Division FF — Health and Human Services
DIVISION FF Health and Human Services
SEC. 2. Table of Contents.
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.
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. 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.
SEC. 1103. Suicide Prevention Lifeline Improvement.
“(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.”
“(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.”
“(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.”
“(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.”
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.
“(1) are proposing to create, improve, or enhance screening, prevention, and treatment”
“(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.”
“(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
“(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) 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.”
SEC. 1112. Maternal Mental Health Hotline.
“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.
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.
“(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.”
“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.”
SEC. 1122. Crisis Care Coordination.
“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.”
“(C) suicide intervention and prevention.”
“(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
“(C) Raising awareness of suicide prevention resources and promoting help seeking among those at risk for suicide.”
“(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
SEC. 1123. Treatment of Serious Mental Illness.
“(5) Demographic information regarding participation of those served by the grant compared to demographic information in the population of the grant recipient.”
; and
“(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.”
SEC. 1124. Study on the Costs of Serious Mental Illness.
CHAPTER 4 Anna Westin Legacy
SEC. 1131. Maintaining Education and Training on Eating Disorders.
“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.
“(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).”
CHAPTER 6 Peer-Supported Mental Health Services
SEC. 1151. Peer-Supported Mental Health Services.
“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.
“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.
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.
“(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
“(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.
SEC. 1217. Formula Grants to States.
SEC. 1218. Projects for Assistance in Transition from Homelessness.
SEC. 1219. Grants for Reducing Overdose Deaths.
“(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).”
“(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.”
“(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.”
SEC. 1220. Opioid Overdose Reversal Medication Access and Education Grant Programs.
“(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;”
“(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.”
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.
“(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.
“(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.”
“(A) officials representing the agencies described in subsection (e)(2);”
“(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.
“(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.
SEC. 1235. Grants for States to Promote the Availability of Recovery Housing and Services.
“(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.
SEC. 1237. Technical Correction.
CHAPTER 4 Substance Use Prevention, Treatment, and Recovery Services Block Grant
SEC. 1241. Eliminating Stigmatizing Language Relating to Substance Use.
“(4) The term ‘substance use disorder’ means the recurrent use of alcohol or other drugs that causes clinically significant impairment.”
SEC. 1242. Authorized Activities.
SEC. 1243. State Plan Requirements.
“(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
SEC. 1244. Updating Certain Language Relating to Tribes.
“(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.”
SEC. 1245. Block Grants for Substance Use Prevention, Treatment, and Recovery Services.
SEC. 1246. Requirement of Reports and Audits by States.
“(3) the amount provided to each recipient in the previous fiscal year.”
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.
“(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.”
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.
“(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.”
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.
“(1) pharmacists on how to verify the identity of the patient;”
“(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.”
“(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.”
SEC. 1272. Synthetic Opioid and Emerging Drug Misuse Danger Awareness.
The Secretary shall update such campaign to address emerging drug misuse issues, as appropriate.
SEC. 1273. Grant Program for State and Tribal Response to Opioid Use Disorders.
“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.
“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.
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.
“(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.
“(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).”
Subtitle D Children and Youth
CHAPTER 1 Supporting Children’s Mental Health Care Access
SEC. 1401. Technical Assistance for School-Based Health Centers.
“(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.
“(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
SEC. 1403. Co-Occurring Chronic Conditions and Mental Health in Youth Study.
SEC. 1404. Best Practices for Behavioral and Mental Health Intervention Teams.
“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.
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.
“(1) In general.—The Secretary”
; and
“(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.”
SEC. 1422. Youth Suicide Early Intervention and Prevention Strategies.
“(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”
“(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.”
SEC. 1423. Mental Health and Substance Use Disorder Services for Students in Higher Education.
“(3) An assessment of the mental health and substance use disorder needs of the populations served by recipients of grants under this section.”
; and
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. 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.”
SEC. 2102. Advisory Committee to the Director of the Centers for Disease Control and Prevention.
“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.
“(F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and”
; and
“(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”
“(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.”
“(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.”
“(i) based on”
“(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
“(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.”
“(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.—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.”
SEC. 2104. Office of Pandemic Preparedness and Response Policy.
“(10) The Director of the Office of Pandemic Preparedness and Response Policy.”
CHAPTER 2 State and Local Readiness
SEC. 2111. Improving State and Local Public Health Security.
“(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”
“(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”
“(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;”
SEC. 2112. Supporting Access to Mental Health and Substance Use Disorder Services During Public Health Emergencies.
“(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;”
“(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.”
“(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
“(D) relevant preparedness and response activities;”
SEC. 2113. Trauma Care Reauthorization.
“(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.”
“(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
“(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.”
“(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.”
“(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.”
“(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”
“(3) Effective date.—The matching requirement described in paragraph (1) shall take effect on October 1, 2025.”
