including such threats associated with foreign talent programs, by countries seeking to exploit United States technology and other proprietary information as it relates to such biomedical research and development, and make recommendations for additional policies and procedures to protect such information;
(3)
identify national security risks and potential misuse of proprietary information, and identifiable, sensitive information of biomedical research participants and other applicable risks, including with respect to peer review, and make recommendations for additional policies and procedures to protect such information;
(4)
develop a framework to identify areas of biomedical research and development supported by the Federal Government that are emerging areas of interest for state actors and would compromise national security if they were to be subjected to undue foreign influence; and
(5)
regularly review recommendations or policies developed under this section and make additional recommendations or updates, as appropriate.
(b)
Report to President and to Congress.— Not later than 1 year after the date of enactment of this Act, the Secretary shall prepare and submit, in a manner that does not compromise national security, to the President and the Committee on Health, Education, Labor, and Pensions and the Select Committee on Intelligence of the Senate, the Committee on Energy and Commerce and the Permanent Select Committee on Intelligence of the House of Representatives, and other congressional committees as appropriate, a report on the findings and recommendations pursuant to subsection (a).

SEC. 2325. Gao Study.

(a)
In General.— The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study to assess the extent to which the Department of Health and Human Services (referred to in this section as the “Department”) utilizes or provides funding to entities that utilize such funds for human genomic sequencing services or genetic services (as such term is defined in section 201(6) of the Genetic Information Nondiscrimination Act of 2008 (42 U.S.C. 2000ff(6))) provided by entities, or subsidiaries of such entities, organized under the laws of a country or countries of concern, in the estimation of the Director of National Intelligence or the head of another Federal department or agency, as appropriate.
(b)
Considerations.— In carrying out the study under this section, the Comptroller General shall—
(1)
consider—
(A)
the extent to which the country or countries of concern could obtain human genomic information of citizens and residents of the United States from such entities that sequence, analyze, collect, or store human genomic information and which the Director of National Intelligence or the head of another Federal department or agency reasonably anticipates may use such information in a manner inconsistent with the national security interests of the United States;
(B)
whether the Department or recipient of such funds from the Department sought to provide funding to, or to use, domestic entities with no such ties to the country or countries of concern for such purposes and any barriers to the use of domestic entities; and
(C)
whether data use agreements, data security measures, and other such measures taken by the Department or recipient of such funds from the Department are sufficient to protect the identifiable, sensitive information of the people of the United States and the national security interests of the United States; and
(2)
make recommendations to address any vulnerabilities to the United States national security identified, as appropriate.
(c)
Estimation.— In conducting the study under this section, the Comptroller General may, as appropriate and necessary to complete such study, investigate specific instances of such utilization of genetic sequencing services or genetic services, as described in subsection (a), to produce estimates of the potential prevalence of such utilization among entities in receipt of Departmental funds.
(d)
Report.— Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit a report on the study under this section, in a manner that does not compromise national security, to the Committee on Health, Education, Labor, and Pensions and the Select Committee on Intelligence of the Senate, and the Committee on Energy and Commerce and the Permanent Select Committee on Intelligence of the House of Representatives. The report shall be submitted in unclassified form, to the extent practicable, but may include a classified annex.

SEC. 2326. Report on Progress to Address Undue Foreign Influence.

Not later than 1 year after the date of enactment of this Act and annually thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce in the House of Representatives, in a manner that does not compromise national security, a report on actions taken by the Secretary—
(1)
to address cases of noncompliance with disclosure requirements or research misconduct related to foreign influence, including—
(A)
the number of potential noncompliance cases investigated by the National Institutes of Health or reported to the National Institutes of Health by a research institution, including relating to undisclosed research support, undisclosed conflicts of interest or other conflicts of commitment, and peer review violations;
(B)
the number of cases referred to the Office of Inspector General of the Department of Health and Human Services, the Office of National Security of the Department of Health and Human Services, the Federal Bureau of Investigation, or other law enforcement agencies;
(C)
a description of enforcement actions taken for noncompliance related to undue foreign influence; and
(D)
any other relevant information; and
(2)
to prevent, address, and mitigate instances of noncompliance with disclosure requirements or research misconduct related to foreign influence.

CHAPTER 4 Advanced Research Projects Agency–health

SEC. 2331. Advanced Research Projects Agency–health.

(a)
In General.— Title IV of the Public Health Service Act is amended by adding at the end the following:

“PART J— ADVANCED RESEARCH PROJECTS AGENCY–HEALTH.

“SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY–HEALTH.

“(a) Establishment.—

“(1) In general.—There is established within the National Institutes of Health the Advanced Research Projects Agency–Health (referred to in this section as ‘ARPA–H’). Not later than 180 days after the date of enactment of this section, the Secretary shall transfer all functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health as in existence on the date of enactment of this section, to ARPA–H established by the preceding sentence.

“(2) Organization.—

“(A) In general.—There shall be within ARPA–H—

“(i) an Office of the Director;

“(ii) not more than 8 program offices; and

“(iii) such special project offices as the Director may establish.

“(B) Requirement.—Not fewer than two-thirds of the program offices of ARPA–H shall be exclusively dedicated to supporting research and development activities, consistent with the goals and functions described in subsection (b).

“(C) Notification.—The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives if the Director determines that additional program offices are required to carry out this section.

“(3) Exemption from certain policies of nih.—

“(A) In general.—Except as otherwise provided for in this section, and subject to subparagraph (B), in establishing ARPA–H pursuant to paragraph (1), the Secretary may exempt ARPA–H from policies and requirements of the National Institutes of Health that are in effect on the day before the date of enactment of this section as necessary and appropriate to ensure ARPA–H can most effectively achieve the goals described in subsection (b)(1).

“(B) Notice.—Not later than 90 days after the date of enactment of this section, the Secretary shall publish a notice in the Federal Register describing the specific policies and requirements of the National Institutes of Health from which the Secretary intends to exempt ARPA–H, including a rationale for such exemptions.

“(b) Goals and Functions.—

“(1) Goals.—The goals of ARPA–H shall be to—

“(A) foster the development of novel, breakthrough, and broadly applicable capabilities and technologies to accelerate transformative innovation in biomedical science and medicine in a manner that cannot be readily accomplished through traditional Federal biomedical research and development programs or commercial activity;

“(B) revolutionize the detection, diagnosis, mitigation, prevention, treatment, and cure of diseases and health conditions by overcoming long-term and significant technological and scientific barriers to developing transformative health technologies;

“(C) promote high-risk, high-reward innovation to enable the advancement of transformative health technologies; and

“(D) contribute to ensuring the United States—

“(i) pursues initiatives that aim to maintain global leadership in science and innovation; and

“(ii) improves the health and wellbeing of its citizens by supporting the advancement of biomedical science and innovation.

“(2) Functions.—ARPA–H shall achieve the goals specified in paragraph (1) by addressing specific scientific or technical questions by involving high-impact transformative, translational, applied, and advanced research in relevant areas of science, by supporting—

“(A) discovery, identification, and promotion of revolutionary advancements in science;

“(B) translation of scientific discoveries into transformative health technologies with potential application for biomedical science and medicine;

“(C) creation of platform capabilities that draw on multiple disciplines;

“(D) delivery of proofs of concept that demonstrate meaningful advances with potential clinical application;

“(E) development of new capabilities and methods to identify potential targets and technological strategies for early disease detection and intervention, such as advanced computational tools and predictive models; and

“(F) acceleration of transformational health technological advances in areas with limited technical certainty.

“(c) Director.—

“(1) In general.—The President shall appoint a director of ARPA–H (in this section referred to as the ‘Director’).

“(2) Qualifications.—The Director shall be an individual who, by reason of professional background and experience—

“(A) is especially qualified to advise the Secretary on, and manage—

“(i) research and development programs; and

“(ii) large-scale, high-risk initiatives with respect to health research and technology development across multiple sectors, including identifying and supporting potentially transformative health technologies; and

“(B) has a demonstrated ability to identify and develop partnerships to address strategic needs in meeting the goals described in subsection (b)(1).

“(3) Reporting.—The Director shall report to the Secretary of Health and Human Services.

“(4) Duties.—The duties of the Director shall include the following:

“(A) Establish strategic goals, objectives, and priorities for ARPA–H to advance the goals described in subsection (b)(1).

“(B) Approve the projects and programs of ARPA–H and restructure, expand, or terminate any project or program within ARPA–H that is not achieving its goals.

“(C) Develop funding criteria and assess the success of programs through the establishment of technical milestones.

“(D) Request that applications for funding disclose current and previous research and development efforts related to such applications, as appropriate, and identify any challenges associated with such efforts, including any scientific or technical barriers encountered in the course of such efforts or challenges in securing sources of funding, as applicable.

“(E) Coordinate with the heads of relevant Federal departments and agencies to facilitate sharing of data and information, as applicable and appropriate, and ensure that research supported by ARPA–H is informed by and supplements, not supplants, the activities of such departments and agencies and is free of unnecessary duplication of effort.

“(F) Ensure ARPA–H does not provide funding for a project unless the program manager determines that the project aligns with the goals described in subsection (b)(1).

“(G) Prioritize investments based on considerations such as—

“(i) scientific opportunity and potential impact, especially in areas that fit within the strategies and operating practices of ARPA–H and require public-private partnerships to effectively advance research and development activities; and

“(ii) the potential applications that an innovation may have to address areas of currently unmet need in medicine and health, including health disparities and the potential to prevent progression to serious disease.

“(H) Encourage strategic collaboration and partnerships with a broad range of entities, which may include institutions of higher education, minority-serving institutions (defined, for the purposes of this section, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institutions described in section 371(a) of such Act), industry, nonprofit organizations, Federally funded research and development centers, or consortia of such entities.

“(5) Term.—Notwithstanding section 405(a)(2), the Director—

“(A) shall be appointed for a 4-year term; and

“(B) may be reappointed for 1 consecutive 4-year term.

“(6) Autonomy of agency regarding recommendations and testimony.—No office or agency of the United States shall have authority to require the Director to submit legislative recommendations, or testimony or comments on legislation, to any officer or agency of the United States for approval, comments, or review prior to the submission of such recommendations, testimony or comments to Congress, if such recommendations, testimony, or comments to Congress include a statement indicating that the views expressed therein are those of the Director and do not necessarily reflect the views of the President or another Federal department, agency, or office.

“(7) Deputy director.—The Director shall appoint a Deputy Director to serve as the principal assistant to the Director.

“(8) Nonapplication of certain provision.—The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) related to consultants and individual scientists appointed for limited periods of time shall not apply to the Director appointed under this subsection.

“(d) Application of Certain Flexibilities.—The flexibilities provided to the National Institutes of Health under section 301(g) shall apply to ARPA–H with respect to the functions described in subsection (b)(2).

“(e) Protection of Information.—

“(1) No authorization for disclosure.—Nothing in this section shall be construed as authorizing the Director to disclose any information that is a trade secret or other privileged or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(2) Reporting.—If there have been requests under section 522 of title 5, United States Code, or the Secretary has used such authority to withhold information within the preceding year, not later than 1 year after the date of enactment of this section, and annually thereafter, the Director shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—

“(A) the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure; and

“(B) the nature of any request under section 552 of title 5, United States Code, or section 1905 of title 18, United States Code, that was denied using such authority.

“(3) Clarification.—The protections for trade secrets or other privileged or confidential information described in paragraph (1) shall not be construed to limit the availability or disclosure of information necessary to inform and facilitate the evaluation required under subsection (k)(2). Any such information made available to members of the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the ‘National Academies’) for such evaluation shall be kept confidential by such members and shall not be used for any purposes other than informing and facilitating the evaluation required under subsection (k)(2).

“(f) Cooperation With the Food and Drug Administration.—

“(1) In general.—In order to facilitate the enhanced collaboration and communication with respect to the most current priorities of ARPA–H, the Food and Drug Administration may meet with ARPA–H and any other Federal partners at appropriate intervals to discuss the development status, and actions that may be taken to facilitate the development, of medical products and projects that are the highest priorities to ARPA–H.

“(2) Reimbursement.—Utilizing interagency agreements or other appropriate resource allocation mechanisms available, the Director shall reimburse, using funds made available to ARPA–H, the Food and Drug Administration, as appropriate, for activities identified by the Commissioner of Food and Drugs and the Director as being conducted by the Food and Drug Administration under the authority of this subsection.

“(g) Awards.—

“(1) In general.—In carrying out this section, the Director may—

“(A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs;

“(B) award contracts, which may include multi-year contracts subject to section 3903 of title 41, United States Code;

“(C) award cash prizes, utilizing the authorities and processes established under section 24 of the Stevenson-Wydler Technology Innovation Act of 1980; and

“(D) enter into other transactions, as defined by section 319L(a)(3), subject to paragraph (2).

“(2) Limitations on entering into other transactions.—

“(A) Use of competitive procedures.—To the maximum extent practicable, competitive procedures shall be used when entering into other transactions under this section.

“(B) Written determination required.—The authority of paragraph (1)(D) may be exercised for a project if the program manager—

“(i) submits a request to the Director for each individual use of such authority before conducting or supporting a program, including an explanation of why the use of such authority is essential to promoting the success of the project;

“(ii) receives approval for the use of such authority from the Director; and

“(iii) for each year in which the program manager has used such authority in accordance with this paragraph, submits a report to the Director on the activities of the program related to such project.

“(3) Exemptions from certain requirements.—Research funded by ARPA–H shall not be subject to the requirements of section 406(a)(3)(A)(ii) or section 492.

“(h) Facilities Authority.—

“(1) In general.—The Director is authorized, for administrative purposes, to—

“(A) acquire (by purchase, lease, condemnation or otherwise), construct, improve, repair, operate, and maintain such real and personal property as are necessary to carry out this section; and

“(B) lease an interest in property for not more than 20 years, notwithstanding section 1341(a)(1) of title 31, United States Code.

“(2) Locations.—

“(A) In general.—ARPA–H, including its headquarters, shall not be located on any part of the existing National Institutes of Health campuses.

“(B) Number of locations.—ARPA–H shall have offices or facilities in not less than 3 geographic areas.

“(C) Considerations.—In determining the location of each office or facility, the Director shall make a fair and open consideration of—

“(i) the characteristics of the intended location; and

“(ii) the extent to which such location will facilitate advancement of the goals and functions specified in subsection (b).

“(i) Personnel.—

“(1) In general.—The Director may—

“(A) appoint and remove scientific, engineering, medical, and professional personnel, which may include temporary or term-limited appointments as determined by the Director to fulfill the mission of ARPA–H, without regard to any provision in title 5, United States Code, governing appointments and removals under the civil service laws;

“(B) notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, fix the base pay compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code; and

“(C) contract with private recruiting firms for assistance in identifying highly qualified candidates for technical positions needed to carry out this section.

“(2) Support staff.—The Director may use authorities in existence on the date of enactment of this section that are provided to the Secretary to hire administrative, financial, clerical, and other staff necessary to carry out functions that support the goals and functions described in subsection (b).

“(3) Number of personnel.—The Director may appoint not more than 210 personnel under this section. The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives if the Director determines that additional personnel are required to carry out this section.

“(4) Clarification on previous positions.—

“(A) In general.—Except as provided in subparagraph (B), the Director shall ensure that the personnel who are appointed to staff or support ARPA–H are individuals who, at the time of appointment and for 3 years prior to such appointment, were not employed by the National Institutes of Health. The Director may grant an exemption only for individuals who are uniquely qualified, by way of professional background and expertise, to advance the goals and functions specified in subsection (b).

“(B) Nonapplication of provision.—The restriction provided under subparagraph (A) shall not apply to any individuals who are employed by ARPA–H on the date of enactment of this section.

“(5) Additional considerations.—In appointing personnel under this subsection, the Director—

“(A) may contract with private entities for the purposes of recruitment services;

“(B) shall make efforts to recruit a diverse workforce, including individuals underrepresented in science, engineering, and medicine, including racial and ethnic minorities, provided such efforts do not conflict with applicable Federal civil rights law, and individuals with a variety of professional experiences or backgrounds; and

“(C) shall recruit program managers with demonstrated expertise in a wide range of scientific disciplines and management skills.

“(6) Use of intergovernmental personnel act.—To the extent needed to carry out the authorities under paragraph (1) and the goals and functions specified in subsection (b), the Director may utilize hiring authorities under sections 3371 through 3376 of title 5, United States Code.

“(7) Authority to accept federal detailees.—The Director may accept officers or employees of the United States or members of the uniformed service on a detail from an element of the Federal Government, on a reimbursable or a nonreimbursable basis, as jointly agreed to by the heads of the receiving and detailing elements, for a period not to exceed 3 years.

“(j) Program Managers.—

“(1) In general.—The Director shall appoint program managers for 3-year terms (and may reappoint such program managers for 1 additional consecutive 3-year term) for the programs carried out by ARPA–H.

“(2) Duties.—A program manager shall—

“(A) establish, in consultation with the Director, research and development goals for programs, including timelines and milestones, and make such goals available to the public;

“(B) manage applications and proposals, through the appropriate officials, for making awards as described in subsection (g) for activities consistent with the goals and functions described in subsection (b);

“(C) issue funding opportunity announcements, using uniform administrative processes, as appropriate;

“(D) select, on the basis of merit, each of the projects to be supported under a program carried out by ARPA–H, and taking into consideration—

“(i) the scientific, technical merit, and novelty of the proposed project;

“(ii) the ability of the applicant to successfully carry out the proposed project;

“(iii) the potential future commercial applications of the project proposed by the applicant, including whether such applications may have the potential to address areas of currently unmet need within biomedicine and improve health outcomes;

“(iv) the degree to which the proposed project has the potential to transform biomedicine and addresses a scientific or technical question pursuant to subsection (b);

“(v) the potential for the project to take an interdisciplinary approach; and

“(vi) such other criteria as established by the Director;

“(E) provide project oversight and management of strategic initiatives to advance the program, including by conducting project reviews not later than 18 months after the date of funding awards to identify and monitor progress of milestones with respect to each project and prior to disbursement of additional funds;

“(F) provide recommendations to the Director with respect to advancing the goals and functions specified in subsection (b);

“(G) encourage research collaborations and cultivate opportunities for the application or utilization of successful projects, including through identifying and supporting applicable public-private partnerships or partnerships between or among award recipients;

“(H) provide recommendations to the Director to establish, expand, restructure, or terminate partnerships or projects; and

“(I) communicate and collaborate with leaders and experts within the health care and biomedical research and development fields, including from both the public and private sectors and, as necessary, through the convening of workshops and meetings, to identify research and development gaps and opportunities and solicit stakeholder input on programs and goals.

“(k) Reports and Evaluation.—

“(1) Annual report.—

“(A) In general.—Beginning not later than 1 year after the date of enactment of this section, as part of the annual budget request submitted for each fiscal year, the Director shall submit a report on the actions undertaken, and the results generated, by ARPA–H, including—

“(i) a description of projects supported by ARPA–H in the previous fiscal year and whether such projects are meeting the goals developed by the Director pursuant to subsection (c)(4)(A);

“(ii) a description of projects terminated in the previous fiscal year, and the reason for such termination;

“(iii) a description of planned programs starting in the next fiscal year, pending the availability of funding;

“(iv) activities conducted in coordination with other Federal departments and agencies;

“(v) a description of any successes with, or barriers to, coordinating with other Federal departments and agencies to achieve the goals and functions under subsection (b);

“(vi) aggregated demographic information, if available, of direct recipients and performers in funded projects and of the ARPA–H workforce (consistent with the reporting requirements under paragraph (3)); and

“(vii) a summary of award recipient compliance with section 2321 of the PREVENT Pandemics Act.

“(B) Submission to congress.—The report under subparagraph (A) shall be submitted to—

“(i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives; and

“(ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate.

“(2) Evaluation.—

“(A) In general.—Not later than 5 years after the date of the enactment of this section, the Director shall seek to enter into an agreement with the National Academies under which the National Academies conducts an evaluation of whether ARPA–H is meeting the goals and functions specified in subsection (b).

“(B) Submission of results.—The agreement entered into under subparagraph (A) shall require the National Academies to submit the evaluation conducted under such agreement to the Director, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, and make the report publicly available.

“(3) Reporting related to arpa–h personnel.—

“(A) In general.—The Director shall establish and maintain records regarding the use of the authority under subsection (i)(1)(A), including—

“(i) the number of positions filled through such authority;

“(ii) the types of appointments of such positions;

“(iii) the titles, occupational series, and grades of such positions;

“(iv) the number of positions publicly noticed to be filled under such authority;

“(v) the number of qualified applicants who apply for such positions;

“(vi) the qualification criteria for such positions; and

“(vii) the demographic information of individuals appointed to such positions.

“(B) Reports to congress.—Not later than 2 years after the date of enactment of this section, and annually thereafter for each fiscal year in which such authority is used, the Director shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under subsection (i) within the fiscal year and how the positions relate to the goals and functions of ARPA–H.

“(C) GAO report.—Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the use of the authority provided under subsection (i)(1)(A). Such report shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include information on—

“(i) the number of positions publicly noticed and filled under the authority under subsection (i);

“(ii) the occupational series, grades, and types of appointments of such positions;

“(iii) how such positions related to advancing the goals and functions of ARPA–H;

“(iv) how the Director made appointment decisions under subsection (i);

“(v) a summary of sources used to identify candidates for filling such positions, as applicable;

“(vi) the number of individuals appointed;

“(vii) aggregated demographic information related to individuals appointed; and

“(viii) any challenges, limitations, or gaps related to the use of the authority under subsection (i) and any related recommendations to address such challenges, limitations, or gaps.

“(l) Strategic Plan.—Not later than 1 year after the date of the enactment of this section, and every 3 years thereafter, the Director shall provide to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a strategic plan describing how ARPA–H will carry out investments each fiscal year in the following 3-year period. The requirements regarding individual institute and center strategic plans under section 402(m), including paragraph (3) of such subsection, shall not apply to ARPA–H.

“(m) Independent Review.—Not later than 1 year after the date of the enactment of this section, and every 4 years thereafter, the Comptroller General of the United States shall conduct, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an independent review of the biomedical research and development portfolio of the Department of Health and Human Services, including ARPA–H, the National Institutes of Health, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority—

“(1) to assess the degree of any potential duplication of existing Federal programs and projects; and

“(2) to make any recommendations regarding any potential reorganization, consolidation, or termination of such programs and projects.

“(n) Prioritization.—

“(1) In general.—The Director shall—

“(A) prioritize awarding grants, cooperative agreements, contracts, prizes, and other transaction awards to entities that will conduct funded work in the United States;

“(B) as appropriate and practicable, encourage nondomestic recipients of any grants, cooperative agreements, contracts, prizes, and other transactions under this section to collaborate with a domestic entity;

“(C) not make awards under this section to nondomestic entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C. 3059)); and

“(D) in accordance with the requirements of chapter 33 of title 41, United States Code, and the Federal Acquisition Regulation, not make awards under this section to entities that have more than 3 ongoing concurrent awards under this section.

“(2) Clarification.—In making an award under this section, the Director may waive the requirements of subparagraphs (A), (B), and (D) of paragraph (1) if such requirements cannot reasonably be met, and the proposed project has the potential to advance the goals described in subsection (b)(1). The Director shall provide notice to Congress not later than 30 days after waiving such requirements.

“(o) Additional Consultation.—In carrying out this section, the Director may consult with—

“(1) the President’s Council of Advisors on Science and Technology;

“(2) representatives of professional or scientific organizations, including academia and industry, with expertise in specific technologies under consideration or development by ARPA–H;

“(3) an existing advisory committee providing advice to the Secretary or the head of any operating or staff division of the Department;

“(4) the advisory committee established under subsection (p); and

“(5) any other entity the Director may deem appropriate.

“(p) Advisory Committee.—

“(1) In general.—There is established an ARPA–H Interagency Advisory Committee (referred to in this subsection as the ‘Advisory Committee’) to coordinate efforts and provide advice and assistance on specific program or project tasks and the overall direction of ARPA–H.

“(2) Members.—The Advisory Committee established under paragraph (1) shall consist of the heads of the following agencies or their designees:

“(A) The National Institutes of Health.

“(B) The Centers for Disease Control and Prevention.

“(C) The Food and Drug Administration.

“(D) The Office of the Assistant Secretary for Preparedness and Response.

“(E) The Office of the Assistant Secretary of Health.

“(F) The Defense Advanced Research Projects Agency.

“(G) The Office of Science of the Department of Energy.

“(H) The National Science Foundation.

“(I) Any other agency or office with subject matter expertise that the Director of ARPA–H determines appropriate to advance programs or projects under this section.

“(3) Nonapplicability of faca.—The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the Advisory Committee.

“(4) Advisory nature.—The functions of the Advisory Committee shall be advisory in nature, and nothing in this subsection shall be construed as granting such Committee authority over the activities authorized under this section.

“(5) Performance measures framework.—

“(A) In general.—The Director, in consultation with the Advisory Committee, shall develop a performance measures framework for programs or projects supported by ARPA–H in order to inform and facilitate the evaluation required under subsection (k)(2), including identification of any data needed to perform such evaluation,

“(B) Availability of performance measures.—The Director shall provide to the National Academies such performance measures and data necessary to perform the evaluation required under subsection (k)(2).

“(q) Rule of Construction.—The authorities under this section, with respect to the Director, are additional authorities that do not supersede or modify any existing authorities.

“(r) Transformative Health Technology Defined.—In this section, the term ‘transformative health technology’ means a novel, broadly applicable capability or technology—

“(1) that has potential to revolutionize the detection, diagnosis, mitigation, prevention, cure, or treatment of a disease or health condition that can cause severe health outcomes and which is an area of currently unmet need; and

“(2) for which—

“(A) significant scientific or technical challenges exist; or

“(B) incentives in the commercial market are unlikely to result in the adequate or timely development of such capability or technology.

“(s) Authorization of Appropriations.—To carry out this section, there is authorized to be appropriated $500,000,000 for each of the fiscal years 2024 through 2028, to remain available until expended.

“(t) Additional Budget Clarification.—Any budget request for ARPA–H shall propose a separate appropriation from the other accounts of the National Institutes of Health.”

(b)
GAO Report on Certain Research Requirements.— The Comptroller General of the United States shall conduct a review to assess the extent to which relevant research conducted or supported by the National Institutes of Health meets Federal animal research requirements pursuant of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Such review shall also consider whether, for research conducted or supported by the National Institutes of Health that involves the use of animals, the processes of the National Institutes of Health for reviewing initial research proposals and monitoring funded research include a review of project protocols and methods to ensure that results generated by such project may be reasonably anticipated to be reproducible and replicable and achieve similar results, as applicable, in clinical trials. Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit a report on the review required under this subsection to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

Subtitle D Modernizing and Strengthening the Supply Chain for Vital Medical Products

SEC. 2401. Warm Base Manufacturing Capacity for Medical Countermeasures.

(a)
In General.— Section 319L of the Public Health Service Act (42 U.S.C. 247d–7e) is amended—
(1)
in subsection (a)(6)(B)—
(A)
by redesignating clauses (iv) and (v) as clauses (v) and (vi), respectively;
(B)
by inserting after clause (iii), the following:

“(iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products;”

; and

(C)
in clause (vi) (as so redesignated), by inserting “ manufacturing,” after “ improvement,”;
(2)
in subsection (b)—
(A)
in the first sentence of paragraph (1), by inserting “ support for domestic manufacturing surge capacity and capabilities,” after “ initiatives for innovation,”; and
(B)
in paragraph (2)—
(i)
in subparagraph (B), by striking “ and” at the end;
(ii)
by redesignating subparagraph (C) as subparagraph (D); and
(iii)
by inserting after subparagraph (B), the following:

“(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; and”

(3)
in subsection (c)—
(A)
in paragraph (2)(B), by inserting before the semicolon “ , including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities, consistent with subsection (a)(6)(B)(iv)”;
(B)
in paragraph (4)—
(i)
in subparagraph (A)—
(I)
in clause (i)—
(aa)
in subclause (I), by striking “ and” at the end; and
(bb)
by adding at the end the following:

“(III) facilitating such communication, as appropriate, regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and

“(IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act;”

(II)
in clause (ii)(III), by striking “ and” at the end;
(III)
by redesignating clause (iii) as clause (iv); and
(IV)
by inserting after clause (ii), the following:

“(iii) communicate regularly with entities in receipt of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and”

(ii)
in subparagraph (B)—
(I)
in clause (iii), by striking “ and” at the end;
(II)
in clause (iv), by striking the period and inserting “ ; and”; and
(III)
by adding at the end the following:

“(v) award contracts, grants, and cooperative agreements and enter into other transactions to support, maintain, and improve domestic manufacturing surge capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency.”

(iii)
in subparagraph (C)—
(I)
in clause (i), by striking “ and” at the end;
(II)
in clause (ii), by striking the period at the end and inserting “ ; and”; and
(III)
by adding at the end the following:

“(iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act, to ensure that facilities performing manufacturing, pursuant to an award under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this Act, as appropriate, including current good manufacturing practice pursuant to section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act; and”

(iv)
in subparagraph (D)(i), by inserting “ , including to improve manufacturing capacities and capabilities for medical countermeasures” before the semicolon;
(v)
in subparagraph (E)(ix), by striking “ 2023” and inserting “ 2028”; and
(vi)
by adding at the end the following:

“(G) Annual reports by award recipients.—As a condition of receiving an award under subparagraph (B)(v), a recipient shall develop and submit to the Secretary annual reports related to the maintenance of such capacity and capabilities, including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary.”

; and

(C)
in paragraph (5), by adding at the end the following:

“(H) Supporting warm-base and surge capacity and capabilities.—Pursuant to an award under subparagraph (B)(v), the Secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security. The Secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development, as appropriate, to provide for the maintenance of such capacity and capabilities.”

; and

(4)
in subsection (f)—
(A)
in paragraph (1), by striking “ Not later than 180 days after the date of enactment of this subsection” and inserting “ Not later than 180 days after the date of enactment of the PREVENT Pandemics Act”;
(B)
in paragraph (2)—
(i)
in the matter preceding subparagraph (A), by striking “ this subsection” and inserting “ the PREVENT Pandemics Act”;
(ii)
in subparagraph (B), by striking “ and” at the end; and
(iii)
in subparagraph (C), by striking the period and inserting “ ; and”; and
(C)
by adding at the end the following:

“(D) plans for the near-, mid-, and long-term sustainment of manufacturing activities carried out under this section, including such activities pursuant to subsection (c)(5)(H), specific actions to regularly assess the ability of recipients of an award under subsection (c)(4)(B)(v) to rapidly manufacture countermeasures as required by the Secretary, and recommendations to address challenges, if any, related to such activities.”

SEC. 2402. Supply Chain Considerations for the Strategic National Stockpile.

Subclause (II) of section 319F–2(a)(2)(B)(i) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(2)(B)(i)) is amended to read as follows:

“(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including—

“(aa) consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies on the health care system; and

“(bb) an assessment of the current supply chain for such products, including information on supply chain redundancies, any known domestic manufacturing capacity for such products, and any related vulnerabilities;”

SEC. 2403. Strategic National Stockpile Equipment Maintenance.

Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is amended—
(1)
in subparagraph (B), by inserting “ , regularly reviewed, and updated” after “ followed”; and
(2)
by amending subparagraph (D) to read as follows:

“(D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that—

“(i) emerging threats, advanced technologies, and new countermeasures are adequately considered;

“(ii) the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment; and

“(iii) such contents are in working condition or usable, as applicable, and are ready for deployment, which may include conducting maintenance services on such contents of the stockpile and disposing of such contents that are no longer in working condition, or usable, as applicable;”

SEC. 2404. Improving Transparency and Predictability of Processes of the Strategic National Stockpile.

(a)
Guidance.— Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue guidance describing the processes by which the Secretary deploys the contents of the Strategic National Stockpile under section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), or otherwise distributes medical countermeasures, as applicable, to States, territories, Indian Tribes and Tribal organizations (as such terms are defined under section 4 of the Indian Self-Determination and Education Assistance Act), and other applicable entities. Such guidance shall include information related to processes by which to request access to the contents of the Strategic National Stockpile, factors considered by the Secretary when making deployment or distribution decisions, and processes and points of contact through which entities may contact the Secretary to address any issues related to products requested or received by such entity from the stockpile, and on other relevant topics.
(b)
Annual Meetings.— Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is amended—
(1)
in subparagraph (I), by striking “ and” at the end;
(2)
in subparagraph (J), by striking the period at the end and inserting “ ; and”; and
(3)
by adding at the end the following:

“(K) convene meetings, not less than once per year, with representatives from State, local, and Tribal health departments or officials, relevant industries, other Federal agencies, and other appropriate stakeholders, in a manner that does not compromise national security, to coordinate and share information related to maintenance and use of the stockpile, including a description of future countermeasure needs and additions, modifications, and replenishments of the contents of the stockpile, and considerations related to the manufacturing and procurement of products consistent with the requirements of the with the requirements of chapter 83 of title 41, United States Code (commonly referred to as the ‘Buy American Act’), as appropriate.”

SEC. 2405. Improving Supply Chain Flexibility for the Strategic National Stockpile.

(a)
In General.— Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—
(1)
in subsection (a)—
(A)
in paragraph (3)(F), by striking “ as required by the Secretary of Homeland Security” and inserting “ at the discretion of the Secretary, in consultation with, or at the request of, the Secretary of Homeland Security,”;
(B)
by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively;
(C)
by inserting after paragraph (4) the following:

“(5) Vendor-managed inventory and warm-base surge capacity.—

“(A) In general.—For the purposes of maintaining the stockpile under paragraph (1) and carrying out procedures under paragraph (3), the Secretary may enter into contracts or cooperative agreements with vendors, which may include manufacturers or distributors of medical products, with respect to medical products intended to be delivered to the ownership of the Federal Government. Each such contract or cooperative agreement shall be subject to such terms and conditions as the Secretary may specify, including terms and conditions with respect to—

“(i) procurement, maintenance, storage, and delivery of products, in alignment with inventory management and other applicable best practices, under such contract or cooperative agreement, which may consider, as appropriate, costs of transporting and handling such products; or

“(ii) maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities are available, and that such capacity and capabilities are able to support the rapid manufacture, purchase, storage, and delivery of such products, as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency.

“(B) Report.—Not later than 2 years after the date of enactment of the PREVENT Pandemics Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on any contracts or cooperative agreements entered into under subparagraph (A) for purposes of establishing and maintaining vendor-managed inventory or reserve manufacturing capacity and capabilities for products intended for the stockpile, including a description of—

“(i) the amount of each award;

“(ii) the recipient of each award;

“(iii) the product or products covered through each award; and

“(iv) how the Secretary works with each recipient to ensure situational awareness related to the manufacturing capacity for, or inventory of, such products and coordinates the distribution and deployment of such products, as appropriate and applicable.”

; and

(D)
in subparagraph (A) of paragraph (6), as so redesignated—
(i)
in clause (viii), by striking “ ; and” and inserting a semicolon;
(ii)
in clause (ix), by striking the period and inserting “ ; and”; and
(iii)
by adding at the end the following:

“(x) with respect to reports issued in 2027 or any subsequent year, an assessment of selected contracts or cooperative agreements entered into pursuant to paragraph (5).”

; and

(2)
in subsection (c)(2)(C), by striking “ on an annual basis” and inserting “ not later than March 15 of each year”.
(b)
Authorization of Appropriations.— Section 319F–2(f)(1) of the Public Health Service Act (42 U.S.C. 247d–6b(f)(1)) is amended by striking “ $610,000,000 for each of fiscal years 2019 through 2023” and inserting “ $610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023”.

SEC. 2406. Reimbursement for Certain Supplies.

Paragraph (7) of section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as so redesignated by section 405(a)(1)(B), is amended to read as follows:

“(7) Reimbursement for certain supplies.—

“(A) In general.—The Secretary may, at appropriate intervals, make available for purchase excess contents procured for, and maintained within, the stockpile under paragraph (1) to any Federal agency or State, local, or Tribal government. The Secretary shall make such contents available for purchase only if—

“(i) such contents are in excess of what is required for appropriate maintenance of such stockpile;

“(ii) the Secretary determines that the costs for maintaining such excess contents are not appropriate to expend to meet the needs of the stockpile; and

“(iii) the Secretary determines that such action does not compromise national security and is in the national interest.

“(B) Reimbursement and collection.—The Secretary may require reimbursement for contents that are made available under subparagraph (A), in an amount that reflects the cost of acquiring and maintaining such contents and the costs incurred to make available such contents in the time and manner specified by the Secretary. Amounts collected under this subsection shall be credited to the appropriations account or fund that incurred the costs to procure such contents, and shall remain available, without further appropriation, until expended, for the purposes of the appropriation account or fund so credited.

“(C) Rule of construction.—This paragraph shall not be construed to preclude transfers of contents in the stockpile under other authorities.

“(D) Report.—Not later than 2 years after the date of enactment of the PREVENT Pandemics Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the use of the authority provided under this paragraph, including details of each action taken pursuant to this paragraph, the account or fund to which any collected amounts have been credited, and how the Secretary has used such amounts.

“(E) Sunset.—The authority under this paragraph shall terminate on September 30, 2028.”

SEC. 2407. Action Reporting on Stockpile Depletion.

Section 319 of the Public Health Service Act (42 U.S.C. 247d), as amended by section 2223, is further amended by adding at the end the following:

“(h) Stockpile Depletion Reporting.—The Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 319F–2(a) to respond to a public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on—

“(1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests;

“(2) the amount of such products that remain within the stockpile following such deployment; and

“(3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.”

SEC. 2408. Provision of Medical Countermeasures to Indian Programs and Facilities.

(a)
Clarification.— Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is amended—
(1)
in subparagraph (C), by striking “ and local” and inserting “ local, and Tribal”; and
(2)
in subparagraph ( J), by striking “ and local” and inserting “ local, and Tribal”.
(b)
Distribution of Medical Countermeasures to Indian Tribes.— Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 319F–4 the following:

“SEC. 319F–5. PROVISION OF MEDICAL COUNTERMEASURES TO INDIAN PROGRAMS AND FACILITIES.

“In the event that the Secretary deploys the contents of the Strategic National Stockpile under section 319F–2(a), or otherwise distributes medical countermeasures to States to respond to a public health emergency declared by the Secretary under section 319, the Secretary shall, in consultation with the applicable States, make such contents or countermeasures directly available to Indian Tribes and Tribal organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304), which may include through health programs or facilities operated by the Indian Health Service, that are affected by such public health emergency.”

SEC. 2409. Grants for State Strategic Stockpiles.

(a)
Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended by adding at the end the following:

“(i) Pilot Program to Support State Medical Stockpiles.—

“(1) In general.—The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, shall award grants or cooperative agreements to not fewer than 5 States, or consortia of States, with consideration given to distribution among the geographical regions of the United States, to establish, expand, or maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies determined by the State to be necessary to respond to a public health emergency declared by the Governor of a State or by the Secretary under section 319, or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, in order to support the preparedness goals described in paragraphs (2) through (6) and (8) of section 2802(b). A recipient of such an award may not use award funds to support the stockpiling of security countermeasures (as defined in subsection (c)(1), unless the eligible entity provides justification for maintaining such countermeasures and the Secretary determines such justification is appropriate and applicable.

