Division A — 21st Century Cures

“(D) $34,851,000,000 for fiscal year 2018;

“(E) $35,585,871,000 for fiscal year 2019; and

“(F) $36,472,442,775 for fiscal year 2020.”

“(d)

(1)

(A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—

“(i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the Federal Government; and

“(ii) may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded.

“(B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

“(C) The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is—

“(i) required by Federal, State, or local laws, excluding instances described in subparagraph (D);

“(ii) necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

“(iii) made with the consent of the individual to whom the information, document, or biospecimen pertains; or

“(iv) made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

“(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii).

“(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal process, and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding.

“(F) Identifiable, sensitive information collected by a person to whom a certificate has been issued under subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for perpetuity.

“(G) The Secretary shall take steps to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements of this subsection.

“(2) The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of this subsection.

“(3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual’s participation in the research.

“(4) For purposes of this subsection, the term ‘identifiable, sensitive information’ means information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and—

“(A) through which an individual is identified; or

“(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.”

“SEC. 404M. NEXT GENERATION OF RESEARCHERS.

“(a) Next Generation of Researchers Initiative.—There shall be established within the Office of the Director of the National Institutes of Health, the Next Generation of Researchers Initiative (referred to in this section as the ‘Initiative’), through which the Director shall coordinate all policies and programs within the National Institutes of Health that are focused on promoting and providing opportunities for new researchers and earlier research independence.

“(b) Activities.—The Director of the National Institutes of Health, through the Initiative shall—

“(1) promote policies and programs within the National Institutes of Health that are focused on improving opportunities for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;

“(2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity;

“(3) coordinate, as appropriate, with relevant agencies, professional and academic associations, academic institutions, and others, to improve and update existing information on the biomedical research workforce in order to inform programs related to the training, recruitment, and retention of biomedical researchers; and

“(4) carry out other activities, including evaluation and oversight of existing programs, as appropriate, to promote the development of the next generation of researchers and earlier research independence.”

“(3) Strategic planning.—

“(A) In general.—The directors of the national institutes and national centers shall consult at least once annually with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Office of Research on Women’s Health regarding objectives of the national institutes and national centers to ensure that future activities by such institutes and centers take into account women and minorities and are focused on reducing health disparities.

“(B) Strategic plans.—Any strategic plan issued by a national institute or national center shall include details on the objectives described in subparagraph (A).”

“(a) Appointment.—

“(1) In general.—The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.

“(2) Appointment.—

“(A) Term.—A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.

“(B) Reappointment.—At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.

“(C) Vacancies.—If the office of a Director of a national research institute or national center becomes vacant before the end of such Director’s term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.

“(D) Current directors.—Each Director of a national research institute or national center who is serving on the date of enactment of the 21st Century Cures Act shall be deemed to be appointed for a 5-year term under this subsection beginning on such date of enactment.

“(E) Rule of construction.—Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director’s 5-year term.

“(F) Nature of appointment.—Appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the National Institutes of Health and its components, including compliance with any legal requirement that the Secretary or Director of National Institutes of Health determines relevant.

“(3) 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 Directors appointed under this subsection.”

“(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an ‘R-series grant’), other than an award constituting a noncompetitive renewal of such a grant, or a noncompetitive administrative supplement to such a grant, the Director of such national research institute or national center shall, consistent with the peer review process—

“(A) review and make the final decision with respect to making the award; and

“(B) take into consideration, as appropriate—

“(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 402(m);

“(ii) programs or projects funded by other agencies on similar research topics; and

“(iii) advice by staff and the advisory council or board of such national research institute or national center.”

“(n) Unique Research Initiatives.—

“(1) In general.—The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—

“(A) the Precision Medicine Initiative under section 498E; or

“(B) section 402(b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 402A(c)(1) for purposes of carrying out such section 402(b)(7) may be used to engage in such other transactions.

“(2) Requirements.—The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—

“(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;

“(B) receives approval for the use of such authority from the Director of NIH; and

“(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.”

“SEC. 404N. POPULATION FOCUSED RESEARCH.

“The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by—

“(1) facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable;

“(2) facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and

“(3) addressing methodological challenges.”