“(6) any evidence-based or evidence-informed strategies developed or utilized pursuant to subsection (c)(5).”
; and
“(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.”
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.
“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
CHAPTER 2 Improving State, Local, and Tribal Public Health Data
SEC. 2211. Modernizing State, Local, and Tribal Biosurveillance Capabilities and Infectious Disease Data.
“(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
“(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.”
“(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;”
“(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
“(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.”
“(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.”
“(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
SEC. 2212. Genomic Sequencing, Analytics, and Public Health Surveillance of Pathogens.
“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.”
SEC. 2213. Supporting State, Local, and Tribal Public Health Data.
“(A) In general.—In carrying out”
; and
“(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.”
“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.”
SEC. 2214. Epidemic Forecasting and Outbreak Analytics.
“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.
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.
“(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
“(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
“(A) In general.—For each year”
“(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.”
“(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.”
SEC. 2222. Awards to Support Community Health Workers and Community Health.
“(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.”
“(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;”
“(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;”
“(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.”
“(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.”
“(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.”
SEC. 2223. Improving Public Health Emergency Response Capacity.
“(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.”
SEC. 2224. Increasing Educational Opportunities for Allied Health Professions.
“(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.
“(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
SEC. 2226. Leadership Exchange Pilot for Public Health and Medical Preparedness and Response Positions at the Department of Health and Human Services.
“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.
“(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.”
“(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.”
“(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
CHAPTER 4 Enhancing Public Health Preparedness and Response
SEC. 2231. Centers for Public Health Preparedness and Response.
“(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
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.
“(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.
SEC. 2236. Supporting Children During Public Health Emergencies.
“(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.”
“(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
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. 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.
“(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.
“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.
CHAPTER 2 Improving Biosafety and Biosecurity
SEC. 2311. Improving Control and Oversight of Select Biological Agents and Toxins.
“(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;”
“(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
“(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
SEC. 2312. Strategy for Federal High-Containment Laboratories.
SEC. 2313. National Science Advisory Board for Biosecurity.
“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.”
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.
“(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.
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.
“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.”
Subtitle D Modernizing and Strengthening the Supply Chain for Vital Medical Products
SEC. 2401. Warm Base Manufacturing Capacity for Medical Countermeasures.
“(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) 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”
“(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;”
“(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”
“(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) 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”
“(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
“(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
“(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.
“(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.
“(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.
“(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.
“(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
“(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
SEC. 2406. Reimbursement for Certain Supplies.
“(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.
“(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.
“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.
“(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.”
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.
“(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.
“(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.”
SEC. 2503. Platform Technologies.
“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.”
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.
“(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.”
SEC. 2512. Extending Expiration Dates for Certain Drugs.
SEC. 2513. Combating Counterfeit Devices.
“(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.”
SEC. 2514. Preventing Medical Device Shortages.
“(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.”
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.
“(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.”
“(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
SEC. 3202. Improving the Treatment of Rare Diseases and Conditions.
“(8) the science of small population studies.”
SEC. 3203. Emerging Technology Program.
“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.
“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.”
“Sec. 3016. 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.
“(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.”
“(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.—Approval of a product”
“(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
“(A) In general.—The Secretary may”
“(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.”
“(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.”
“(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).”
SEC. 3211. Antifungal Research and Development.
SEC. 3212. Advancing Qualified Infectious Disease Product Innovation.
“(4) an application pursuant to section 351(a) of the Public Health Service Act.”
“(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).”
SEC. 3213. Advanced Manufacturing Technologies Designation Program.
“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.
SEC. 3222. Therapeutic Equivalence Evaluations.
“(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.
SEC. 3224. Enhancing Access to Affordable Medicines.
“(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.
“(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.
SEC. 3303. Gao Report on Third-Party Review.
SEC. 3304. Certificates to Foreign Governments.
“(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.
“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.”
“(3) The failure to comply with any requirement under section 524B(b)(2) (relating to ensuring device cybersecurity).”
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. 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.”
“(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.
“(i) In general.—No fee”
; and
“(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.”
Subtitle D Infant Formula
SEC. 3401. Protecting Infants and Improving Formula Supply.
“(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.”
“(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.”
“(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.”
“(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.”
“(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.”
“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.”
“(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).”
Subtitle E Cosmetics
SEC. 3501. Short Title.
SEC. 3502. Amendments to Cosmetic Requirements.
“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.
“(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
“(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).”
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.
“(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.”
“(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.
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.
“(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.”
SEC. 3613. Improving Food and Drug Administration Inspections.
“(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.”
“(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) 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.
SEC. 3615. Unannounced Foreign Facility Inspections Pilot Program.
SEC. 3616. Enhancing Coordination and Transparency on Inspections.