“(2) Requirements.—

“(A) Application.—To be eligible to receive an award under paragraph (1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such State or States, and submit to the Secretary an application that contains such information as the Secretary may require, including—

“(i) a plan for such stockpile, consistent with paragraph (4), including—

“(I) a description of the activities such entity will carry out under the agreement;

“(II) an assurance that such entity will use funds under such award in alignment with the requirements of chapter 83 of title 41, United States Code (commonly referred to as the ‘Buy American Act’); and

“(III) an outline of proposed expenses; and

“(ii) a description of how such entity will coordinate with relevant entities in receipt of an award under section 319C–1 or 319C–2 pursuant to paragraph (4), including through promoting alignment between the stockpile plan established pursuant to clause (i) and applicable plans that are established by such entity pursuant to section 319C–1 or 319C–2.

“(B) Matching funds.—

“(i) Subject to clause (ii), the Secretary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to—

“(I) for each of fiscal years 2023 and 2024, not less than $1 for each $20 of Federal funds provided in the award; and

“(II) for fiscal year 2025 and each fiscal year thereafter, not less than $1 for each $10 of Federal funds provided in the award.

“(ii) Waiver.—The Secretary may, upon the request of a State, waive the requirement under clause (i), in whole or in part, if the Secretary determines that extraordinary economic conditions in the State in the fiscal year involved or in the previous fiscal year justify the waiver. A waiver provided by the Secretary under this subparagraph shall apply only to the fiscal year involved.

“(C) Administrative expenses.—Not more than 10 percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses.

“(3) Lead entity.—An entity in receipt of an award under paragraph (1) may designate a lead entity, which may be a public or private entity, as appropriate, to manage the stockpile at the direction of the State or consortium of States.

“(4) Use of funds.—An entity in receipt of an award under paragraph (1) shall use such funds to—

“(A) purchase, store, and maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies to be used during a public health emergency, major disaster, or emergency described in paragraph (1), in such numbers, types, and amounts as the entity determines necessary, consistent with such entity’s stockpile plan established pursuant to paragraph (2)(A)(i);

“(B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency, major disaster, or other emergency described in paragraph (1);

“(C) replenish and make necessary additions or modifications to the contents of such stockpile, including to address potential depletion;

“(D) in consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile;

“(E) ensure that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as appropriate;

“(F) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that, to the extent practicable, new technologies and medical products are considered;

“(G) carry out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies, major disasters, or other emergencies described in paragraph (1) of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other training for recipients of awards under section 319C–1 or 319C–2, as applicable; and

“(H) carry out other activities related to the State strategic stockpile as the entity determines appropriate, to support State efforts to prepare for, and respond to, public health threats.

“(5) Supplement not supplant.—Awards under paragraph (1) shall supplement, not supplant, the maintenance and use of the Strategic National Stockpile by the Secretary under subsection (a).

“(6) Guidance for states.—Not later than 180 days after the date of enactment of this subsection, the Secretary, in consultation with States, health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such guidance as appropriate, for States related to maintaining and replenishing a stockpile of medical products, which may include strategies and best practices related to—

“(A) types of medical products and medical supplies that are critical to respond to public health emergencies, and may be appropriate for inclusion in a stockpile by States, with consideration of threats that require the large-scale and simultaneous deployment of stockpiles, including the stockpile maintained by the Secretary pursuant to subsection (a), and long-term public health and medical response needs;

“(B) appropriate management of the contents of a stockpile, including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the State and appropriate disposition of excess products, as applicable; and

“(C) the procurement of medical products and medical supplies consistent with the requirements of chapter 83 of title 41, United States Code (commonly referred to as the ‘Buy American Act’).

“(7) Technical assistance.—The Secretary shall provide assistance to States, including technical assistance, as appropriate, in establishing, maintaining, improving, and utilizing a medical stockpile, including appropriate inventory management and disposition of products.

“(8) Reporting.—

“(A) State reports.—Each entity receiving an award under paragraph (1) shall update, as appropriate, the plan established pursuant to paragraph (2)(A)(i) and submit to the Secretary an annual report on implementation of such plan, including any changes to the contents of the stockpile supported under such award. The Secretary shall use information obtained from such reports to inform the maintenance and management of the Strategic National Stockpile pursuant to subsection (a).

“(B) Reports to congress.—Not later than 1 year after the initial issuance of awards pursuant to paragraph (1), and annually thereafter for the duration of the program established under this subsection, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on such program, including—

“(i) Federal and State expenditures to support stockpiles under such program;

“(ii) activities conducted pursuant to paragraph (4); and

“(iii) any additional information from the States that the Secretary determines relevant.

“(9) Authorization of appropriations.—To carry out this subsection, there is authorized to be appropriated $3,500,000,000 for each of fiscal years 2023 and 2024, to remain available until expended.”

(b)
GAO Report.— Not later than 3 years after the date on which awards are first issued pursuant to subsection (i)(1) of section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b), as added by subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the State stockpiles established or maintained pursuant to this section. Such report shall include an assessment of—
(1)
coordination and communication between the Secretary of Health and Human Services and entities in receipt of an award under this section, or a lead entity designated by such entity;
(2)
technical assistance provided by the Secretary of Health and Human Services to such entities; and
(3)
the impact of such stockpiles on the ability of the State to prepare for and respond to a public health emergency, major disaster, or other emergency described in subsection (i)(1) of section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b), as added by subsection (a), including the availability and distribution of items from such State stockpile to health care entities and other applicable entities.

SEC. 2410. Study on Incentives for Domestic Production of Generic Medicines.

(a)
In General.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services shall—
(1)
conduct a study on the feasibility, including related to sustainment, and potential effectiveness, and utility of providing incentives for increased domestic production and capacity of specified generic medicines and their active pharmaceutical ingredients, which may include through applicable nonprofit or for-profit private entities; and
(2)
not later than 1 year after the date of enactment of this Act, submit a report on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(b)
Specified Generic Medicine.— In this section, the term “specified generic medicine” means a generic drug approved under section 505(j) of the Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is —
(1)
used to prevent, mitigate, or treat a serious or life-threatening disease or condition, or used in a common procedure that could be life-threatening without such medicine;
(2)
an antibiotic or antifungal used to treat a serious or life threatening infectious disease;
(3)
critical to the public health during a public health emergency; or
(4)
life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition.

SEC. 2411. Increased Manufacturing Capacity for Certain Critical Antibiotic Drugs.

(a)
Program.—
(1)
In general.— The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and Commissioner of Food and Drugs, may award contracts to increase the domestic manufacturing capacity of certain antibiotic drugs with identified supply chain vulnerabilities, or the active pharmaceutical ingredient or key starting material of such antibiotic drugs.
(2)
Eligible entities.— To be eligible to receive an award under this subsection, an entity shall—
(A)
be a manufacturer that is in compliance with, or demonstrates capability to comply with, the relevant requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
(B)
prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—
(i)
a description of proposed activities to be supported by an award under this subsection to increase manufacturing capacity for such antibiotic drug or drugs;
(ii)
the antibiotic drug or drugs, or related active pharmaceutical ingredients or key starting materials for such drug or drugs, that such entity intends to manufacture with any increased manufacturing capacity supported by an award under this subsection;
(iii)
any additional products such increased manufacturing capacity could be used to manufacture;
(iv)
a description of the current supply chain for such antibiotic drugs, including any existing and applicable manufacturing facilities, known vulnerabilities in the supply chain, known or potential supply limitations, such as foreign export restrictions, or subsidies from foreign governments, as applicable;
(v)
a description of how such entity may use advanced or flexible manufacturing in carrying out the terms of an award under this subsection; and
(vi)
a strategic plan regarding the maintenance, operation, and sustainment of such increased manufacturing capacity following the expiration of a contract under this subsection.
(3)
Use of funds.— A recipient of an award under this subsection shall use such funds to build, expand, upgrade, modify, or recommission a facility located in the United States, which may include the purchase or upgrade of equipment, as applicable, to support increased manufacturing capacity of certain antibiotic drugs for which supply chain vulnerabilities exist, or the active pharmaceutical ingredient or key starting material of such antibiotic drugs.
(4)
Reports.— An entity in receipt of an award under this subsection shall submit to the Secretary such reports as the Secretary may require related to increasing domestic manufacturing capacity of antibiotic drugs pursuant to a contract under this subsection, including actions taken to implement the strategic plan required under paragraph (2)(B)(vi).
(5)
Contract terms.— The following shall apply to a contract to support increased domestic manufacturing capacity under this subsection:
(A)
Milestone-based payments.— The Secretary may provide payment, including advance payment or partial payment for significant milestones, if the Secretary makes a determination that such payment is necessary and appropriate.
(B)
Repayment.— The contract shall provide that such payment is required to be repaid if there is a failure to perform by the manufacturer under the contract; if the specified milestones are reached, an advance or partial payment shall not be required to be repaid.
(C)
Contract duration.—
(i)
In general.— Each contract shall be for a period not to exceed 5 years.
(ii)
Non-renewability.— A contract shall not be renewable.
(iii)
Notifications of extensions and terminations.— If the Secretary decides to terminate a contract prior to its expiration, the Secretary shall notify the manufacturer within 90 days of such determination.
(D)
Additional terms.— The Secretary, in any contract under this subsection—
(i)
may specify—
(I)
the amount of funding that will be dedicated by the Secretary for supporting increased manufacturing capacity under such contract; and
(II)
the amount of manufacturing capacity that such eligible entity must meet; and
(ii)
shall provide a clear statement of defined Federal Government purpose limited to uses related to increasing domestic manufacturing capacity for antibiotic drugs to address identified supply chain vulnerabilities and challenges to establishing and maintaining domestic manufacturing capacity.
(E)
Sustainment.— Each contract shall provide for the eligible entity to update the strategic plan required under paragraph (2)(B)(vi) throughout the duration of such contract, as required by the Secretary.
(b)
Report.— Not later than 2 years after the date of enactment of this Act and every year thereafter until the termination or expiration of all such contracts, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on any activities supported under subsection (a), including—
(1)
the antibiotic drugs for which the Secretary prioritized awards under subsection (a), including a description of how the Secretary consulted with stakeholders to inform such prioritization;
(2)
information regarding each contract awarded pursuant to subsection (a), including—
(A)
the recipient of each such contract, including any recipients of a subaward;
(B)
the milestone and performance requirements pursuant to each such contract;
(C)
the duration of each such contract;
(D)
the amount of funding provided by the Secretary pursuant to each such contract, including any advanced or partial payments;
(E)
the antibiotic drugs supported through each such contract, including a description of the medical necessity of each such antibiotic drug and any supply chain vulnerabilities, limitations, and related characteristics identified pursuant to subsection (a)(2)(B)(iv) for each such antibiotic drug; and
(F)
the amount of increased manufacturing capacity for such antibiotic drug that each such contract supports; and
(3)
a description of how such contracts address supply chain vulnerabilities, including increasing manufacturing capacity of antibiotic drugs in the United States; and
(4)
a description of the strategic plan submitted pursuant to subsection (a)(2)(B)(vi) by each recipient of an award under subsection (a).
(c)
Rule of Construction.— Nothing in this section shall be construed—
(1)
to limit, directly or indirectly, or otherwise impact the private distribution, purchase, or sale of antibiotic drugs or active pharmaceutical ingredients or key starting materials; or
(2)
to authorize the Secretary to disclose any information that is a trade secret, or other privileged or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
(d)
Definitions.— For purposes of this section:
(1)
Active pharmaceutical ingredient.— The term “active pharmaceutical ingredient” has the meaning given such term in section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41).
(2)
Antibiotic drug.— The term “antibiotic drug” means an antibacterial or antifungal drug approved by the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is of significant priority to providing health care and is medically necessary to have available at all times in an amount adequate to serve patient needs.
(3)
Key starting material.— The term “key starting material” means any component of a drug that the Secretary determines to be necessary to the safety and effectiveness of the drug.
(4)
Secretary.— The term “Secretary” means the Secretary of Health and Human Services.
(e)
Sunset.— The authority to enter into new contracts under this section shall cease to be effective 3 years after the date of enactment of this Act, and, beginning on the date that is 8 years after the date of enactment of this Act, this section shall have no force or effect.

Subtitle E Enhancing Development and Combating Shortages of Medical Products

CHAPTER 1 Development and Review

SEC. 2501. Accelerating Countermeasure Development and Review.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended by adding at the end the following:

“(h) Accelerating Countermeasure Development and Review During an Emergency.—

“(1) Acceleration of countermeasure development and review.—The Secretary may, at the request of the sponsor of a countermeasure, during a domestic, military, or public health emergency or material threat described in section 564A(a)(1)(C), expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or section 351 of the Public Health Service Act.

“(2) Actions.—The actions to expedite the development and review of a countermeasure under paragraph (1) may include the following:

“(A) Expedited review of submissions made by sponsors of countermeasures to the Food and Drug Administration, including rolling submissions of countermeasure applications and other submissions.

“(B) Expedited and increased engagement with sponsors regarding countermeasure development and manufacturing, including—

“(i) holding meetings with the sponsor and the review team and providing timely advice to, and interactive communication with, the sponsor regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or authorization is as efficient as practicable;

“(ii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

“(iii) assigning a cross-disciplinary project lead for the review team to facilitate;

“(iv) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; and

“(v) streamlining the review of approved, licensed, cleared, or authorized countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures.

“(C) Expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing.

“(D) Other steps to expedite the development and review of a countermeasure application submitted for approval, licensure, clearance, or authorization, as the Secretary determines appropriate.

“(3) Limitation of effect.—Nothing in this subsection shall be construed to require the Secretary to grant, or take any other action related to, a request of a sponsor to expedite the development and review of a countermeasure for approval, licensure, clearance, or authorization under paragraph (1).”

SEC. 2502. Third Party Test Evaluation During Emergencies.

(a)
In General.— Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended by section 2501, is further amended by adding at the end the following:

“(i) Third Party Evaluation of Tests Used During an Emergency.—

“(1) In general.—For purposes of conducting evaluations regarding whether an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regulations)) for which a request for emergency use authorization is submitted under section 564 meets the criteria for issuance of such authorization, the Secretary may, as appropriate, consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.

“(2) Requirements regarding evaluations and recommendations.—

“(A) In general.—In evaluating and making recommendations to the Secretary regarding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and document whether the relevant criteria under subsection (c)(2) of section 564 for issuance of authorization under such section are met with respect to the in vitro diagnostic product.

“(B) Written recommendations.—Recommendations made by a person under this subsection shall be submitted to the Secretary in writing, and shall include the reasons for such recommendation and other information that may be requested by the Secretary.

“(3) Rule of construction.—Nothing in this subsection shall be construed to require the Secretary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph (1) for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 564.”

(b)
Guidance.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall issue draft guidance on consultations with persons under subsection (i) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as added by subsection (a), including considerations concerning conflicts of interest, compensation arrangements, and information sharing. Not later than 1 year after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

SEC. 2503. Platform Technologies.

(a)
In General.— Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506J of such Act (21 U.S.C. 356j) the following:

“SEC. 506K. PLATFORM TECHNOLOGIES.

“(a) In General.—The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b).

“(b) Criteria.—A platform technology incorporated within or utilized by a drug or biological product is eligible for designation as a designated platform technology under this section if—

“(1) the platform technology is incorporated in, or utilized by, a drug approved under section 505 of this Act or a biological product licensed under section 351 of the Public Health Service Act;

“(2) preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and

“(3) data or information submitted by the applicable person under paragraph (2) indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review process.

“(c) Request for Designation.—A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request.

“(d) Designation.—

“(1) In general.—Not later than 90 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b).

“(2) Designation.—If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate.

“(3) Determination not to designate.—If the Secretary determines that the platform technology does not meet the criteria under subsection (b), the Secretary shall include with the determination not to designate the technology a written description of the rationale for such determination.

“(4) Revocation of designation.—The Secretary may revoke a designation made under paragraph (2), if the Secretary determines that the designated platform technology no longer meets the criteria described in subsection (b). The Secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing, including a description of the rationale for such determination.

“(5) Applicability.—Nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this Act or the Public Health Service Act.

“(e) Actions.—The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology, including—

“(1) engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 505(b) of this Act or safety, purity, or potency under section 351(a) of the Public Health Service Act;

“(2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable, which may include holding meetings with the sponsor and the review team throughout the development of the drug; and

“(3) considering inspectional findings, including prior findings, related to the manufacture of a drug that incorporates or utilizes the designated platform technology.

“(f) Leveraging Data From Designated Platform Technologies.—The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this Act and section 351(a) of the Public Health Service Act, allow the sponsor of an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 564, in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that—

“(1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or

“(2) the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1).

“(g) Changes to a Designated Platform Technology.—A sponsor of more than one application approved under section 505(b) of this Act or section 351(a) of the Public Health Service Act for drugs that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable drug or biological product.

“(h) Definitions.—For purposes of this section:

“(1) The term ‘platform technology’ means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates—

“(A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biological product;

“(B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and

“(C) facilitates the manufacture or development of more than one drug or biological product through a standardized production or manufacturing process or processes.

“(2) The term ‘designated platform technology’ means a platform technology that is designated as a platform technology under subsection (d).

“(i) Rule of Construction.—Nothing in this section shall be construed to—

“(1) alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act or license biological products pursuant to section 351 of the Public Health Service Act, including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or

“(2) confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing information contained in another application submitted by the holder of an approved application under section 505(c) of this Act or of a license under section 351(a) of the Public Health Service Act.”

(b)
Guidance.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue draft guidance on the implementation of this section. Such guidance shall include examples of drugs that can be manufactured using platform technologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary’s review of platform technologies, information regarding submitting for designation, considerations for persons submitting a request for designation who have been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of products that incorporate or utilize designated platform technologies, and recommendations and requirements for making and reporting manufacturing changes to a designated platform technology in accordance with section 506K(g) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and section 506A of such Act (21 U.S.C. 356a), as applicable.
(c)
Report.— Not later than September 30, 2026, and annually thereafter until September 30, 2029, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that shall include—
(1)
the number of requests for designation under the program under section 506K of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);
(2)
the number of designations under such program issued, active, and revoked;
(3)
the resources required to carry out such program (including the review time used for full-time equivalent employees);
(4)
any efficiencies gained in the development, manufacturing, and review processes associated with such designations; and
(5)
recommendations, if any, to strengthen the program to better leverage platform technologies that can be used in more than one drug and meet patient needs in a manner as timely as possible, taking into consideration the resources available to the Secretary of Health and Human Services for carrying out such program.

SEC. 2504. Increasing Eua Decision Transparency.

Section 564(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(h)) is amended—
(1)
in paragraph (1)—
(A)
by inserting “ on the internet website of the Food and Drug Administration and” after “ promptly publish”;
(B)
by striking “ application under section 505(i), 512(j), or 520(g), even if such summary may indirectly reveal the existence of such application” and inserting “ application, request, or submission under this section or section 505(b), 505(i), 505(j), 512(b), 512(j), 512(n), 515, 510(k), 513(f)(2), 520(g), 520(m), 571, or 572 of this Act, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission”; and
(C)
by inserting before the period at the end of the second sentence the following: “ , which may include a summary of the data and information supporting such revisions”; and
(2)
in paragraph (2), by adding at the end the following: “ Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code”.

SEC. 2505. Improving Fda Guidance and Communication.

(a)
FDA Report and Implementation of Good Guidance Practices.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall develop, and publish on the website of the Food and Drug Administration—
(1)
a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and
(2)
a plan for implementation of such best practices, including across other applicable agencies, which shall address—
(A)
streamlining development and review of guidance documents within centers and across the Food and Drug Administration;
(B)
streamlining processes for regulatory submissions to the Food and Drug Administration, including through the revision or issuance of guidance documents; and
(C)
implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the COVID–19 public health emergency, as appropriate.
(b)
Report and Implementation of FDA Best Practices for Communicating With External Stakeholders.— The Secretary, acting through the Commissioner of Food and Drugs, shall develop and publish on the website of the Food and Drug Administration a report on the practices of the Food and Drug Administration to broadly communicate with external stakeholders, other than through guidance documents, which shall include—
(1)
a review of the types and methods of public communication that the Food and Drug Administration uses to communicate and interact with medical product sponsors and other external stakeholders;
(2)
the identification of best practices for the efficient development, issuance, and use of such communications; and
(3)
a plan for implementation of best practices for communication with external stakeholders, which shall address—
(A)
advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regulatory clarity to product sponsors and other stakeholders, and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders, including the use of tools such as product submission templates, webinars, and frequently asked questions communications;
(B)
streamlining processes for regulatory submissions; and
(C)
implementing innovative communication development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as appropriate.
(c)
Consultation.— In developing and publishing the report and implementation plan under this section, the Secretary shall consult with stakeholders, including researchers, academic organizations, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, clinical laboratories, health care providers, patient groups, and other appropriate stakeholders.
(d)
Manner of Issuance.— For purposes of carrying out this section, the Secretary may update an existing report or plan, and may combine the reports and implementation plans described in subsections (a) and (b) into one or more documents.
(e)
Timing.— The Secretary shall—
(1)
not later than 1 year after the date of enactment of this Act, publish a draft of the reports and plans required under this section; and
(2)
not later than 180 days after publication of the draft reports and plans under paragraph (1)—
(A)
publish a final report and plan; and
(B)
begin implementation of the best practices pursuant to such final plan.

CHAPTER 2 Mitigating Shortages

SEC. 2511. Ensuring Registration of Foreign Drug and Device Manufacturers.

(a)
Registration of Certain Foreign Establishments.— Section 510(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is amended by adding at the end the following:

“(5) The requirements of paragraphs (1) and (2) shall apply regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States.”

(b)
Updating Regulations.— Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall update regulations, as appropriate, to implement the amendment made by subsection (a).

SEC. 2512. Extending Expiration Dates for Certain Drugs.

(a)
In General.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue draft guidance, or revise existing guidance, to address recommendations for sponsors of applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) regarding—
(1)
the submission of stability testing data in such applications, including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expiration dates;
(2)
establishing in the labeling of drugs the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may—
(A)
help prevent or mitigate drug shortages; and
(B)
affect product quality; and
(3)
the use of innovative approaches for drug and combination product stability modeling to support initial product expiration dates and expiration date extensions.
(b)
Report.— Not later than 2 years after the date of enactment of this Act, and again 2 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—
(1)
the number of drugs for which the Secretary has requested the manufacturer make a labeling change regarding the expiration date; and
(2)
for each drug for which the Secretary has requested a labeling change with respect to the expiration date, information regarding the circumstances of such request, including—
(A)
the name and dose of such drug;
(B)
the rationale for the request;
(C)
whether the drug, at the time of the request, was listed on the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e), or was at risk of shortage;
(D)
whether the request was made in connection with a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d); and
(E)
whether the manufacturer made the requested change by the requested date, and for instances where the manufacturer does not make the requested change, the manufacturer’s justification for not making the change, if the manufacturer agrees to provide such justification for inclusion in the report.

SEC. 2513. Combating Counterfeit Devices.

(a)
Prohibited Acts.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

“(fff)

(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.

“(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.

“(3) The doing of any act which causes a device to be a counterfeit device, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit device.”

(b)
Penalties.— Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended—
(1)
in subsection (b)(8), by inserting “ , or who violates section 301(fff)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit device,” after “ a counterfeit drug”; and
(2)
in subsection (c), by inserting “ ; or (6) for having violated section 301(fff)(2) if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a device being a counterfeit device, or for having violated section 301(fff)(3) if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the device was a counterfeit device” before the period.
(c)
Seizure.— Section 304(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is amended—
(1)
by striking “ , and (E)” and inserting “ , (E)”; and
(2)
by inserting “ , (F) Any device that is a counterfeit device, (G) Any container, packaging, or labeling of a counterfeit device, and (H) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit device or devices” before the period.

SEC. 2514. Preventing Medical Device Shortages.

(a)
Notifications.— Section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amended—
(1)
in subsection (f), by inserting “ or (h)” after “ subsection (a)”;
(2)
by redesignating subsections (h) and (i) as subsections (i) and (j), respectively; and
(3)
by inserting after subsection (g) the following:

“(h) Additional Notifications.—The Secretary may receive voluntary notifications from a manufacturer of a device that is life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, or any other device the Secretary determines to be critical to the public health, pertaining to a permanent discontinuance in the manufacture of the device (except for any discontinuance as a result of an approved modification of the device) or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States, and the reasons for such discontinuance or interruption.”

(b)
Guidance on Voluntary Notifications of Discontinuance or Interruption of Device Manufacture.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as added by subsection (a). Such guidance shall include a description of circumstances in which a voluntary notification under such subsection (h) may be appropriate, recommended timeframes for such a notification, the process for receiving such a notification, and actions the Secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.
(c)
Guidance on Device Shortage Notification Requirement.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J.

SEC. 2515. Technical Corrections.

(a)
Technical Corrections to the CARES Act.— Division A of the CARES Act (Public Law 116–136) is amended—
(1)
in section 3111(1), by striking “ in paragraph (1)” and inserting “ in the matter preceding paragraph (1)”;
(2)
in section 3112(d)(1), by striking “ and subparagraphs (A) and (B)” and inserting “ as subparagraphs (A) and (B)”; and
(3)
in section 3112(e), by striking “ Federal Food, Drug, Cosmetic Act” and inserting “ Federal Food, Drug, and Cosmetic Act”.
(b)
Technical Corrections to the Federal Food, Drug, and Cosmetic Act Related to the CARES Act.—
(1)
Section 506c.— Section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)) is amended, in the flush text at the end, by striking the second comma after “ in the United States”.
(2)
Effective date.— The amendment made by paragraph (1) shall take effect as if included in section 3112 of division A of the CARES Act (Public Law 116–136).
(c)
Other Technical Correction to the Federal Food, Drug, and Cosmetic Act.— Section 505B(f)(6)(I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(f)(6)(I)) is amended by striking “ subsection (a)(3)(B)” and inserting “ subsection (a)(4)(C)”.

TITLE III Food and Drug Administration

SEC. 3001. Short Title.

This title may be cited as the “Food and Drug Omnibus Reform Act of 2022”.

SEC. 3002. Definition.

In this title, except as otherwise specified, the term “Secretary” means the Secretary of Health and Human Services.

Subtitle A Reauthorizations

SEC. 3101. Reauthorization of the Critical Path Public-Private Partnership.

Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking “ $1,265,753 for the period beginning on October 1, 2022 and ending on December 23, 2022” and inserting “ $6,000,000 for each of fiscal years 2023 through 2027”.

SEC. 3102. Reauthorization of the Best Pharmaceuticals for Children Program.

Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “ $5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022” and inserting “ $25,000,000 for each of fiscal years 2023 through 2027”.

SEC. 3103. Reauthorization of the Humanitarian Device Exemption Incentive.

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “ December 24, 2022” and inserting “ October 1, 2027”.

SEC. 3104. Reauthorization of the Pediatric Device Consortia Program.

Section 305(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note) is amended by striking “ $1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022” and inserting “ $7,000,000 for each of fiscal years 2023 through 2027”.

SEC. 3105. Reauthorization of Provision Pertaining to Drugs Containing Single Enantiomers.

Section 505(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)) is amended—
(1)
in paragraph (1)(A)(ii)(II), by adding “ (other than bioavailability studies)” after “ any clinical investigations”; and
(2)
in paragraph (4), by striking “ December 24, 2022” and inserting “ October 1, 2027”.

SEC. 3106. Reauthorization of Certain Device Inspections.

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “ December 24, 2022” and inserting “ October 1, 2027”.

SEC. 3107. Reauthorization of Orphan Drug Grants.

Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended—
(1)
in subsection (a)—
(A)
by striking “ and (3)” and inserting “ (3)”; and
(B)
by inserting before the period at the end the following: “ , and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions”; and
(2)
in subsection (c), by striking “ $6,328,767 for the period beginning on October 1, 2022, and ending on December 23, 2022” and inserting “ $30,000,000 for each of fiscal years 2023 through 2027”.

SEC. 3108. Reauthorization of Reporting Requirements Related to Pending Generic Drug Applications and Priority Review Applications.

Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended, in the matter preceding paragraph (1), by striking “ December 23, 2022” and inserting “ October 1, 2027”.

SEC. 3109. Reauthorization of Third-Party Review Program.

Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “ December 24, 2022” and inserting “ on October 1, 2027” .

Subtitle B Drugs and Biologics

CHAPTER 1 Research, Development, and Competition Improvements

SEC. 3201. Prompt Reports of Marketing Status by Holders of Approved Applications for Biological Products.

(a)
In General.— Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended—
(1)
in subsection (a)—
(A)
in the matter preceding paragraph (1), by striking “ The holder of an application approved under subsection (c) or (j) of section 505” and inserting “ The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;
(B)
in paragraph (2), by striking “ established name” and inserting “ established name (or, in the case of a biological product, the proper name)”; and
(C)
in paragraph (3), by striking “ or abbreviated application number” and inserting “ , abbreviated application number, or biologics license application number”; and
(2)
in subsection (b)—
(A)
in the matter preceding paragraph (1), by striking “ The holder of an application approved under subsection (c) or (j)” and inserting “ The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;
(B)
in paragraph (1), by striking “ established name” and inserting “ established name (or, in the case of a biological product, the proper name)”; and
(C)
in paragraph (2), by striking “ or abbreviated application number” and inserting “ , abbreviated application number, or biologics license application number”.
(b)
Additional One-Time Report.— Subsection (c) of section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to read as follows:

“(c) Additional One-Time Report.—Within 180 days of the date of enactment of the Food and Drug Omnibus Reform Act of 2022, all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) of the Public Health Service Act and shall submit a written notice to the Secretary—

“(1) stating that all of the application holder’s biological products in the list published under such section 351(k)(9)(A) that are not listed as discontinued are available for sale; or

“(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale.”

(c)
Purple Book.— Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended—
(1)
by striking subsection (d) and inserting the following:

“(d) Failure To Meet Requirements.—If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may—

“(1) move the application holder’s drugs from the active section of the list published under section 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and

“(2) identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.”

; and

(2)
in subsection (e)—
(A)
by inserting after the first sentence the following: “ The Secretary shall update the list published under section 351(k)(9)(A) of the Public Health Service Act based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 351(k)(9)(B) of the Public Health Service Act.”;
(B)
by striking “ monthly updates to the list” and inserting “ monthly updates to the lists referred to in the preceding sentences”; and
(C)
by striking “ and shall update the list based on” and inserting “ and shall update such lists based on”.
(d)
Technical Corrections.— Section 506I(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended—
(1)
by striking “ subsection 505(j)(7)(A)” and inserting “ section 505(j)(7)(A)”; and
(2)
by striking “ subsection 505(j)(7)(C)” and inserting “ section 505(j)(7)(C)”.

SEC. 3202. Improving the Treatment of Rare Diseases and Conditions.

(a)
Report on Orphan Drug Program.—
(1)
In general.— Not later than September 30, 2026, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report summarizing the activities of the Food and Drug Administration, with respect to the period of fiscal years 2023 through fiscal year 2025, related to designating drugs under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or condition and approving such drugs under section 505 of such Act (21 U.S.C. 355) or licensing such drugs under section 351 of the Public Health Service Act (42 U.S.C. 262), including—
(A)
the number of applications for such drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) received by the Food and Drug Administration, the number of such applications accepted and rejected for filing, and the numbers of such applications pending, approved, and for which a complete response letter has been issued by the Food and Drug Administration;
(B)
the number of applications for which the sponsor requested written recommendations pursuant to section 525 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa) and the number of such applications for which the sponsor received such written recommendations;
(C)
a description of trends in drug approvals for rare diseases and conditions across review divisions at the Food and Drug Administration;
(D)
the extent to which the Food and Drug Administration is consulting with external experts pursuant to section 569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8(a)(2)) on topics pertaining to drugs for a rare disease or condition, including how and when any such consultation is occurring;
(E)
the number of applications for which the Secretary allowed the sponsor to rely upon data and information pursuant to section 529A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff–1); and
(F)
a description of the Food and Drug Administration’s efforts to promote best practices in the development of novel treatments for rare diseases or conditions, including—
(i)
reviewer training on policies, methods, and tools related to rare diseases and conditions; and
(ii)
new regulatory science and coordinated support for patient and stakeholder engagement.
(2)
Public availability.— The Secretary shall make the report under paragraph (1) available to the public, including by posting the report on the website of the Food and Drug Administration.
(3)
Information disclosure.— Nothing in this subsection shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United States Code, or subject to withholding under paragraph (4) of section 552(b) of title 5, United States Code (commonly referred to as the “Freedom of Information Act”).
(b)
Guidance.— Not later than 9 months after the date of enactment of this Act, the Secretary shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development”, issued on February 1, 2019.
(c)
Study on European Union Safety and Efficacy Reviews of Drugs for Rare Diseases and Conditions.—
(1)
In general.— The Secretary shall enter into a contract with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the “National Academies”) to conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union, including—
(A)
flexibilities, authorities, or mechanisms available to regulators in the United States and the European Union specific to rare diseases or conditions;
(B)
the consideration and use of supplemental data submitted during review processes in the United States and the European Union, including data associated with open label extension studies and expanded access programs specific to rare diseases or conditions;
(C)
an assessment of collaborative efforts between United States and European Union regulators related to—
(i)
product development programs under review;
(ii)
policies under development and those recently issued; and
(iii)
scientific information related to product development or regulation; and
(D)
recommendations for how Congress can support collaborative efforts described in subparagraph (C).
(2)
Consultation.— The contract under paragraph (1) shall provide for consultation with relevant stakeholders, including—
(A)
representatives from the Food and Drug Administration and the European Medicines Agency;
(B)
patients with rare diseases or conditions; and
(C)
patient groups that—
(i)
represent patients with rare diseases or conditions; and
(ii)
have international patient outreach.
(3)
Report.— The contract under paragraph (1) shall provide for, not later than 2 years after the date of entering into such contract—
(A)
the completion of the study under paragraph (1); and
(B)
the submission of a report on the results of such study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
(4)
Public availability.— The contract under paragraph (1) shall provide for the National Academies to make the report under paragraph (3) available to the public, including by posting the report on the website of the National Academies.
(d)
Public Meeting.—
(1)
In general.— Not later than December 31, 2023, the Secretary, acting through the Commissioner of Food and Drugs, shall convene one or more public meetings to solicit input from stakeholders regarding the approaches described in paragraph (2).
(2)
Approaches.— The public meeting or meetings under paragraph (1) shall address approaches to increasing and improving engagement with rare disease or condition patients, groups representing such patients, rare disease or condition experts, and experts on small population studies, in order to improve the understanding with respect to rare diseases or conditions of—
(A)
patient burden;
(B)
treatment options; and
(C)
side effects of treatments, including understanding the risks of side effects relative to the health status of the patient and the progression of the disease or condition.
(3)
Public docket.— The Secretary shall establish a public docket to receive written comments related to the approaches addressed during each public meeting under paragraph (1). Such public docket shall remain open for 60 days following the date of each such public meeting.
(4)
Reports.— Not later than 180 days after each public meeting under paragraph (1), the Commissioner of Food and Drugs shall develop and publish on the website of the Food and Drug Administration a report on—
(A)
the approaches discussed at the public meeting; and
(B)
any related recommendations.
(e)
Consultation on the Science of Small Population Studies.— Section 569(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8(b)) is amended—
(1)
in paragraph (6), by striking “ ; and” and inserting a semicolon;
(2)
in paragraph (7), by striking the period and inserting “ ; and”; and
(3)
by adding at the end the following:

“(8) the science of small population studies.”

(f)
GAO Report.—
(1)
In general.— Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report assessing the policies, practices, and programs of the Food and Drug Administration with respect to the review of applications for approval of drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and licensing of biological products under section 351 of the Public Health Service Act (42 U.S.C. 262) intended to treat rare diseases and conditions.
(2)
Content of report.— The report under paragraph (1) shall—
(A)
describe the activities of the Food and Drug Administration dedicated to the development and review of drugs and biological products intended to treat rare diseases and conditions under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and section 351 of the Public Health Service Act (42 U.S.C. 262);
(B)
describe challenges with developing and obtaining approval or licensure of drugs and biological products intended to treat rare diseases and conditions, such as challenges related to designing and conducting clinical trials, clinical trial subject recruitment and enrollment, study endpoints, and ensuring data quality, assessing the benefit-risk profile of drugs and biological products intended to treat rare diseases and conditions, and meeting requirements for approval or licensure;
(C)
assess the effectiveness of policies and practices of the Food and Drug Administration related to the review of applications for drugs and biological products intended to treat rare diseases and conditions, including—
(i)
initiatives to support the development and review of drugs and biological products intended to treat rare diseases and conditions, including initiatives related to regulatory science, clinical trial design, statistical analysis, and other relevant topics;
(ii)
consideration of relevant patient-focused drug development data and information, including patient experience data and the views of patients, pursuant to section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c);
(iii)
training and other efforts to ensure the expertise of personnel of the Food and Drug Administration regarding the review of applications for drugs and biological products intended to treat rare diseases and conditions; and
(iv)
consultations and engagement with stakeholders and external experts pursuant to section 569 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8);
(D)
assess the extent to which the Food and Drug Administration is applying the policies and practices described in subparagraph (C) consistently across review divisions, and the factors that influence the extent to which such application is consistent; and
(E)
include recommendations to address challenges and deficiencies identified, including recommendations to improve the effectiveness, consistency, and coordination of policies, practices, and programs of the Food and Drug Administration related to the review of applications for drugs and biological products intended to treat rare diseases and conditions.
(g)
Definition.— In this section, the terms “rare disease or condition”, “rare diseases or conditions”, and “rare diseases and conditions” have the meaning given the term “rare disease or condition” in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(a)(2)).

SEC. 3203. Emerging Technology Program.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.) is amended by inserting after section 566 of such Act (21 U.S.C. 360bbb–5) the following:

“SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

“(a) Program Establishment.—

“(1) In general.—The Secretary shall establish a program to support the adoption of, and improve the development of, innovative approaches to drug design and manufacturing.

“(2) Actions.—In carrying out the program under paragraph (1), the Secretary may—

“(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing;

“(B) solicit information regarding, and conduct or support research on, innovative approaches to drug product design and manufacturing;

“(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested persons, as appropriate;

“(D) convene working groups to support drug product design and manufacturing research and development;

“(E) support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing;

“(F) advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing;

“(G) convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing; and

“(H) award grants or contracts to carry out or support the program under paragraph (1).

“(3) Grants and contracts.—To seek a grant or contract under this section, an entity shall submit an application—

“(A) in such form and manner as the Secretary may require; and

“(B) containing such information as the Secretary may require, including a description of—

“(i) how the entity will conduct the activities to be supported through the grant or contract; and

“(ii) how such activities will further research and development related to, or adoption of, innovative approaches to drug product design and manufacturing.

“(b) Guidance.—The Secretary shall—

“(1) issue or update guidance to help facilitate the adoption of, and advance the development of, innovative approaches to drug product design and manufacturing; and

“(2) include in such guidance descriptions of—

“(A) any regulatory requirements related to the development or review of technologies related to innovative approaches to drug product design and manufacturing, including updates and improvements to such technologies after product approval; and

“(B) data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.