“(2) Where research substances and living organisms are made available under paragraph (1) through contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary.

“(3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts.”

“(iii) Option to make certain clinical trial information available earlier.—The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).

“(iv) Combination products.—An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—

“(I) an applicable drug clinical trial, if the Secretary determines under section 503(g) of the Federal Food, Drug, and Cosmetic Act that the primary mode of action of such product is that of a drug or biological product; or

“(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.”

“(1) In general.—In the case”

; and

“(2) Reporting requirements.—For any new and competing project of clinical research subject to the requirements under this section that receives a grant award 1 year after the date of enactment of the 21st Century Cures Act, or any date thereafter, for which a valid analysis is provided under paragraph (1)—

“(A) and which is an applicable clinical trial as defined in section 402(j), the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section 402(j)(3), and the Director of the National Institutes of Health shall, as appropriate, consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity, including pursuant to section 402(j)(5)(A)(ii) when applicable; and

“(B) the Director of the National Institutes of Health shall encourage the reporting of the results of such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.”

“(b) Statement of Patient Experience.—

“(1) In general.—Following the approval of an application that was submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act at least 180 days after the date of enactment of the 21st Century Cures Act, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application.

“(2) Data and information.—The data and information referred to in paragraph (1) are—

“(A) patient experience data;

“(B) information on patient-focused drug development tools; and

“(C) other relevant information, as determined by the Secretary.

“(c) Patient Experience Data.—For purposes of this section, the term ‘patient experience data’ includes data that—

“(1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and

“(2) are intended to provide information about patients’ experiences with a disease or condition, including—

“(A) the impact of such disease or condition, or a related therapy, on patients’ lives; and

“(B) patient preferences with respect to treatment of such disease or condition.”

“SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

“(a) Process for Qualification.—

“(1) In general.—The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—

“(A)

(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and

“(ii) the Secretary accepts or declines to accept such letter of intent;

“(B)

(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and

“(ii) the Secretary accepts or declines to accept the qualification plan; and

“(C)

(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;

“(ii) the Secretary determines whether to accept such qualification package for review; and

“(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.

“(2) Acceptance and review of submissions.—

“(A) In general.—Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as ‘qualification submissions’).

“(B) Acceptance factors; nonacceptance.—The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.

“(C) Prioritization of qualification review.—The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—

“(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and

“(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.

“(D) Engagement of external experts.—The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).

“(3) Review of full qualification package.—The Secretary shall—

“(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

“(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

“(4) Qualification.—The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).

“(b) Effect of Qualification.—

“(1) In general.—A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).

“(2) Use of a drug development tool.—Subject to paragraph (3), a drug development tool qualified under this section may be used for—

“(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act; or

“(B) supporting the investigational use of a drug or biological product under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.

“(3) Rescission or modification.—

“(A) In general.—The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.

“(B) Meeting for review.—If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary’s decision to rescind or modify the determination before the effective date of the rescission or modification.

“(c) Transparency.—

“(1) In general.—Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:

“(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—

“(i) the stage of the review process applicable to the submission;

“(ii) the date of the most recent change in stage status;

“(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and

“(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.

“(B) The Secretary’s formal written determinations in response to such qualification submissions.

“(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.

“(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).

“(E) A comprehensive list of—

“(i) all drug development tools qualified under subsection (a); and

“(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act.

“(2) Relation to trade secrets act.—Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code.

“(3) Applicability.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information contained in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(d) Rule of Construction.—Nothing in this section shall be construed—

“(1) to alter the standards of evidence under subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act (as applicable); or

“(2) to limit the authority of the Secretary to approve or license products under this Act or the Public Health Service Act, as applicable (as in effect before the date of the enactment of the 21st Century Cures Act).

“(e) Definitions.—In this section:

“(1) Biomarker.—The term ‘biomarker’—

“(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and

“(B) includes a surrogate endpoint.

“(2) Biomedical research consortia.—The term ‘biomedical research consortia’ means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 101(a) of the Higher Education Act of 1965), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.

“(3) Clinical outcome assessment.—The term ‘clinical outcome assessment’ means—

“(A) a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

“(B) includes a patient-reported outcome.