“(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
“(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.”
“(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
“(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.”
“(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
“(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.
“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.
“(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.
SEC. 3623. Strategic Workforce Plan and Report.
“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.
“(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
SEC. 3625. Facilities Management.
“(I) for fiscal year 2023, to defray”
“(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
“(I) for fiscal year 2023,”
“(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
“(I) for fiscal year 2023,”
“(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
“(I) for fiscal year 2023, to defray”
“(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
SEC. 3626. User Fee Program Transparency and Accountability.
“(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.”
; and
“(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
“(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;”
“(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;”
“(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.”
“(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
“(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
“(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) 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;”
“(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.”
“(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
“(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) 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;”
“(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.”
“(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
“(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) 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;”
“(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) 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
“(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.
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.
“(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.”
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.
“(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
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.
“(II) marriage and family therapist services (as defined in subsection (lll)(1)) and mental health counselor services (as defined in subsection (lll)(3));”
“(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.”
“(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)).”
SEC. 4122. Additional Residency Positions.
“(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).”
“(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.”
SEC. 4123. Improving Mobile Crisis Care in Medicare.
“(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.”
“(VI) subsection (b)(12) shall not be taken into account in applying clause (ii)(II) for 2024.”
SEC. 4124. Ensuring Adequate Coverage of Outpatient Mental Health Services under the Medicare Program.
“(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’.”
“(D) intensive outpatient services (as defined in section 1861(ff)(4)),”
; and
“(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
“(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).”
SEC. 4125. Improvements to Medicare Prospective Payment System for Psychiatric Hospitals and Psychiatric Units.
“(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.”
“(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
“(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.”
“(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
SEC. 4126. Exception for Physician Wellness Programs.
“(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.”
“(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.
“(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.
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.
“(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.
“(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.
“(JJ) lymphedema compression treatment items (as defined in subsection (mmm));”
; and
“(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).”
“(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.”
“(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).”
“(iv) Lymphedema compression treatment items (as defined in section 1861(mmm)).”
“(E) lymphedema compression treatment items (as defined in section 1861(mmm));”
SEC. 4134. Permanent In-Home Benefit for Ivig Services.
“(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.”
“(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);”
SEC. 4135. Access to Non-Opioid Treatments for Pain Relief.
“(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).”
“(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.”
SEC. 4136. Technical Amendments to Medicare Separate Payment for Disposable Negative Pressure Wound Therapy Devices.
“(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
“(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.
“(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.
“(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).”
SEC. 4139. Payment Rates for Durable Medical Equipment under the Medicare Program.
SEC. 4140. Extending Acute Hospital Care at Home Waivers and Flexibilities.
“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.
“(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.”
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.
“(i) In general.—Subject to clause (ii), such ratio”
; and
“(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.”
Subtitle E Health Care Tax Provisions
SEC. 4151. Extension of Safe Harbor for Absence of Deductible for Telehealth.
“(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,
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.
“(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.
“(iii) for fiscal year 2023 and each subsequent fiscal year, the amount specified in paragraph (11) for such fiscal year;”
; and
“(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.”
“(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
“(A) a non-compliant State that is one of the 50 States or the District of Columbia shall be reduced—”
“(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
“(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.”
“(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).”
Subtitle B Medicaid and CHIP Coverage
SEC. 5111. Funding Extension of the Children’s Health Insurance Program and Related Provisions.
“(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)).”
SEC. 5112. Continuous Eligibility for Children under Medicaid and Chip.
“(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.”
“(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.”
SEC. 5113. Modifications to Postpartum Coverage under Medicaid and Chip.
SEC. 5114. Extension of Money Follows the Person Rebalancing Demonstration.
“(L) $450,000,000 for each of fiscal years 2024 through 2027.”
“(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).”
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.
“(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
“(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).”
“(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).”
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.
“(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.”
“(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
“(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.”
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.
“(1) Temporary fmap increase.—Subject to subsections (b) and (f)”
“(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.”
“(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.”
“(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.”
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.
“(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.”
“(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.”
“(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.”
“(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).”
“(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.”
“(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.”
“(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).”
“(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.”
“(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.”
“(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).”
“(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.”
“(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.”
“(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.”
SEC. 6102. Extension of Temporary Assistance for Needy Families Program.
SEC. 6103. 1-Year Extension of Child and Family Services Programs.
TITLE VII Supplemental Funding for the World Trade Center Health Program
SEC. 7701. Supplemental Funding for the World Trade Center Health Program.
“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.”
“(9) for each of fiscal years 2028 and 2029, $1,725,000,000; and”
; and
“(10) for fiscal year 2030 and each fiscal year thereafter, $2,000,000,000.”
SEC. 7702. Research Cohort for Emerging Health Impacts on Youth.
“(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.”
“(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.”