“(c) Report to Congress.—Not later than 4 years after the date of enactment of this section, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing—

“(1) an annual accounting of the allocation of funds made available to carry out this section;

“(2) a description of how Food and Drug Administration staff were utilized to carry out this section and, as applicable, any challenges or limitations related to staffing;

“(3) the number of public meetings held or participated in by the Food and Drug Administration pursuant to this section, including meetings convened as part of a working group described in subparagraph (D) or (G) of subsection (a)(2), and the topics of each such meeting; and

“(4) the number of drug products approved or licensed, after the date of enactment of this section, using an innovative approach to drug product design and manufacturing.”

SEC. 3204. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

(a)
In General.— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h) is amended to read as follows:

“SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND CONTINUOUS PHARMACEUTICAL MANUFACTURING.

“(a) In General.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—

“(1) may, to support the advancement, development, and implementation of advanced and continuous pharmaceutical manufacturing—

“(A) solicit requests for designation as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a ‘National Center of Excellence’);

“(B) beginning not later than one year after the date of enactment of the Food and Drug Omnibus Reform Act of 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that—

“(i) request such designation; and

“(ii) meet the eligibility criteria specified in subsection (c); and

“(C) award grants to such institutions or consortia of institutions; and

“(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions.

“(b) Request for Designation.—A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require.

“(c) Eligibility Criteria for Designation.—To be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher education shall include in its request for designation a description of the institution’s or consortium’s—

“(1) physical capacity and technical capabilities to conduct advanced research on, and to develop and implement, advanced and continuous pharmaceutical manufacturing;

“(2) collaboration or partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities;

“(3) proven capacity to design, develop, implement, and demonstrate new, highly effective technologies for use in advanced and continuous pharmaceutical manufacturing;

“(4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing; and

“(5)

(A) experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities to—

“(i) support the implementation of advanced or continuous pharmaceutical manufacturing for companies manufacturing or seeking to manufacture in the United States;

“(ii) support Federal agencies with technical assistance and workforce training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous pharmaceutical manufacturing;

“(iii) organize and conduct advanced research and development activities, with respect to advanced or continuous pharmaceutical manufacturing, needed to develop new and more effective technology, and to develop and support technological leadership;

“(iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing processes; and

“(v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or

“(B) a plan, to be implemented within 2 years, to establish partnerships described in subparagraph (A).

“(d) Termination of Designation.—The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.

“(e) Conditions for Designation.—As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees—

“(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);

“(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);

“(3) to develop, along with industry partners (which may include large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or consortium designated under this section, if any, a strategic plan for developing an advanced and continuous pharmaceutical manufacturing workforce;

“(4) to develop, along with industry partners and other institutions or consortia of such institutions designated under this section, a strategic plan for strengthening existing, and developing new, partnerships with other institutions of higher education or consortia thereof, or nonprofit organizations; and

“(5) to provide an annual report to the Food and Drug Administration regarding the designee’s activities under this section, including a description of how the designee continues to meet and make progress on the criteria specified in subsection (c).

“(f) Funding.—

“(1) In general.—The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the purposes of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including—

“(A) expanding capacity for advanced research on, and development of, advanced and continuous pharmaceutical manufacturing; and

“(B) implementing advanced research capacity and capabilities in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to public health threats, mitigate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other circumstances with respect to which the Secretary may determine the rapid development of new products or new manufacturing processes may be appropriate.

“(2) Consistency with fda mission.—As a condition on receipt of funding under this subsection, a National Center of Excellence shall consider any input from the Secretary regarding the use of funding related to—

“(A) best practices to increase, and provide for the advancement of, advanced and continuous pharmaceutical manufacturing through the National Center of Excellence; and

“(B) the extent to which activities conducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration.

“(3) Rule of construction.—Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.

“(g) Annual Review and Reports.—

“(1) Annual report to congress.—Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—

“(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section;

“(B) include in such report an accounting of the Federal administrative expenses described in subsection (i)(2) over the reporting period; and

“(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.

“(2) Center of excellence report.—An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and annually thereafter for the duration of the grant period, submit to the Secretary a summary of programs and activities funded under the grant.

“(3) Periodic review.—The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.

“(4) Additional report to congress.—Not later than 1 year after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including—

“(A) a national framework of principles related to the implementation of advanced and continuous pharmaceutical manufacturing;

“(B) a plan for the development of Federal regulations and guidance to support and facilitate the incorporation of advanced or continuous manufacturing into the development of pharmaceuticals;

“(C) a plan for development of Federal regulations or guidance related to the review of advanced and continuous pharmaceutical manufacturing, including how such manufacturing practices may be incorporated into the review of medical product applications; and

“(D) a summary of relevant feedback related to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract manufacturers, and other relevant entities.

“(h) Definitions.—In this section:

“(1) Advanced and continuous pharmaceutical manufacturing.—The term ‘advanced and continuous pharmaceutical manufacturing’ refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods—

“(A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or

“(B) for which the input materials are continuously fed into and transformed within the process, and the output materials are continuously removed from the system, utilizing an integrated manufacturing process that consists of a series of 2 or more simultaneous unit operations.

“(2) Biological product.—The term ‘biological product’ has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

“(3) Drug.—The term ‘drug’ has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).

“(4) Institution of higher education.—The term ‘institution of higher education’ has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)).

“(5) Secretary.—The term ‘Secretary’ means the Secretary of Health and Human Services.

“(i) Authorization of Appropriations.—

“(1) In general.—There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.

“(2) Federal administrative expenses.—Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.”

(b)
Transition Rule.— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section, shall apply with respect to grants awarded under such section before such date of enactment.
(c)
Clerical Amendment.— The item relating to section 3016 in the table of contents in section 1(b) of the 21st Century Cures Act (Public Law 114–255) is amended to read as follows:

“Sec. 3016. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.”.

SEC. 3205. Public Workshop on Cell Therapies.

Not later than 3 years after the date of the enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall convene a public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of certain human cell-, tissue-, and cellular-based medical products (and the latest scientific information about such products) that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), namely, stem cell and other cellular therapies.

SEC. 3206. Clarifications to Exclusivity Provisions for First Interchangeable Biosimilar Biological Products.

Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 262(k)(6)) is amended—
(1)
in the matter preceding subparagraph (A)—
(A)
by striking “ Upon review of” and inserting “ The Secretary shall not make approval as an interchangeable biological product effective with respect to”;
(B)
by striking “ relying on” and inserting “ that relies on”; and
(C)
by striking “ the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use”; and
(2)
in the flush text that follows subparagraph (C)(ii), by striking “ taken.” and inserting “ taken, and the term ‘first interchangeable biosimilar biological product’ means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference product.”.

SEC. 3207. Gao Report on Nonprofit Pharmaceutical Organizations.

(a)
GAO Review.— The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall prepare a report on—
(1)
what is known about nonprofit pharmaceutical manufacturing organizations, including the impact of such organizations on the development, availability, and cost of prescription drugs in the United States, which may include information with respect to the capacity and capability to help prevent or mitigate shortages of such drugs, and any challenges to manufacturing or other operations; and
(2)
recommendations to address such challenges.
(b)
Report.— Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit the report described in subsection (a) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

SEC. 3208. Rare Disease Endpoint Advancement Pilot Program.

(a)
In General.— The Secretary shall establish a pilot program under which the Secretary establishes procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through—
(1)
determining eligibility of participants for such program; and
(2)
developing and implementing a process for applying to, and participating in, such a program.
(b)
Public Workshops.— The Secretary shall conduct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics relevant to the development of endpoints for rare diseases, which may include discussions about—
(1)
novel endpoints developed through the pilot program established under this section; and
(2)
as appropriate, the use of real world evidence and real world data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.
(c)
Reports.—
(1)
Interim report.— Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the completed and ongoing activities in the pilot program established under this section and public workshops described in subsection (b).
(2)
Final report.— Not later than September 30, 2027, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the outcomes of the pilot program established under this section.
(d)
Guidance.— Not later than September 30, 2027, the Secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.
(e)
Sunset.— The Secretary may not accept any new application or request to participate in the program established by this section on or after October 1, 2027.

SEC. 3209. Animal Testing Alternatives.

(a)
In General.— Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
(1)
in subsection (i)—
(A)
in paragraph (1)(A), by striking “ preclinical tests (including tests on animals)” and inserting “ nonclinical tests”; and
(B)
in paragraph (2)(B), by striking “ animal” and inserting “ nonclinical tests”; and
(2)
by inserting after subsection (y) the following:

“(z) Nonclinical Test Defined.—For purposes of this section, the term ‘nonclinical test’ means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:

“(1) Cell-based assays.

“(2) Organ chips and microphysiological systems.

“(3) Computer modeling.

“(4) Other nonhuman or human biology-based test methods, such as bioprinting.

“(5) Animal tests.”

(b)
Biosimilar Biological Product Applications.— Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows:

“(bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and”

SEC. 3210. Modernizing Accelerated Approval.

(a)
In General.— Section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is amended—
(1)
in paragraph (2)—
(A)
by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
(B)
by striking “ Approval of a product” and inserting the following:

“(A) In general.—Approval of a product”

(C)
in clause (i) of such subparagraph (A), as so redesignated, by striking “ appropriate postapproval studies” and inserting “ an appropriate postapproval study or studies”; and
(D)
by adding at the end the following:

“(B) Studies not required.—If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.

“(C) Postapproval study conditions.—Not later than the date of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.

“(D) Studies begun before approval.—The Secretary may require, as appropriate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.”

; and

(2)
in paragraph (3)—
(A)
in the matter preceding subparagraph (A), by striking “ (as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing)” and inserting “ described in subparagraph (B)”;
(B)
by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively and adjusting the margins accordingly;
(C)
by striking “ The Secretary may” and inserting the following:

“(A) In general.—The Secretary may”

(D)
in clause (i) of such subparagraph (A), as so redesignated, by striking “ drug with due diligence” and inserting “ product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C)”;
(E)
in clause (iii) of such subparagraph (A), as so redesignated, by inserting “ shown to be” after “ product is not”; and
(F)
by adding at the end the following:

“(B) Expedited procedures described.—Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval—

“(i) providing the sponsor with—

“(I) due notice;

“(II) an explanation for the proposed withdrawal;

“(III) an opportunity for a meeting with the Commissioner or the Commissioner’s designee; and

“(IV) an opportunity for written appeal to—

“(aa) the Commissioner; or

“(bb) a designee of the Commissioner who has not participated in the proposed withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal;

“(ii) providing an opportunity for public comment on the proposal to withdraw approval;

“(iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on the website of the Food and Drug Administration; and

“(iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request.”

(b)
Reports of Postmarketing Studies.— Section 506B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended—
(1)
by redesignating paragraph (2) as paragraph (3); and
(2)
by inserting after paragraph (1) the following:

“(2) Accelerated approval.—Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.”

(c)
Enforcement.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by title II, is further amended by adding at the end the following:

“(ggg) The failure of a sponsor of a product approved under accelerated approval pursuant to section 506(c)—

“(1) to conduct with due diligence any postapproval study required under section 506(c) with respect to such product; or

“(2) to submit timely reports with respect to such product in accordance with section 506B(a)(2).”

(d)
Guidance.—
(1)
In general.— The Secretary shall issue guidance describing—
(A)
how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration;
(B)
the use of novel clinical trial designs that may be used to conduct appropriate postapproval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as amended by subsection (a);
(C)
the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(3)(B)); and
(D)
considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A) of such Act (21 U.S.C. 356(c)(1)(A)), including considerations in evaluating the evidence related to any such endpoints.
(2)
Final guidance.— The Secretary shall issue—
(A)
draft guidance under paragraph (1) not later than 18 months after the date of enactment of this Act; and
(B)
final guidance not later than 1 year after the close of the public comment period on such draft guidance.
(e)
Accelerated Approval Council.—
(1)
In general.— Not later than 1 year after the date of enactment of this Act, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the “Council”) within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)).
(2)
Membership.— The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers:
(A)
The Director of the Center for Drug Evaluation and Research.
(B)
The Director of the Center for Biologics Evaluation and Research.
(C)
The Director of the Oncology Center of Excellence.
(D)
The Director of the Office of New Drugs.
(E)
The Director of the Office of Orphan Products Development.
(F)
The Director of the Office of Tissues and Advanced Therapies.
(G)
The Director of the Office of Medical Policy.
(H)
At least 3 directors of review divisions or offices overseeing products approved under accelerated approval, including at least one director within the Office of Neuroscience.
(3)
Duties of the council.—
(A)
Meetings.— The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.
(B)
Policy development.— The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such engagement may include—
(i)
developing guidance for Food and Drug Administration staff and best practices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval;
(ii)
providing training for product review teams; and
(iii)
advising review divisions on best practices with respect to product-specific development, review, and withdrawal of products under accelerated approval.
(4)
Publication of a report.— Not later than 1 year after the date of enactment of this Act, and annually thereafter, the Council shall publish on the public website of the Food and Drug Administration a report on the activities of the Council.
(f)
Rule of Construction.— Nothing in this section (including the amendments made by this section) shall be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for which a notice of proposed withdrawal has been published in the Federal Register prior to the date of enactment of this Act. Such proceedings may continue under procedures in effect prior to the date of enactment of this Act.

SEC. 3211. Antifungal Research and Development.

(a)
Draft Guidance.— Not later than 3 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever).
(b)
Final Guidance.— Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance.
(c)
Workshop.— To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Secretary shall hold a public workshop.

SEC. 3212. Advancing Qualified Infectious Disease Product Innovation.

(a)
In General.— Section 505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amended—
(1)
in subsection (c)—
(A)
in paragraph (2), by striking “ ; or” and inserting “ ;”;
(B)
in paragraph (3), by striking the period and inserting “ ; or”; and
(C)
by adding at the end the following:

“(4) an application pursuant to section 351(a) of the Public Health Service Act.”

(2)
in subsection (d)(1), by inserting “ of this Act or section 351(a) of the Public Health Service Act” after “ section 505(b)”; and
(3)
by amending subsection (g) to read as follows:

“(g) Qualified Infectious Disease Product.—The term ‘qualified infectious disease product’ means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—

“(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and

“(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—

“(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

“(B) qualifying pathogens listed by the Secretary under subsection (f).”

(b)
Priority Review.— Section 524A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) is amended by inserting “ of this Act, or section 351(a) of the Public Health Service Act, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness” before the period.

SEC. 3213. Advanced Manufacturing Technologies Designation Program.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by title II, is further amended by inserting after section 506K the following:

“SEC. 506L. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PROGRAM.

“(a) In General.—Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).

“(b) Designation Process.—The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by—

“(1) reducing development time for a drug using the designated manufacturing method; or

“(2) increasing or maintaining the supply of—

“(A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or

“(B) a drug that is on the drug shortage list under section 506E.

“(c) Evaluation and Designation of an Advanced Manufacturing Technology.—

“(1) Submission.—A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—

“(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and

“(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.

“(2) Evaluation and designation.—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).

“(d) Review of Advanced Manufacturing Technologies.—If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—

“(1) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and

“(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.

“(e) Implementation and Evaluation of Advanced Manufacturing Technologies Program.—

“(1) Public meeting.—The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss, and obtain input and recommendations from relevant stakeholders regarding—

“(A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and

“(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.

“(2) Program guidance.—

“(A) In general.—The Secretary shall—

“(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the program under this section; and

“(ii) not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementation of such program.

“(B) Content.—The guidance described in subparagraph (A) shall address—

“(i) the process by which a person may request a designation under subsection (b);

“(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;

“(iii) the process to expedite the development and review of applications under subsection (d); and

“(iv) the criteria described in subsection (b) for eligibility for such a designation.

“(3) Report.—Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:

“(A) The number of persons that have requested designations and that have been granted designations.

“(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.

“(C) The average number of calendar days for completion of evaluations under subsection (c)(2).

“(D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2).

“(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.

“(f) Sunset.—The Secretary—

“(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2032; and

“(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health.”

CHAPTER 2 Transparency, Program Integrity, and Regulatory Improvements

SEC. 3221. Safer Disposal of Opioids.

Section 505–1(e)(4)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)(4)(B)) is amended by striking “ for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation))”.

SEC. 3222. Therapeutic Equivalence Evaluations.

Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the following:

“(v)

(I) With respect to an application submitted pursuant to subsection (b)(2) for a drug that is subject to section 503(b) for which the sole difference from a listed drug relied upon in the application is a difference in inactive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regulations (or any successor regulations), the Secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the prescription drug product section of the list under this paragraph as follows:

“(aa) With respect to such an application submitted after the date of enactment of the Food and Drug Omnibus Reform Act of 2022, the evaluation shall be made with respect to a listed drug relied upon in the application pursuant to subsection (b)(2) that is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application pursuant to subsection (b)(2) at the time of approval of such application or not later than 180 days after the date of such approval, provided that the request for such an evaluation is made in the original application (or in a resubmission to a complete response letter), and all necessary data and information are submitted in the original application (or in a resubmission in response to a complete response letter) for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

“(bb) With respect to such an application approved prior to or on the date of enactment of the Food and Drug Omnibus Reform Act of 2022, the evaluation shall be made not later than 180 days after receipt of a request for a therapeutic equivalence evaluation submitted as part of a supplement to such application; or with respect to an application that was submitted prior to the date of enactment of the Food and Drug Omnibus Reform Act of 2022 but not approved as of the date of enactment of such Act, the evaluation shall be made not later than 180 days after the date of approval of such application if a request for such evaluation is submitted as an amendment to the application, provided that—

“(AA) such request for a therapeutic equivalence evaluation is being sought with respect to a listed drug relied upon in the application, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug for which a therapeutic equivalence evaluation is sought; and

“(BB) the amendment or supplement, as applicable, containing such request, or the relevant application, includes all necessary data and information for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

“(II) When the Secretary makes an evaluation under subclause (I), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug.”

SEC. 3223. Public Docket on Proposed Changes to Third-Party Vendors.

(a)
In General.—
(1)
Opening public docket.— Not later than 90 days after the date of enactment of this Act, the Secretary shall open a single public docket to solicit comments on factors that generally should be considered by the Secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies to change third-party vendors engaged by sponsors to aid in implementation and management of the strategies.
(2)
Factors.— Such factors include the potential effects of changes in third-party vendors on—
(A)
patient access; and
(B)
prescribing and administration of the drugs by health care providers.
(3)
Closing public docket.— The Secretary may close such public docket not earlier than 90 days after such docket is opened.
(4)
No delay.— Nothing in this section shall delay agency action on any modification to a risk evaluation and mitigation strategy.
(b)
GAO Report.— Not later than December 31, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on—
(1)
the number of changes in third-party vendors (engaged by sponsors to aid implementation and management of risk evaluation and mitigation strategies) for an approved risk evaluation and mitigation strategy the Secretary has approved under section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(h));
(2)
any issues affecting patient access to the drug that is subject to the strategy or considerations with respect to the administration or prescribing of such drug by health care providers that arose as a result of such changes; and
(3)
how such issues were resolved, as applicable.

SEC. 3224. Enhancing Access to Affordable Medicines.

Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iii) and inserting the following:

“(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection;

“(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application;

“(iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling; and”

Subtitle C Medical Devices

SEC. 3301. Dual Submission for Certain Devices.

Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:

“(k) For a device authorized for emergency use under section 564 for which, in accordance with section 564(m), the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 353(d)(3) of the Public Health Service Act, the sponsor of such device may, when submitting a request for classification under section 513(f)(2), submit a single submission containing—

“(1) the information needed for such a request; and

“(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 353(d)(3) of the Public Health Service Act.”

SEC. 3302. Medical Devices Advisory Committee Meetings.

(a)
In General.— The Secretary shall convene one or more panels of the Medical Devices Advisory Committee not less than once per year for the purpose of providing advice to the Secretary on topics related to medical devices used in pandemic preparedness and response, including topics related to in vitro diagnostics.
(b)
Required Panel Member.— A panel convened under subsection (a) shall include at least 1 population health-specific representative.
(c)
Sunset.— This section shall cease to be effective on October 1, 2027.

SEC. 3303. Gao Report on Third-Party Review.

Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the third-party review program under section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m). Such report shall include—
(1)
a description of the financial and staffing resources used to carry out such program;
(2)
a description of actions taken by the Secretary pursuant section 523(b)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(b)(2)(C)); and
(3)
the results of an audit of the performance of select persons accredited under such program.

SEC. 3304. Certificates to Foreign Governments.

Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended—
(1)
in subparagraph (E), by striking clause (iii); and
(2)
by adding at the end the following:

“(F)

(i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 510, if the device is listed pursuant to section 510(j), the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States.

“(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this Act.

“(iii)

(I) A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B).

“(II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a ‘Certificate to Foreign Government’ and shall have a document title including the words ‘Certificate to Foreign Government’.

“(iv) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph.”

SEC. 3305. Ensuring Cybersecurity of Medical Devices.

(a)
In General.— Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:

“SEC. 524B. ENSURING CYBERSECURITY OF DEVICES.

“(a) In General.—A person who submits an application or submission under section 510(k), 513, 515(c), 515(f), or 520(m) for a device that meets the definition of a cyber device under this section shall include such information as the Secretary may require to ensure that such cyber device meets the cybersecurity requirements under subsection (b).

“(b) Cybersecurity Requirements.—The sponsor of an application or submission described in subsection (a) shall—

“(1) submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures;

“(2) design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches to the device and related systems to address—

“(A) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and

“(B) as soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks;

“(3) provide to the Secretary a software bill of materials, including commercial, open-source, and off-the-shelf software components; and

“(4) comply with such other requirements as the Secretary may require through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.

“(c) Definition.—In this section, the term ‘cyber device’ means a device that—

“(1) includes software validated, installed, or authorized by the sponsor as a device or in a device;

“(2) has the ability to connect to the internet; and

“(3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.

“(d) Exemption.—The Secretary may identify devices, or categories or types of devices, that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section. The Secretary shall publish in the Federal Register, and update, as appropriate, a list of the devices, or categories or types of devices, so identified by the Secretary.”

(b)
Prohibited Act.— Section 301(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the following:

“(3) The failure to comply with any requirement under section 524B(b)(2) (relating to ensuring device cybersecurity).”

(c)
Rule of Construction.— Nothing in this section, including the amendments made by this section, shall be construed to affect the Secretary’s authority related to ensuring that there is a reasonable assurance of the safety and effectiveness of devices, which may include ensuring that there is a reasonable assurance of the cybersecurity of certain cyber devices, including for devices approved or cleared prior to the date of enactment of this Act.
(d)
Effective Date.— The amendments made by subsections (a) and (b) shall take effect 90 days after the date of enactment of this Act. An application or submission submitted before such effective date shall not be subject to the requirements under subsection (a) or (b) of section 524B of the Federal Food, Drug, and Cosmetic Act, as added by this section.
(e)
Guidance for Industry and FDA Staff on Device Cybersecurity.— Not later than 2 years after the date of enactment of this Act, and periodically thereafter as appropriate, the Secretary, in consultation with the Director of the Cybersecurity and Infrastructure Security Agency, shall review and, as appropriate and after soliciting and receiving feedback from device manufacturers, health care providers, third-party-device servicers, patient advocates, and other appropriate stakeholders, update the guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” (or a successor document).
(f)
Resources Regarding Cybersecurity of Devices.— Not later than 180 days after the date of enactment of this Act, and not less than annually thereafter, the Secretary shall update public information provided by the Food and Drug Administration, including on the website of the Food and Drug Administration, with information regarding improving cybersecurity of devices. Such information shall include information on identifying and addressing cyber vulnerabilities for health care providers, health systems, and device manufacturers, and how such entities may access support through the Cybersecurity and Infrastructure Security Agency and other Federal entities, including the Department of Health and Human Services, to improve the cybersecurity of devices.
(g)
GAO Report.— Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall publish a report identifying challenges in cybersecurity for devices, including legacy devices that may not support certain software security updates. Through such report, the Comptroller General shall examine—
(1)
challenges for device manufacturers, health care providers, health systems, and patients in accessing Federal support to address vulnerabilities across Federal agencies;
(2)
how Federal agencies can strengthen coordination to better support cybersecurity for devices; and
(3)
statutory limitations and opportunities for improving cybersecurity for devices.
(h)
Definition.— In this section, the term “device” has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).

SEC. 3306. Bans of Devices for One or More Intended Uses.

(a)
In General.— Section 516(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f(a)) is amended—
(1)
in paragraph (1), by inserting “ for one or more intended uses” before the semicolon at the end; and
(2)
in the matter following paragraph (2), by inserting “ or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 1006 when intended for such use or uses” after “ banned device”.
(b)
Rule of Construction.— Nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f), as amended by this section, and chapter 5 of title 5, United States Code, regulations promulgated pursuant to such section 516, as amended by this section.

SEC. 3307. Third Party Data Transparency.

(a)
In General.— To the extent the Secretary relies on any data, analysis, or other information or findings provided by entities that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Administration, in regulatory decision-making with respect to devices, the Secretary shall—
(1)
request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and
(2)
in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information.
(b)
Report.— Not later than September 30, 2023, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals communications issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved.
(c)
Rule of Construction.— Nothing in this section shall be construed to require the delay of any regulatory decision-making or other action of the Food and Drug Administration.

SEC. 3308. Predetermined Change Control Plans for Devices.

(a)
In General.— Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B (21 U.S.C. 360e–3) the following:

“SEC. 515C. PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.

“(a) Approved Devices.—

“(1) In general.—Notwithstanding section 515(d)(5)(A), a supplemental application shall not be required for a change to a device approved under section 515, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2).

“(2) Predetermined change control plan.—The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 515), if the device remains safe and effective without any change.

“(3) Scope.—The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

“(b) Cleared Devices.—

“(1) In general.—Notwithstanding section 510(k), a premarket notification shall not be required for a change to a device cleared under section 510(k), if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2).

“(2) Predetermined change control plan.—The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 510(k) that describes planned changes that may be made to the device (and that would otherwise require a new notification), if—

“(A) the device remains safe and effective without any such change; and

“(B) the device would remain substantially equivalent to the predicate.

“(3) Scope.—The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.

“(c) Predicate Devices.—In making a determination of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device.”

(b)
Conforming Amendments.—
(1)
Cleared devices.— Section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)(1)) is amended, in the first sentence, by inserting “ , or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C” before the period at the end.
(2)
Approved devices.— Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended by striking “ A supplemental” and inserting “ Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental”.
(3)
Documentation of rationale for significant decisions.— Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is amended to read as follows:

“(1) In general.—The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.”

SEC. 3309. Small Business Fee Waiver.

(a)
In General.— Section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
(1)
by striking “ No fee” and inserting the following:

“(i) In general.—No fee”

; and

(2)
by adding at the end the following:

“(ii) Small businesses fee waiver.—

“(I) Definition of small business.—For purposes of this clause, the term ‘small business’ means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

“(II) Waiver.—The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.

“(III) Firms submitting tax returns to the united states internal revenue service.—The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.

“(IV) Firms not submitting tax returns to the united states internal revenue service.—In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment’s firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.

“(V) Request for waiver.—An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.”

(b)
Taxing Authority.— Section 738(d)(2)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)(2)(B)(iii)) is amended by inserting “ , if extant,” after “ national taxing authority”.

Subtitle D Infant Formula

SEC. 3401. Protecting Infants and Improving Formula Supply.

(a)
Definitions.—
(1)
In general.— In this section, the term “infant formula” has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)).
(2)
Critical food.— Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

“(ss) The term ‘critical food’ means a food that is—

“(1) an infant formula; or

“(2) a medical food, as defined in section 5(b)(3) of the Orphan Drug Act.”

(b)
Office of Critical Foods.—
(1)
In general.— The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office.
(2)
Duties.— The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(2).
(c)
Premarket Submissions of Infant Formula to Address Shortages.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following:

“(j) Premarket Submissions To Address Shortages.—

“(1) In general.—The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.

“(2) Effective period.—The waiver authority under this subsection shall remain in effect—

“(A) for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2) with respect to a shortage of infant formula; or

“(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.”

(d)
Report.— Not later than one year after the date of enactment of this Act, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(1)
the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) each year since 2012;
(2)
how many of such submissions received requests from the Secretary for additional information;
(3)
how long after receiving such submissions the Secretary sent such requests for additional information;
(4)
what additional information the Secretary requested of the persons submitting such submissions; and
(5)
the date each new infant formula described in subparagraph (A) was first marketed, if available.
(e)
Infant Formula Flexibilities.— The Secretary shall publish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions.
(f)
International Harmonization of Infant Formula Requirements.—
(1)
In general.— The Secretary—
(A)
shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and
(B)
may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture infant formula for export to the United States.
(2)
Study on infant formula.—
(A)
In general.— Not later than 60 days after the date of enactment of this Act, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the “National Academies”) to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States.
(B)
Contents of the report.— The report developed pursuant to the agreement under subparagraph (A) shall—
(i)
assess and evaluate—
(I)
infant formula marketed in the United States;
(II)
any challenges in supply, or market competition with respect to such infant formula; and
(III)
any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements; and
(ii)
include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States.
(C)
Final report.— The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after the date of enactment of this Act, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(g)
Transparency and Accountability To Support Infant Formula Innovation.—
(1)
Congressional notification of recall.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (c), is further amended by adding at the end the following:

“(k) Congressional Notification of Recall.—

“(1) In general.—Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall.

“(2) Contents.—A notification under paragraph (1) shall include the following:

“(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.

“(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.

“(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.

“(D) An initial estimate of the disruption in domestic production that may result from the recall.”

(2)
Annual report to congress.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by paragraph (1), is further amended by adding at the end the following:

“(l) Annual Report to Congress.—

“(1) In general.—Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information:

“(A) The number of submissions received by the Secretary under subsection (d).

“(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market.

“(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b).

“(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b).

“(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities.

“(2) Confidentiality.—The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”

(3)
New infant formula submissions.— Section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) is amended by adding at the end the following:

“(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.”

(4)
List of nutrients.— Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) is amended by striking “ or, if revised by the Secretary under paragraph (2), as so revised” and inserting the following: “ , which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table”.
(5)
Guidance.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance regarding information sponsors may consider including in submissions required under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)), including considerations for meeting each of the requirements of paragraphs (1), (2), and (3) of subsection (d).
(6)
Technical correction.— Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(B)) is amended by striking “ subsection (c)(1)” and inserting “ subsection (d)(1)”.
(h)
Response to Recall.—
(1)
Manufacturer submission.—
(A)
In general.— Promptly after the initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall.
(B)
Contents.— A submission under subparagraph (A) shall include the following:
(i)
A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including—
(I)
to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and
(II)
if appropriate, to restore operation of the impacted facilities.
(ii)
In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula.
(2)
Report to congress.—
(A)
In general.— Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(B)
Contents.— A report under subparagraph (A) shall include the following:
(i)
Information concerning the current domestic supply of infant formula, including—
(I)
a breakdown of the specific types of formula involved; and
(II)
an estimate of how long current supplies will last.
(ii)
If a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States—
(I)
actions to work with the impacted manufacturer or other manufacturers to increase production; and
(II)
specification of—
(aa)
any additional authorities needed regarding production or importation to fill a supply gap; and
(bb)
any supplemental funding necessary to address the shortage.
(3)
Sunset.— This subsection shall cease to have force or effect on September 30, 2026.
(i)
Coordination With Manufacturer.—
(1)
In general.—
(A)
Communication following inspection.— Upon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to—
(i)
address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and
(ii)
safely restart production at the facility.
(B)
Response to manufacturer.— Not later than 7 days after receiving a written communication from a manufacturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions.
(2)
Inspections.— The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula.
(3)
Annual inspections.— Not later than 6 months after the date of enactment of this Act, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation.
(j)
National Strategy on Infant Formula.—
(1)
In general.— The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after the date of enactment of this Act, a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need.
(2)
Immediate national strategy.— The national strategy under paragraph (1) shall include efforts—
(A)
to increase the resiliency of the infant formula supply chain in the short-term by—
(i)
assessing causes of any supply disruption or shortage of infant formula in existence as of the date of enactment of this Act and potential causes of future supply disruptions and shortages;
(ii)
assessing and addressing immediate infant formula needs associated with the shortage; and
(iii)
developing a plan to increase infant formula supply, including through increased competition; and
(B)
to ensure the development and updating of education and communication materials for parents and caregivers that cover—
(i)
where and how to find infant formula;
(ii)
comparable infant formulas on the market;
(iii)
what to do if a specialty infant formula is unavailable;
(iv)
safe practices for handling infant formula; and
(v)
other topics, as appropriate.
(3)
Long-term strategy.— Not later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the national strategy under paragraph (1) to include efforts to improve preparedness against infant formula shortages in the long-term by—
(A)
outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages;
(B)
recommending measures for protecting the integrity of the infant formula supply and preventing contamination;
(C)
outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and
(D)
recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers.
(k)
Meaningful Disruption in the Production of Critical Food.— Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following:

“SEC. 424. REQUIREMENTS FOR CRITICAL FOOD.

“(a) Notification of Meaningful Disruption for Critical Food.—

“(1) In general.—A manufacturer of a critical food (as defined in section 201(ss)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.

“(2) Distribution of information.—Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.

“(3) Confidentiality.—Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(4) Meaningful disruption.—In this subsection, the term ‘meaningful disruption’—

“(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and

“(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

“(b) Risk Management Plans.—Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—

“(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;

“(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and

“(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 704.

“(c) Failure To Meet Requirements.—

“(1) In general.—If a person fails to submit information required under, and in accordance with, subsection (a)—

“(A) the Secretary shall issue a letter to such person informing such person of such failure; and

“(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—

“(i) the letter issued under subparagraph (A); and

“(ii) at the request of such person, any response to such letter such person submitted to the Secretary.

“(2) Exception.—If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.”

(l)
Specialty Infant Formula for Importation.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (f)(2), is further amended by adding at the end the following:

“(m) Waiver of Requirements for Importation of Specialty Infant Formula.—

“(1) In general.—The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this Act applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to—

“(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this Act; or

“(B) the distribution and sale of such imported specialty infant formula.

“(2) Rule of construction.—Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this Act with respect to, specialty infant formula that is subject to a waiver under paragraph (1).

“(3) Definition of specialty infant formula.—In this subsection, the term ‘specialty infant formula’ means infant formula described in subsection (h)(1).”

(m)
Importation for Personal Use.—
(1)
In general.— Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), during the 90-day period beginning on the date of enactment of this Act, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from—
(A)
Canada;
(B)
any country in the European Union; or
(C)
any other country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(2)
Limitations.— Infant formula may be imported pursuant to paragraph (1) only if the infant formula—
(A)
is exclusively for personal use and will not be commercialized or promoted; and
(B)
does not present an unreasonable risk to human health.
(3)
Reporting of adverse events.— If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs.
(4)
Public notice.— The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that—
(A)
infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration;
(B)
the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
(C)
the nutritional content of infant formula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements.
(5)
Sense of congress.— It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation.

Subtitle E Cosmetics

SEC. 3501. Short Title.

This subtitle may be cited as the “Modernization of Cosmetics Regulation Act of 2022”.

SEC. 3502. Amendments to Cosmetic Requirements.

Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amended by adding at the end the following:

“SEC. 604. DEFINITIONS.

“In this chapter:

“(1) Adverse event.—The term ‘adverse event’ means any health-related event associated with the use of a cosmetic product that is adverse.

“(2) Cosmetic product.—The term ‘cosmetic product’ means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

“(3) Facility.—

“(A) In general.—The term ‘facility’ includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

“(B) Such term does not include any of the following:

“(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.

“(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.

“(iii) Hospitals, physicians’ offices, and health care clinics.

“(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.

“(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.

“(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.

“(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.

“(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:

“(I) Labeling.

“(II) Relabeling.

“(III) Packaging.

“(IV) Repackaging.

“(V) Holding.

“(VI) Distributing.

“(C) Clarification.—For the purposes of subparagraph (B)(viii), the terms ‘packaging’ and ‘repackaging’ do not include filling a product container with a cosmetic product.

“(4) Responsible person.—The term ‘responsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.

“(5) Serious adverse event.—The term ‘serious adverse event’ means an adverse event that—

“(A) results in—

“(i) death;

“(ii) a life-threatening experience;

“(iii) inpatient hospitalization;

“(iv) a persistent or significant disability or incapacity;

“(v) a congenital anomaly or birth defect;

“(vi) an infection; or

“(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or

“(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

“SEC. 605. ADVERSE EVENTS.

“(a) Serious Adverse Event Reporting Requirements.—The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.

“(b) Submission of Reports.—

“(1) Serious adverse event report.—The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.

“(2) New medical information.—The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.

“(3) Consolidation of reports.—The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.

“(c) Exemptions.—The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health.

“(d) Contact Information.—The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 609(a).

“(e) Maintenance and Inspection of Adverse Event Records.—

“(1) Maintenance.—The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 612, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 612(b), shall maintain such records for a period of 3 years.

“(2) Inspection.—

“(A) In general.—The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704.

“(B) Authorized person.—For purposes of this paragraph, the term ‘authorized person’ means an officer or employee of the Department of Health and Human Services who has—

“(i) appropriate credentials, as determined by the Secretary; and

“(ii) been duly designated by the Secretary to have access to the records required under this section.

“(f) Fragrance and Flavor Ingredients.—If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under section 552 of title 5, United States Code, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5, United States Code.

“(g) Protected Information.—A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be—

“(1) a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

“(2) a record about an individual under section 552a of title 5, United States Code (commonly referred to as the ‘Privacy Act of 1974’) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the ‘Freedom of Information Act’), and shall not be publicly disclosed unless all personally identifiable information is redacted.

“(h) Effect of Section.—

“(1) In general.—Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.

“(2) Personally identifiable information.—Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

“(A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

“(B) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

“(3) Use of reports.—Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with this section.

“(4) Rule of construction.—The submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event.

“SEC. 606. GOOD MANUFACTURING PRACTICE.

“(a) In General.—The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 601. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph during an inspection conducted under section 704.

“(b) Considerations.—In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.

“(c) Timeframe.—The Secretary shall publish a notice of proposed rulemaking not later than 2 years after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 and shall publish a final such rule not later than 3 years after such date of enactment.

“SEC. 607. REGISTRATION AND PRODUCT LISTING.

“(a) Submission of Registration.—

“(1) Initial registration.—

“(A) Existing facilities.—Every person that, on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after date of enactment of such Act.

“(B) New facilities.—Every person that owns or operates a facility that first engages, after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.

“(2) Biennial renewal of registration.—A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.

“(3) Contract manufacturers.—If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.

“(4) Updates to content.—A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).

“(5) Abbreviated renewal registrations.—The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).

“(b) Format; Contents of Registration.—

“(1) In general.—Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.

“(2) Contents.—The registration under subsection (a) shall contain—

“(A) the facility’s name, physical address, email address, and telephone number;

“(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;

“(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);

“(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and

“(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.

“(c) Cosmetic Product Listing.—

“(1) In general.—For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.

“(2) Cosmetic product listing.—The responsible person of a cosmetic product that is marketed on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 shall submit to the Secretary a cosmetic product listing not later than 1 year after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, or for a cosmetic product that is first marketed after the date of enactment of such Act, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).

“(3) Abbreviated renewal.—The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.

“(4) Contents of listing.—

“(A) In general.—Each such cosmetic product listing shall include—

“(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;

“(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;

“(iii) the applicable cosmetic category or categories for the cosmetic product;

“(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and

“(v) the product listing number, if any previously assigned by the Secretary under subsection (d).

“(B) Flexible listings.—A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

“(5) Updates to content.—A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.

“(6) Submission.—A responsible person may submit product listing information as part of a facility registration or separately.

“(d) Facility Registration and Product Listing Numbers.—At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1), the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available.