“(4) Context of use.—The term ‘context of use’ means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.

“(5) Drug development tool.—The term ‘drug development tool’ includes—

“(A) a biomarker;

“(B) a clinical outcome assessment; and

“(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.

“(6) Patient-reported outcome.—The term ‘patient-reported outcome’ means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person.

“(7) Qualification.—The terms ‘qualification’ and ‘qualified’ mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this Act.

“(8) Requestor.—The term ‘requestor’ means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.

“(9) Surrogate endpoint.—The term ‘surrogate endpoint’ means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

“(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

“(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).”

“(5) Termination of authority.—The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2020, unless the rare pediatric disease product application—

“(A) is for a drug that, not later than September 30, 2020, is designated under subsection (d) as a drug for a rare pediatric disease; and

“(B) is, not later than September 30, 2022, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.”

“(5)

(A) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under subsection (b), if such supplemental application complies with subparagraph (B).

“(B) A supplemental application is eligible for review as described in subparagraph (A) only if—

“(i) there is existing data available and acceptable to the Secretary demonstrating the safety of the drug; and

“(ii) all data used to develop the qualified data summaries are submitted to the Secretary as part of the supplemental application.

“(C) The Secretary shall post on the Internet website of the Food and Drug Administration and update annually—

“(i) the number of applications reviewed solely under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service Act;

“(ii) the average time for completion of review under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service Act;

“(iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service Act; and

“(iv) the number of applications reviewed under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service Act for which the Secretary made use of full data sets in addition to the qualified data summary.

“(D) In this paragraph—

“(i) the term ‘qualified indication’ means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and

“(ii) the term ‘qualified data summary’ means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication.”

“(E)

(i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under this subsection, if such supplemental application complies with the requirements of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.

“(ii) In this subparagraph, the terms ‘qualified indication’ and ‘qualified data summary’ have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.”

“(2)

(A) For purposes of this paragraph, the term ‘health care economic information’ means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.

“(B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.”

“SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS.

“(a) Purpose; Identification of Criteria.—

“(1) Purpose.—The purpose of this section is to clarify the Secretary’s authority to—

“(A) efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies;

“(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and

“(C) clear under section 510(k), classify under section 513(f)(2), or approve under section 515, antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs.

“(2) Identification of criteria.—The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—

“(A) if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or

“(B) if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.

“(3) Bases for initial identification.—The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant—

“(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;

“(B) the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used; and

“(C) such other evidence and information as the Secretary considers appropriate.

“(b) Susceptibility Test Interpretive Criteria Website.—

“(1) In general.—Not later than 1 year after the date of the enactment of the 21st Century Cures Act, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria in accordance with paragraph (2) (referred to in this section as the ‘Interpretive Criteria Website’).

“(2) Listing of susceptibility test interpretive criteria standards and interpretive criteria.—

“(A) In general.—The list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are—

“(i) established by a nationally or internationally recognized standard development organization that—

“(I) establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking;

“(II) holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and

“(III) permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and

“(ii) recognized in whole, or in part, by the Secretary under subsection (c).

“(B) Other list.—The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where—

“(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;

“(ii) the Secretary withdraws under subsection (c)(1)(A) recognition of a standard, in whole or in part, otherwise applicable to such a drug;

“(iii) the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or

“(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—

“(I) differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and

“(II) are determined by the Secretary to be appropriate for the drug.

“(C) Required statements.—The Interpretive Criteria Website shall include statements conveying—

“(i) that the website provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to a certain drug (or drugs);

“(ii) that—

“(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause (i) to be included on the website; and

“(II) the clinical significance of such susceptibility information in such instances is unknown;

“(iii) that the approved product labeling for specific drugs provides the uses for which the Secretary has approved the product; and

“(iv) any other information that the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website.

“(3) Notice.—Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register.

“(4) Inapplicability of misbranding provision.—The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502.

“(5) Trade secrets and confidential information.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.

“(c) Recognition of Susceptibility Test Interpretive Criteria.—

“(1) Evaluation and publication.—

“(A) In general.—Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall—

“(i) evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and

“(ii) publish on the public website of the Food and Drug Administration a notice—

“(I) withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;

“(II) recognizing the new or updated standards;

“(III) recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and

“(IV) making any necessary updates to the lists under subsection (b)(2).