“(e) Confidentiality.—In response to a request under section 552 of title 5, United States Code, information described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration or listing under this section shall be withheld under section 552(b)(3) of title 5, United States Code.

“(f) Suspensions.—

“(1) Suspension of registration of a facility.—The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.

“(2) Notice of suspension.—Before suspending a facility registration under this section, the Secretary shall provide—

“(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and

“(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.

“(3) Hearing on suspension.—The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

“(4) Post-hearing corrective action plan.—If, after providing opportunity for an informal hearing under paragraph (3), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant.

“(5) Vacating of order; reinstatement.—Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility.

“(6) Effect of suspension.—If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility.

“(7) No delegation.—The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

“SEC. 608. SAFETY SUBSTANTIATION.

“(a) Substantiation of Safety.—A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.

“(b) Coal-Tar Hair Dye.—Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 601(a). A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.

“(c) Definitions.—For purposes of this section:

“(1) Adequate substantiation of safety.—The term ‘adequate substantiation of safety’ means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.

“(2) Safe.—The term ‘safe’ means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

“SEC. 609. LABELING.

“(a) General Requirement.—Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.

“(b) Fragrance Allergens.—The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.

“(c) Cosmetic Products for Professional Use.—

“(1) Definition of professional.—For purposes of this subsection, the term ‘professional’ means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.

“(2) Professional use labeling.—A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—

“(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and

“(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this Act and section 4(a) of the Fair Packaging and Labeling Act.

“SEC. 610. RECORDS.

“(a) In General.—If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).

“(b) Rule of Construction.—Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this Act, including section 605 or 606.

“SEC. 611. MANDATORY RECALL AUTHORITY.

“(a) In General.—If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.

“(b) Hearing.—The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.

“(c) Order Resolution.—After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—

“(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

“(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or

“(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

“(d) Action Following Order.—Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order.

“(e) Notice to Persons Affected.—If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public.

“(f) Public Notification.—In conducting a recall under this section, the Secretary shall—

“(1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification—

“(A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and

“(B) that includes, at a minimum—

“(i) the name of the cosmetic subject to the recall;

“(ii) a description of the risk associated with such article; and

“(iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and

“(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.

“(g) No Delegation.—The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

“(h) Effect.—Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this chapter.

“SEC. 612. SMALL BUSINESSES.

“(a) In General.—Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.

“(b) Requirements Applicable to All Manufacturers and Processors of Cosmetics.—The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:

“(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

“(2) Cosmetic products that are injected.

“(3) Cosmetic products that are intended for internal use.

“(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

“SEC. 613. EXEMPTION FOR CERTAIN PRODUCTS AND FACILITIES.

“(a) In General.—Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of chapter V shall be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611.

“(b) Exception.—A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of chapter V shall not be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611, with respect to such cosmetic products.

“SEC. 614. PREEMPTION.

“(a) In General.—No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this chapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.

“(b) Limitation.—Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product.

“(c) Savings.—Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law.

“(d) Rule of Construction.—Nothing in this section shall be construed to amend, expand, or limit the provisions under section 752.”

SEC. 3503. Enforcement and Conforming Amendments.

(a)
In General.—
(1)
Prohibited acts.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 3210, is further amended—
(A)
by adding at the end the following:

“(hhh) The failure to register or submit listing information in accordance with section 607.

“(iii) The refusal or failure to follow an order under section 611.”

; and

(B)
in paragraph (d), by striking “ or 564” and inserting “ , 564, or 607”.
(2)
Adulterated products.— Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the following:

“(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 606.

“(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in section 608(c).”

(3)
Misbranded cosmetics.— Section 602(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362(b)) is amended—
(A)
by striking “ and (2)” and inserting “ (2)”; and
(B)
by inserting after “ numerical count” the following: “ ; and (3) the information required under section 609”.
(4)
Adverse event reporting.— The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—
(A)
in section 301(e) (21 U.S.C. 331(e))—
(i)
by striking “ 564, 703” and inserting “ 564, 605, 703”; and
(ii)
by striking “ 564, 760” and inserting “ 564, 605, 611, 760”;
(B)
in section 301(ii) (21 U.S.C. 331(ii))—
(i)
by striking “ 760 or 761) or” and inserting “ 604, 760, or 761) or”; and
(ii)
by inserting “ or required under section 605(a)” after “ report (as defined under section 760 or 761”;
(C)
in section 801(a) (21 U.S.C. 381(a))—
(i)
by striking “ under section 760 or 761” and inserting “ under section 605, 760, or 761”;
(ii)
by striking “ defined in such section 760 or 761” and inserting “ defined in section 604, 760, or 761”;
(iii)
by striking “ of such section 760 or 761” and inserting “ of such section 605, 760, or 761”; and
(iv)
by striking “ described in such section 760 or 761” and inserting “ described in such section 605, 760, or 761”; and
(D)
in section 801(b) (21 U.S.C. 381(b))—
(i)
by striking “ requirements of sections 760 or 761,” and inserting “ requirements of section 605, 760, or 761”;
(ii)
by striking “ as defined in section 760 or 761” and inserting “ as defined in section 604, 760, or 761”; and
(iii)
by striking “ with section 760 or 761” and inserting “ with section 605, 760, or 761”.
(b)
Effective Dates.—
(1)
In general.— The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act.
(2)
Labeling requirement.— Section 609(a) of the Federal Food, Drug, and Cosmetic Act, as added by section 802, shall take effect on the date that is 2 years after the date of enactment of this Act.
(c)
Confidentiality.—
(1)
In general.— The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential commercial information that is obtained by the Secretary of Health and Human Services pursuant to this subtitle, including the amendments made by this subtitle.
(2)
Clarification.— Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.

SEC. 3504. Records Inspection.

Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by inserting after the second sentence the following: “ In the case of a facility (as defined in section 604) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 605, 606, and 610, when the standard for records inspection under such section applies.”.

SEC. 3505. Talc-Containing Cosmetics.

The Secretary of Health and Human Services—
(1)
not later than one year after the date of enactment of this Act, shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and
(2)
not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.

SEC. 3506. Pfas in Cosmetics.

(a)
In General.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research.
(b)
Report.— Not later than 3 years after enactment of this Act, the Secretary shall publish on the website of the Food and Drug Administration a report summarizing the results of the assessment conducted under subsection (a).

SEC. 3507. Sense of the Congress on Animal Testing.

It is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.

SEC. 3508. Funding.

There is authorized to be appropriated $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027, for purposes of conducting the activities under this subtitle (including the amendments made by this subtitle) and hiring personnel required to carry out this subtitle (including the amendments made by this subtitle).

Subtitle F Cross-Cutting Provisions

CHAPTER 1 Clinical Trial Diversity and Modernization

SEC. 3601. Diversity Action Plans for Clinical Studies.

(a)
Drugs.— Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(z)

(1) With respect to a clinical investigation of a new drug that is a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies), the sponsor of such drug shall submit to the Secretary a diversity action plan.

“(2) Such diversity action plan shall include—

“(A) the sponsor’s goals for enrollment in such clinical study;

“(B) the sponsor’s rationale for such goals; and

“(C) an explanation of how the sponsor intends to meet such goals.

“(3) The sponsor shall submit to the Secretary such diversity action plan, in the form and manner specified by the Secretary in guidance, as soon as practicable but not later than the date on which the sponsor submits the protocol to the Secretary for such a phase 3 study or other pivotal study of the drug. The sponsor may submit modifications to the diversity action plan. Any such modifications shall be in the form and manner specified by the Secretary in guidance.

“(4)

(A) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in paragraph (1), (2), or (3) if the Secretary determines that a waiver is necessary based on what is known or what can be determined about the prevalence or incidence of the disease or condition for which the new drug is under investigation (including in terms of the patient population that may use the drug), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

“(B) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

“(5) No diversity action plan shall be required for a submission described in section 561.”

(b)
Devices.— Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended by adding at the end the following:

“(9)

(A)

(i) The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary.

“(ii) The sponsor of a device for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a diversity action plan for any clinical study with respect to the device. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 for such device.

“(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include—

“(i) the sponsor’s goals for enrollment in the clinical study;

“(ii) the sponsor’s rationale for such goals; and

“(iii) an explanation of how the sponsor intends to meet such goals.

“(C)

(i) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in subparagraph (A) or (B) if the Secretary determines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

“(ii) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

“(D) No diversity action plan shall be required for a submission described in section 561.”

SEC. 3602. Guidance on Diversity Action Plans for Clinical Studies.

(a)
In General.— The Secretary shall update or issue guidance relating to—
(1)
the format and content of the diversity action plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z); 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may include characteristics such as geographic location and socioeconomic status, including with respect to—
(A)
the rationale for the sponsor’s enrollment goals, which may include—
(i)
the estimated prevalence or incidence in the United States of the disease or condition for which the drug or device is being investigated in the relevant clinical trial, if such estimated prevalence or incidence is known or can be determined based on available data;
(ii)
what is known about the disease or condition for which the drug or device is being investigated;
(iii)
any relevant pharmacokinetic or pharmacogenomic data;
(iv)
what is known about the patient population for such disease or condition, including, to the extent data is available—
(I)
demographic information, which may include age group, sex, race, geographic location, socioeconomic status, and ethnicity;
(II)
non-demographic factors, including co-morbidities affecting the patient population; and
(III)
potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and
(v)
any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women; and
(B)
an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel;
(2)
submission of any modifications to the diversity action plan;
(3)
considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate;
(4)
criteria that the Secretary will consider in assessing whether to grant a sponsor’s request to waive the requirement to submit a diversity action plan under section 505(z)(4) or 520(g)(9)(C) of the Federal Food, Drug, and Cosmetic Act (as amended by section 3601); and
(5)
how sponsors may include in regular reports otherwise required by the Secretary—
(A)
the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and
(B)
any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet goals referred to in paragraph (1)(A); and
(C)
if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the sponsor’s reasons for why the sponsor does not expect to meet such goals.
(b)
Issuance.— The Secretary shall—
(1)
not later than 12 months after the date of enactment of this Act, issue new draft guidance or update existing draft guidance described in subsection (a); and
(2)
not later than 9 months after closing the comment period on such draft guidance, finalize such guidance.
(c)
Applicability.— Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601, shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under this section.

SEC. 3603. Public Workshops to Enhance Clinical Study Diversity.

(a)
In General.— Not later than one year after the date of enactment of this Act, the Secretary, in consultation with drug sponsors, medical device sponsors, clinical research organizations, academia, patients, and other stakeholders, shall convene one or more public workshops to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate, and other topics, including—
(1)
how and when to collect and present the prevalence or incidence data on a disease or condition by demographic subgroup, including possible sources for such data and methodologies for assessing such data;
(2)
considerations for the dissemination, as appropriate, after approval, of information to the public on clinical study enrollment demographic data;
(3)
the establishment of goals for enrollment in clinical trials, including the relevance of the estimated prevalence or incidence, as applicable, in the United States of the disease or condition for which the drug or device is being developed; and
(4)
approaches to support inclusion of underrepresented populations and to encourage clinical study participation that reflects the population expected to use the drug or device under study, including with respect to—
(A)
the establishment of inclusion and exclusion criteria for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellectual or developmental disabilities or mental illness;
(B)
considerations regarding informed consent with respect to individuals with intellectual or developmental disabilities or mental illness, including ethical and scientific considerations;
(C)
the appropriate use of decentralized trials or digital health tools;
(D)
clinical endpoints;
(E)
biomarker selection; and
(F)
studying analysis.
(b)
Public Docket.— The Secretary shall establish a public comment period to receive written comments related to the topics addressed during each public workshop convened under this section. The public comment period shall remain open for 60 days following the date on which each public workshop is convened.
(c)
Report.— Not later than 180 days after the close of the public comment period for each public workshop convened under this section, the Secretary shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such workshop. The report shall include a summary of topics and responses to any recommendations raised in such workshop.

SEC. 3604. Annual Summary Report on Progress to Increase Diversity in Clinical Studies.

(a)
In General.— Beginning not later than 2 years after the date of enactment of this Act, and each year thereafter, the Secretary shall submit to the Congress, and publish on the public website of the Food and Drug Administration, a report that—
(1)
summarizes, in aggregate, the diversity action plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601; and
(2)
contains information, in the aggregate, on—
(A)
for drugs, biological products, and devices approved, licensed, cleared, or classified under section 505, 515, 510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2)), or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications; and
(B)
the reasons provided, if any, for why enrollment goals from submitted diversity action plans were not met.
(b)
Confidentiality.— Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

SEC. 3605. Public Meeting on Clinical Study Flexibilities Initiated in Response to Covid–19 Pandemic.

(a)
In General.— Not later than 180 days after the date on which the COVID–19 emergency period ends, the Secretary shall convene a public meeting to discuss the recommendations provided by the Food and Drug Administration during the COVID–19 emergency period to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID–19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards”, as updated on August 8, 2021, and by any subsequent updates to such guidance. The Secretary shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical studies during the COVID–19 emergency period and organizations representing patients.
(b)
Topics.— Not later than 90 days after the date on which the public meeting under subsection (a) is convened, the Secretary shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such meeting. Such topics shall include discussion of—
(1)
the actions sponsors took to utilize such recommendations and the frequency at which such recommendations were employed;
(2)
the characteristics of the sponsors, studies, and patient populations impacted by such recommendations;
(3)
a consideration of how recommendations intended to mitigate disruption of clinical studies during the COVID–19 emergency period, including any recommendations to consider decentralized clinical studies when appropriate, may have affected access to clinical studies for certain patient populations, especially unrepresented or underrepresented racial and ethnic minorities; and
(4)
recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations.
(c)
COVID–19 Emergency Period Defined.— In this section, the term “COVID–19 emergency period” has the meaning given the term “emergency period” in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)).

SEC. 3606. Decentralized Clinical Studies.

(a)
Guidance.— The Secretary shall—
(1)
not later than 1 year after the date of enactment of this Act, issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices, including recommendations for how to advance the use of flexible and novel clinical trial designs and to help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population, including with respect to race, ethnicity, age, sex, and geographic location, when appropriate; and
(2)
not later than 1 year after closing the comment period on such draft guidance, finalize such guidance.
(b)
Content of Guidance.— The guidance under subsection (a) shall address the following:
(1)
Recommendations related to digital health technology or other assessment options, such as telehealth, local laboratories, local health care providers, or other options for remote data collection, could support decentralized clinical studies, including guidance on considerations for selecting technological platforms and mediums, data collection and use, data integrity and security, and communication to study participants through digital technology.
(2)
Recommendations for subject recruitment, retention, and engagement, including considerations for sponsors to minimize or reduce burdens for clinical study participants through the use of digital health technology, telehealth, local health care providers and laboratories, health care provider home visits, direct-to-participant engagement, electronic informed consent, or other means, as appropriate.
(3)
Recommendations with respect to the evaluation of data collected within a decentralized clinical study setting.
(4)
Recommendations for methods of remote data collection, including clinical trial participant experience data, through the use of digital health technologies, telemedicine, local laboratories, local health care providers, or other options for data collection.
(5)
Considerations for sponsors to minimize or reduce burdens for clinical trial participants associated with participating in a clinical trial, such as the use of digital technologies, telemedicine, local laboratories, local health care providers, or other data collection or assessment options, health care provider home visits, direct-to-participant shipping of investigational drugs and devices, and electronic informed consent, as appropriate.
(6)
Recommendations regarding conducting decentralized clinical trials to facilitate and encourage meaningful diversity among clinical trial participants, including with respect to race, ethnicity, age, sex, and geographic location, as appropriate.
(7)
Recommendations for strategies and methods for recruiting, retaining, and engaging with clinical trial participants, including communication regarding the role of clinical trial participants and community partners to facilitate clinical trial recruitment and engagement, including with respect to diverse and underrepresented populations, as appropriate.
(8)
Considerations for review and oversight by sponsors and institutional review boards, including remote trial oversight.
(9)
Recommendations for decentralized clinical trial protocol designs and processes for evaluating such proposed clinical trial designs.
(10)
Recommendations related to digital health technology and other remote assessment tools that may support decentralized clinical trials, including guidance on appropriate technological platforms and tools, data collection and use, data integrity, and communication to clinical trial participants through such technology.
(11)
A description of the manner in which the Secretary will assess or evaluate data collected within a decentralized clinical trial to support the development of the drug or device, if the manner is different from that used for a nondecentralized trial.
(12)
Considerations for sponsors to validate digital technologies and establish appropriate clinical endpoints for use in decentralized trials.
(13)
Considerations for privacy and security of personally identifiable information of trial participants.
(14)
Considerations for conducting clinical trials using centralized approaches in conjunction with decentralized approaches.
(c)
Definition.— In this section, the term “decentralized clinical study” means a clinical study in which some or all of the study-related activities occur at a location separate from the investigator’s location.

SEC. 3607. Modernizing Clinical Trials.

(a)
Clarifying the Use of Digital Health Technologies in Clinical Trials.—
(1)
In general.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance regarding the appropriate use of digital health technologies in clinical trials to help improve recruitment for, retention in, participation in, and data collection during, clinical trials, and provide for novel clinical trial designs utilizing such technology for purposes of supporting the development of, and review of applications for, drugs and devices. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
(2)
Content.— The guidance described in paragraph (1) shall include—
(A)
recommendations for data collection methodologies by which sponsors may incorporate the use of digital health technologies in clinical trials to collect data remotely from trial participants;
(B)
considerations for privacy and security protections for data collected during a clinical trial, including—
(i)
recommendations for the protection of trial participant data that are collected or used in research using digital health technologies;
(ii)
compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), subpart B of part 50 of title 21, Code of Federal Regulations, subpart C of part 56 of title 21, Code of Federal Regulations, the Federal policy for the protection of human subjects under subpart A of part 46 of title 45, Code of Federal Regulations (commonly known as the “Common Rule”), and part 2 of title 42, Code of Federal Regulations (or any successor regulations); and
(iii)
recommendations for the protection of clinical trial participant data against cybersecurity threats, as applicable;
(C)
considerations on data collection methods to help increase recruitment of clinical trial participants and the level of participation of such participants, reduce burden on clinical trial participants, and optimize data quality;
(D)
recommendations for the use of electronic methods to obtain informed consent from clinical trial participants, taking into consideration applicable Federal law, including subpart B of part 50 of title 21, Code of Federal Regulations (or successor regulations), and, as appropriate, State law;
(E)
best practices for communication between sponsors and the Secretary on the development of data collection methods;
(F)
the appropriate format to submit such data to the Secretary;
(G)
a description of the manner in which the Secretary may assess or evaluate data collected through digital health technologies to support the development of the drug or device;
(H)
recommendations regarding the data and information needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial, and a description of how the Secretary will evaluate such data and information; and
(I)
recommendations for increasing access to, and the use of, digital health technologies in clinical trials to facilitate the inclusion of diverse and underrepresented populations, as appropriate, including considerations for access to, and the use of, digital health technologies in clinical trials by people with disabilities and pediatric populations.
(b)
Seamless and Concurrent Clinical Trials.—
(1)
In general.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance on the use of seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of applications for drugs, as appropriate. Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
(2)
Content.— The guidance described in paragraph (1) shall include—
(A)
recommendations on the use of expansion cohorts and other seamless clinical trial designs to assess different aspects of product candidates in one continuous trial, including how such clinical trial designs can be used as part of meeting the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
(B)
recommendations on the use of clinical trial designs that involve the concurrent conduct of different or multiple clinical trial phases, and the concurrent conduct of preclinical testing, to expedite the development of new drugs and facilitate the timely collection of data;
(C)
recommendations for how to streamline trial logistics and facilitate the efficient collection and analysis of clinical trial data, including any planned interim analyses and how such analyses could be used to streamline the product development and review processes;
(D)
considerations to assist sponsors in ensuring the rights, safety, and welfare of clinical trial participants, maintaining compliance with good clinical practice regulations, minimizing risks to clinical trial data integrity, and ensuring the reliability of clinical trial results;
(E)
recommendations for communication between sponsors and the Food and Drug Administration on the development of seamless, concurrent, or other adaptive clinical trial designs, including review of, and feedback on, clinical trial protocols; and
(F)
a description of the manner in which the Secretary will assess or evaluate data collected through seamless, concurrent, or other adaptive clinical trial designs to support the development of drugs.
(c)
International Harmonization.— The Secretary shall, as appropriate, work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation and use of decentralized clinical trials, digital technology in clinical trials, and seamless, concurrent, and other adaptive or innovative clinical trial designs.

CHAPTER 2 Inspections

SEC. 3611. Device Inspections.

(a)
In General.— Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking “ restricted devices” each place it appears and inserting “ devices”.
(b)
Records or Other Information.—
(1)
Establishments.— Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended—
(A)
by striking “ an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and inserting “ an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),”; and
(B)
by striking “ records requested.” and inserting the following: “ records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.”.
(2)
Guidance.—
(A)
In general.— The Secretary shall issue or update guidance describing—
(i)
circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, as amended by paragraph (1);
(ii)
processes for responding to such requests electronically or in physical form; and
(iii)
factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
(B)
Timing.— The Secretary shall—
(i)
not later than 1 year after the date of enactment of this Act, issue draft guidance under subparagraph (A); and
(ii)
not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A).

SEC. 3612. Bioresearch Monitoring Inspections.

(a)
In General.— Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the end the following:

“(5)

(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.

“(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.

“(C)

(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—

“(I) developing an application or other submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);

“(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or

“(III) holding any records or other information described in subparagraph (B).

“(ii) A person described in this clause is—

“(I) the sponsor of an application or submission specified in subparagraph (E);

“(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;

“(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or

“(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).

“(D)

(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—

“(I) permitting the Secretary to record or copy such information for purposes of this paragraph;

“(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and

“(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.

“(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

“(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.

“(E) The studies and submissions described in this subparagraph are each of the following:

“(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described in paragraph (1).

“(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act.

“(iii) Any other clinical investigation of—

“(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or

“(II) a device subject to section 520(g).

“(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.

“(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.”

(b)
Review of Processes and Practices; Guidance for Industry.—
(1)
In general.— The Secretary shall—
(A)
review processes and practices in effect as of the date of enactment of this Act applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and
(B)
evaluate whether any updates are needed to facilitate the consistency of such processes and practices.
(2)
Guidance.—
(A)
In general.— The Secretary shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.
(B)
Timing.— The Secretary shall—
(i)
not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and
(ii)
not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A).

SEC. 3613. Improving Food and Drug Administration Inspections.

(a)
Risk Factors for Establishments.— Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended—
(1)
by redesignating subparagraph (F) as subparagraph (G); and
(2)
by inserting after subparagraph (E) the following:

“(F) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act, including the history of violations related to products exported from such country or region that are subject to such regulation.”

(b)
Use of Records.— Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) is amended—
(1)
by redesignating subparagraph (C) as subparagraph (D); and
(2)
by inserting after subparagraph (B) the following:

“(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.”

(c)
Recognition of Foreign Government Inspections.— Section 809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended—
(1)
in subsection (a)(1), by inserting “ preapproval or” before “ risk-based inspections”; and
(2)
by adding at the end the following:

“(c) Periodic Review.—

“(1) In general.—Beginning not later than 1 year after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.

“(2) Reports to congress.—Beginning not later than 4 years after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).”

SEC. 3614. Gao Report on Inspections of Foreign Establishments Manufacturing Drugs.

(a)
In General.— Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on inspections conducted by—
(1)
the Secretary of foreign establishments pursuant to subsections (h) and (i) of section 510 and section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360; 374); or
(2)
a foreign government or an agency of a foreign government pursuant to section 809 of such Act (21 U.S.C. 384e).
(b)
Contents.— The report conducted under subsection (a) shall include—
(1)
what alternative tools, including remote inspections or remote evaluations, other countries are utilizing to facilitate inspections of foreign establishments;
(2)
how frequently trusted foreign regulators conduct inspections of foreign facilities that could be useful to the Food and Drug Administration to review in lieu of its own inspections;
(3)
how frequently and under what circumstances, including for what types of inspections, the Secretary utilizes existing agreements or arrangements under section 809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the use of such agreements could be appropriately expanded;
(4)
whether the Secretary has accepted reports of inspections of facilities in China and India conducted by entities with which they have entered into such an agreement or arrangement;
(5)
what additional foreign governments or agencies of foreign governments the Secretary has considered entering into a mutual recognition agreement with and, if applicable, reasons why the Secretary declined to enter into a mutual recognition agreement with such foreign governments or agencies;
(6)
what tools, if any, the Secretary used to facilitate inspections of domestic facilities that could also be effectively utilized to appropriately inspect foreign facilities;
(7)
what steps the Secretary has taken to identify and evaluate tools and strategies the Secretary may use to continue oversight with respect to inspections when in-person inspections are disrupted;
(8)
how the Secretary is considering incorporating alternative tools into the inspection activities conducted pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
(9)
what steps the Secretary has taken to identify and evaluate how the Secretary may use alternative tools to address workforce shortages to carry out such inspection activities.

SEC. 3615. Unannounced Foreign Facility Inspections Pilot Program.

(a)
In General.— The Secretary shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection. Such pilot program shall evaluate—
(1)
differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;
(2)
costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;
(3)
barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and
(4)
approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.
(b)
Pilot Program Scope.— The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the Secretary’s evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.).
(c)
Pilot Program Initiation.— The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act.
(d)
Report.— The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—
(1)
findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;
(2)
findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and
(3)
the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act.

SEC. 3616. Enhancing Coordination and Transparency on Inspections.

(a)
Coordination.— Section 506D of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is amended—
(1)
by adding at the end the following:

“(g) Coordination.—The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program regarding—

“(1) the reviews of reports shared pursuant to section 704(b)(2); and

“(2) any feedback or corrective or preventive actions in response to such reports.”

; and

(2)
by amending subsection (f) to read as follows:

“(f) Temporary Sunset.—Subsection (a) shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act. Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act and ending on the date of enactment of the Food and Drug Omnibus Reform Act of 2022. Subsections (b), (c), and (e) shall be in effect beginning on the date of enactment of the Food and Drug Omnibus Reform Act of 2022.”

(b)
Reporting.—
(1)
Amendments.— Section 506C–1(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1(a)) is amended—
(A)
by redesignating paragraphs (3) through (7) as paragraphs (5) through (9), respectively;
(B)
by inserting after paragraph (2) the following:

“(3) describes the coordination and alignment activities undertaken pursuant to section 506D(g);

“(4) provides the number of reports that were required under section 704(b)(2) to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent;”

; and

(C)
in paragraph (5)(A), as so redesignated, by striking “ paragraph (7)” and inserting “ paragraph (9)”.
(2)
Applicability.— The amendments made by paragraph (1) shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1) on or after March 31, 2024.
(c)
Reporting of Mutual Recognition Agreements for Inspections and Review Activities.— Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended—
(1)
in paragraph (6)—
(A)
in the matter preceding subparagraph (A), by striking “ Beginning in 2014, not” and inserting “ Not”;
(B)
by amending subparagraph (A) to read as follows:

“(A)

(i) the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year;

“(ii) the number of such registered establishments in each region of interest;

“(iii) the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the Secretary inspected in the previous fiscal year;

“(iv) the number of inspections to support actions by the Secretary on applications under section 505 of this Act or section 351 of the Public Health Service Act, including the number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year;

“(v) the number of routine surveillance inspections the Secretary conducted in the previous fiscal year, including in each region of interest;

“(vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv), including in each region of interest; and

“(vii) the number of inspections the Secretary has recognized pursuant to an agreement entered into pursuant to section 809, or otherwise recognized, for each of the types of inspections described in clauses (v) and (vi), including for inspections of establishments in each region of interest.”

(C)
in subparagraph (B), by striking “ ; and” and inserting a semicolon;
(D)
in subparagraph (C), by striking the period and inserting “ ; and”; and
(E)
by adding at the end the following:

“(D) the status of the efforts of the Food and Drug Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section 809, including any obstacles to expanding the use of such recognition.”

; and

(2)
by adding at the end the following:

“(7) Region of interest.—For purposes of paragraph (6)(A), the term ‘region of interest’ means a foreign geographic region or country, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate.”

SEC. 3617. Enhancing Transparency of Drug Facility Inspection Timelines.

Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355 note) is amended to read as follows:

“SEC. 902. ANNUAL REPORT ON INSPECTIONS.

“Not later than 120 days after the end of each fiscal year, the Secretary of Health and Human Services shall post on the website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or approval of a device under section 515 of such Act (21 U.S.C. 360e) that were conducted during the previous fiscal year. Such information shall include the following:

“(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including—

“(A) the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));

“(B) the median time for drugs for which a notification has been submitted in accordance with section 506C(a) of such Act (21 U.S.C. 356c(a)) during the previous fiscal year; and

“(C) the median time for drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C. 356e) at the time of such request.

“(2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).

“(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken.

“(4) The number of facilities that failed to implement adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).”

CHAPTER 3 Miscellaneous

SEC. 3621. Regulation of Certain Products as Drugs.

Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) is amended by adding at the end the following:

“(h)

(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 201(g) and not a device under section 201(h).

“(2) For purposes of this subsection:

“(A) The term ‘contrast agent’ means an article that is intended for use in conjunction with a medical imaging device, and—

“(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

“(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

“(B) The term ‘radioactive drug’ has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—

“(i) an implant or article similar to an implant;

“(ii) an article that applies radiation from outside of the body; or

“(iii) the radiation source of an article described in clause (i) or (ii).

“(C) The term ‘OTC monograph drug’ has the meaning given such term in section 744L.

“(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 201(g)) if such product—

“(A) is not described in paragraph (1); and

“(B) meets the definition of a device under section 201(h),

“(4) The Secretary shall waive the application fee under sections 736 and 744B for applications for drugs that are—

“(A) on the date of enactment of the Prescription Drug User Fee Amendments of 2022, legally marketed as devices; and

“(B) deemed drugs pursuant to paragraph (1)”

SEC. 3622. Women’s Health Research Roadmap.

Not later than 2 years after the date of enactment of this Act, the Office of Women’s Health of the Food and Drug Administration, established under section 1011 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399b), shall—
(1)
review and, as appropriate, update the Women’s Health Research Roadmap issued in December 2015; and
(2)
brief the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the review and, as appropriate, any resulting update.

SEC. 3623. Strategic Workforce Plan and Report.

Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting after section 714A the following:

“SEC. 714B. STRATEGIC WORKFORCE PLAN AND REPORT.

“(a) In General.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop, begin implementation of, and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated strategy and report to provide direction for the activities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the development, review, and regulation of medical products. Each such report shall be known as the ‘Food and Drug Administration Strategic Workforce Plan’.

“(b) Use of the Food and Drug Administration Strategic Workforce Plan.—Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plans developed under subsection (a).

“(c) Contents of the Food and Drug Administration Strategic Workforce Plan.—Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall—

“(1) include agency-wide human capital strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Administration;

“(2) establish specific actions the Secretary will take to achieve such strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years;

“(3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the actions the Secretary will take to overcome those challenges and mitigate those risks;

“(4) establish performance measures, benchmarks, or other elements that the Secretary will use to measure and evaluate progress in achieving such strategic goals and priorities and the effectiveness of such strategic goals and priorities; and

“(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.

“(d) Considerations.—In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider—

“(1) the number of employees (including senior leadership and non-senior leadership employees) eligible for retirement, the expertise of such employees, and the employing center of such employees;

“(2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates;

“(3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results;

“(4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve the strategic goals and priorities described in subsection (c);

“(5) the statutory hiring authorities used to hire Food and Drug Administration employees, and the time to hire across different hiring authorities; and

“(6) any other timely and relevant information, as the Secretary determines appropriate.

“(e) Evaluation of Progress.—Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of—

“(1) the progress the Secretary has made, based on the performance measures, benchmarks, and other elements that measure successful recruitment, hiring, training, development, and retention activities; and

“(2) whether actions taken in response to the Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities described in subsection (c)(1).

“(f) Additional Considerations.—The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID–19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, including protecting such workforce during public health emergencies.”

SEC. 3624. Enhancing Food and Drug Administration Hiring Authority for Scientific, Technical, and Professional Personnel.

Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3a) is amended—
(1)
in subsection (a)—
(A)
by inserting “ , including cross-cutting operational positions,” after “ professional positions”; and
(B)
by inserting “ and the regulation of food and cosmetics” after “ medical products”; and
(2)
in subsection (d)(1)—
(A)
in the matter preceding subparagraph (A)—
(i)
by striking “ the 21st Century Cures Act” and inserting “ the Food and Drug Omnibus Reform Act of 2022”; and
(ii)
by striking “ that examines the extent” and all that follows through “ , including” and inserting “ that includes”;
(B)
in subparagraph (A)—
(i)
by inserting “ updated” before “ analysis”; and
(ii)
by striking “ ; and” and inserting a semicolon;
(C)
by redesignating subparagraph (B) as subparagraph (C);
(D)
by inserting after subparagraph (A) the following:

“(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and”

; and

(E)
in the matter preceding clause (i) of subparagraph (C), as so redesignated, by striking “ a recruitment” and inserting “ an updated recruitment”.

SEC. 3625. Facilities Management.

(a)
PDUFA Authority.— Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is amended—
(1)
in subparagraph (A)(ii)—
(A)
by striking “ shall be available to defray” and inserting the following:

“(I) for fiscal year 2023, to defray”

(B)
by striking the period and inserting “ ; and”; and
(C)
by adding at the end the following:

“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.”

; and

(2)
in subparagraph (B), by striking “ for the process for the review of human drug applications” and inserting “ as described in subclause (I) or (II) of such subparagraph, as applicable”.
(b)
BsUFA Authority.— Section 744H(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(f)(2)) is amended—
(1)
in subparagraph (B)(i)—
(A)
by striking “ available for a fiscal year beginning after fiscal year 2012” and inserting the following:

“(I) for fiscal year 2023,”

(B)
by striking “ the fiscal year involved.” and inserting “ such fiscal year; and”; and
(C)
by adding at the end the following:

“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.”

; and

(2)
in subparagraph (C), by striking “ subparagraph (B) in any fiscal year if the costs described in such subparagraph” and inserting “ subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable,”.
(c)
GDUFA Authority.— Section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) is amended—
(1)
in subsection (e)(2), by striking “ 744A(11)(C)” and inserting “ 744A(12)(C)”; and
(2)
in subsection (i)(2)—
(A)
in subparagraph (A)(ii)—
(i)
by striking “ available for a fiscal year beginning after fiscal year 2012” and inserting the following:

“(I) for fiscal year 2023,”

(ii)
by striking “ the fiscal year involved.” and inserting “ such fiscal year; and”; and
(iii)
by adding at the end the following:

“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 744A(3) applicable to the fiscal year involved.”

; and

(B)
in subparagraph (B), by striking “ for human generic activities” and inserting “ as described in subclause (I) or (II) of such subparagraph, as applicable,”.
(d)
MDUFA Authority.— Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by section 3309, is further amended—
(1)
in subsection (e)(2)(B)(iii), by inserting “ , if extant,” after “ national taxing authority”;
(2)
in subsection (h)(2)—
(A)
in subparagraph (A)(ii)—
(i)
by striking “ shall be available to defray” and inserting the following:

“(I) for fiscal year 2023, to defray”

(ii)
by striking the period and inserting “ ; and”; and
(iii)
by adding at the end the following:

“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.”

; and

(B)
in subparagraph (B)(i), in the matter preceding subclause (I), by striking “ for the process for the review of device applications” and inserting “ as described in subclause (I) or (II) of such subparagraph, as applicable”; and
(3)
in subsection (g)(3), by striking “ 737(9)(C)” and inserting “ 737(10)(C)”.
(e)
Technical Correction.—
(1)
In general.— Section 905(b)(2) of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended by striking “ Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended” and inserting “ Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as so redesignated by section 203(f)(2)(B)(i), is amended”.
(2)
Effective date.— The amendment made by paragraph (1) shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52).

SEC. 3626. User Fee Program Transparency and Accountability.

(a)
PDUFA.—
(1)
Reauthorization; reporting requirements.— Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)) is amended—
(A)
in paragraph (1)—
(i)
in subparagraph (B)—
(I)
in clause (vii), by striking “ ; and” and inserting a semicolon;
(II)
in clause (viii), by striking the period and inserting “ ; and”; and
(III)
by adding at the end the following:

“(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.”

; and

(ii)
by adding at the end the following flush text: “Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.”;
(B)
by adding at the end of paragraph (3)(B) the following:

“(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.”

; and

(C)
in paragraph (4)—
(i)
by amending subparagraph (A) to read as follows:

“(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 736, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”

(ii)
by amending subparagraph (B) to read as follows:

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—

“(i) drivers of such changes; and

“(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;”

(iii)
in subparagraph (C), by striking the period and inserting “ ; and”; and
(iv)
by adding at the end the following:

“(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.”

(2)
Reauthorization.— Section 736B(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(f)) is amended—
(A)
by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively;
(B)
by inserting after paragraph (3) the following:

“(4) Updates to congress.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.”

; and

(C)
in paragraph (7), as so redesignated—
(i)
in subparagraph (A)—
(I)
by striking “ Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the” and inserting “ The”; and
(II)
by inserting “ , not later than 30 days after each such negotiation meeting” before the period at the end; and
(ii)
in subparagraph (B), by inserting “ , in sufficient detail,” after “ shall summarize”.
(b)
MDUFA.—
(1)
Reauthorization; reporting requirements.— Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)) is amended—
(A)
in clause (ii)—
(i)
in subclause (II), by striking “ ; and” and inserting a semicolon;
(ii)
in subclause (III), by striking the period and inserting a semicolon; and
(iii)
by adding at the end the following:

“(IV) the number of investigational device exemption applications submitted under section 520(g) per fiscal year, including for each review division; and

“(V) the number of expedited development and priority review requests and designations under section 515B per fiscal year, including for each review division.

; and

(B)
in clause (iv) (relating to rationale for MDUFA program changes)—
(i)
by amending subclause (I) to read as follows:

“(I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 738, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”

(ii)
by amending subclause (II) to read as follows:

“(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—

“(aa) drivers of such changes; and

“(bb) changes in the average total cost per full-time equivalent in the medical device review program;”

(iii)
in subclause (III), by striking the period and inserting “ ; and”; and
(iv)
by adding at the end the following:

“(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.”

(2)
Reauthorization.— Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended—
(A)
by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively;
(B)
by inserting after paragraph (3) the following:

“(4) Updates to congress.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.”

; and

(C)
in paragraph (7), as so redesignated—
(i)
in subparagraph (A)—
(I)
by striking “ Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the” and inserting “ The”; and
(II)
by inserting “ , not later than 30 days after each such negotiation meeting” before the period at the end; and
(ii)
in subparagraph (B), by inserting “ , in sufficient detail,” after “ shall summarize”.
(c)
GDUFA.—
(1)
Reauthorization; reporting requirements.— Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)(3)) is amended—
(A)
by amending subparagraph (A) to read as follows:

“(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744B, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”

(B)
by amending subparagraph (B) to read as follows:

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including—

“(i) identifying drivers of such changes; and

“(ii) changes in the total average cost per full-time equivalent in the generic drug review program;”

(C)
in subparagraph (C), by striking the period at the end and inserting “ ; and”; and
(D)
by adding at the end the following:

“(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application.”

(2)
Reauthorization.— Section 744C(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(f)) is amended—
(A)
by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively;
(B)
by inserting after paragraph (3) the following:

“(4) Updates to congress.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.”