“(B) Upon approval of a drug.—Upon the approval of an initial or supplemental application for an antimicrobial drug under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to this subsection, or for which there are no relevant interpretive criteria standards recognized, or interpretive criteria otherwise listed, by the Secretary pursuant to this subsection, the Secretary shall update the lists under subparagraphs (A) and (B) of subsection (b)(2) to include the susceptibility test interpretive criteria upon which such approval was based.

“(2) Bases for updating interpretive criteria standards.—In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider—

“(A) the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;

“(B) information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);

“(C) any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and

“(D) such other information or factors as the Secretary determines appropriate.

“(3) Annual compilation of notices.—Each year, the Secretary shall compile the notices published under paragraph (1)(A) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria—

“(A) recognized by the Secretary under this subsection; or

“(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

“(4) Relation to section 514(c).—Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1).

“(5) Voluntary use of interpretive criteria.—Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to subsection (b)(2).

“(d) Antimicrobial Drug Labeling.—

“(1) Drugs marketed prior to establishment of interpretive criteria website.—

“(A) In general.—With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug, not later than 1 year after establishment of the Interpretive Criteria Website described in subsection (b)(1), shall remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website.

“(B) Labeling changes.—The labeling changes required by this section shall be considered a minor change under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable annual report.

“(2) Drugs marketed subsequent to establishment of interpretive criteria website.—With respect to antimicrobial drugs approved on or after the date of the establishment of the Interpretive Criteria Website described in subsection (b)(1), the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.

“(e) Special Condition for Marketing of Antimicrobial Susceptibility Testing Devices.—

“(1) In general.—Notwithstanding sections 501, 502, 505, 510, 513, and 515, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.

“(2) Conditions applicable to antimicrobial susceptibility testing devices.—The conditions specified in this paragraph are the following:

“(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—

“(i) included in a standard recognized by the Secretary under subsection (c); or

“(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

“(B) The labeling of such device includes statements conveying—

“(i) that the device provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs;

“(ii) that—

“(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria, fungi, or other microorganisms, as applicable, to such drugs; and

“(II) the clinical significance of such susceptibility information in those instances is unknown;

“(iii) that the approved labeling for drugs tested using such a device provides the uses for which the Secretary has approved such drugs; and

“(iv) any other information the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph (A).

“(C) The antimicrobial susceptibility testing device meets all other requirements to be cleared under section 510(k), classified under section 513(f)(2), or approved under section 515.

“(f) Definitions.—In this section:

“(1) The term ‘antimicrobial susceptibility testing device’ means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

“(2) The term ‘qualified infectious disease product’ means a qualified infectious disease product designated under section 505E(d).

“(3) The term ‘susceptibility test interpretive criteria’ means—

“(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and

“(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.

“(4)

(A) The term ‘antimicrobial drug’ means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—

“(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;

“(ii) may include a qualified infectious disease product designated under section 505E(d); and

“(iii) is subject to section 503(b)(1).

“(B) If provided by the Secretary through regulations, such term may include—

“(i) drugs other than systemic antibacterial and antifungal drugs; and

“(ii) biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity.

“(5) The term ‘interpretive criteria standard’ means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).

“(g) Rule of Construction.—Nothing in this section shall be construed to—

“(1) alter the standards of evidence under subsection (c) or (d) of section 505 (including the substantial evidence standard under section 505(d)) or under section 351 of the Public Health Service Act (as applicable); or

“(2) with respect to clearing devices under section 510(k), classifying devices under section 513(f)(2), or approving devices under section 515—

“(A) apply with respect to any drug, device, or biological product, in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria, fungi, or other microorganisms, as applicable, to such drug to reflect patient morbidity and mortality in accordance with this section; or

“(B) unless specifically stated, have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.”

“SEC. 515C. BREAKTHROUGH DEVICES.

“(a) Purpose.—The purpose of this section is to encourage the Secretary, and provide the Secretary with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the Food and Drug Administration’s review of, devices that represent breakthrough technologies.