; and

(C)
in paragraph (7), as so redesignated—
(i)
in subparagraph (A)—
(I)
by striking “ Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the” and inserting “ The”; and
(II)
by inserting “ , not later than 30 days after each such negotiation meeting” before the period at the end; and
(ii)
in subparagraph (B), by inserting “ , in sufficient detail,” after “ shall summarize”.
(d)
BsUFA.—
(1)
Reauthorization; reporting requirements.— Section 744I(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)(4)) is amended—
(A)
by amending subparagraph (A) to read as follows:

“(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744H, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”

(B)
by amending subparagraph (B) to read as follows:

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying—

“(i) drivers of such changes; and

“(ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program;”

(C)
in subparagraph (C), by striking the period at the end and inserting “ ; and”; and
(D)
by adding at the end the following:

“(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.”

(2)
Reauthorization.— Section 744I(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(f)) is amended—
(A)
by redesignating paragraphs (2) and (3) as paragraphs (5) and (6), respectively;
(B)
by inserting after paragraph (1) the following:

“(2) Prior public input.—Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall—

“(A) publish a notice in the Federal Register requesting public input on the reauthorization;

“(B) hold a public meeting at which the public may present its views on the reauthorization;

“(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

“(D) publish the comments on the Food and Drug Administration’s website.

“(3) Periodic consultation.—Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2).

“(4) Updates to congress.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.”

; and

(C)
by adding at the end the following:

“(7) Minutes of negotiation meetings.—

“(A) Public availability.—The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

“(B) Content.—The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.”

SEC. 3627. Improving Information Technology Systems of the Food and Drug Administration.

(a)
FDA Strategic Information Technology Plan.—
(1)
In general.— Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration. Each such report shall be known as the “Food and Drug Administration Strategic Information Technology Plan”. The first such report may include the Data and Technology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthorization Act of 2022 (division F of Public Law 117–180).
(2)
Content of strategic plan.— The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include—
(A)
agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission;
(B)
specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and priorities;
(C)
specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns;
(D)
challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks;
(E)
the ways in which the Food and Drug Administration will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and
(F)
a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.
(3)
Evaluation of progress.— Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of—
(A)
the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and
(B)
whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans.
(b)
GAO Report.—
(1)
In general.— Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the implementation of the Food and Drug Administration Strategic Information Technology Plan adopted pursuant to subsection (a).
(2)
Content of report.— The report required under paragraph (1) shall include an assessment of—
(A)
the development and implementation of the Food and Drug Administration Strategic Information Technology Plan, including the sufficiency of the plan, progress of the Food and Drug Administration in meeting the results-oriented goals, milestones, and performance measures identified in such plan and any gaps in such implementation;
(B)
the efficiency and effectiveness of the Food and Drug Administration’s expenditures on information technology systems over the preceding 10 fiscal years, including the implementation by the Food and Drug Administration of the Technology Modernization Action Plan and Data Modernization Action Plan;
(C)
challenges posed by the information technology systems of the Food and Drug Administration for carrying out the Food and Drug Administration’s public health mission, including on meeting user fee agreement performance goals, conducting inspections, responding to identified safety concerns, and keeping pace with new scientific and medical advances; and
(D)
recommendations for the Food and Drug Administration to address the identified challenges, improve its implementation of the Food and Drug Administration Strategic Information Technology Plan, and to otherwise improve the Food and Drug Administration’s information technology systems.

SEC. 3628. Reporting on Mailroom and Office of the Executive Secretariat of the Food and Drug Administration.

(a)
Report.— Not later than 90 days after the date of enactment of this Act, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—
(1)
information related to policies, procedures, and activities of the mailroom and the Office of the Executive Secretariat of the Food and Drug Administration, including—
(A)
taking receipt, tracking, managing, and prioritizing confidential informant complaints;
(B)
taking receipt of common carrier packages to the Food and Drug Administration;
(C)
the organizational structure and management of the mailroom;
(D)
the organizational structure and management of the Office of the Executive Secretariat;
(E)
the total number of employees and contractors in the mailroom including those working remotely and those working in person;
(F)
the total number of employees and contractors in the Office of the Executive Secretariat;
(G)
the number of vacant positions in the mailroom;
(H)
the number of vacant positions in the Office of the Executive Secretariat;
(I)
the average number of days for response to correspondence received by the Office of the Secretariat;
(J)
the extent to which there is a backlog of common carrier packages received by the mailroom and the number of common carrier packages in any backlog;
(K)
the extent to which there is a backlog of correspondence in the Office of the Executive Secretariat that has not been appropriately responded to by the Food and Drug Administration and the number of correspondence or common carrier packages in any backlog;
(L)
a rationale for the failure of the Office of the Executive Secretariat to respond to correspondence in any backlog and the position of the decision-making official who determined not to respond to such correspondence;
(M)
the number of whistleblower correspondence received, including within each agency center;
(N)
the amount of resources expended for the mailroom, including a breakdown of budget authority and user fee dollars;
(O)
the amount of resources expended for the Office of the Executive Secretariat and correspondence-related activities, including a breakdown of budget authority and user fee dollars; and
(P)
the performance of third-party contractors responsible for correspondence-related activities with respect to the receipt and tracking of correspondence, and efforts by the Food and Drug Administration to improve performance by such contractors; and
(2)
the development and implementation of new or revised policies and procedures of the Food and Drug Administration to monitor and ensure—
(A)
the effective receipt, tracking, managing, and prioritization of such complaints; and
(B)
the effective receipt of common carrier packages to the Food and Drug Administration.
(b)
Annual Report.— Not later than the end of each of fiscal years 2023 and 2024, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the implementation of the new or revised policies of the Food and Drug Administration reported under subsection (a)(2), and since such implementation—
(1)
the volume of incoming common carrier packages to the mailroom;
(2)
the volume of incoming correspondence to the Office of the Executive Secretariat;
(3)
the extent to which new backlogs occur in the processing of common carrier packages received by the mailroom;
(4)
the extent to which new backlogs occur in the processing of correspondence received by the Office of the Executive Secretariat;
(5)
the length of time required to resolve each such backlog;
(6)
any known issues of unreasonable delays in correspondence being provided to the intended recipient, or in correspondence being lost, and the measures taken to remedy such delays or lost items;
(7)
the average number of days it takes to respond to correspondence received by the Office of the Executive Secretariat;
(8)
the resources expended by the mailroom, including a breakdown of budget authority and user fee dollars; and
(9)
the resources expended by the Office of the Executive Secretariat on correspondence-related activities, including a breakdown of budget authority and user fee dollars.
(c)
GAO Report.— Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the policies and practices of the Division of Executive Operations of the Office of the Executive Secretariat of the Food and Drug Administration with respect to the receipt, tracking, managing, and prioritization of correspondence.

SEC. 3629. Facilitating the Use of Real World Evidence.

(a)
Guidance.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise existing guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making, as follows:
(1)
With respect to drugs, such guidance shall address the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product application under section 351 of the Public Health Service Act (42 U.S.C. 262), and to support an investigational use exemption submission under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications and submissions, as appropriate.
(2)
With respect to devices, such guidance shall address the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e), to support an investigational use exemption submission under section 520(g) of such Act (21 U.S.C. 360j(g)), and to support a determination by the Secretary for purposes of section 353 of the Public Health Service Act (42 U.S.C. 263a) (including the category described under subsection (d)(3) of such section). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), including considerations related to a determination under section 353(d)(3) of the Public Health Service Act (42 U.S.C. 263a(d)(3)), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or determinations, as appropriate.
(b)
Report to Congress.— Not later than 2 years after the end of the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—
(1)
the number of applications, submissions, or requests submitted for clearance, approval, or authorization under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262), for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) was previously granted;
(2)
of the number of applications so submitted, the number of such applications—
(A)
for which real world evidence was submitted and used to support a regulatory decision; and
(B)
for which real world evidence was submitted and determined to be insufficient to support a regulatory decision; and
(3)
a summary explanation of why, in the case of applications described in paragraph (2)(B), real world evidence could not be used to support regulatory decisions.
(c)
Information Disclosure.— Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 1905 of title 18, United States Code, or subject to withholding under subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the “Freedom of Information Act”).

SEC. 3630. Facilitating Exchange of Product Information Prior to Approval.

(a)
In General.— Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended—
(1)
in paragraph (a)—
(A)
by striking “ drugs for coverage” and inserting “ drugs or devices for coverage”; and
(B)
by striking “ drug” each place it appears and inserting “ drug or device”, respectively;
(2)
in paragraphs (a)(1) and (a)(2)(B), by striking “ under section 505 or under section 351 of the Public Health Service Act” and inserting “ under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act”;
(3)
in paragraph (a)(1)—
(A)
by striking “ under section 505 or under section 351(a) of the Public Health Service Act” and inserting “ under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act”; and
(B)
by striking “ in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act” and inserting “ in section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act”; and
(4)
by adding at the end the following:

“(gg)

(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable), provided—

“(A) the product information includes—

“(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established;

“(ii) information related to the stage of development of the drug or device involved, such as—

“(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated;

“(II) how the study or studies relate to the overall plan for the development of the drug or device; and

“(III) whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;

“(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—

“(I) all material aspects of study design, methodology, and results; and

“(II) all material limitations related to the study design, methodology, and results;

“(iv) where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act, and a copy of the most current required labeling; and

“(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and

“(B) the product information does not include—

“(i) information that represents that an unapproved product—

“(I) has been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable); or

“(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or

“(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—

“(I) is so approved, granted marketing authorization, cleared, or licensed; or

“(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.

“(2) For purposes of this paragraph, the term ‘product information’ includes—

“(A) information describing the drug or device (such as drug class, device description, and features);

“(B) information about the indication or indications being investigated;

“(C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 505, 510(k), 513, or 515 of this Act or section 351 of the Public Health Service Act;

“(D) drug or device pricing information;

“(E) patient utilization projections;

“(F) product-related programs or services; and

“(G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.”

(b)
GAO Study and Report.— Beginning on the date that is 5 years and 6 months after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study on the provision and use of information pursuant to section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by this subsection (a), between manufacturers of drugs and devices (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities described in such section 502(gg). Such study shall include an analysis of the following:
(1)
The types of information communicated between such manufacturers and payors.
(2)
The manner of communication between such manufacturers and payors.
(3)
(A)
Whether such manufacturers file an application for approval, marketing authorization, clearance, or licensing of a new drug or device or the new use of a drug or device that is the subject of communication between such manufacturers and payors under section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
(B)
How frequently the Food and Drug Administration approves, grants marketing authorization, clears, or licenses the new drug or device or new use.
(C)
The timeframe between the initial communications permitted under section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), regarding an investigational drug or device or investigational use, and the initial marketing of such drug or device.

SEC. 3631. Streamlining Blood Donor Input.

Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary and that is initiated by the Secretary to solicit information from blood donors or potential blood donors to support the development of recommendations by the Secretary, acting through the Commissioner of Food and Drugs, concerning blood donation.

TITLE IV Medicare Provisions

Subtitle A Medicare Extenders

SEC. 4101. Extension of Increased Inpatient Hospital Payment Adjustment for Certain Low-Volume Hospitals.

(a)
In General.— Section 1886(d)(12) of the Social Security Act (42 U.S.C. 1395ww(d)(12)) is amended—
(1)
in subparagraph (B), in the matter preceding clause (i), by striking “ during the portion of fiscal year 2023 beginning on December 24, 2022, and ending on September 30, 2023, and in fiscal year 2024” and inserting “ in fiscal year 2025”;
(2)
in subparagraph (C)(i)—
(A)
in the matter preceding subclause (I)—
(i)
by striking “ or portion of a fiscal year”; and
(ii)
by striking “ through 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ” and inserting “ through 2024”;
(B)
in subclause (III), by striking “ through 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ” and inserting “ through 2024”; and
(C)
in subclause (IV), by striking “ the portion of fiscal year 2023 beginning on December 24, 2022, and ending on September 30, 2023, and fiscal year 2024” and inserting “ fiscal year 2025”; and
(3)
in subparagraph (D)—
(A)
in the matter preceding clause (i), by striking “ through 2022 or during the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ” and inserting “ through 2024”; and
(B)
in clause (ii), by striking “ through 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ” and inserting “ through 2024”.
(b)
Implementation.— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including the amendments made by, this section by program instruction or otherwise.

SEC. 4102. Extension of the Medicare-Dependent Hospital Program.

(a)
In General.— Section 1886(d)(5)(G) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amended—
(1)
in clause (i), by striking “ December 24, 2022” and inserting “ October 1, 2024”; and
(2)
in clause (ii)(II), by striking “ December 24, 2022” and inserting “ October 1, 2024”.
(b)
Conforming Amendments.—
(1)
Extension of target amounts.— Section 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended—
(A)
in the matter preceding clause (i), by striking “ December 24, 2022” and inserting “ October 1, 2024”; and
(B)
in clause (iv), by striking “ fiscal year 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022,” and inserting “ fiscal year 2024”.
(2)
Permitting hospitals to decline reclassification.— Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. 1395ww note) is amended by striking “ fiscal year 2000 through fiscal year 2022, or the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022” and inserting “ or fiscal year 2000 through fiscal year 2024”.

SEC. 4103. Extension of Add-On Payments for Ambulance Services.

Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is amended—
(1)
in paragraph (12)(A), by striking “ January 1, 2023” and inserting “ January 1, 2025”; and
(2)
in paragraph (13), by striking “ January 1, 2023” in each place it appears and inserting “ January 1, 2025” in each such place.

Subtitle B Other Expiring Medicare Provisions

SEC. 4111. Extending Incentive Payments for Participation in Eligible Alternative Payment Models.

(a)
In General.— Section 1833(z) of the Social Security Act (42 U.S.C. 1395l(z)) is amended—
(1)
in paragraph (1)(A)—
(A)
by striking “ 2024” and inserting “ 2025”; and
(B)
by inserting “ (or, with respect to 2025, 3.5 percent)” after “ 5 percent”;
(2)
in paragraph (2)—
(A)
in subparagraph (B)—
(i)
in the header, by striking “ 2024” and inserting “ 2025”; and
(ii)
in the matter preceding clause (i), by striking “ 2024” and inserting “ 2025”;
(B)
in subparagraph (C)—
(i)
in the header, by striking “ 2025” and inserting “ 2026”; and
(ii)
in the matter preceding clause (i), by striking “ 2025” and inserting “ 2026”; and
(C)
in subparagraph (D), by striking “ 2023 and 2024” and inserting “ 2023, 2024, and 2025”; and
(3)
in paragraph (4)(B), by inserting “ (or, with respect to 2025, 3.5 percent)” after “ 5 percent”.
(b)
Conforming Amendments.— Section 1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C. 1395w–4(q)(1)(C)(iii)) is amended—
(1)
in subclause (II), by striking “ 2024” and inserting “ 2025”; and
(2)
in subclause (III), by striking “ 2025” and inserting “ 2026”.

SEC. 4112. Extension of Support for Physicians and Other Professionals in Adjusting to Medicare Payment Changes.

Section 1848 of the Social Security Act (42 U.S.C. 1395w–4) is amended—
(1)
in subsection (c)(2)(B)(iv)(V), by striking “ 2021 or 2022” and inserting “ 2021, 2022, 2023, or 2024”; and
(2)
in subsection (t)—
(A)
in the subsection header, by striking “ 2021 and 2022” and inserting “ 2021 Through 2024”;
(B)
in paragraph (1)—
(i)
in the matter preceding subparagraph (A), by striking “ during 2021 and 2022” and inserting “ during 2021, 2022, 2023, and 2024”; and
(ii)
in subparagraph (A), by striking at the end “ and”;
(iii)
in subparagraph (B), by striking at the end the period and inserting a semicolon; and
(iv)
by adding at the end the following new subparagraphs:

“(C) such services furnished on or after January 1, 2023, and before January 1, 2024, by 2.5 percent; and

“(D) such services furnished on or after January, 1, 2024, and before January 1, 2025, by 1.25 percent.”

; and

(C)
in paragraph (2)(C)—
(i)
in the subparagraph header, by striking “ 2021 and 2022” and inserting “ 2021 through 2024”;
(ii)
by striking “ for services furnished in 2021 or 2022” and inserting “ for services furnished in 2021, 2022, 2023, or 2024”; and
(iii)
by striking “ or 2022, respectively” and inserting “ , 2022, 2023, or 2024, respectively”.

SEC. 4113. Advancing Telehealth Beyond Covid–19.

(a)
Removing Geographic Requirements and Expanding Originating Sites for Telehealth Services.— Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
(1)
in paragraph (2)(B)(iii)—
(A)
by striking “ With” and inserting “ In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, with”; and
(B)
by striking “ that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)” and inserting “ that are furnished during the period beginning on the first day after the end of such emergency period and ending December 31, 2024”; and
(2)
in paragraph (4)(C)(iii)—
(A)
by striking “ With” and inserting “ In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, with”; and
(B)
by striking “ that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)” and inserting “ that are furnished during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024”.
(b)
Expanding Practitioners Eligible to Furnish Telehealth Services.— Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) is amended by striking “ and, for the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)” and inserting “ and, in the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, for the period beginning on the first day after the end of such emergency period and ending on December 31, 2024”.
(c)
Extending Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics.— Section 1834(m)(8)(A) of the Social Security Act (42 U.S.C. 1395m(m)(8)(A)) is amended by striking “ during the 151-day period beginning on the first day after the end of such emergency period” and inserting “ in the case that such emergency period ends before December 31, 2024, during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024”.
(d)
Delaying the In-person Requirements Under Medicare for Mental Health Services Furnished Through Telehealth and Telecommunications Technology.—
(1)
Delay in requirements for mental health services furnished through telehealth.— Section 1834(m)(7)(B)(i) of the Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended, in the matter preceding subclause (I), by striking “ on or after the day that is the 152nd day after the end of the period at the end of the emergency sentence described in section 1135(g)(1)(B))” and inserting “ on or after January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1135(g)(1)(B))”.
(2)
Mental health visits furnished by rural health clinics.— Section 1834(y) of the Social Security Act (42 U.S.C. 1395m(y)) is amended—
(A)
in the heading, by striking “ to hospice patients”; and
(B)
in paragraph (2), by striking “ prior to the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B))” and inserting “ prior to January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1135(g)(1)(B))”.
(3)
Mental health visits furnished by federally qualified health centers.— Section 1834(o)(4) of the Social Security Act (42 U.S.C. 1395m(o)(4) is amended—
(A)
in the heading, by striking “ to hospice patients”; and
(B)
in subparagraph (B), by striking “ prior to the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B))” and inserting “ prior to January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1135(g)(1)(B))”.
(e)
Allowing for the Furnishing of Audio-only Telehealth Services.— Section 1834(m)(9) of the Social Security Act (42 U.S.C. 1395m(m)(9)) is amended by striking “ The Secretary shall continue to provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this paragraph that are furnished via an audio-only telecommunications system during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)” and inserting “ In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, the Secretary shall continue to provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this paragraph that are furnished via an audio-only communications system during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024”.
(f)
Use of Telehealth to Conduct Face-to-face Encounter Prior to Recertification of Eligibility for Hospice Care During Emergency Period.— Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is amended by striking “ and during the 151-day period beginning on the first day after the end of such emergency period” and inserting “ and, in the case that such emergency period ends before December 31, 2024, during the period beginning on the first day after the end of such emergency period described in such section 1135(g)(1)(B) and ending on December 31, 2024”.
(g)
Study on Telehealth and Medicare Program Integrity.—
(1)
In general.—
(A)
Study.— The Secretary shall conduct a study using medical record review, as described in subparagraph (C), on program integrity related to telehealth services under part B of title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.).
(B)
Scope of study.— In conducting the study under subparagraph (A), the Secretary shall review and analyze information (to the extent that such information is available) on the duration of telehealth services furnished, the types of telehealth services furnished, and, to the extent feasible, the impact of the telehealth services furnished on future utilization of health care services by Medicare beneficiaries, such as the utilization of additional telehealth services or in-person services, including hospitalizations and emergency department visits. The Secretary may also review and analyze information on—
(i)
any geographic differences in utilization of telehealth services;
(ii)
documentation of the care and methods of delivery associated with telehealth services; and
(iii)
other areas, as determined appropriate by the Secretary.
(C)
Medical record review.— In conducting the study under subparagraph (A), the Secretary shall conduct medical record review of a sample of claims for telehealth services with dates of service during the period beginning on January 1, 2022, and ending on December 31, 2024. For such claims with a date of service during the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), the Secretary shall only conduct medical record review of those claims that have undergone standard program integrity review (as defined in paragraph (2)(B)), as determined appropriate by the Secretary.
(D)
Reports.—
(i)
Interim report.— Not later than October 1, 2024, the Secretary shall submit to the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives an interim report on the study conducted under subparagraph (A).
(ii)
Final report.— Not later than April 1, 2026, the Secretary shall submit to the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives a final report on the study conducted under subparagraph (A).
(2)
Definitions.— In this subsection:
(A)
Secretary.— The term “Secretary” means the Secretary of Health and Human Services.
(B)
Standard program integrity review.— The term “standard program integrity review” refers to the review of any claim that requires a review of the associated medical record by the Secretary to determine the medical necessity of the services furnished or to identify potential fraud.
(C)
Telehealth service.— The term “telehealth service” has the meaning given that term in section 1834(m)(4)(F) of the Social Security Act (42 U.S.C. 1395(m)(4)(F)).
(3)
Funding.— In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $10,000,000, to remain available until expended, for purposes of carrying out this subsection.
(h)
Program Instruction Authority.— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including amendments made by, this section through program instruction or otherwise.

SEC. 4114. Revised Phase-In of Medicare Clinical Laboratory Test Payment Changes.

(a)
Revised Phase-in of Reductions From Private Payor Rate Implementation.— Section 1834A(b)(3) of the Social Security Act (42 U.S.C. 1395m–1(b)(3)) is amended—
(1)
in subparagraph (A), by striking “ through 2025” and inserting “ through 2026”; and
(2)
in subparagraph (B)—
(A)
in clause (ii), by striking “ and 2022” and inserting “ through 2023”; and
(B)
in clause (iii), by striking “ 2023 through 2025” and inserting “ 2024 through 2026”.
(b)
Revised Reporting Period for Reporting of Private Sector Payment Rates for Establishment of Medicare Payment Rates.— Section 1834A(a)(1)(B) of the Social Security Act (42 U.S.C. 1395m–1(a)(1)(B)) is amended—
(1)
in clause (i), by striking “ December 31, 2022” and inserting “ December 31, 2023”; and
(2)
in clause (ii)—
(A)
by striking “ January 1, 2023” and inserting “ January 1, 2024”; and
(B)
by striking “ March 31, 2023” and inserting “ March 31, 2024”.

Subtitle C Medicare Mental Health Provisions

SEC. 4121. Coverage of Marriage and Family Therapist Services and Mental Health Counselor Services under Part B of the Medicare Program.

(a)
Coverage of Services.—
(1)
In general.— Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—
(A)
in subparagraph (GG), by striking “ and” after the semicolon at the end;
(B)
in subparagraph (HH), by striking the period at the end and inserting “ ; and”; and
(C)
by adding at the end the following new subparagraph:

“(II) marriage and family therapist services (as defined in subsection (lll)(1)) and mental health counselor services (as defined in subsection (lll)(3));”

(2)
Definitions.— Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

“(lll) Marriage and Family Therapist Services; Marriage and Family Therapist; Mental Health Counselor Services; Mental Health Counselor.—

“(1) Marriage and family therapist services.—The term ‘marriage and family therapist services’ means services furnished by a marriage and family therapist (as defined in paragraph (2)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital), which the marriage and family therapist is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) of the State in which such services are furnished, as would otherwise be covered if furnished by a physician or as an incident to a physician’s professional service.

“(2) Marriage and family therapist.—The term ‘marriage and family therapist’ means an individual who—

“(A) possesses a master’s or doctor’s degree which qualifies for licensure or certification as a marriage and family therapist pursuant to State law of the State in which such individual furnishes the services described in paragraph (1);

“(B) is licensed or certified as a marriage and family therapist by the State in which such individual furnishes such services;

“(C) after obtaining such degree has performed at least 2 years of clinical supervised experience in marriage and family therapy; and

“(D) meets such other requirements as specified by the Secretary.

“(3) Mental health counselor services.—The term ‘mental health counselor services’ means services furnished by a mental health counselor (as defined in paragraph (4)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital), which the mental health counselor is legally authorized to perform under State law (or the State regulatory mechanism provided by the State law) of the State in which such services are furnished, as would otherwise be covered if furnished by a physician or as incident to a physician’s professional service.

“(4) Mental health counselor.—The term ‘mental health counselor’ means an individual who—

“(A) possesses a master’s or doctor’s degree which qualifies for licensure or certification as a mental health counselor, clinical professional counselor, or professional counselor under the State law of the State in which such individual furnishes the services described in paragraph (3);

“(B) is licensed or certified as a mental health counselor, clinical professional counselor, or professional counselor by the State in which the services are furnished;

“(C) after obtaining such a degree has performed at least 2 years of clinical supervised experience in mental health counseling; and

“(D) meets such other requirements as specified by the Secretary.”

(3)
Amount of payment.— Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)), as amended by section 11101(b) of Public Law 117–169, is further amended—
(A)
by striking “ , and (EE)” and inserting “ (EE)”; and
(B)
by inserting before the semicolon at the end the following: “ and (FF) with respect to marriage and family therapist services and mental health counselor services under section 1861(s)(2)(II), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or 75 percent of the amount determined for payment of a psychologist under subparagraph (L)”.
(4)
Exclusion of marriage and family therapist services and mental health counselor services from skilled nursing facility prospective payment system.— Section 1888(e)(2)(A)(ii) of the Social Security Act (42 U.S.C. 1395yy(e)(2)(A)(ii)) is amended by inserting “ marriage and family therapist services (as defined in section 1861(lll)(1)), mental health counselor services (as defined in section 1861(lll)(3)),” after “ qualified psychologist services,”.
(5)
Inclusion of marriage and family therapists and mental health counselors as practitioners for assignment of claims.— Section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the end the following new clauses:

“(vii) A marriage and family therapist (as defined in section 1861(lll)(2)).

“(viii) A mental health counselor (as defined in section 1861(lll)(4)).”

(b)
Coverage of Certain Mental Health Services Provided in Certain Settings.—
(1)
Rural health clinics and federally qualified health centers.— Section 1861(aa)(1)(B) of the Social Security Act (42 U.S.C. 1395x(aa)(1)(B)) is amended by striking “ or by a clinical social worker (as defined in subsection (hh)(1))” and inserting “ , by a clinical social worker (as defined in subsection (hh)(1)), by a marriage and family therapist (as defined in subsection (lll)(2)), or by a mental health counselor (as defined in subsection (lll)(4))”.
(2)
Hospice programs.— Section 1861(dd)(2)(B)(i)(III) of the Social Security Act (42 U.S.C. 1395x(dd)(2)(B)(i)(III)) is amended by inserting “ , marriage and family therapist, or mental health counselor” after “ social worker”.
(c)
Effective Date.— The amendments made by this section shall apply with respect to services furnished on or after January 1, 2024.

SEC. 4122. Additional Residency Positions.

(a)
In General.— Section 1886(h) of the Social Security Act (42 U.S.C. 1395ww(h)) is amended—
(1)
in paragraph (4)(F)(i), by striking “ and (9)” and inserting “ (9), and (10)”;
(2)
in paragraph (4)(H)(i), by striking “ and (9)” and inserting “ (9), and (10)”; and
(3)
by adding at the end the following new paragraph:

“(10) Distribution of additional residency positions in psychiatry and psychiatry subspecialties.—

“(A) Additional residency positions.—

“(i) In general.—For fiscal year 2026, the Secretary shall, subject to the succeeding provisions of this paragraph, increase the otherwise applicable resident limit for each qualifying hospital (as defined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Secretary may approve effective beginning July 1 of the fiscal year of the increase.

“(ii) Number available for distribution.—The aggregate number of such positions made available under this paragraph shall be equal to 200.

“(iii) Distribution for psychiatry or psychiatry subspecialty residencies.—At least 100 of the positions made available under this paragraph shall be distributed for a psychiatry or psychiatry subspecialty residency (as defined in subparagraph (F)).

“(iv) Timing.—The Secretary shall notify hospitals of the number of positions distributed to the hospital under this paragraph as a result of an increase in the otherwise applicable resident limit by January 31 of the fiscal year of the increase. Such increase shall be effective beginning July 1 of such fiscal year.

“(B) Distribution.—For purposes of providing an increase in the otherwise applicable resident limit under subparagraph (A), the following shall apply:

“(i) Considerations in distribution.—In determining for which qualifying hospitals such an increase is provided under subparagraph (A), the Secretary shall take into account the demonstrated likelihood of the hospital filling the positions made available under this paragraph within the first 5 training years beginning after the date the increase would be effective, as determined by the Secretary.

“(ii) Minimum distribution for certain categories of hospitals.—With respect to the aggregate number of such positions available for distribution under this paragraph, the Secretary shall distribute not less than 10 percent of such aggregate number to each of the following categories of hospitals:

“(I) Hospitals that are located in a rural area (as defined in section 1886(d)(2)(D)) or are treated as being located in a rural area pursuant to section 1886(d)(8)(E).

“(II) Hospitals in which the reference resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applicable resident limit.

“(III) Hospitals in States with—

“(aa) new medical schools that received ‘Candidate School’ status from the Liaison Committee on Medical Education or that received ‘Pre-Accreditation’ status from the American Osteopathic Association Commission on Osteopathic College Accreditation on or after January 1, 2000, and that have achieved or continue to progress toward ‘Full Accreditation’ status (as such term is defined by the Liaison Committee on Medical Education) or toward ‘Accreditation’ status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation); or

“(bb) additional locations and branch campuses established on or after January 1, 2000, by medical schools with ‘Full Accreditation’ status (as such term is defined by the Liaison Committee on Medical Education) or ‘Accreditation’ status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation).

“(IV) Hospitals that serve areas designated as health professional shortage areas under section 332(a)(1)(A) of the Public Health Service Act, as determined by the Secretary.

“(iii) Pro rata application.—The Secretary shall ensure that each qualifying hospital that submits a timely application under subparagraph (A) receives at least 1 (or a fraction of 1) of the positions made available under this paragraph before any qualifying hospital receives more than 1 of such positions.

“(C) Requirements.—

“(i) Limitation.—A hospital may not receive more than 10 additional full-time equivalent residency positions under this paragraph.

“(ii) Prohibition on distribution to hospitals without an increase agreement.—No increase in the otherwise applicable resident limit of a hospital may be made under this paragraph unless such hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of such hospital by the number of such positions made available by such increase under this paragraph.

“(iii) Requirement for hospitals to expand programs.—If a hospital that receives an increase in the otherwise applicable resident limit under this paragraph would be eligible for an adjustment to the otherwise applicable resident limit for participation in a new medical residency training program under section 413.79(e)(3) of title 42, Code of Federal Regulations (or any successor regulation), the hospital shall ensure that any positions made available under this paragraph are used to expand an existing program of the hospital, and not for participation in a new medical residency training program.

“(D) Application of per resident amounts for nonprimary care.—With respect to additional residency positions in a hospital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for nonprimary care computed under paragraph (2)(D) for that hospital.

“(E) Permitting facilities to apply aggregation rules.—The Secretary shall permit hospitals receiving additional residency positions attributable to the increase provided under this paragraph to, beginning in the fifth year after the effective date of such increase, apply such positions to the limitation amount under paragraph (4)(F) that may be aggregated pursuant to paragraph (4)(H) among members of the same affiliated group.

“(F) Definitions.—In this paragraph:

“(i) Otherwise applicable resident limit.—The term ‘otherwise applicable resident limit’ means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account paragraphs (7)(A), (7)(B), (8)(A), (8)(B), and (9)(A).

“(ii) Psychiatry or psychiatry subspecialty residency.—The term ‘psychiatry or psychiatry subspecialty residency’ means a residency in psychiatry as accredited by the Accreditation Council for Graduate Medical Education for the purpose of preventing, diagnosing, and treating mental health disorders.

“(iii) Qualifying hospital.—The term ‘qualifying hospital’ means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii).

“(iv) Reference resident level.—The term ‘reference resident level’ means, with respect to a hospital, the resident level for the most recent cost reporting period of the hospital ending on or before the date of enactment of this paragraph, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.

“(v) Resident level.—The term ‘resident level’ has the meaning given such term in paragraph (7)(C)(i).”

(b)
IME.— Section 1886(d)(5)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(B)) is amended—
(1)
in clause (v), in the third sentence, by striking “ and (h)(9)” and inserting “ (h)(9), and (h)(10)”;
(2)
by moving clause (xii) 4 ems to the left; and
(3)
by adding at the end the following new clause:

“(xiii) For discharges occurring on or after July 1, 2026, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(10), the indirect teaching adjustment factor shall be computed in the same manner as provided under clause (ii) with respect to such resident positions.”

(c)
Prohibition on Judicial Review.— Section 1886(h)(7)(E) of the Social Security Act (42 U.S.C. 1395ww—4(h)(7)(E)) is amended by inserting “ paragraph (10),” after “ paragraph (8),”.

SEC. 4123. Improving Mobile Crisis Care in Medicare.

(a)
Payment for Psychotherapy for Crisis Services Furnished in an Applicable Site of Service.—
(1)
In general.— Section 1848(b) of the Social Security Act (42 U.S.C. 1395w–4(b)) is amended by adding at the end the following new paragraph:

“(12) Payment for psychotherapy for crisis services furnished in an applicable site of service.—

“(A) In general.—The Secretary shall establish new HCPCS codes under the fee schedule established under this subsection for services described in subparagraph (B) that are furnished on or after January 1, 2024.

“(B) Services described.—The services described in this subparagraph are psychotherapy for crisis services that are a furnished in an applicable site of service.

“(C) Amount of payment.—For services described in subparagraph (B) that are furnished to an individual in a year (beginning with 2024), in lieu of the fee schedule amount that would otherwise be determined under this subsection for such year, the fee schedule amount for such services for such year shall be equal to 150 percent of the fee schedule amount for non-facility sites of service for such year determined for services identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes).

“(D) Definitions.—In this paragraph:

“(i) Applicable site of service.—The term ‘applicable site of service’ means a site of service other than a site where the facility rate under the fee schedule under this subsection applies and other than an office setting.

“(ii) Psychotherapy for crisis services.—The code descriptions for services described in subparagraph (B) shall be the same as the code descriptions for services identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes), except that such new codes shall be limited to services furnished in an applicable site of service.”

(2)
Waiver of budget neutrality.— Section 1848(c)(2)(B)(iv) of such Act (42 U.S.C. 1395w–4(c)(2)(B)(iv)) is amended—
(A)
in subclause (IV), by striking “ and” at the end;
(B)
in subclause (V), by striking the period at the end and inserting “ ; and” and
(C)
by adding at the end the following new subclause:

“(VI) subsection (b)(12) shall not be taken into account in applying clause (ii)(II) for 2024.”

(b)
Education and Outreach.— Not later than January 1, 2024, the Secretary shall use existing communications mechanisms to provide education and outreach to stakeholders with respect to the ability of health professionals to bill for psychotherapy for crisis services under the Medicare physician fee schedule under section 1848 of the Social Security Act (42 U.S.C. 1395w–4) when such services are furnished in an applicable site of service to a Medicare beneficiary who is experiencing a mental or behavioral health crisis.
(c)
Open Door Forum.— Not later than January 1, 2024, the Secretary shall convene stakeholders and experts for an open door forum or other appropriate mechanism to discuss current Medicare program coverage and payment policies for services that can be furnished to provide care to a Medicare beneficiary who is experiencing a mental or behavioral health crisis.
(d)
Education and Outreach on the Use of Peer Support Specialists and Other Auxiliary Personnel in Furnishing of Psychotherapy for Crisis Services and Behavioral Health Integration Services.— Not later than January 1, 2024, the Secretary shall use existing communication mechanisms to provide education and outreach to providers of services, physicians, and practitioners with respect to the ability of auxiliary personnel, including peer support specialists, to participate, consistent with applicable requirements for auxiliary personnel, in the furnishing of—
(1)
psychotherapy for crisis services billed under the Medicare physician fee schedule under section 1848 of the Social Security Act (42 U.S.C. 1395w–4), as well as other services that can be furnished to a Medicare beneficiary experiencing a mental or behavioral health crisis; and
(2)
behavioral health integration services.
(e)
Definitions.— In this section:
(1)
Applicable site of service.— The term “applicable site of service” has the meaning given that term in section 1848(b)(12)(D)(i) of the Social Security Act, as added by subsection (a).
(2)
Behavioral health integration services.— The term “behavioral health integration services” means services identified, as of January 1, 2022, by HCPCS codes 99484, 99492, 99493, 99494, and G2214 (and any successor or similar codes as determined appropriate by the Secretary).
(3)
Psychotherapy for crisis services.— The term “psychotherapy for crisis services” means services described in 1848(b)(12)(D)(ii) of the Social Security Act, as added by subsection (a).
(4)
Secretary.— The term “Secretary” means the Secretary of Health and Human Services.

SEC. 4124. Ensuring Adequate Coverage of Outpatient Mental Health Services under the Medicare Program.

(a)
Modification of Definition of Partial Hospitalization Services.— Section 1861(ff)(1) of the Social Security Act (42 U.S.C. 1395x(ff)(1)) is amended by inserting “ for an individual determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week” after “ prescribed by a physician”.
(b)
Coverage of Intensive Outpatient Services.—
(1)
Scope of benefits.—
(A)
Community mental health centers.— Section 1832(a)(2)(J) of the Social Security Act (42 U.S.C. 1395k(a)(2)(J)) is amended by inserting “ and intensive outpatient services” after “ partial hospitalization services”.
(B)
Incident-to services.— Section 1861(s)(2)(B) is amended by inserting “ or intensive outpatient services” after “ partial hospitalization services”.
(2)
Definition.— Section 1861(ff) of the Social Security Act (42 U.S.C. 1395x(ff)) is amended—
(A)
in the header, by inserting “ ; Intensive Outpatient Services” after “ Partial Hospitalization Services”; and
(B)
by adding at the end the following new paragraph:

“(4) The term ‘intensive outpatient services’ has the meaning given the term ‘partial hospitalization services’ in paragraph (1), except that—

“(A) section 1835(a)(2)(F)(i) shall not apply;

“(B) the reference in such paragraph to an individual ‘determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week’ shall be treated as a reference to an individual ‘determined (not less frequently than once every other month) by a physician to have a need for such services for a minimum of 9 hours per week’; and

“(C) the reference to ‘a community mental health center (as defined in subparagraph (B))’ in paragraph (3) shall be treated as a reference to ‘a community mental health center (as defined in subparagraph (B)), a Federally qualified health center, or a rural health clinic’.”