“(b) Establishment of Program.—The Secretary shall establish a program to expedite the development of, and provide for the priority review for, devices, as determined by the Secretary—

“(1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and

“(2)

(A) that represent breakthrough technologies;

“(B) for which no approved or cleared alternatives exist;

“(C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or

“(D) the availability of which is in the best interest of patients.

“(c) Request for Designation.—A sponsor of a device may request that the Secretary designate such device for expedited development and priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under section 515(c), a notification under section 510(k), or a petition for classification under section 513(f)(2).

“(d) Designation Process.—

“(1) In general.—Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection (b). If the Secretary determines that the device meets the criteria, the Secretary shall designate the device for expedited development and priority review.

“(2) Review.—Review of a request under subsection (c) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration.

“(3) Withdrawal.—The Secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection (b) no longer applying because of the subsequent clearance or approval of another device that—

“(A) was designated under this section; or

“(B) was given priority review under section 515(d)(5), as in effect prior to the date of enactment of the 21st Century Cures Act.

“(e) Expedited Development and Priority Review.—

“(1) Actions.—For purposes of expediting the development and review of devices designated under subsection (d) the Secretary shall—

“(A) assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each device for which a request is submitted under subsection (c);

“(B) provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection (c) for the device;

“(C) adopt an efficient process for timely dispute resolution;

“(D) provide for interactive and timely communication with the sponsor of the device during the development program and review process;

“(E) expedite the Secretary’s review of manufacturing and quality systems compliance, as applicable;

“(F) disclose to the sponsor, not less than 5 business days in advance, the topics of any consultation the Secretary intends to undertake with external experts or an advisory committee concerning the sponsor’s device and provide the sponsor the opportunity to recommend such external experts;

“(G) provide for advisory committee input, as the Secretary determines appropriate (including in response to the request of the sponsor) for applications submitted under section 515(c); and

“(H) assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 520(g).

“(2) Additional actions.—In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (d), the Secretary, in collaboration with the device sponsor, may, as appropriate—

“(A) coordinate with the sponsor regarding early agreement on a data development plan;

“(B) take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate;

“(C) facilitate, when scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection with regard to application for approval under section 515(c); and

“(D) agree in writing to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to—

“(i) changes to such protocols agreed to in writing by the sponsor and the Secretary; or

“(ii) a decision, made by the director of the office responsible for reviewing the device submission, that a substantial scientific issue essential to determining the safety or effectiveness of such device exists, provided that such decision is in writing, and is made only after the Secretary provides to the device sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the substantial scientific issue.

“(f) Priority Review Guidance.—

“(1) Content.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—

“(A) set forth the process by which a person may seek a designation under subsection (d);

“(B) provide a template for requests under subsection (c);

“(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and

“(D) identify the criteria and processes the Secretary will use to assign a team of staff, including team leaders, to review devices designated for expedited development and priority review, including any training required for such personnel to ensure effective and efficient review.

“(2) Process.—Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a proposed guidance.

“(g) Rule of Construction.—Nothing in this section shall be construed to affect—

“(1) the criteria and standards for evaluating an application pursuant to section 515(c), a report and request for classification under section 513(f)(2), or a report under section 510(k), including the recognition of valid scientific evidence as described in section 513(a)(3)(B) and consideration and application of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable;

“(2) the authority of the Secretary with respect to clinical holds under section 520(g)(8)(A);

“(3) the authority of the Secretary to act on an application pursuant to section 515(d) before completion of an establishment inspection, as the Secretary determines appropriate; or

“(4) the authority of the Secretary with respect to postmarket surveillance under sections 519(h) and 522.”

“(j) Training and Oversight of Least Burdensome Requirements.—

“(1) The Secretary shall—

“(A) ensure that each employee of the Food and Drug Administration who is involved in the review of premarket submissions, including supervisors, receives training regarding the meaning and implementation of the least burdensome requirements under subsections (a)(3)(D) and (i)(1)(D) of this section and section 515(c)(5); and

“(B) periodically assess the implementation of the least burdensome requirements, including the employee training under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied.