(3)
Exclusion from calculation of certain treatment costs.— Section 1833(c)(2) of the Social Security Act (42 U.S.C. 1395l(c)(2)) is amended by inserting “ or intensive outpatient services” after “ partial hospitalization services”.
(4)
Conforming amendments.—
(A)
Intensive outpatient services.— Section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)) is amended—
(i)
in paragraph (1)—
(I)
in subparagraph (B), by striking “ and” at the end;
(II)
in subparagraph (C), by adding “ and” at the end; and
(III)
by inserting after subparagraph (C) the following new subparagraph:

“(D) intensive outpatient services (as defined in section 1861(ff)(4)),”

; and

(ii)
in paragraph (3), by striking “ through (C)” and inserting “ through (D)”.
(B)
Provider of services.— Section 1866(e)(2) of the Social Security Act (42 U.S.C. 1395cc(e)(2)) is amended by inserting “ , or intensive outpatient services (as described in section 1861(ff)(4))” after “ partial hospitalization services (as described in section 1861(ff)(1))”.
(c)
Special Payment Rule for FQHCs and RHCs.— Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended—
(1)
in subsection (o), by adding at the end the following new paragraph:

“(5) Special payment rule for intensive outpatient services.—

“(A) In general.—In the case of intensive outpatient services furnished by a Federally qualified health center, the payment amount for such services shall be equal to the amount that would have been paid under this title for such services had such services been covered OPD services furnished by a hospital.

“(B) Exclusion.—Costs associated with intensive outpatient services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under this subsection.”

; and

(2)
in subsection (y)—
(A)
in the header, by striking “ to Hospice Patients”; and
(B)
by adding at the end the following new paragraph:

“(3) Special payment rule for intensive outpatient services.—

“(A) In general.—In the case of intensive outpatient services furnished by a rural health clinic, the payment amount for such services shall be equal to the amount that would have been paid under this title for such services had such services been covered OPD services furnished by a hospital.

“(B) Exclusion.—Costs associated with intensive outpatient services shall not be used to determine the amount of payment for rural health clinic services under the methodology for all-inclusive rates (established by the Secretary) under section 1833(a)(3).”

(d)
Effective Date.— The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2024.

SEC. 4125. Improvements to Medicare Prospective Payment System for Psychiatric Hospitals and Psychiatric Units.

(a)
Improvements Through Additional Claims Data.— Section 1886(s) of the Social Security Act (42 U.S.C. 1395ww(s)) is amended by adding at the end the following new paragraph:

“(5) Additional data and information.—

“(A) In general.—The Secretary shall collect data and information as the Secretary determines appropriate to revise payments under the system described in paragraph (1) for psychiatric hospitals and psychiatric units pursuant to subparagraph (D) and for other purposes as determined appropriate by the Secretary. The Secretary shall begin to collect such data by not later than October 1, 2023.

“(B) Data and information.—The data and information to be collected under subparagraph (A) may include—

“(i) charges, including those related to ancillary services;

“(ii) the required intensity of behavioral monitoring, such as cognitive deficit, suicide ideations, violent behavior, and need for physical restraint; and

“(iii) interventions, such as detoxification services for substance abuse, dependence on respirator, total parenteral nutritional support, dependence on renal dialysis, and burn care.

“(C) Method of collection.—The Secretary may collect the additional data and information under subparagraph (A) on cost reports, on claims, or otherwise.

“(D) Revisions to payment rates.—

“(i) In general.—Notwithstanding the preceding paragraphs of this subsection or section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, for rate year 2025 (and for any subsequent rate year, if determined appropriate by the Secretary), the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psychiatric units, as the Secretary determines to be appropriate. Such revisions may be based on a review of data and information collected under subparagraph (A).

“(ii) Review.—The Secretary may make revisions to the diagnosis-related group classifications, in accordance with subsection (d)(4)(C), to reflect nursing and staff resource use and costs involved in furnishing services at such hospitals and units, including considerations for patient complexity and prior admission to an inpatient psychiatric facility, which may be based on review of data and information collected under subparagraph (A), as the Secretary determines to be appropriate.

“(iii) Budget neutrality.—Revisions in payment implemented pursuant to clause (i) for a rate year shall result in the same estimated amount of aggregate expenditures under this title for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this title for such care in such rate year if such revisions had not been implemented.”

(b)
Improvements Through Standardized Patient Assessment Data.— Section 1886(s) of the Social Security Act (42 U.S.C. 1395ww(s)), as amended by subsection (a), is further amended—
(1)
in paragraph (4)—
(A)
in subparagraph (A)(i), by striking “ subparagraph (C)” and inserting “ subparagraphs (C) and (E)”;
(B)
by redesignating subparagraph (E) as subparagraph (F);
(C)
by inserting after subparagraph (D) the following new subparagraph:

“(E) Standardized patient assessment data.—

“(i) In general.—For rate year 2028 and each subsequent rate year, in addition to such data on the quality measures described in subparagraph (C), each psychiatric hospital and psychiatric unit shall submit to the Secretary, through the use of a standardized assessment instrument implemented under clause (iii), the standardized patient assessment data described in clause (ii). Such data shall be submitted with respect to admission and discharge of an individual (and may be submitted more frequently as the Secretary determines appropriate).

“(ii) Standardized patient assessment data described.—For purposes of clause (i), the standardized patient assessment data described in this clause, with respect to a psychiatric hospital or psychiatric unit, is data with respect to the following categories:

“(I) Functional status, such as mobility and self-care at admission to a psychiatric hospital or unit and before discharge from a psychiatric hospital or unit.

“(II) Cognitive function, such as ability to express ideas and to understand, and mental status, such as depression and dementia.

“(III) Special services, treatments, and interventions for psychiatric conditions.

“(IV) Medical conditions and co-morbidities, such as diabetes, congestive heart failure, and pressure ulcers.

“(V) Impairments, such as incontinence and an impaired ability to hear, see, or swallow.

“(VI) Other categories as determined appropriate by the Secretary.

“(iii) Standardized assessment instrument.—

“(I) In general.—For purposes of clause (i), the Secretary shall implement a standardized assessment instrument that provides for the submission of standardized patient assessment data under this title with respect to psychiatric hospitals and psychiatric units which enables comparison of such assessment data across all such hospitals and units to which such data are applicable.

“(II) Funding.—The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 to the Centers for Medicare & Medicaid Services Program Management Account, of $10,000,000 for purposes of carrying out subclause (I).”

; and

(D)
in subparagraph (F), as redesignated by subparagraph (B) of this paragraph, by striking “ subparagraph (C)” and inserting “ subparagraphs (C) and (F)”; and
(2)
by adding at the end the following new paragraph:

“(6) Additional considerations for diagnosis-related group classifications.—

“(A) In general.—Notwithstanding the preceding paragraphs of this subsection (other than paragraph (5)) or section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, beginning not later than rate year 2031, in addition to any revisions pursuant to paragraph (5), the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psychiatric units, as the Secretary determines to be appropriate, to take into account the patient assessment data described in paragraph (4)(E)(ii).

“(B) Budget neutrality.—Revisions in payment implemented pursuant to subparagraph (A) for a rate year shall result in the same estimated amount of aggregate expenditures under this title for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this title for such care in such rate year if such revisions had not been implemented.”

(c)
Improvements Through Inclusion of Patients’ Perspective on Care Quality Measure.— Section 1886(s)(4) of the Social Security Act (42 U.S.C. 1395ww(s)(4)) is amended—
(1)
in subparagraph (D), by adding at the end the following new clause:

“(iv) Patients’ perspective on care.—Not later than for rate year 2031, the quality measures specified under this subparagraph shall include a quality measure of patients’ perspective on care.”

; and

(2)
in subparagraph (E), by inserting “ , including the quality measure of patients’ perspective on care described in subparagraph (D)(iv),” after “ shall report quality measures”.

SEC. 4126. Exception for Physician Wellness Programs.

(a)
In General.— Section 1877(e) of the Social Security Act (42 U.S.C. 1395nn(e)) is amended by adding at the end the following:

“(9) Physician wellness programs.—A bona fide mental health or behavioral health improvement or maintenance program offered to a physician by an entity, if—

“(A) such program—

“(i) consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program;

“(ii) is made available to a physician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician;

“(iii) is set out in a written policy, approved in advance of the operation of the program by the governing body of the entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes—

“(I) a description of the content and duration of the program;

“(II) a description of the evidence-based support for the design of the program;

“(III) the estimated cost of the program;

“(IV) the personnel (including the qualifications of such personnel) conducting the program; and

“(V) the method by which such entity will evaluate the use and success of the program;

“(iv) is offered by an entity described in subparagraph (B) with a formal medical staff to all physicians who practice in the geographic area served by such entity, including physicians who hold bona fide appointments to the medical staff of such entity or otherwise have clinical privileges at such entity;

“(v) is offered to all such physicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician for such entity;

“(vi) is evidence-based and conducted by a qualified health professional; and

“(vii) meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient abuse;

“(B) such entity is—

“(i) a hospital;

“(ii) an ambulatory surgical center;

“(iii) a community health center;

“(iv) a rural emergency hospital;

“(v) a rural health clinic;

“(vi) a skilled nursing facility; or

“(vii) a similar entity, as determined by the Secretary; and

“(C) neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician to such entity or the amount or value of other business generated by such physician for the entity.”

(b)
Exception Under the Anti-kickback Statute.— Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended—
(1)
in subparagraph (J), by striking “ and” at the end;
(2)
in subparagraph (K), by striking the period at the end and inserting “ ; and”; and
(3)
by adding at the end the following:

“(L) a bona fide mental health or behavioral health improvement or maintenance program, if—

“(i) such program—

“(I) consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program;

“(II) is made available to a physician or other clinician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician or other clinician;

“(III) is set out in a written policy, approved in advance of the operation of the program by the governing body of the entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes—

“(aa) a description of the content and duration of the program;

“(bb) a description of the evidence-based support for the design of the program;

“(cc) the estimated cost of the program;

“(dd) the personnel (including the qualifications of such personnel) implementing the program; and

“(ee) the method by which such entity will evaluate the use and success of the program;

“(IV) is offered by an entity described in clause (ii) with a formal medical staff to all physicians and other clinicians who practice in the geographic area served by such entity, including physicians who hold bona fide appointments to the medical staff of such entity or otherwise have clinical privileges at such entity;

“(V) is offered to all such physicians and clinicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician or clinician for such entity;

“(VI) is evidence-based and conducted by a qualified health professional; and

“(VII) meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient abuse;

“(ii) such entity is—

“(I) a hospital;

“(II) an ambulatory surgical center;

“(III) a community health center;

“(IV) a rural emergency hospital;

“(V) a skilled nursing facility; or

“(VI) any similar entity, as determined by the Secretary; and

“(iii) neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician or other clinician to such entity or the amount or value of other business generated by such physician for the entity.”

SEC. 4127. Consideration of Safe Harbor under the Anti-Kickback Statute for Certain Contingency Management Interventions.

Section 1128D(a) of the Social Security Act (42 U.S.C. 1320a–7d(a)) is amended by adding at the end the following new paragraph:

“(3) Consideration of safe harbor for certain contingency management interventions.—

“(A) In general.—Not later than one year after the date of the enactment of this paragraph, the Inspector General shall conduct a review on whether to establish a safe harbor described in paragraph (1)(A)(ii) for evidence-based contingency management incentives and the parameters for such a safe harbor. In conducting the review under the previous sentence, the Inspector General shall consider the extent to which providing such a safe harbor for evidence-based contingency management incentives may result in any of the factors described in paragraph (2).

“(B) Report.—Not later than two years after the date of the enactment of this paragraph, the Secretary and the Inspector General shall submit to Congress recommendations, including based on the review conducted under subparagraph (A), for improving access to evidence-based contingency management interventions while ensuring quality of care, ensuring fidelity to evidence-based practices, and including strong program integrity safeguards that prevent increased waste, fraud, and abuse and prevent medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program.”

SEC. 4128. Provider Outreach and Reporting on Certain Behavioral Health Integration Services.

(a)
Outreach.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to behavioral health integration services described by any of HCPCS codes 99492 through 99494 or 99484 (or any successor code). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements to bill for such codes and the requirements for beneficiary eligibility for such services.
(b)
Reports to Congress.—
(1)
Provider outreach.— Not later than 1 year after the date of the completion of the education initiative described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
(2)
Utilization rates.— Not later than 18 months after the date of the completion of the education initiative described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries (including those beneficiaries accessing services in rural and underserved areas) who, during the preceding year, were furnished services described in subsection (a) for which payment was made under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

SEC. 4129. Outreach and Reporting on Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs.

(a)
Outreach.—
(1)
Provider outreach.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements for billing and the requirements for beneficiary eligibility for such services.
(2)
Beneficiary outreach.— The Secretary shall conduct outreach to Medicare beneficiaries with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))), including a comprehensive, one- time education initiative informing such beneficiaries about the eligibility requirements to receive such services.
(b)
Reports to Congress.—
(1)
Outreach.— Not later than 1 year after the date of the completion of the education initiatives described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
(2)
Utilization rates.— Not later than 18 months after the date of the completion of the education initiatives described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who, during the preceding year, were furnished opioid use disorder treatment services by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))) for which payment was made under title XVIII of such Act (42 U.S.C. 1395 et seq.).

SEC. 4130. Gao Study and Report Comparing Coverage of Mental Health and Substance Use Disorder Benefits and Non-Mental Health and Substance Use Disorder Benefits.

(a)
Study.—
(1)
In general.— The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study that compares the mental health and substance use disorder benefits offered by Medicare Advantage plans (including specialized MA plans for special needs individuals, as defined in section 1859(b)(6) of the Social Security Act (42 U.S.C. 1395w–28(b)(6)) under part C of title XVIII of such Act with—
(A)
benefits (other than mental health and substance use disorder benefits) offered by such Medicare Advantage plans; and
(B)
the mental health and substance use disorder benefits under the original Medicare fee-for-service program under parts A and B of such title XVIII.
(2)
Analysis.— To the extent data is available and reliable, the study under paragraph (1) shall include an analysis of—
(A)
out-of-pocket expenses for in-network care;
(B)
the use of prior authorization and other utilization management tools;
(C)
the mental health and substance use disorder benefits offered; and
(D)
other items determined appropriate by the Comptroller General.
(3)
Plan and service specific.— To the extent practicable, the study under paragraph (1) shall examine differences by type of Medicare Advantage plan and type of item or service.
(4)
Both required and supplemental benefits.— For purposes of the study under paragraph (1), benefits offered by Medicare Advantage plans (including specialized MA plans for special needs individuals) under part C of title XVIII of the Social Security Act shall include both and differentiate between—
(A)
benefits under the original Medicare fee-for-service program, as described in section 1852(a)(1)(B) of such Act (42 U.S.C. 1395w–22(a)(1)(B)); and
(B)
supplemental health care benefits, as described in section 1852(a)(3)(A) of such Act (42 U.S.C. 1395w–22(a)(3)(A)).
(b)
Report.— Not later than 30 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a).

Subtitle D Other Medicare Provisions

SEC. 4131. Temporary Inclusion of Authorized Oral Antiviral Drugs as Covered Part D Drug.

Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C. 1395w–102(e)(1)) is amended—
(1)
in subparagraph (A), by striking at the end “ or”;
(2)
in subparagraph (B), by striking the comma at the end and inserting “ ; or”; and
(3)
by inserting after subparagraph (B) the following new subparagraph:

“(C) for the period beginning on the date of the enactment of this subparagraph and ending on December 31, 2024, an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 564 of the Federal Food, Drug, and Cosmetic Act, on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed. Reg. 18250 et seq.),”

SEC. 4132. Restoration of Cbo Access to Certain Part D Payment Data.

Section 1860D–15(f)(2) of the Social Security Act (42 U.S.C. 1395w–115(f)(2)) is amended—
(1)
in subparagraph (B), by striking at the end “ and”;
(2)
in subparagraph (C), by striking at the end the period and inserting “ ; and”; and
(3)
by adding at the end the following new subparagraph:

“(D) by the Director of the Congressional Budget Office for the purposes of analysis of programs authorized under the Social Security Act, as applicable, and the fulfilment of such Director’s duties under the Congressional Budget and Impoundment Control Act of 1974.”

SEC. 4133. Medicare Coverage of Certain Lymphedema Compression Treatment Items.

(a)
Coverage.—
(1)
In general.— Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by section 4121(a), is amended—
(A)
in subsection (s)(2)—
(i)
in subparagraph (HH), by striking “ and” after the semicolon at the end;
(ii)
in subparagraph (II), by striking the period at the end and inserting “ ; and”; and
(iii)
by adding at the end the following new subparagraph:

“(JJ) lymphedema compression treatment items (as defined in subsection (mmm));”

; and

(B)
by adding at the end the following new subsection:

“(mmm) Lymphedema Compression Treatment Items.—The term ‘lymphedema compression treatment items’ means standard and custom fitted gradient compression garments and other items determined by the Secretary that are—

“(1) furnished on or after January 1, 2024, to an individual with a diagnosis of lymphedema for the treatment of such condition;

“(2) primarily and customarily used to serve a medical purpose and for the treatment of lymphedema, as determined by the Secretary; and

“(3) prescribed by a physician (or a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) to the extent authorized under State law).”

(2)
Payment.—
(A)
In general.— Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) , as amended by section 4121(a), is amended—
(i)
by striking “ and” before “ (FF)”; and
(ii)
by inserting before the semicolon at the end the following: “ , and (GG) with respect to lymphedema compression treatment items (as defined in section 1861(mmm)), the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under the payment basis determined under section 1834(z)”.
(B)
Payment basis and limitations.— Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(z) Payment for Lymphedema Compression Treatment Items.—

“(1) In general.—The Secretary shall determine an appropriate payment basis for lymphedema compression treatment items (as defined in section 1861(mmm)). In making such a determination, the Secretary may take into account payment rates for such items under State plans (or waivers of such plans) under title XIX, the Veterans Health Administration, and group health plans and health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act), and such other information as the Secretary determines appropriate.

“(2) Frequency limitation.—No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish.

“(3) Application of competitive acquisition.—In the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisition area under section 1847(a)—

“(A) the payment basis under this subsection for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and

“(B) the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under section 1847, and in the case of such adjustment, paragraphs (8) and (9) of section 1842(b) shall not be applied.”

(3)
Conforming amendment.— Section 1847(a)(2) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)) is amended by adding at the end the following new subparagraph:

“(D) Lymphedema compression treatment items.—Lymphedema compression treatment items (as defined in section 1861(mmm)) for which payment would otherwise be made under section 1834(z).”

(b)
Inclusion in Requirements for Suppliers of Medical Equipment and Supplies.— Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended—
(1)
in subsection (a)(20)(D), by adding at the end the following new clause:

“(iv) Lymphedema compression treatment items (as defined in section 1861(mmm)).”

(2)
in subsection (j)(5)—
(A)
by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and
(B)
by inserting after subparagraph (D) the following new subparagraph:

“(E) lymphedema compression treatment items (as defined in section 1861(mmm));”

SEC. 4134. Permanent In-Home Benefit for Ivig Services.

(a)
Coverage.— Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—
(1)
in subsection (s)(2)(Z) by inserting “ , and items and services furnished on or after January 1, 2024, related to the administration of intravenous immune globulin,” after “ globulin”; and
(2)
in subsection (zz), by inserting “ furnished before January 1, 2024,” after “ but not including items or services”.
(b)
Payment.— Section 1842(o) of the Social Security Act (42 U.S.C. 1395u(o)) is amended by adding at the end the following new paragraph:

“(8) In the case of intravenous immune globulin described in section 1861(s)(2)(Z) that are furnished on or after January 1, 2024, to an individual by a supplier in the patient’s home, the Secretary shall provide for a separate bundled payment to the supplier for all items and services related to the administration of such intravenous immune globulin to such individual in the patient’s home during a calendar day in an amount that the Secretary determines to be appropriate, which may be based on the payment established pursuant to subsection (d) of section 101 of the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012. For purposes of the preceding sentence, such separate bundled payment shall not apply in the case of an individual receiving home health services under section 1895.”

(c)
Clarification With Respect to Payment for the In-home Administration of IVIG Items and Services.— Section 1834(j)(5) of the Social Security Act (42 U.S.C. 1395m(j)(5)) is amended—
(1)
by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and
(2)
by inserting after subparagraph (D) the following new subparagraph:

“(E) items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, as described in section 1861(zz);”

(d)
Coinsurance.— Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1), as amended by section 4121(a) and section 4133(a), is amended—
(1)
by striking “ and” before “ (GG)”; and
(2)
by inserting before the semicolon at the end the following: “ , and (HH) with respect to items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, as described in section 1861(zz), the amounts paid shall be the lesser of the 80 percent of the actual charge or the payment amount established under section 1842(o)(8)”.
(e)
Additional Funding for Medicare IVIG Demonstration Project.—
(1)
Funding.— There is authorized to be appropriated, and there is hereby appropriated, out of any monies in the Treasury not otherwise appropriated, $4,300,000 for purposes of paying for items and services furnished under the demonstration project established by the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C. 1395l note).
(2)
Supplement, not supplant.— Any amounts appropriated pursuant to this subsection shall be in addition to any other amounts otherwise appropriated pursuant to any other provision of law.

SEC. 4135. Access to Non-Opioid Treatments for Pain Relief.

(a)
In General.— Section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)) is amended—
(1)
in paragraph (2)(E), by inserting “ and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G),” after “ payments under paragraph (6)”; and
(2)
in paragraph (16), by adding at the end the following new subparagraph:

“(G) Temporary additional payments for non-opioid treatments for pain relief.—

“(i) In general.—Notwithstanding any other provision of this subsection, with respect to a non-opioid treatment for pain relief (as defined in clause (iv)) furnished on or after January 1, 2025, and before January 1, 2028, the Secretary shall not package payment for such non-opioid treatment for pain relief into a payment for a covered OPD service (or group of services), and shall make an additional payment as specified in clause (ii) for such non-opioid treatment for pain relief.

“(ii) Amount of payment.—Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is—

“(I) a drug or biological product, the amount of payment for such drug or biological determined under section 1847A that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or

“(II) a medical device, the amount of the hospital’s charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device.

“(iii) Limitation.—The additional payment amount specified in clause (ii) shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of services) with which the non-opioid treatment for pain relief is furnished, as determined by the Secretary.

“(iv) Definition of non-opioid treatment for pain relief.—In this subparagraph, the term ‘non-opioid treatment for pain relief’ means a drug, biological product, or medical device that—

“(I) in the case of a drug or biological product, has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors;

“(II) in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has—

“(aa) an application under section 515 of the Federal Food, Drug, and Cosmetic Act that has been approved with respect to the device, been cleared for market under section 510(k) of such Act, or is exempt from the requirements of section 510(k) of such Act pursuant to subsection (l) or (m) or section 510 of such Act or section 520(g) of such Act; and

“(bb) demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal;

“(III) does not receive transitional pass-through payment under paragraph (6); and

“(IV) has payment that is packaged into a payment for a covered OPD service (or group of services).”

(b)
Ambulatory Surgical Center Payment System.— Section 1833(i) of the Social Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the following new paragraph:

“(10) Temporary additional payments for non-opioid treatments for pain relief.—

“(A) In general.—In the case of surgical services furnished on or after January 1, 2025, and before January 1, 2028, the payment system described in paragraph (2)(D)(i) shall provide, in a budget-neutral manner, for an additional payment for a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) furnished as part of such services in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.

“(B) Transition.—A drug or biological that meets the requirements of section 416.174 of title 42, Code of Federal Regulations (or any successor regulation) and is a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) shall receive additional payment in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.”

(c)
Evaluation of Coverage and Payment for Non-opioid Therapies and Therapeutic Services for Pain Management.—
(1)
Report to congress.— Not later than January 1, 2028, the Secretary of Health and Human Services (in this subsection referred to as the “Secretary”) shall submit to Congress a report—
(A)
identifying limitations, gaps, barriers to access, or deficits in Medicare coverage or reimbursement for restorative therapies, behavioral approaches, and complementary and integrative health services that are identified in the Pain Management Best Practices Inter-Agency Task Force Report and that have demonstrated the ability to replace or reduce opioid consumption;
(B)
recommending actions to address the limitations, gaps, barriers to access, or deficits identified under subparagraph (A) to improve Medicare coverage and reimbursement for such therapies, approaches, and services; and
(C)
comparing, for the 12-month period following the first 6 months in which additional payment for non-opioid treatments for pain relief (as defined in clause (iv) of section 1833(t)(16)(G) of the Social Security Act, as added by subsection (a)) is made under such section 1833(t)(16)(G)—
(i)
with respect to Medicare beneficiaries who received a non-opioid treatment for pain relief (as so defined) as part of a covered OPD service, the quantity of opioids administered, dispensed, and prescribed for the same covered OPD service, including postoperative management; and
(ii)
with respect to Medicare beneficiaries who did not receive a non-opioid treatment for pain relief (as so defined) as part of the same covered OPD service in clause (i)), the quantity of opioids administered, dispensed, and prescribed for the same covered OPD service, including postoperative management.
(2)
Reporting standard and public consultation.— In developing the report described in paragraph (1), the Secretary shall compare results from nationally represented samples of beneficiaries and consult with relevant stakeholders as determined appropriate by the Secretary.
(3)
Exclusive treatment.— Any drug, biological product, or medical device that is a non-opioid treatment for pain relief (as defined in section 1833(t)(16)(G)(iv) of the Social Security Act, as added by subsection (a)) shall not be considered a therapeutic service for purposes of the report under paragraph (1).

SEC. 4136. Technical Amendments to Medicare Separate Payment for Disposable Negative Pressure Wound Therapy Devices.

(a)
In General.— Section 1834(s) of the Social Security Act (42 U.S.C. 1395m(s)) is amended—
(1)
by amending paragraph (3) to read as follows:

“(3) Payment.—

“(A) In general.—The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to—

“(i) for a year before 2024, the amount of the payment that would be made under section 1833(t) (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device;

“(ii) for 2024, the supply price used to determine the relative value for the service under the fee schedule under section 1848 (as of January 1, 2022) for the applicable disposable device, updated by the specified adjustment described in subparagraph (B) for such year; and

“(iii) for 2025 and each subsequent year, the payment amount established under this paragraph for such device for the previous year, updated by the specified adjustment described in subparagraph (B) for such year.

“(B) Specified adjustment.—

“(i) In general.—For purposes of subparagraph (A), the specified adjustment described in this subparagraph for a year is equal to—

“(I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending in June of the previous year; minus

“(II) the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) for such year.

“(ii) Clarification on application of the productivity adjustment.—The application of clause (i)(II) may result in a specified adjustment of less than 0.0 for a year, and may result in the separate payment amount under this subsection for an applicable device for a year being less than such separate payment amount for such device for the preceding year.

“(C) Exclusion of nursing and therapy services from separate payment.—With respect to applicable devices furnished on or after January 1, 2024, the separate payment amount determined under this paragraph shall not include payment for nursing or therapy services described in section 1861(m). Payment for such nursing or therapy services shall be made under the prospective payment system established under section 1895 and shall not be separately billable.”

; and

(2)
by adding at the end the following new paragraph:

“(4) Implementation.—As part of submitting claims for the separate payment established under this subsection, beginning with 2024, the Secretary shall accept and process claims submitted using the type of bill that is most commonly used by home health agencies to bill services under a home health plan of care.”

SEC. 4137. Extension of Certain Home Health Rural Add-On Payments.

Subsection (b)(1)(B) of section 421 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173; 117 Stat. 2283; 42 U.S.C. 1395fff note), as amended by section 5201(b) of the Deficit Reduction Act of 2005 (Public Law 109–171; 120 Stat. 46), section 3131(c) of the Patient Protection and Affordable Care Act (Public Law 111–148; 124 Stat. 428), section 210 of the Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 114–10; 129 Stat. 151), and section 50208 of the Bipartisan Budget Act of 2018 (Public Law 115–123; 132 Stat. 187) is amended—
(1)
in clause (iii), by striking “ and” at the end; and
(2)
by adding at the end the following new clause:

“(v) in the case of episodes and visits ending during 2023, by 1 percent; and”

SEC. 4138. Remedying Election Revocations Relating to Administration of Covid–19 Vaccines.

(a)
In General.— Section 1821(b)(5)(A) of the Social Security Act (42 U.S.C. 1395i–5(b)(5)(A)) is amended—
(1)
in clause (i), by striking “ or” or at the end;
(2)
in clause (ii), by striking the period at the end and inserting “ , or”; and
(3)
by adding at the end the following new clause:

“(iii) effective beginning on the date of the enactment of this clause, that is a COVID–19 vaccine and its administration described in section 1861(s)(10)(A).”

(b)
Special Rules for COVID–19 Vaccines Relating to Revocation of Election.— Notwithstanding paragraphs (3) and (4) of section 1821(b) of the Social Security Act (42 U.S.C. 1395i–5(b)), in the case of an individual with a revocation of an election under such section prior to the date of enactment of this Act by reason of receiving a COVID–19 vaccine and its administration described in section 1861(s)(10)(A) of such Act (42 U.S.C. 1395x(s)(10)(A)), the following rules shall apply:
(1)
Beginning on such date of enactment, such individual may make an election under such section, which shall take effect immediately upon its execution, if such individual would be eligible to make such an election if they had not received such COVID–19 vaccine and its administration.
(2)
Such revoked election shall not be taken into account for purposes of determining the effective date for an election described in subparagraph (A) or (B) of such paragraph (4).

SEC. 4139. Payment Rates for Durable Medical Equipment under the Medicare Program.

(a)
Areas Other Than Rural and Noncontiguous Areas.— The Secretary shall implement section 414.210(g)(9)(v) of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in the first sentence of such section to all applicable items and services furnished in areas other than rural or noncontiguous areas (as such terms are defined for purposes of such section) through the remainder of the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)) or December 31, 2023, whichever is later.
(b)
All Areas.— The Secretary shall not implement section 414.210(g)(9)(vi) of title 42, Code of Federal Regulations (or any successor regulation) until the date immediately following the last day of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), or January 1, 2024, whichever is later.
(c)
Implementation.— Notwithstanding any other provision of law, the Secretary may implement the provisions of this section by program instruction or otherwise.

SEC. 4140. Extending Acute Hospital Care at Home Waivers and Flexibilities.

Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by inserting after section 1866F the following new section:

“SEC. 1866G. EXTENSION OF ACUTE HOSPITAL CARE AT HOME INITIATIVE.

“(a) In General.—

“(1) Extension.—With respect to inpatient hospital admissions occurring during the period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B) and ending on December, 31, 2024, the Secretary of Health and Human Services shall grant waivers and flexibilities (as described in paragraph (2)) to an individual hospital that submits a request for such waivers and flexibilities and meets specified criteria (as described in paragraph (3)) in order to participate in the Acute Hospital Care at Home initiative of the Secretary.

“(2) Acute hospital care at home waivers and flexibilities.—For the purposes of paragraph (1), the waivers and flexibilities described in this paragraph are the following waivers and flexibilities that were made available to individual hospitals under the Acute Hospital Care at Home initiative of the Secretary during the emergency period described in section 1135(g)(1)(B):

“(A) Subject to paragraph (3)(D), waiver of the requirements to provide 24-hour nursing services on premises and for the immediate availability of a registered nurse under section 482.23(b) of title 42, Code of Federal Regulations (or any successor regulation), and the waivers of the physical environment and Life Safety Code requirements under section 482.41 of title 42, Code of Federal Regulations (or any successor regulation).

“(B) Flexibility to allow a hospital to furnish inpatient services, including routine services, outside the hospital under arrangements, as described in Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID–19 (87 Fed. Reg. 71748 et seq.).

“(C) Waiver of the telehealth requirements under clause (i) of section 1834(m)(4)(C), as amended by section 4113(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, such that the originating sites described in clause (ii) of such section shall include the home or temporary residence of the individual.

“(D) Other waivers and flexibilities that, as of the date of enactment of this section, were in place for such initiative during such emergency period.

“(3) Specified criteria.—For purposes of paragraph (1), the specified criteria for granting such waivers and flexibilities to individual hospitals are:

“(A) The hospital shall indicate to the Secretary the criteria it would use to ensure that hospital services be furnished only to an individual who requires an inpatient level of care, and shall require that a physician document in the medical record of each such individual that the individual meets such criteria.

“(B) The hospital and any other entities providing services under arrangements with the hospital shall ensure that the standard of care to treat an individual at home is the same as the standard of care to treat such individual as an inpatient of the hospital.

“(C) The hospital shall ensure that an individual is only eligible for services under paragraph (1) if the individual is a hospital inpatient or is a patient of the hospital’s emergency department for whom the hospital determines that an inpatient level of care is required (as described in subparagraph (A)).

“(D) The hospital shall meet all patient safety standards determined appropriate by the Secretary, in addition to those that otherwise apply to the hospital, except those for which the waivers and flexibilities under this subsection apply.

“(E) The hospital shall provide to the Secretary, at a time, form and manner determined by the Secretary, any data and information the Secretary determines necessary to do the following:

“(i) Monitor the quality of care furnished, and to the extent practicable, ensure the safety of individuals and analyze costs of such care.

“(ii) Undertake the study described in subsection (b).

“(F) The hospital meets such other requirements and conditions as the Secretary determines appropriate.

“(4) Termination.—The Secretary may terminate a hospital from participation in such initiative (and the waivers and flexibilities applicable to such hospital) if the Secretary determines that the hospital no longer meets the criteria described in paragraph (3).

“(b) Study and Report.—

“(1) In general.—The Secretary shall conduct a study to—

“(A) analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative of the Secretary to determine which individuals may be furnished services under such initiative; and

“(B) analyze and compare, to the extent practicable—

“(i) quality of care furnished to individuals with similar conditions and characteristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hospital readmission rates, hospital mortality rates, length of stay, infection rates, and patient experience of care;

“(ii) clinical conditions treated and diagnosis-related groups of discharges from the inpatient setting and under the Acute Hospital Care at Home initiative;

“(iii) costs incurred by furnishing care in the inpatient setting and through the Acute Hospital Care at Home initiative;

“(iv) the quantity, mix and intensity of such services (such as in-person visits and virtual contacts with patients) furnished in the Acute Hospital Care at Home initiative and furnished in the inpatient setting; and

“(v) socioeconomic information on beneficiaries treated under the initiative, including racial and ethnic data, income, and whether such beneficiaries are dually eligible for benefits under this title and title XIX.

“(2) Report.—Not later than September 30, 2024, the Secretary of Health and Human Services shall post on a website of the Centers for Medicare & Medicaid Services a report on the study conducted under paragraph (1).

“(3) Funding.—In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $5,000,000, to remain available until expended, for purposes of carrying out this subsection.

“(c) Implementation.—Notwithstanding any other provision of law, the Secretary may implement this section by program instruction or otherwise.

“(d) Publicly Available Information.—The Secretary shall, as feasible, make the information collected under subsections (a)(3)(E) and (b)(1) available on the Medicare.gov internet website (or a successor website).”

SEC. 4141. Extension of Pass-Through Status under the Medicare Program for Certain Devices Impacted by Covid–19.

(a)
In General.— Section 1833(t)(6) of the Social Security Act (42 U.S.C. 1395l(t)(6)) is amended—
(1)
in subparagraph (B)(iii), in the matter preceding subclause (I), by striking “ A category” and inserting “ Subject to subparagraph (K), a category”; and
(2)
by adding at the end the following new subparagraph:

“(K) Pass-through extension for certain devices.—

“(i) In general.—In the case of a device whose period of pass-through status under this paragraph will end on December 31, 2022, such pass-through status shall be extended for a 1–year period beginning on January 1, 2023.

“(ii) No adjustment for packaged costs.—For purposes of the 1–year period described in clause (i), the Secretary shall not remove the packaged costs of such device (as determined by the Secretary) from the payment amount under this subsection for a covered OPD service (or group of services) with which it is packaged.

“(iii) No application of aggregate limit or budget neutrality.—Notwithstanding any other provision of this subsection, this subparagraph shall not be taken into account—

“(I) in applying the limit on annual aggregate adjustments under subparagraph (E) for 2023; or

“(II) in making any budget neutrality adjustments under this subsection for 2023.”

(b)
Implementation.— Notwithstanding any other provision of law, the Secretary of Health and Human Service may implement the amendments made by subsection (a) by program instruction or otherwise.

SEC. 4142. Increasing Transparency for Home Health Payments under the Medicare Program.

(a)
Transparency.— In notice and comment rulemaking used to implement section 1895(b)(3)(D) of the Social Security Act (42 U.S.C. 1395fff(b)(3)(D), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, on the date of the notice of proposed rulemaking, make available through the internet website of the Centers for Medicare & Medicaid Services the following:
(1)
Electronic data files showing the Centers for Medicare & Medicaid Services simulation of 60-day episodes under the home health prospective payment system in effect prior to the Patient Driven Groupings Model using data from 30-day periods paid under such Model, if such data are used in determining payment adjustments under clauses (ii) or (iii) of such section 1895(b)(3)(D).
(2)
To the extent practicable, a description of actual behavior changes, as described in clause (i) of such section 1895(b)(3)(D), including behavior changes as a result of the implementation of sections 1895(b)(2)(B) and 1895(b)(4)(B) of the Social Security Act (42 U.S.C. 1395fff(b)(2)(B) and 1395(b)(4)(B)) that occurred in calendar years 2020 through 2026.
(b)
Engagement With Stakeholders.—
(1)
In general.— Not later than 90 days after the date of enactment of this section, the Secretary shall use an open door forum, a town hall meeting, a web-based forum, or other appropriate mechanism to receive input from home health stakeholders and interested parties on Medicare home health payment rate development, including the items described in paragraphs (1) and (2) of subsection (a) with respect to the home health prospective payment system rate for calendar year 2023.
(2)
Requirement.— At least 30 days before the forum, meeting, or other mechanism referred to in paragraph (1), the Secretary shall make available through the internet website of the Centers for Medicare & Medicaid Services the items described in paragraphs (1) and (2) of subsection (a) with respect to the home health prospective payment system rate for calendar year 2023 as finalized in the final rule entitled “Medicare Program; Calendar Year 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements” published in the Federal Register on November 4, 2022 (87 Fed. Reg. 66790).
(c)
Construction.— Nothing in this section shall be construed to require any change in the methodology used by the Secretary to implement such section 1895(b)(3)(D), to restrict the Secretary’s discretion in establishing the methodology to implement such section, or to suggest that the Secretary’s promulgation of the methodology implementing such Calendar Year 2023 home health final rule was inadequate under Chapter 5 of title 5, United States Code (commonly known as the “Administrative Procedures Act”) or any other provision of law.

SEC. 4143. Waiver of Cap on Annual Payments for Nursing and Allied Health Education Payments.

(a)
In General.— Section 1886(l)(2)(B) of the Social Security Act (42 U.S.C. 1395ww(l)(2)(B)) is amended—
(1)
by striking “ payments.—Such ratio” and inserting

“(i) In general.—Subject to clause (ii), such ratio”

; and

(2)
by adding at the end the following new clause:

“(ii) Exception to annual limitation for each of 2010 through 2019.—For each of 2010 through 2019, the limitation under clause (i) on the total amount of additional payments for nursing and allied health education to be distributed to hospitals under this subsection for portions of cost reporting periods occurring in the year shall not apply to such payments made in such year to those hospitals that, as of the date of the enactment of this clause, are operating a school of nursing, a school of allied health, or a school of nursing and allied health.”

(b)
No Affect on Payments for Direct Graduate Medical Education.— Section 1886(h)(3)(D)(iii) of the Social Security Act (42 U.S.C. 1395ww(h)(3)(D)(iii)) is amended by adding at the end the following sentence: “ In applying the preceding sentence for each of 2010 through 2019, the Secretary shall not take into account any increase in the total amount of such additional payment amounts for such nursing and allied health education for portions of cost reporting periods occurring in the year pursuant to the application of paragraph (2)(B)(ii) of such subsection.”.
(c)
Retroactive Application.— The amendments made by this section shall apply to payments made for portions of cost reporting periods occurring in 2010 through 2019.
(d)
Funding.— In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $3,000,000, to remain available until expended, for purposes of carrying out the amendments made by this section.

Subtitle E Health Care Tax Provisions

SEC. 4151. Extension of Safe Harbor for Absence of Deductible for Telehealth.

(a)
In General.— Section 223(c)(2)(E) of the Internal Revenue Code of 1986 is amended by striking “ In the case of plan years” and all that follows through “ a plan” and inserting

“(i) months beginning after March 31, 2022, and before January 1, 2023, and

“(ii) plan years beginning on or before December 31, 2021, or after December 31, 2022, and before January 1, 2025,

(b)
Certain Coverage Disregarded.— Section 223(c)(1)(B)(ii) of the Internal Revenue Code of 1986 is amended by striking “ (in the case of plan years beginning on or before December 31, 2021, or in the case of months beginning after March 31, 2022, and before January 1, 2023)” and inserting “ (in the case of months or plan years to which paragraph (2)(E) applies)”.
(c)
Effective Date.— The amendments made by this section shall apply to plan years beginning after December 31, 2022.

Subtitle F Offsets

SEC. 4161. Reduction of Medicare Improvement Fund.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking “ $7,278,000,000” and inserting “ $180,000,000”.

SEC. 4162. Extension of Adjustment to Calculation of Hospice Cap Amount under Medicare.

Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C. 1395f(i)(2)(B)) is amended—
(1)
in clause (ii), by striking “ 2031” and inserting “ 2032”; and
(2)
in clause (iii), by striking “ 2031” and inserting “ 2032”.

SEC. 4163. Medicare Direct Spending Reductions.

Section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is amended—
(1)
in subparagraph (B), in the matter preceding clause (i)—
(A)
by striking “ On the dates OMB issues its sequestration preview reports” and inserting “ On the date on which the President submits the budget under section 1105 of title 31, United States Code,”; and
(B)
by striking “ pursuant to section 254(c),”;
(2)
in subparagraph (C), by moving the margin 2 ems to the left;
(3)
by striking subparagraphs (D) and (E); and
(4)
by adding at the end the following:

“(D) On the date on which the President submits the budget under section 1105 of title 31, United States Code, for fiscal year 2032, the President shall order a sequestration of payments for the Medicare programs specified in section 256(d), effective upon issuance, such that, notwithstanding the 2 percent limit specified in subparagraph (A) for such payments—

“(i) with respect to the first 6 months in which such order is effective for such fiscal year, the payment reduction shall be 2.0 percent; and

“(ii) with respect to the second 6 months in which such order is effective for such fiscal year, the payment reduction shall be 0 percent.”

TITLE V Medicaid and Chip Provisions

Subtitle A Territories

SEC. 5101. Medicaid Adjustments for the Territories.

(a)
Revising Allotments for Puerto Rico.— Section 1108(g) of the Social Security Act (42 U.S.C. 1308(g)) is amended—
(1)
in paragraph (2)—
(A)
in subparagraph (A)—
(i)
in clause (i)—
(I)
by striking “ clause (ii)” and inserting “ clause (ii) or (iii)”; and
(II)
by striking “ and” at the end;
(ii)
in clause (ii), by striking the semicolon and inserting “ ; and”; and
(iii)
by adding at the end the following new clause:

“(iii) for fiscal year 2023 and each subsequent fiscal year, the amount specified in paragraph (11) for such fiscal year;”

; and

(B)
in the matter following subparagraph (E), by striking “ each fiscal year after fiscal year 2021” and inserting “ fiscal year 2022 (and, in the case of a territory other than Puerto Rico, for each subsequent fiscal year)”; and
(2)
by adding at the end the following new paragraphs:

“(11) Allotment amounts for puerto rico for fiscal year 2023 and subsequent fiscal years.—For purposes of paragraph (2)(A)(iii), subject to paragraphs (12) and (13), the amounts specified in this paragraph are the following:

“(A) For fiscal year 2023, $3,275,000,000.

“(B) For fiscal year 2024, $3,325,000,000.

“(C) For fiscal year 2025, $3,475,000,000.

“(D) For fiscal year 2026, $3,645,000,000.

“(E) For fiscal year 2027, $3,825,000,000.

“(F) For fiscal year 2028, the sum of the amount that would have been provided under this subsection for Puerto Rico for such fiscal year in accordance with clause (i) of paragraph (2)(A) (without regard to clause (iii) of such paragraph) had the amount provided under this subsection for Puerto Rico for each of fiscal years 2020 through 2027 been equal to the following:

“(i) For fiscal year 2020, the sum of the amount provided under this subsection for Puerto Rico for fiscal year 2019, increased by the percentage increase in the medical care component of the Consumer Price Index for all urban consumers (as published by the Bureau of Labor Statistics) for the 12-month period ending in March preceding the beginning of the fiscal year, rounded to the nearest $100,000.

“(ii) For each of fiscal years 2021 through 2027, the sum of the amount provided under this subparagraph for the preceding fiscal year, increased in accordance with the percentage increase described in clause (i), rounded to the nearest $100,000.

“(G) For fiscal year 2029 and each subsequent fiscal year, the sum of the amount specified in this paragraph for the preceding fiscal year, increased by the percentage increase in the medical care component of the Consumer Price Index for all urban consumers (as published by the Bureau of Labor Statistics) for the 12-month period ending in March preceding the beginning of the fiscal year, rounded to the nearest $100,000.

“(12) Additional increase for puerto rico.—

“(A) In general.—For fiscal year 2023 and each subsequent fiscal year through fiscal year 2027, the amount specified in paragraph (11) for the fiscal year shall be equal to the amount specified for such fiscal year under such paragraph increased by $300,000,000 if the Secretary certifies that, with respect to such fiscal year, Puerto Rico’s State plan under title XIX (or waiver of such plan) establishes a reimbursement floor, implemented through a directed payment arrangement plan, for physician services that are covered under the Medicare part B fee schedule in the Puerto Rico locality established under section 1848(b) that is not less than 75 percent of the payment that would apply to such services if they were furnished under part B of title XVIII during such fiscal year.

“(B) Application to managed care.—In certifying whether Puerto Rico has established a reimbursement floor under a directed payment arrangement plan that satisfies the requirements of subparagraph (A)—

“(i) for fiscal year 2023, the Secretary shall apply such requirements to payments for physician services under a managed care contract entered into or renewed after the date of enactment of this paragraph and disregard payments for physician services under any managed care contract that was entered into prior to such date; and

“(ii) for each subsequent fiscal year through fiscal year 2027—

“(I) the Secretary shall disregard payments made under subcapitated arrangements for services such as primary care case management; and

“(II) if the reimbursement floor for physician services applicable under a managed care contract satisfies the requirements of subparagraph (A) for the fiscal year in which the contract is entered into or renewed, such reimbursement floor shall be deemed to satisfy such requirements for the subsequent fiscal year.

“(C) Nonapplication of increase in determining allotments for subsequent fiscal years.—An increase under this paragraph for a fiscal year may not be taken into account in calculating the amount specified under paragraph (11) for the succeeding fiscal year.

“(13) Further increase for puerto rico.—

“(A) In general.—For each of fiscal years 2023 through 2027, the amount specified in paragraph (11) for the fiscal year shall be equal to the amount specified for such fiscal year under such paragraph (increased, if applicable, in accordance with paragraph (12)) and further increased—

“(i) in the case of each of fiscal years 2023 through 2025, by $75,000,000 if the Secretary determines that Puerto Rico fully satisfies the requirements described in paragraph (7)(A)(i) for such fiscal year; and

“(ii) in the case of each of fiscal years 2026 and 2027, by $75,000,000 if the Secretary determines that Puerto Rico fully satisfies the requirements described in—

“(I) paragraph (7)(A)(i) for such fiscal year; and

“(II) paragraph (7)(A)(v) for such fiscal year.

“(B) Nonapplication of increase in determining allotments for subsequent fiscal years.—An increase under this paragraph for a fiscal year may not be taken into account in calculating the amount specified under paragraph (11) for the succeeding fiscal year.”

(b)
Extension of Increased FMAPs.— Section 1905(ff) of the Social Security Act (42 U.S.C. 1396d(ff)) is amended—
(1)
in the header, by striking “ Temporary”;
(2)
in paragraph (2)—
(A)
by striking “ subject to section 1108(g)(7)(C),”; and
(B)
by striking “ December 23, 2022” and inserting “ September 30, 2027,”; and
(3)
in paragraph (3), by striking “ for the period beginning December 21, 2019, and ending December 23, 2022” and inserting “ beginning December 21, 2019”.
(c)
Application of Asset Verification Program Requirements to Puerto Rico.— Section 1940 of the Social Security Act (42 U.S.C. 1396w) is amended—
(1)
in subsection (a)—
(A)
in paragraph (3)(A), by adding at the end the following new clause:

“(iii) Implementation in puerto rico.—The Secretary shall require Puerto Rico to implement an asset verification program under this subsection by January 1, 2026.”

; and

(B)
in paragraph (4)—
(i)
in the paragraph heading, by striking “ Exemption of territories” and inserting “ Exemption of certain territories”; and
(ii)
by striking “ and the District of Columbia” and inserting “ , the District of Columbia, and Puerto Rico”; and
(2)
in subsection (k)—
(A)
in paragraph (1)—
(i)
by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and adjusting the margins accordingly;
(ii)
in the matter preceding clause (i), as so redesignated—
(I)
by striking “ beginning on or after January 1, 2021”; and
(II)
by striking “ for a non-compliant State shall be reduced—” and inserting the following:

“(A) a non-compliant State that is one of the 50 States or the District of Columbia shall be reduced—

(iii)
in clause (iv), as so redesignated, by striking the period at the end and inserting “ ; and”; and
(iv)
by adding at the end the following new subparagraph:

“(B) a non-compliant State that is Puerto Rico shall be reduced—

“(i) for calendar quarters in fiscal year 2026 beginning on or after January 1, 2026, by 0.12 percentage points;

“(ii) for calendar quarters in fiscal year 2027, by 0.25 percentage points;

“(iii) for calendar quarters in fiscal year 2028, by 0.35 percentage points; and

“(iv) for calendar quarters in fiscal year 2029 and each fiscal year thereafter, by 0.5 percentage points.”

; and

(B)
in paragraph (2)(A), by striking “ or the District of Columbia” and inserting “ , the District of Columbia, or Puerto Rico”.
(d)
Extension of Reporting Requirement.— Section 1108(g)(9) of the Social Security Act (42 U.S.C. 1308(g)(9)) is amended—
(1)
in subparagraph (A), by inserting “ and for fiscal year 2023 and each subsequent fiscal year (or, in the case of Puerto Rico, and for fiscal year 2023 and each subsequent fiscal year before fiscal year 2028)” after “ fiscal year 2021)”; and
(2)
in subparagraph (B)(i), by inserting “ or by reason of the amendments made by section 5101 of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022” before the period at the end.
(e)
Puerto Rico Program Integrity.— Section 1108(g)(7)(A) of the Social Security Act (42 U.S.C. 1308(g)(7)(A)) is amended—
(1)
in clause (iii), in the header, by inserting “ reporting” after “ reform”; and
(2)
by adding at the end the following new clause:

“(v) Contracting and procurement oversight lead requirement.—

“(I) In general.—Not later than 6 months after the date of the enactment of this clause, the agency responsible for the administration of Puerto Rico’s Medicaid program under title XIX shall designate an officer (other than the director of such agency) to serve as the Contracting and Procurement Oversight Lead to carry out the duties specified in subclause (II).

“(II) Duties.—Not later than 60 days after the end of each fiscal quarter (beginning with the first fiscal quarter beginning on or after the date that is 1 year after the date of the enactment of this clause), the officer designated pursuant to subclause (I) shall, with respect to each contract described in clause (iii) with an annual value exceeding $150,000 entered into during such quarter, certify to the Secretary either—

“(aa) that such contract has met the procurement standards identified under any of sections 75.327, 75.328, and 75.329 of title 45, Code of Federal Regulations (or successor regulations); or

“(bb) that extenuating circumstances (including a lack of multiple entities competing for such contract) prevented the compliance of such contract with such standards.

“(III) Publication.—The officer designated pursuant to subclause (I) shall make public each certification containing extenuating circumstances described in subclause (II)(bb) not later than 30 days after such certification is made, including a description of, and justification of, such extenuating circumstances.

“(IV) Review of compliance.—Not later than 2 years after the date of the enactment of this clause, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on the compliance of Puerto Rico with the provisions of this clause.”

(f)
Medicaid Data Systems Improvement Payments.— Section 1108 of the Social Security Act (42 U.S.C. 1308) is amended by adding at the end the following new subsection:

“(i) Data Systems Improvement Payments.—

“(1) In general.—Subject to paragraphs (2) and (3), the Secretary shall pay to each eligible territory an amount equal to 100 percent of the qualifying data system improvement expenditures incurred by such territory on or after October 1, 2023.

“(2) Treatment as medicaid payments.—

“(A) In general.—Payments to eligible territories made under this paragraph shall be considered to have been made under, and are subject to the requirements of, section 1903.

“(B) Nonduplication.—No payment shall be made under title XIX (other than as provided under paragraph (1)), title XXI, or any other provision of law with respect to an expenditure for which payment is made under such paragraph.

“(3) Allotments.—The Secretary shall specify an allotment for each eligible territory for payments made under paragraph (1) in a manner such that—

“(A) the total amount of payments made under such paragraph for all eligible territories does not exceed $20,000,000; and

“(B) each eligible territory receives an equitable allotment of such payments.

“(4) No effect on territorial caps.—A payment to an eligible territory under this subsection shall not be taken into account for purposes of applying the payment limits under subsections (f) and (g).

“(5) Definitions.—In this subsection:

“(A) Eligible territory.—The term ‘eligible territory’ means American Samoa, Guam, the Northern Mariana Islands, and the Virgin Islands.

“(B) Qualifying data system improvement expenditure.—The term ‘qualifying data system improvement expenditure’ means an expenditure by an eligible territory to improve, update, or enhance a data system that is used by the territory to carry out an administrative activity for which Federal financial participation is available under section 1903(a).”

(g)
Strategic Plan and Evaluation.—
(1)
In general.— Each territory described in paragraph (2) shall—
(A)
not later than September 30, 2023, submit to the Secretary of Health and Human Services a 4-year strategic plan that outlines the territory’s goals relating to workforce development, financing, systems implementation and operation, and program integrity with respect to the territory’s Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.); and
(B)
not later than September 30, 2027, submit to the Secretary of Health and Human Services an analysis of the extent to which the territory has achieved, or is making progress toward achieving, the goals described in such strategic plan, and any policy changes relating to such goals that were adopted by the territory after the submission of the plan.
(2)
Territories described.— The territories described in this paragraph are American Samoa, Guam, the Northern Mariana Islands, and the Virgin Islands.

Subtitle B Medicaid and CHIP Coverage

SEC. 5111. Funding Extension of the Children’s Health Insurance Program and Related Provisions.

(a)
In General.— Section 2104(a) of the Social Security Act (42 U.S.C. 1397dd(a)) is amended—
(1)
in paragraph (27), by striking “ through 2026” and inserting “ through 2028”; and
(2)
in paragraph (28)—
(A)
in the matter preceding subparagraph (A), by striking “ for fiscal year 2027” and inserting “ for fiscal year 2029”;
(B)
in subparagraph (A), by striking “ beginning on October 1, 2026, and ending on March 31, 2027” and inserting “ beginning on October 1, 2028, and ending on March 31, 2029”; and
(C)
in subparagraph (B), by striking “ beginning on April 1, 2027, and ending on September 30, 2027” and inserting “ beginning on April 1, 2029, and ending on September 30, 2029”.
(b)
CHIP Allotments.—
(1)
In general.— Section 2104(m) of the Social Security Act (42 U.S.C. 1397dd(m)) is amended—
(A)
in paragraph (2)(B)(i), by striking “ , 2023, and 2027” and inserting “ 2023, and 2029”;
(B)
in paragraph (5), by striking “ or 2027” and inserting “ or 2029”;
(C)
in paragraph (7)—
(i)
in subparagraph (A), by striking “ fiscal year 2027,” and inserting “ fiscal year 2029”; and
(ii)
in the flush left matter at the end, by striking “ or fiscal year 2026.” and inserting “ fiscal year 2026, or fiscal year 2028.”;
(D)
in paragraph (9), by striking “ or 2027” and inserting “ or 2029”; and
(E)
in paragraph (11)—
(i)
in the paragraph header, by striking “ fiscal year 2027” and inserting “ fiscal year 2029”; and
(ii)
in subparagraph (C)—
(I)
by striking “ fiscal year 2026” each place it appears and inserting “ fiscal year 2028”; and
(II)
by striking “ fiscal year 2027” and inserting “ fiscal year 2029”.
(2)
Conforming amendments.— Section 50101(b)(2) of the Bipartisan Budget Act of 2018 (Public Law 115–123) is amended—
(A)
in the paragraph header, by striking “ fiscal year 2027” and inserting “ fiscal year 2029”;
(B)
by striking “ fiscal year 2027” each place it appears and inserting “ fiscal year 2029”; and
(C)
by striking “ beginning on October 1, 2026, and ending on March 31, 2027” and inserting “ beginning on October 1, 2028, and ending on March 31, 2029”.
(c)
Other Related CHIP Policies.—
(1)
Pediatric quality measures program.— Section 1139A(i)(1) of the Social Security Act (42 U.S.C. 1320b–9a(i)(1)) is amended—
(A)
in subparagraph (C), by striking at the end “ and”;
(B)
in subparagraph (D), by striking the period at the end and inserting “ ; and”; and
(C)
by adding at the end the following new subparagraph:

“(E) for each of fiscal years 2028 and 2029, $15,000,000 for the purpose of carrying out this section (other than subsections (e), (f), and (g)).”

(2)
Assurance of eligibility standards for children.— Section 2105(d)(3) of the Social Security Act (42 U.S.C. 1397ee(d)(3)) is amended—
(A)
in the paragraph heading, by striking “ through september 30, 2027” and inserting “ through september 30, 2029”; and
(B)
in subparagraph (A) by striking “ September 30, 2027” each place it appears and inserting “ September 30, 2029”.
(3)
Qualifying states option.— Section 2105(g)(4) of the Social Security Act (42 U.S.C. 1397ee(g)(4)) is amended—
(A)
in the paragraph heading, by striking “ through 2027” and inserting “ through 2029”; and
(B)
in subparagraph (A), by striking “ through 2027” and inserting “ through 2029”.
(4)
Outreach and enrollment program.— Section 2113 of the Social Security Act (42 U.S.C. 1397mm) is amended—
(A)
in subsection (a)—
(i)
in paragraph (1), by striking “ through 2027” and inserting “ through 2029”; and
(ii)
in paragraph (3), by striking “ through 2027” and inserting “ through 2029”; and
(B)
in subsection (g)—
(i)
by striking “ 2017,,” and inserting “ 2017,”;
(ii)
by striking “ and $48,000,000” and inserting “ $48,000,000”; and
(iii)
by inserting after “ through 2027” the following: “ , and $40,000,000 for the period of fiscal years 2028 and 2029”.
(5)
Child enrollment contingency fund.— Section 2104(n) of the Social Security Act (42 U.S.C. 1397dd(n)) is amended—
(A)
by striking “ 2024 through 2026” each place it appears and inserting “ 2024 through 2028”; and
(B)
by striking “ 2023, and 2027” each place it appears and inserting “ 2023, and 2029”.
(d)
Extension of Certain Provisions.—
(1)
Express lane eligibility option.— Section 1902(e)(13)(I) of the Social Security Act (42 U.S.C. 1396a(e)(13)(I)) is amended by striking “ 2027” and inserting “ 2029”.
(2)
Conforming amendments for assurance of affordability standard for children and families.— Section 1902(gg)(2) of the Social Security Act (42 U.S.C. 1396a(gg)(2)) is amended—
(A)
in the paragraph heading, by striking “ through september 30, 2027” and inserting “ through september 30, 2029”; and
(B)
by striking “ 2027” each place it appears and inserting “ 2029,”.

SEC. 5112. Continuous Eligibility for Children under Medicaid and Chip.

(a)
Under the Medicaid Program.— Section 1902(e) of the Social Security Act (42 U.S.C. 1396a(e)) is amended by striking paragraph (12) and inserting the following new paragraph:

“(12) 1 year of continuous eligibility for children.—The State plan (or waiver of such State plan) shall provide that an individual who is under the age of 19 and who is determined to be eligible for benefits under a State plan (or waiver of such plan) approved under this title under subsection (a)(10)(A) shall remain eligible for such benefits until the earlier of—

“(A) the end of the 12-month period beginning on the date of such determination;

“(B) the time that such individual attains the age of 19; or

“(C) the date that such individual ceases to be a resident of such State.”

(b)
Under the Children’s Health Insurance Program.— Section 2107(e)(1) of the Social Security Act (42 U.S.C. 1397gg(e)(1)) is amended—
(1)
by redesignating subparagraphs (K) through (T) as subparagraphs (L) through (U), respectively; and
(2)
by inserting after subparagraph (J) the following new subparagraph:

“(K) Section 1902(e)(12) (relating to 1 year of continuous eligibility for children), except that a targeted low-income child enrolled under the State child health plan or waiver may be transferred to the Medicaid program under title XIX for the remaining duration of the 12-month continuous eligibility period, if the child becomes eligible for full benefits under title XIX during such period.”

(c)
Effective Date.— The amendments made by this section shall take effect on the first day of the first fiscal quarter that begins on or after the date that is 1 year after the date of enactment of this Act.

SEC. 5113. Modifications to Postpartum Coverage under Medicaid and Chip.

Effective as if included in the enactment of sections 9812 and 9822 of the American Rescue Plan Act of 2021 (Public Law 117–2), subsection (b) of each such section is amended by striking “ during the 5-year period”.

SEC. 5114. Extension of Money Follows the Person Rebalancing Demonstration.

(a)
In General.— Subsection (h) of section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended—
(1)
in paragraph (1)—
(A)
in each of subparagraphs (F), (H), and (J), by striking “ and” after the semicolon;
(B)
in subparagraph (K), by striking the period and inserting “ ; and”; and
(C)
by adding at the end the following:

“(L) $450,000,000 for each of fiscal years 2024 through 2027.”

(2)
in paragraph (2), by striking “ September 30, 2023” and inserting “ September 30 of the subsequent fiscal year”; and
(3)
by adding at the end the following new paragraph:

“(3) Technical assistance.—In addition to amounts otherwise available, there is appropriated to the Secretary, out of any money in the Treasury not otherwise appropriated for fiscal 2023 and for each subsequent 3-year period through fiscal year 2029, $5,000,000, to remain available until expended, for carrying out subsections (f) and (g).”

(b)
Redistribution of Unexpended Grant Awards.— Subsection (e)(2) of section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended by adding at the end the following new sentence: “ Any portion of a State grant award for a fiscal year under this section that is unexpended by the State at the end of the fourth succeeding fiscal year shall be rescinded by the Secretary and added to the appropriation for the fifth succeeding fiscal year.”.

SEC. 5115. Extension of Medicaid Protections Against Spousal Impoverishment for Recipients of Home and Community-Based Services.

Section 2404 of the Patient Protection and Affordable Care Act (42 U.S.C. 1396r–5 note) is amended by striking “ September 30, 2023” and inserting “ September 30, 2027”.

Subtitle C Medicaid and CHIP Mental Health

SEC. 5121. Medicaid and Chip Requirements for Health Screenings, Referrals, and Case Management Services for Eligible Juveniles in Public Institutions.

(a)
Medicaid State Plan Requirement.— Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended—
(1)
in subsection (a)(84)—
(A)
in subparagraph (A), by inserting “ , subject to subparagraph (D),” after “ but”;
(B)
in subparagraph (B), by striking “ and” at the end;
(C)
in subparagraph (C), by adding “ and” at the end; and
(D)
by adding at the end the following new subparagraph:

“(D) in the case of an individual who is an eligible juvenile described in subsection (nn)(2) and is within 30 days of the date on which such eligible juvenile is scheduled to be released from a public institution following adjudication, the State shall have in place a plan, and in accordance with such plan, provide for—

“(i) in the 30 days prior to the release of such eligible juvenile from such public institution (or not later than one week, or as soon as practicable, after release from the public institution), and in coordination with such institution, any screening or diagnostic service which meets reasonable standards of medical and dental practice, as determined by the State, or as indicated as medically necessary, in accordance with paragraphs (1)(A) and (5) of section 1905(r), including a behavioral health screening or diagnostic service; and

“(ii) in the 30 days prior to the release of such eligible juvenile from such public institution, and for at least 30 days following the release of such eligible juvenile from such institution, targeted case management services, including referrals for such eligible juvenile to the appropriate care and services available in the geographic region of the home or residence of such eligible juvenile (where feasible) under the State plan (or waiver of such plan);”

; and

(2)
in subsection (nn)(3), by striking “ (30)” and inserting “ (31)”.
(b)
Authorization of Federal Financial Participation.— The subdivision (A) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) following paragraph (31) of such section is amended by inserting “ , or in the case of an eligible juvenile described in section 1902(a)(84)(D) with respect to the screenings, diagnostic services, referrals, and targeted case management services required under such section” after “ (except as a patient in a medical institution”.
(c)
CHIP Conforming Amendments.—
(1)
Section 2102 of the Social Security Act (42 U.S.C. 1397bb) is amended by adding at the end the following new subsection:

“(d) Treatment of Children Who Are Inmates of a Public Institution.—

“(1) In general.—The State child health plan shall provide that—

“(A) the State shall not terminate eligibility for child health assistance under the State child health plan for a targeted low-income child because the child is an inmate of a public institution, but may suspend coverage during the period the child is such an inmate;

“(B) in the case of a targeted low-income child who was determined eligible for child health assistance under the State child health plan (or waiver of such plan) immediately before becoming an inmate of a public institution, the State shall, prior to the child’s release from such public institution, conduct a redetermination of eligibility for such child with respect to such child health assistance (without requiring a new application from the child) and, if the State determines pursuant to such redetermination that the child continues to meet the eligibility requirements for such child health assistance, the State shall restore coverage for such child health assistance to such child upon the child’s release from such public institution; and

“(C) in the case of a targeted low-income child who is determined eligible for child health assistance while an inmate of a public institution (subject to the exception to the exclusion of children who are inmates of a public institution described in section 2110(b)(7)), the State shall process any application for child health assistance submitted by, or on behalf of, the child such that the State makes a determination of eligibility for the child with respect to child health assistance upon release of the child from the public institution.

“(2) Required coverage of screenings, diagnostic services, referrals, and case management for certain inmates pre-release.—A State child health plan shall provide that, in the case of a targeted low-income child who is within 30 days of the date on which such child is scheduled to be released from a public institution following adjudication, the State shall have in place a plan for providing, and shall provide in accordance with such plan, screenings, diagnostic services, referrals, and case management services otherwise covered under the State child health plan (or waiver of such plan) in the same manner as described in section 1902(a)(84)(D).”

(2)
Section 2110(b) of the Social Security Act (42 U.S.C. 1397jj(b)) is amended—
(A)
in paragraph (2)(A), by inserting “ except as provided in paragraph (7),” before “ a child who is an inmate of a public institution”; and
(B)
by adding at the end the following new paragraph:

“(7) Exception to exclusion of children who are inmates of a public institution.—In the case of a child who is an inmate of a public institution, during the 30 days prior to the release of the child from such institution the child shall not be considered to be described in paragraph (2)(A) with respect to the screenings, diagnostic services, referrals, and case management services otherwise covered under the State child health plan (or waiver of such plan) that the State is required to provide under section 2102(d)(2).”

(d)
Effective Date.— The amendments made by this section shall apply beginning on the first day of the first calendar quarter that begins on or after the date that is 24 months after the date of enactment of this Act.

SEC. 5122. Removal of Limitations on Federal Financial Participation for Inmates Who Are Eligible Juveniles Pending Disposition of Charges.

(a)
Medicaid.—
(1)
In general.— The subdivision (A) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) following paragraph (31) of such section, as amended by section 5121(b), is further amended by inserting “ , or, at the option of the State, for an individual who is an eligible juvenile (as defined in section 1902(nn)(2)), while such individual is an inmate of a public institution (as defined in section 1902(nn)(3)) pending disposition of charges” after “ or in the case of an eligible juvenile described in section 1902(a)(84)(D) with respect to the screenings, diagnostic services, referrals, and case management required under such section”.
(2)
Conforming amendment.— Section 1902(a)(84)(A) of the Social Security Act (42 U.S.C. 1396a(a)(84)(A)) is amended by inserting “ (or in the case of a State electing the option described in the subdivision (A) following paragraph (31) of section 1905(a), during such period beginning after the disposition of charges with respect to such individual)” after “ is such an inmate”.
(b)
CHIP.— Section 2110(b)(7) of the Social Security Act (42 U.S.C. 13977jj(b)(7)), as added by section 5121(c)(2)(B), is amended—
(1)
in the heading, by striking “ Exception” and inserting “ Exceptions”; and
(2)
by adding at the end the following new sentence: “ At the option of the State, a child who is an inmate of a public institution shall not be considered to be described in paragraph (2)(A) during the period that the child is an inmate of such institution pending disposition of charges.”.
(c)
Effective Date.— The amendments made by this section shall take effect on the first day of the first calendar quarter that begins after the date that is 24 months after the date of enactment of this Act and shall apply to items and services furnished for periods beginning on or after such date.

SEC. 5123. Requiring Accurate, Updated, and Searchable Provider Directories.

(a)
Application to Managed Care.— Section 1932(a)(5) of the Social Security Act (42 U.S.C. 1396u–2(a)(5)) is amended—
(1)
in subparagraph (B)(i), by inserting “ , including as required by subparagraph (E)” before the period at the end; and
(2)
by adding at the end the following new subparagraph:

“(E) Provider directories.—

“(i) In general.—Each managed care organization, prepaid inpatient health plan (as defined by the Secretary), prepaid ambulatory health plan (as defined by the Secretary), and, when appropriate, primary care case management entity (as defined by the Secretary) with a contract with a State to enroll individuals who are eligible for medical assistance under the State plan under this title or under a waiver of such plan, shall publish (and update on at least a quarterly basis or more frequently as required by the Secretary) on a public website, a searchable directory of network providers, which shall include physicians, hospitals, pharmacies, providers of mental health services, providers of substance use disorder services, providers of long term services and supports as appropriate, and such other providers as required by the Secretary, and that includes with respect to each such provider—

“(I) the name of the provider;

“(II) the specialty of the provider;

“(III) the address at which the provider provides services;

“(IV) the telephone number of the provider; and

“(V) information regarding—

“(aa) the provider’s cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or by a skilled medical interpreter who provides interpretation services at the provider’s office;

“(bb) whether the provider is accepting as new patients, individuals who receive medical assistance under this title;

“(cc) whether the provider’s office or facility has accommodations for individuals with physical disabilities, including offices, exam rooms, and equipment;

“(dd) the Internet website of such provider, if applicable; and

“(ee) whether the provider offers covered services via telehealth; and

“(VI) other relevant information, as required by the Secretary.

“(ii) Network provider defined.—In this subparagraph, the term ‘network provider’ includes any provider, group of providers, or entity that has a network provider agreement with a managed care organization, a prepaid inpatient health plan (as defined by the Secretary), a prepaid ambulatory health plan (as defined by the Secretary), or a primary care case management entity (as defined by the Secretary) or a subcontractor of any such entity or plan, and receives payment under this title directly or indirectly to order, refer, or render covered services as a result of the State’s contract with the entity or plan. For purposes of this subparagraph, a network provider shall not be considered to be a subcontractor by virtue of the network provider agreement.”

(b)
Conforming Amendments to State Plan Requirements.— Section 1902(a) of the Social Security Act (42 U.S.C. 1396a) is amended—
(1)
by striking paragraph (83) and inserting the following:

“(83) provide that in the case of a State plan (or waiver of the plan) that provides medical assistance on a fee-for-service basis or through a primary care case-management system described in section 1915(b)(1), the State shall publish (and update on at least a quarterly basis or more frequently as required by the Secretary) on the public website of the State agency administering the State plan, a searchable directory of the providers described in subsection (mm) that, in addition to such other requirements as the Secretary may specify, such as making paper directories available to enrollees, includes with respect to each such provider—

“(A) the name of the provider;

“(B) the specialty of the provider;

“(C) the address at which the provider provides services;

“(D) the telephone number of the provider;

“(E) information regarding—

“(i) the provider’s cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or by a skilled medical interpreter who provides interpretation services at the provider’s office;

“(ii) whether the provider is accepting as new patients individuals who receive medical assistance under this title;

“(iii) whether the provider’s office or facility has accommodations for individuals with physical disabilities, including offices, exam rooms, and equipment;

“(iv) the Internet website of such provider, if applicable; and

“(v) whether the provider offers covered services via telehealth; and

“(F) other relevant information as required by the Secretary;”

; and

(2)
by striking subsection (mm) and inserting the following:

“(mm) Directory Provider Described.—

“(1) In general.—A provider described in this subsection, at a minimum, includes physicians, hospitals, pharmacies, providers of mental health services, providers of substance use disorder services, providers of long term services and supports as appropriate, and such other providers as required by the Secretary, and—

“(A) in the case of a provider or a provider type for which the State agency, as a condition of receiving payment for items and services furnished by the provider to individuals eligible to receive medical assistance under the State plan (or a waiver of the plan), requires the enrollment of the provider with the State agency, includes a provider that—

“(i) is enrolled with the agency as of the date on which the directory is published or updated (as applicable) under subsection (a)(83); and

“(ii) received payment under the State plan in the 12-month period preceding such date; and

“(B) in the case of a provider or a provider type for which the State agency does not require such enrollment, includes a provider that received payment under the State plan (or a waiver of the plan) in the 12-month period preceding the date on which the directory is published or updated (as applicable) under subsection (a)(83).

“(2) State option to include other participating providers.—At State option, a provider described in this subsection may include any provider who furnishes services and is participating under the State plan under this title or under a waiver of such plan.”

(c)
General Application to CHIP.— Section 2107(e)(1)(G) of the Social Security Act (42 U.S.C. 1397gg(e)(1)(G)) is amended by inserting “ and subsection (a)(83) of section 1902 (relating to searchable directories of the providers described in subsection (mm) of such section)” before the period.
(d)
Effective Date.— The amendments made by this section shall take effect on July 1, 2025.

SEC. 5124. Supporting Access to a Continuum of Crisis Response Services under Medicaid and Chip.

(a)
Guidance.— Not later than July 1, 2025, the Secretary, in coordination with the Administrator of the Centers for Medicare & Medicaid Services and the Assistant Secretary for Mental Health and Substance Use, shall issue guidance to States regarding Medicaid and CHIP that includes the following:
(1)
Provides, in consultation with health care providers and stakeholders with expertise in mental health and substance use disorder crisis response services, recommendations for an effective continuum of crisis response services that—
(A)
includes crisis call centers, including 988 crisis services hotlines, mobile crisis teams, crisis response services delivered in home, community, residential facility, and hospital settings, and coordination with follow-on mental health and substance use disorder services, such as intensive outpatient and partial hospitalization programs, as well as connections to social services and supports;
(B)
promotes access to appropriate and timely mental health and substance use disorder crisis response services in the least restrictive setting appropriate to an individual’s needs; and
(C)
promotes culturally competent, trauma-informed care, and crisis de-escalation.
(2)
Outlines the Federal authorities through which States may finance and enhance under Medicaid and CHIP the availability of crisis response services across each stage of the continuum of crisis response services.
(3)
Addresses how States under Medicaid and CHIP may support the ongoing implementation of crisis call centers, including 988 crisis services hotlines, and how Medicaid administrative funding, including enhanced matching, and the Medicaid Information Technology Architecture 3.0 framework, may be used to establish or enhance regional or statewide crisis call centers, including 988 crisis services hotlines, that coordinate in real time.
(4)
Identifies how States under Medicaid and CHIP may support access to crisis response services that are responsive to the needs of children, youth, and families, including through CHIP health services initiatives, behavioral disorder-specific crisis response, trained peer support services, and establishing or enhancing crisis call centers that are youth-focused.
(5)
Identifies policies and practices to meet the need for crisis response services with respect to differing patient populations, including urban, rural, and frontier communities, differing age groups, cultural and linguistic minorities, individuals with co-occurring mental health and substance use disorder conditions, and individuals with disabilities.
(6)
Identifies policies and practices to promote evidence-based suicide risk screenings and assessments.
(7)
Identifies strategies to facilitate timely provision of crisis response services, including how States can enable access to crisis response services without requiring a diagnosis, the use of presumptive eligibility at different stages of the continuum of crisis response services, the use of telehealth to deliver crisis response services, strategies to make crisis response services available 24/7 in medically underserved regions, and best practices used by States and health providers for maximizing capacity to deliver crisis response services, such as identifying and repurposing available beds, space, and staff for crisis response services.
(8)
Describes best practices for coordinating Medicaid and CHIP funding with other payors and sources of Federal funding for mental health and substance use disorder crisis response services, and best practices for Medicaid and CHIP financing when the continuum of crisis response services serves individuals regardless of payor.
(9)
Describes best practices for establishing effective connections with follow-on mental health and substance use disorder services, as well as with social services and supports.
(10)
Describes best practices for coordinating and financing a continuum of crisis response services through Medicaid managed care organizations, prepaid inpatient health plans, prepaid ambulatory health plans, and fee-for-service delivery systems, including when States carve-out from delivery through Medicaid managed care organizations, prepaid inpatient health plans, prepaid ambulatory health plans, or fee-for-service systems, mental health or substance use disorder benefits or a subset of such services.
(11)
Identifies strategies and best practices for measuring and monitoring utilization of, and outcomes related to, crisis response services.
(b)
Technical Assistance Center.—
(1)
In general.— Not later than July 1, 2025, the Secretary, in coordination with the Administrator of the Centers for Medicare & Medicaid Services and the Assistant Secretary for Mental Health and Substance Use, shall establish a technical assistance center to help States under Medicaid and CHIP design, implement, or enhance a continuum of crisis response services for children, youth, and adults. Such technical assistance shall, at least in part, provide support to States in—
(A)
leveraging the Federal authorities through which Medicaid and CHIP may finance mental health and substance use disorder crisis response services;
(B)
coordinating Medicaid and CHIP funds with other sources of Federal funding for mental health and substance use disorder crisis response services; and
(C)
after the guidance described in subsection (a) is issued, adopting the best practices and strategies identified in such guidance.
(2)
Compendium of best practices.— The Secretary shall develop and maintain a publicly available compendium of best practices for the successful operation under Medicaid and CHIP of a continuum of crisis response services. The Secretary annually shall review the information available through the compendium and shall update such information when appropriate.
(c)
Funding.— There is appropriated to the Secretary, out of any funds in the Treasury not otherwise appropriated, to remain available until expended for purposes of carrying out subsections (a) and (b), $8,000,000.
(d)
Definitions.— In this section:
(1)
Secretary.— The term “Secretary” means the Secretary of Health and Human Services.
(2)
State.— The term “State” means each of the 50 States, the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

Subtitle D Transitioning From Medicaid FMAP Increase Requirements

SEC. 5131. Transitioning from Medicaid Fmap Increase Requirements.

(a)
In General.— Section 6008 of the Families First Coronavirus Response Act (42 U.S.C. 1396d note) is amended—
(1)
in subsection (a)—
(A)
by striking “ Subject to subsection (b)” and inserting the following:

“(1) Temporary fmap increase.—Subject to subsections (b) and (f)”

(B)
by striking “ the last day of the calendar quarter in which the last day of such emergency period occurs” and inserting “ December 31, 2023”;
(C)
by striking “ 6.2 percentage points” and inserting “ the applicable number of percentage points for the quarter (as determined in paragraph (2))”; and
(D)
by adding at the end the following new paragraph:

“(2) Applicable number of percentage points.—For purposes of paragraph (1), the applicable number of percentage points for a calendar quarter is the following:

“(A) For each calendar quarter that occurs during the portion of the period described in paragraph (1) that ends on March 31, 2023, 6.2 percentage points.

“(B) For the calendar quarter that begins on April 1, 2023, and ends on June 30, 2023, 5 percentage points.

“(C) For the calendar quarter that begins on July 1, 2023, and ends on September 30, 2023, 2.5 percentage points.

“(D) For the calendar quarter that begins on October 1, 2023, and ends on December 31, 2023, 1.5 percentage points.”

(2)
in subsection (b)—
(A)
in the matter preceding paragraph (1), by striking “ subsection (a)” and inserting “ subsection (a)(1)”;
(B)
in paragraph (2), by striking “ , with respect to an individual enrolled under such plan (or waiver),”; and
(C)
in paragraph (3)—
(i)
by striking “ as of the date of enactment of this section” and inserting “ as of March 18, 2020,”;
(ii)
by striking “ such date of enactment” and inserting “ March 18, 2020,”;
(iii)
by striking “ the last day of the month in which the emergency period described in subsection (a) ends” and inserting “ March 31, 2023,”; and
(iv)
by striking “ the end of the month in which such emergency period ends” and inserting “ March 31, 2023,”;
(3)
by redesignating the subsection (d) added by section 11 of division X of the Consolidated Appropriations Act, 2021 (Public Law 116–260) as subsection (e); and
(4)
by adding at the end the following new subsections:

“(f) Eligibility Redeterminations During Transition Period.—

“(1) In general.—For each calendar quarter occurring during the portion of the period described in subsection (a)(1) that begins on April 1, 2023, and ends on December 31, 2023 (such portion to be referred to in this subsection as the ‘transition period’), if a State described in such subsection satisfies the conditions of subsection (b) and paragraph (2) of this subsection, the State shall receive the increase to the Federal medical assistance percentage of the State applicable under subsection (a). Nothing in this subsection shall be construed as prohibiting a State, following the expiration of the condition described in paragraph (3) of subsection (b), from initiating renewals, post-enrollment verifications, and redeterminations over a 12-month period for all individuals who are enrolled in such plan (or waiver) as of April 1, 2023.

“(2) Conditions for fmap increase during transition period.—The conditions of this paragraph with respect to a State and the transition period are the following:

“(A) Compliance with federal requirements.—The State conducts eligibility redeterminations under title XIX of the Social Security Act in accordance with all Federal requirements applicable to such redeterminations, including renewal strategies authorized under section 1902(e)(14)(A) of the Social Security Act (42 U.S.C. 1396a(e)(14)(A)) or other alternative processes and procedures approved by the Secretary of Health and Human Services.

“(B) Maintenance of up-to-date contact information.—The State, using the National Change of Address Database Maintained by the United States Postal Service, State health and human services agencies, or other reliable sources of contact information, attempts to ensure that it has up-to-date contact information (including a mailing address, phone number, and email address) for each individual for whom the State conducts an eligibility redetermination.

“(C) Requirement to attempt to contact beneficiaries prior to disenrollment.—The State does not disenroll from the State plan or waiver any individual who is determined ineligible for medical assistance under the State plan or waiver pursuant to such a redetermination on the basis of returned mail unless the State first undertakes a good faith effort to contact the individual using more than one modality.

“(g) Applicable Quarters.—A State that ceases to meet the requirements of subsection (b) or (f) (as applicable) shall not qualify for the increase described in subsection (a) in the Federal medical assistance percentage for such State for the calendar quarter in which the State ceases to meet such requirements.”

(b)
Reporting and Enforcement and Corrective Action.— Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection:

“(tt) Requirements Relating to Transition From Families First Coronavirus Response Act FMAP Increase Requirements; Enforcement and Corrective Action.—

“(1) Reporting requirements.—For each month occurring during the period that begins on April 1, 2023, and ends on June 30, 2024, each State shall submit to the Secretary, on a timely basis, a report, that the Secretary shall make publicly available, on the activities of the State relating to eligibility redeterminations conducted during such period, and which include, with respect to the month for which the report is submitted, the following information:

“(A) The number of eligibility renewals initiated, beneficiaries renewed on a total and ex parte basis, and individuals whose coverage for medical assistance, child health assistance, or pregnancy-related assistance was terminated.

“(B) The number of individuals whose coverage for medical assistance, child health assistance, or pregnancy-related assistance was so terminated for procedural reasons.

“(C) Where applicable, the number of individuals who were enrolled in a State child health plan or waiver in the form described in paragraph (1) of section 2101(a).

“(D) Unless the Administrator of the Centers for Medicare & Medicaid Services reports such information on behalf of the State:

“(i) In a State with a Federal or State American Health Benefit Exchange established under title I of the Patient Protection and Affordable Care Act in which the systems used to determine eligibility for assistance under this title or title XXI are not integrated with the systems used to determine eligibility for coverage under a qualified health plan with advance payment under section 1412(a) of the Patient Protection and Affordable Care Act of any premium tax credit allowed under section 36B of the Internal Revenue Code of 1986—

“(I) the number of individuals whose accounts were received via secure electronic transfer by the Federal or State American Health Benefit Exchange, or a basic health program established under section 1331 of the Patient Protection and Affordable Care Act;

“(II) the number of individuals identified in subclause (I) who were determined eligible for a qualified health plan, as defined in section 1301(a)(1) of the Patient Protection and Affordable Care Act, or (if applicable) the basic health program established under section 1331 of such Act; and

“(III) the number of individuals identified in subclause (II) who made a qualified health plan selection or were enrolled in a basic health program plan (if applicable).

“(ii) In a State with a State American Health Benefit Exchange established under title I of the Patient Protection and Affordable Care Act in which the systems used to determine eligibility for assistance under this title or title XXI are integrated with the systems used to determine eligibility for coverage under a qualified health plan with advance payment under section 1412(a) of the Patient Protection and Affordable Care Act of any premium tax credit allowed under section 36B of the Internal Revenue Code of 1986—

“(I) the number of individuals who were determined eligible for a qualified health plan, as defined in section 1301(a)(1) of the Patient Protection and Affordable Care Act, or (if applicable) the basic health program established under section 1331 of such Act; and

“(II) the number of individuals identified in subclause (I) who made a qualified health plan selection or were enrolled in a basic health program plan (if applicable).

“(E) The total call center volume, average wait times, and average abandonment rate (as determined by the Secretary) for each call center of the State agency responsible for administering the State plan under this title (or a waiver of such plan) during such month.

“(F) Such other information related to eligibility redeterminations and renewals during the period described in paragraph (1), as identified by the Secretary.

“(2) Enforcement and corrective action.—

“(A) In general.—For each fiscal quarter that occurs during the period that begins on July 1, 2023, and ends on June 30, 2024, if a State does not satisfy the requirements of paragraph (1), the Federal medical assistance percentage determined for the State for the quarter under section 1905(b) shall be reduced by the number of percentage points (not to exceed 1 percentage point) equal to the product of 0.25 percentage points and the number of fiscal quarters during such period for which the State has failed to satisfy such requirements.

“(B) Corrective action plan; additional authority.—

“(i) In general.—The Secretary may assess a State’s compliance with all Federal requirements applicable to eligibility redeterminations and the reporting requirements described in paragraph (1), and, if the Secretary determines that a State did not comply with any such requirements during the period that begins on April 1, 2023, and ends on June 30, 2024, the Secretary may require the State to submit and implement a corrective action plan in accordance with clause (ii).

“(ii) Corrective action plan.—A State that receives a written notice from the Secretary that the Secretary has determined that the State is not in compliance with a requirement described in clause (i) shall—

“(I) not later than 14 days after receiving such notice, submit a corrective action plan to the Secretary;

“(II) not later than 21 days after the date on which such corrective action plan is submitted to the Secretary, receive approval for the plan from the Secretary; and

“(III) begin implementation of such corrective action plan not later than 14 days after such approval.

“(iii) Effect of failure to submit or implement a corrective action plan.—If a State fails to submit or implement an approved corrective action plan in accordance with clause (ii), the Secretary may, in addition to any reduction applied under subparagraph (A) to the Federal medical assistance percentage determined for the State and any other remedy available to the Secretary for the purpose of carrying out this title, require the State to suspend making all or some terminations of eligibility for medical assistance from the State plan under this title (including any waiver of such plan) that are for procedural reasons until the State takes appropriate corrective action, as determined by the Secretary, and may impose a civil money penalty of not more than $100,000 for each day a State is not in compliance.”

(c)
Effective Date.— The amendments made by this section take effect on April 1, 2023.

Subtitle E Medicaid Improvement Fund

SEC. 5141. Medicaid Improvement Fund.

Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w–1(b)(3)(A)) is amended by striking “ for fiscal year 2025 and thereafter, $0” and inserting “ for fiscal year 2028 and thereafter, $7,000,000,000”.

TITLE VI Human Services

SEC. 6101. Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022.

(a)
Short Title.— This section may be cited as the “Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022”.
(b)
Outcomes Dashboard.— Section 511(d)(1) of the Social Security Act (42 U.S.C. 711(d)(1)) is amended—
(1)
in the paragraph heading, by striking “ benchmark areas” and inserting “ benchmark areas related to individual family outcomes”;
(2)
in subparagraph (D)(i), by striking “ (B)” and inserting “ (C)”; and
(3)
by redesignating subparagraphs (B) through (D) as subparagraphs (C) through (E), respectively, and inserting after subparagraph (A) the following:

“(B) Outcomes dashboards.—The Secretary shall, directly or by grant or contract, establish and operate a website accessible to the public that includes an annually updated dashboard that—

“(i) provides easy-to-understand information on the outcomes achieved by each eligible entity with respect to each of the benchmarks described in subparagraph (A) of this paragraph that apply to the eligible entity, which shall be based on only the data elements or types of data collected before the date of the enactment of this section unless administering agencies and the Secretary agree pursuant to subsection (h)(6) that additional data is required;

“(ii) includes a template provided by the Secretary that will enable comparison among eligible entities not referred to in subsection (k)(2)(A) of—

“(I) a profile of each eligible entity showing outcome indicators and how the outcomes compare to benchmarks described in subclause (II);

“(II) information on the outcome indicators and requisite outcome levels established for each eligible entity;

“(III) information on each model employed in the program operated by each eligible entity, and regarding each benchmark area described in subsection (d)(1)(A) in which the model used by the eligible entity is expected to affect participant outcomes;

“(IV) the most recently available information from the report required by subparagraph (E) of this paragraph;

“(V) an electronic link to the State needs assessment under subsection (b)(1); and

“(VI) information regarding any penalty imposed, or other corrective action taken, by the Secretary against a State for failing to achieve a requisite outcome level or any other requirement imposed by or under this section, and an indication as to whether the eligible entity is operating under a corrective action plan under subparagraph (E)(ii) of this paragraph, and if so, a link to the plan, an explanation of the reason for the implementation of the plan, and a report on any progress made in operating under the plan;

“(iii) includes information relating to those eligible entities for which funding is reserved under subsection (k)(2)(A), with modifications as necessary to reflect tribal sovereignty, data privacy, and participant confidentiality; and

“(iv) protects data privacy and confidentiality of participant families.”

(c)
Funding.—
(1)
Grant amounts.—
(A)
In general.— Section 511(c)(4) of the Social Security Act (42 U.S.C. 711(c)(4)) is amended to read as follows:

“(4) Grant amounts.—

“(A) Base grants.—

“(i) In general.—

“(I) General rule.—With respect to each of fiscal years 2023 through 2027 for which an eligible entity not referred to in subsection (k)(2)(A) is awarded a base grant under this section, the amount of the grant payable to the eligible entity for the fiscal year is the amount described by clause (ii) of this subparagraph with respect to the eligible entity, except as provided in subclause (II) of this clause.

“(II) Substitution of successor eligible entity for predecessor.—If the 1st fiscal year for which an eligible entity is awarded a base grant under this section for a program operated in a State is among fiscal years 2024 through 2027, the amount described by clause (ii) with respect to the eligible entity is the amount of the base grant for which a program operated in the State was eligible under this subparagraph for fiscal year 2023.

“(ii) Amount described.—

“(I) General rule.—Subject to the succeeding provisions of this clause, the amount described by this clause with respect to an eligible entity is—

“(aa) the amount made available under subsection (k) for base grants for fiscal year 2023 that remains after making the reservations required by subsection (k)(2) or any other reductions required by Federal law for fiscal year 2023; multiplied by

“(bb) the percentage of children in all States who have not attained 5 years of age (as determined by the Secretary on the basis of the data most recently available before fiscal year 2023) that is represented by the number of such children in the State in which the eligible entity is operating a program pursuant to this section (as so determined).

“(II) Adjustments to ensure stable funding.—If the amount otherwise payable to an eligible entity under subclause (I) for fiscal year 2023 is less than 90 percent, or greater than 110 percent, of the amount payable under this section to the eligible entity for the program for fiscal year 2021, the Secretary shall increase the amount otherwise so payable to 90 percent, or decrease the amount otherwise so payable to 110 percent, as the case may be, of the amount otherwise so payable.

“(III) Adjustment to ensure all base grant funds are allocated.—If the amount described by subclause (I)(aa) is different than the total of the amounts otherwise described by subclause (I) after applying subclause (II), the Secretary shall increase or decrease the amounts otherwise so described after applying subclause (II) by such equal percentage as is necessary to reduce that difference to zero.

“(IV) Minimum base grant amount.—Notwithstanding the preceding provisions of this clause, the amount described by this clause with respect to an eligible entity shall be not less than $1,000,000.

“(B) Matching grants.—

“(i) Amount of grant.—

“(I) General rule.—With respect to each of fiscal years 2024 through 2027 for which an eligible entity not referred to in subsection (k)(2)(A) is awarded a grant under this section, the Secretary shall increase the amount of the grant payable to the eligible entity for the fiscal year under subparagraph (A) of this paragraph by the matching amount (if any) determined under subclause (II) of this clause with respect to the eligible entity for the fiscal year and the additional matching amount (if any) determined under clause (iii) of this subparagraph with respect to the eligible entity for the fiscal year.

“(II) Matching amount.—

“(aa) In general.—Subject to item (bb) of this subclause, the matching amount with respect to an eligible entity for a fiscal year is 75 percent of the sum of—

“(AA) the total amount obligated by the eligible entity for home visiting services in the State for the fiscal year, from Federal funds made available for the fiscal year under this subparagraph; and

“(BB) the total amount so obligated by the eligible entity from non-Federal funds, determined under subclause (III).

“(bb) Limitation.—The matching amount with respect to an eligible entity for a fiscal year shall not exceed the allotment under subclause (IV) for the State in which the eligible entity is operating a program under this section for the fiscal year.

“(III) Determination of obligations from non-federal funds.—For purposes of this clause, the total amount obligated by an eligible entity from non-Federal funds is the total of the amounts that are obligated by the eligible entity from non-Federal sources, to the extent that—

“(aa) the services are delivered in compliance with subsections (d)(2) and (d)(3);

“(bb) the eligible entity has reported the obligations to the Secretary; and

“(cc) the amount is not counted toward meeting the maintenance of effort requirement in subsection (f).

“(IV) State allotments.—The amount allotted under this subclause for a State in which an eligible entity is operating a program under this section for a fiscal year is—

“(aa) the minimum matching grant allocation amount for the fiscal year; plus

“(bb)

(AA) the amount (if any) by which the amount made available under subsection (k) for matching grants for the fiscal year that remains after making the reservations required by subsection (k)(2) or any other reduction required by Federal law for the fiscal year exceeds the sum of the minimum matching grant allocation amounts for all eligible entities for the fiscal year; multiplied by

“(BB) the percentage of children in all States who have not attained 5 years of age and are members of families with income not exceeding the poverty line (as determined by the Secretary on the basis of the most recently available data) that is represented by the number of such children in the State (as so determined).

“(V) Minimum matching grant allocation amount.—Subject to subclause (VI), for purposes of subclause (IV), the minimum matching grant allocation amount for a fiscal year is—

“(aa) in the case of fiscal year 2024, $776,000;

“(bb) in the case of fiscal year 2025, $1,000,000;

“(cc) in the case of fiscal year 2026, $1,500,000; and

“(dd) in the case of fiscal year 2027, $2,000,000.

“(VI) Special rule.—If, after making any reductions otherwise required by law for a fiscal year, the amount made available for matching grants under this clause for the fiscal year is insufficient to provide the minimum matching grant allocation amount to each eligible entity operating a program under this section for the fiscal year, the Secretary may make a proportionate adjustment to the minimum matching grant allocation amount for the fiscal year to accommodate the reductions.

“(ii) Submission of statement expressing interest in additional matching funds if available.—Before the beginning of a fiscal year for which an eligible entity desires a matching grant under this subparagraph for a program operated under this section, the eligible entity shall submit to the Secretary a statement as to whether the eligible entity desires additional matching grant funds that may be made available under clause (iii) for the fiscal year.

“(iii) Carryover and reallocation of unobligated funds.—

“(I) In general.—If the Secretary determines that an amount allotted under clause (i)(IV) of this subparagraph for a fiscal year will not be awarded during the fiscal year, or that an amount made available under subsection (k)(1) for a fiscal year for matching grants will not be obligated by an eligible entity for the fiscal year, the amount shall be available for matching grants under this subparagraph for the succeeding fiscal year for eligible entities that have made submissions under clause (ii) of this subparagraph for additional matching grant funds from the amount.

“(II) State allotments.—The Secretary shall allot to each eligible entity that has made such a submission for a fiscal year—

“(aa) the total amount (if any) made available under subclause (I) for the fiscal year; multiplied by

“(bb) the percentage of children who have not attained 5 years of age and are members of families with income not exceeding the poverty line (as determined by the Secretary on the basis of the most recently available data) in all of the States in which any eligible entity that has made such a submission is so operating a program, that is represented by the number of such children in the State (as so determined) in which the eligible entity is operating such a program.

“(III) Additional matching amount.—

“(aa) In general.—Subject to item (bb) of this subclause, the additional matching amount with respect to an eligible entity for a fiscal year is 75 percent of the sum of—

“(AA) the total amount obligated by the eligible entity for home visiting services in the State for the fiscal year, from Federal funds made available for the fiscal year under this subparagraph; and

“(BB) the total amount so obligated by the eligible entity from non-Federal funds, determined under clause (i)(III),

“(bb) Limitation.—The additional matching amount with respect to an eligible entity for a fiscal year shall not exceed the allotment under subclause (II) for the State in which the eligible entity is operating a program under this section for the fiscal year.”

(B)
Maintenance of effort.— Section 511(f) of such Act (42 U.S.C. 711) is amended to read as follows:

“(f) Maintenance of Effort.—

“(1) In general.—Notwithstanding any other provision of this section, the Secretary may not make a grant to an eligible entity under this section for a fiscal year if the total amount of non-Federal funds obligated by the eligible entity in the State in the fiscal year for a program operated pursuant to this section is less than the total amount of non-Federal funds reported to have been expended by any eligible entity for such a program in the State in fiscal year 2019 or 2021, whichever is the lesser.

“(2) Publication of amounts.—Not later than June 30, 2023, the Secretary shall cause to have published in the Federal Register the amount of non-Federal funds expended as described in this section that has been reported by each eligible entity not referred to in subsection (k)(2)(A) for each of fiscal years 2019 and 2021.

“(3) Grace period.—The Secretary may, in exceptional circumstances, allow an eligible entity a period to come into compliance with this subsection. The Secretary shall provide technical assistance to any eligible entity to assist the entity in doing so.”

(2)
Reservations of funds for certain purposes.— Section 511(j)(2) of such Act (42 U.S.C. 711(j)(2)) is amended—
(A)
in the matter preceding subparagraph (A), by striking “ the amount” and inserting “ each amount made available for base grants and each amount made available for matching grants”;
(B)
in subparagraph (A)—
(i)
by striking “ 3” and inserting “ 6”;
(ii)
by inserting “ and administering” before “ grants”; and
(iii)
by striking “ and” at the end; and
(C)
by striking subparagraph (B) and inserting the following:

“(B) 2 percent of such amount for purposes of providing technical assistance, directly or through grants or contracts—

“(i) for purposes as otherwise described in subsections (c)(5), (d)(1)(C)(iii), (d)(1)(E)(iii), and (d)(4)(E); and

“(ii) to entities referred to in subparagraph (A) of this paragraph;

“(C) 2 percent of such amount for purposes of the provision of workforce support, retention, and case management, including workforce-related technical assistance, to eligible entities, research and evaluation, and program administration, directly or through grants or contracts, of which the Secretary shall use not more than $1,500,000 to establish and operate the Jackie Walorski Center for Evidence-Based Case Management; and

“(D) 3 percent of such amount for purposes of research and evaluation (directly or through grants or contracts), and for administering this section (directly, through contracts, or otherwise).”

(3)
Appropriations.—
(A)
In general.— Section 511(j)(1) of the Social Security Act (42 U.S.C. 711(j)(1)) is amended by striking subparagraphs (A) through (H) and inserting the following:

“(A) for fiscal year 2023, $500,000,000 for base grants;

“(B) for fiscal year 2024, $550,000,000, of which $500,000,000 shall be for base grants and $50,000,000 shall be for matching grants;

“(C) for fiscal year 2025, $600,000,000, of which $500,000,000 shall be for base grants and $100,000,000 shall be for matching grants;

“(D) for fiscal year 2026, $650,000,000, of which $500,000,000 shall be for base grants and $150,000,000 shall be for matching grants; and

“(E) for fiscal year 2027, $800,000,000, of which $500,000,000 shall be for base grants and $300,000,000 shall be for matching grants.”

(B)
Special rule.— Obligations and expenditures made pursuant to section 201 of division D of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (Public Law 117–180) and section 201 of division C of the Further Continuing Appropriations and Extensions Act, 2023 shall be charged to the appropriation made by section 511(j)(1)(A) of the Social Security Act for fiscal year 2023 (as added by subparagraph (A) of this paragraph).
(C)
Repeal.— Section 201 of title II of division D of Public Law 117–180 and section 201 of division C of the Further Continuing Appropriations and Extensions Act, 2023 are hereby repealed.
(4)
Disposition of excess funds reserved for research, evaluation, and administration.— Section 511(j) of the Social Security Act (42 U.S.C. 711(j)) is amended by adding at the end the following:

“(5) Disposition of excess funds reserved for research, evaluation, and administration.—To the extent that the amounts reserved under paragraph (2)(D) for a fiscal year are not obligated in the fiscal year, the Secretary may use the funds for any purpose described in this section or to offset any reduction with respect to this section that is required by Federal law.”

(d)
Requirement That Home Visiting Programs Be Targeted and Intensive.— Section 511(d)(3) of the Social Security Act (42 U.S.C. 711(d)(3)) is amended by redesignating subparagraph (B) as subparagraph (C) and inserting after subparagraph (A) the following:

“(B) Use of grant to provide or support targeted, intensive home visiting services.—The program uses the grant to provide or support targeted, intensive home visiting services for the populations described in paragraph (5).”

(e)
Limitation on Use of Funds for Administration.—
(1)
In general.— Section 511(d) of the Social Security Act (42 U.S.C. 711(d)) is amended by adding at the end the following:

“(5) Limitation on use of funds for administrative costs.—

“(A) In general.—Except as provided in subparagraph (B) of this paragraph, an eligible entity to which funds are provided under subsection (c) or (h)(2)(B) shall not use more than 10 percent of the funds to cover the costs of administration.

“(B) Authority to grant exceptions.—

“(i) In general.—The Secretary may authorize an eligible entity that meets a condition of clause (ii) of this subparagraph to exceed the percentage limitation in subparagraph (A) with respect to a program conducted under this subsection by not more than 5 percentage points, subject to such terms and conditions as the Secretary deems appropriate.

“(ii) Conditions.—An eligible entity meets a condition of this clause if the eligible entity—

“(I) conducts the program by directly providing home visits to eligible families and without a sub-recipient;

“(II) in the fiscal year for which the grant for the program is made under this section, proposes to expand services in 1 or more communities identified in the statewide needs assessment under subsection (b) and in which home visiting services are not provided; or

“(III) has conducted the program for fewer than 3 years.”

(2)
Conforming amendments.— Section 511(i)(2) of such Act (42 U.S.C. 711(i)(2)) is amended by striking subparagraph (C) and redesignating subparagraphs (D) through (G) as subparagraphs (C) through (F), respectively.
(f)
Annual Report to Congress.—
(1)
In general.— Section 511 of the Social Security Act (42 U.S.C. 711) is amended by redesignating subsections (j) and (k) as subsections (k) and (l), respectively, and inserting after subsection (i) the following:

“(j) Annual Report to Congress.—By December 31, 2023, and annually thereafter, the Secretary shall submit to the Congress a written report on the grants made under this section for the then preceding fiscal year, which shall include—

“(1) an eligible entity-by-eligible entity summary of the outcomes measured by the entity with respect to each benchmark described in subsection (e)(5) that apply to the entity;

“(2) information regarding any technical assistance funded under subparagraph (B) or (C) of subsection (k)(2), including the type of any such assistance provided;

“(3) information on the demographic makeup of families served by each such entity to the extent possible while respecting participant confidentiality, including race, ethnicity, educational attainment at enrollment, household income, and other demographic markers as determined by the Secretary;

“(4) the information described in subsection (d)(1)(E);

“(5) the estimated share of the eligible population served using grants made under this section;

“(6) a description of each service delivery model funded under this section by the eligible entities in each State, and the share (if any) of the grants expended on each model;

“(7) a description of non-Federal expenditures by eligible entities to qualify for matching funds under subsection (c)(4);

“(8) information on the uses of funds reserved under subsection (k)(2)(C);

“(9) information relating to those eligible entities for which funding is reserved under subsection (k)(2)(A), with modifications as necessary to reflect tribal data sovereignty, data privacy, and participant confidentiality; and

“(10) a list of data elements collected from eligible entities, and the purpose of each data element in measuring performance or enforcing requirements under this section.”

(2)
Conforming amendments.—
(A)
Section 511 of such Act (42 U.S.C. 711) is amended—
(i)
in subsection (b)(1)(B)(iii), by striking “ (k)(2)” and inserting “ (l)(2)”; and
(ii)
in subsection (h)(2)(B)—
(I)
by striking “ (j)” and inserting “ (k)”; and
(II)
by striking “ (k)(1)(B)” and inserting “ (l)(1)(B)”.
(B)
Section 511A(c) of such Act (42 U.S.C. 711a(c)) is amended in each of paragraphs (5) and (7) by striking “ 511(k)(2)” and inserting “ 511(l)(2)”.
(g)
Reduction of Administrative Burden.— Section 511(h) of the Social Security Act (42 U.S.C. 711(h)) is amended by adding at the end the following:

“(6) Reduction of administrative burden.—

“(A) In general.—The Secretary shall reduce the burden, on States and public and private implementing agencies at the local level, of administering this section, by—

“(i) reviewing and revising administrative data collection instruments and forms to eliminate duplication and streamline reporting requirements for States, eligible entities referred to in subsection (k)(2)(A), and nonprofit organizations referred to in subsection (l)(1)(B), including timelines for submitting reports;

“(ii) conducting an analysis of the total number of hours reported by administering agencies on complying with paperwork requirements, and exploring, in consultation with administering agencies, ways to reduce the number of hours spent by at least 15 percent;

“(iii) conducting a review of paperwork and data collection requirements for tribal grantees, and exploring, in consultation with tribes and tribal organizations, ways to reduce administrative burden, respect sovereignty, and acknowledge the different focus points for tribal grantees;

“(iv) collecting input from relevant State fiscal officials to align fiscal requirements and oversight for States and eligible entities to ensure consistency with standards and guidelines for other Federal formula grant programs; and

“(v) consulting with administering agencies and service delivery model representatives on needed and unneeded data elements regarding the dashboards provided for in subsection (d)(1)(B), consistent with the data requirements of such subsection.

“(B) Findings on paperwork reduction.—

“(i) Inclusion in report.—In the 1st report submitted pursuant to subsection (j) more than 18 months after the date of the enactment of this Act, the Secretary shall include the findings of the Secretary with respect to the matters described in subparagraph (A).

“(ii) Implementation.—Within 2 years after complying with clause (i), the Secretary shall implement the findings referred to in clause (i).”

(h)
Virtual Home Visiting Authorization and Restrictions.—
(1)
Virtual home visits.—
(A)
Application requirements.— Section 511(e) of the Social Security Act (42 U.S.C. 711(e)) is amended by redesignating paragraph (10) as paragraph (11) and inserting after paragraph (9) the following:

“(10) At the option of the eligible entity—

“(A) a description of any limitations or constraints on virtual home visits under the program, including—

“(i) a description of the plan of the eligible entity to encourage in-person home visits; and

“(ii) a description of the considerations to be used in determining when a virtual home visit is appropriate, including client consent, client preference, geographic limitations, model fidelity, and hazardous conditions including public health emergencies, weather events, health concerns for home visitors and client families, and other local issues;

“(B) an assurance that—

“(i) the virtual home visit is implemented as a model enhancement; or

“(ii) the Secretary has identified the home visit as part of an effective model or model adaptation, based on an evidence of effectiveness review conducted using the criteria established under subsection (d)(3)(A)(iii); and

“(C) an assurance to the Secretary that at least 1 in-person home visit shall be conducted for each client family under the program during the 12-month period that begins with the entry of the client family into the program, and during each succeeding 12-month period, except that any such period in which a public health emergency declared under Federal law, or under the law of the State in which the program is conducted, is in effect shall be extended by the length of time in which the declaration is in effect.”

(B)
Applicable rules.— Section 511(d) of such Act (42 U.S.C. 711(d)) is amended by redesignating paragraph (4) and paragraph (5) (as added by subsection (e)(1) of this section) as paragraphs (5) and (6), respectively, and inserting after paragraph (3) the following:

“(4) Virtual home visits.—

“(A) In general.—A virtual home visit conducted under the program shall be considered a home visit for purposes of this section if the application for funding of the program submitted pursuant to this section most recently after the effective date of this paragraph includes the material described in subsection (e)(10).

“(B) Standards for training applicable to virtual service delivery.—The standards for training requirements applicable to virtual service delivery under a home visiting model shall be equivalent to those that apply to in-person service delivery under the model.

“(C) Reporting requirement.—A grant made under this section for the program may not be used for any virtual home visit during a year, unless the eligible entity to which the grant is made submits the report described in subsection (e)(8)(A) for the year.

“(D) Virtual home visit defined.—In this section, the term ‘virtual home visit’ means a visit conducted solely by use of electronic information and telecommunications technologies.

“(E) Technical assistance.—If the Secretary finds that an eligible entity has not complied with the assurance described in subsection (e)(10)(C), the Secretary shall, directly or through grants, contracts, or cooperative agreements, provide the eligible entity with such technical assistance as is necessary to assist the eligible entity in doing so.”

(C)
Program requirement.— Section 511(d)(3)(C) of such Act (42 U.S.C. 711(d)(3)(C)), as so redesignated by subsection (d) of this section, is amended by adding at the end the following:

“(vii) If the application submitted by the eligible entity includes the assurance described in subsection (e)(10)(C) with respect to the program, the program provides in-person service consistent with the assurances.”

(D)
Reports.— Section 511(e)(8)(A) of such Act (42 U.S.C. 711(e)(8)(A)) is amended by inserting “ , including the number of virtual home visits conducted under the program in the year covered by the report, disaggregated with respect to each home visiting model under which the virtual home visits are conducted” before the semicolon.
(2)
Transition rule.—
(A)
In general.— A virtual home visit conducted before the effective date of the amendments made by this subsection under an early childhood home visitation program funded under section 511 of the Social Security Act shall be considered a home visit for purposes of such section.
(B)
Virtual home visit defined.— In subparagraph (A), the term “virtual home visit” means a visit conducted solely by use of electronic information and telecommunications technologies.
(i)
Effective Date.—
(1)
In general.— Except as provided in paragraph (2), this section and the amendments made by this section shall take effect on October 1, 2022.
(2)
Virtual home visiting provisions.— The amendments made by subsection (h) shall take effect on October 1, 2023.

SEC. 6102. Extension of Temporary Assistance for Needy Families Program.

Activities authorized by part A of title IV (other than under section 403(c) or 418) and section 1108(b) of the Social Security Act shall continue through September 30, 2023, in the manner authorized for fiscal year 2022, and out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated such sums as may be necessary for such purpose.

SEC. 6103. 1-Year Extension of Child and Family Services Programs.

(a)
The following provisions of the Social Security Act are each amended by striking “ 2022” and inserting “ 2023”:
(1)
Section 436(a) (42 U.S.C. 629f(a)).
(2)
Section 436(b)(4)(A) (42 U.S.C. 629f(b)(4)(A)).
(3)
Section 436(b)(5) (42 U.S.C. 629f(b)(5)).
(4)
Section 438(d) (42 U.S.C. 629h(d)).
(b)
The following provisions of the Social Security Act are each amended by striking “ 2021” and inserting “ 2023”:
(1)
Section 425 (42 U.S.C. 625).
(2)
Section 437(a) (42 U.S.C. 629g(a)).
(3)
Section 437(f)(3)(A) (42 U.S.C. 629g(f)(3)(A)).
(4)
Section 437(f)(10) (42 U.S.C. 629g(f)(10)).

TITLE VII Supplemental Funding for the World Trade Center Health Program

SEC. 7701. Supplemental Funding for the World Trade Center Health Program.

(a)
In General.— Title XXXIII of the Public Health Service Act (42 U.S.C. 300mm et seq.) is amended by adding at the end the following:

“SEC. 3352. SUPPLEMENTAL FUND.

“(a) In General.—There is established a fund to be known as the World Trade Center Health Program Supplemental Fund (referred to in this section as the ‘Supplemental Fund’), consisting of amounts deposited into the Fund under subsection (b).

“(b) Amount.—Out of any money in the Treasury not otherwise appropriated, there is appropriated for fiscal year 2023 $1,000,000,000, for deposit into the Supplemental Fund, which amounts shall remain available through fiscal year 2032.

“(c) Uses of Funds.—Amounts deposited into the Supplemental Fund under subsection (b) shall be available, without further appropriation and without regard to any spending limitation under section 3351(c), to the WTC Program Administrator as needed at the discretion of such Administrator, for carrying out any provision in this title, including sections 3303 and 3341(c).

“(d) Return of Funds.—Any amounts that remain in the Supplemental Fund on September 30, 2032, shall be deposited into the Treasury as miscellaneous receipts.”

(b)
Conforming Amendments.— Title XXXIII of the Public Health Service Act (42 U.S.C. 300mm et seq.) is amended—
(1)
in section 3311(a)(4)(B)(i)(II) (42 U.S.C. 300mm–21(a)(4)(B)(i)(II)), by striking “ section 3351” and inserting “ sections 3351 and 3352”;
(2)
in section 3321(a)(3)(B)(i)(II) (42 U.S.C. 300mm–31(a)(3)(B)(i)(II)), by striking “ section 3351” and inserting “ sections 3351 and 3352”;
(3)
in section 3331 (42 U.S.C. 300mm–41)—
(A)
in subsection (a), by inserting “ and the World Trade Center Health Program Supplemental Fund” before the period at the end; and
(B)
in subsection (d)—
(i)
in paragraph (1)(B), by inserting “ (excluding any expenditures from amounts in the World Trade Center Health Program Supplemental Fund under section 3352)” before the period at the end; and
(ii)
in paragraph (2), in the flush text following subparagraph (C), by inserting “ (excluding any expenditures from amounts in the World Trade Center Health Program Supplemental Fund under section 3352)” before the period at the end; and
(4)
in section 3351(b) (42 U.S.C. 300mm–61(b))—
(A)
in paragraph (2), by inserting “ or as available from the World Trade Center Health Program Supplemental Fund under section 3352” before the period at the end; and
(B)
in paragraph (3), by inserting “ or as available from the World Trade Center Health Program Supplemental Fund under section 3352” before the period at the end.
(c)
Prevention and Public Health Fund.— Section 4002(b) of the Patient Protection and Affordable Care Act (42 U.S.C. 300u-11(b)) is amended—
(1)
in paragraph (8), by striking “ $1,800,000,000; and” and inserting “ $1,525,000,000;”;
(2)
by striking paragraph (9) and inserting the following:

“(9) for each of fiscal years 2028 and 2029, $1,725,000,000; and”

; and

(3)
by adding at the end the following:

“(10) for fiscal year 2030 and each fiscal year thereafter, $2,000,000,000.”

SEC. 7702. Research Cohort for Emerging Health Impacts on Youth.

(a)
In General.— Section 3341 of the Public Health Service Act (42 U.S.C. 300mm–51) is amended—
(1)
in subsection (a)—
(A)
in the matter preceding paragraph (1), by striking “ With respect” through “ subtitle B, the” and inserting “ The”; and
(B)
by striking “ of such individuals” each place it appears;
(2)
in subsection (b)(1), by inserting “ and individuals who were exposed within a geographic area related to the September 11, 2001, terrorist attacks in a manner similar to the exposure within such geographic area experienced by individuals meeting the eligibility criteria under section 3311(a)(2) or 3321(a)(1)(B)” after “ treatment”;
(3)
by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and
(4)
by inserting after subsection (b) the following:

“(c) Research Cohort for Emerging Health Impacts on Youth.—

“(1) In general.—The WTC Program Administrator, in consultation with the Secretary of Education, shall establish a research cohort of sufficient size to conduct future research studies on the health and educational impacts of exposure to airborne toxins, or any other hazard or adverse condition, resulting from the September 11, 2001, terrorist attacks, including on the population of individuals who were 21 years of age or younger at the time of exposure, including such individuals who are screening-eligible WTC survivors or certified-eligible WTC survivors.

“(2) Populations studied.—The research cohort under paragraph (1) may include—

“(A) individuals who, on September 11, 2001, were 21 years of age or younger and were—

“(i) outside the New York City disaster area; and

“(ii) in—

“(I) the area of Manhattan not further north than 14th Street; or

“(II) Brooklyn; and

“(B) control populations, including populations of individuals who, on September 11, 2001, were 21 years of age or younger.”

(b)
Funding.— Section 3351(b) of such Act (42 U.S.C. 300mm–61(b)) is amended by inserting after paragraph (3) the following:

“(4) Limitation for research cohort for emerging health impacts on youth.—Notwithstanding paragraph (1), the amounts made available under such paragraph may not be used for fiscal years 2023 through 2032 to carry out subsection (c) of section 3341.”

(c)
Conforming Amendment.— Section 3301(f)(2)(E) of such Act (42 U.S.C. 300mm(f)(2)(E)) is amended by striking “ section 3341(a)” and inserting “ subsection (a) or (c) of section 3341”.