“(2) Not later than 18 months after the date of enactment of the 21st Century Cures Act, the ombudsman for any organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall—

“(A) conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training in implementing the least burdensome requirements;

“(B) include in such audit interviews of persons who are representatives of the device industry regarding their experiences in the device premarket review process, including with respect to the application of least burdensome concepts to premarket review and decisionmaking;

“(C) include in such audit a list of the measurement tools the Secretary uses to assess the implementation of the least burdensome requirements, including under paragraph (1)(B) and section 517A(a)(3), and may also provide feedback on the effectiveness of such tools in the implementation of the least burdensome requirements;

“(D) summarize the findings of such audit in a final audit report; and

“(E) within 30 calendar days of completion of such final audit report, make such final audit report available—

“(i) 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

“(ii) on the Internet website of the Food and Drug Administration.”

“(5)

(A) In requesting additional information with respect to an application under this section, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.

“(B) For purposes of subparagraph (A), the term ‘necessary’ means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.

“(C) For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

“(D) Nothing in this paragraph alters the standards for premarket approval of a device.”

“(3) Application of least burdensome requirements.—The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as applicable.”

“(q) Reusable Medical Devices.—

“(1) In general.—Not later than 180 days after the date of enactment of the 21st Century Cures Act, the Secretary shall identify and publish a list of reusable device types for which reports under subsection (k) are required to include—

“(A) instructions for use, which have been validated in a manner specified by the Secretary; and

“(B) validation data, the types of which shall be specified by the Secretary;

“(2) Revision of list.—The Secretary shall revise the list under paragraph (2), as the Secretary determines appropriate, with notice in the Federal Register.

“(3) Content of reports.—Reports under subsection (k) that are submitted after the publication of the list described in paragraph (1), for devices or types of devices included on such list, shall include such instructions for use and validation data.”

“(o) Regulation of Medical and Certain Decisions Support Software.—

“(1) The term device, as defined in section 201(h), shall not include a software function that is intended—

“(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;

“(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

“(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—

“(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;

“(ii) such records are part of health information technology that is certified under section 3001(c)(5) of the Public Health Service Act; and

“(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

“(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or

“(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—

“(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);

“(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and

“(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

“(2) In the case of a product with multiple functions that contains—

“(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 201(h); and

“(B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 201(h),

“(3)

(A) Notwithstanding paragraph (1), a software function described in subparagraph (C), (D), or (E) of paragraph (1) shall not be excluded from the definition of device under section 201(h) if—

“(i) the Secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences; and

“(ii) the software function has been identified in a final order issued by the Secretary under subparagraph (B).

“(B) Subparagraph (A) shall apply only if the Secretary—

“(i) publishes a notification and proposed order in the Federal Register;

“(ii) includes in such notification the Secretary’s finding, including the rationale and identification of the evidence on which such finding was based, as described in subparagraph (A)(i); and

“(iii) provides for a period of not less than 30 calendar days for public comment before issuing a final order or withdrawing such proposed order.

“(C) In making a finding under subparagraph (A)(i) with respect to a software function, the Secretary shall consider—

“(i) the likelihood and severity of patient harm if the software function were to not perform as intended;

“(ii) the extent to which the software function is intended to support the clinical judgment of a health care professional;

“(iii) whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function; and

“(iv) the intended user and user environment, such as whether a health care professional will use a software function of a type described in subparagraph (E) of paragraph (1).

“(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to—

“(A) exercise enforcement discretion as to any device subject to regulation under this Act;

“(B) regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans; or

“(C) regulate software as a device under this Act if such software meets the criteria under section 513(a)(1)(C).”

“(9) The Secretary shall classify an accessory under this section based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.”

“SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL PERSONNEL.

“(a) In General.—The Secretary may, notwithstanding title 5, United States Code, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service.

“(b) Compensation.—

“(1) In general.—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, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and set—

“(A) the annual rate of pay of any individual appointed under subsection (a); and

“(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before the date of enactment of the 21st Century Cures Act.

“(2) Limitation.—The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code.

“(3) Public availability.—The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.

“(c) Rule of Construction.—The authorities under this section shall not be construed to affect the authority provided under section 714.

“(d) Report on Workforce Planning.—

“(1) In general.—Not later than 18 months after the date of enactment of the 21st Century Cures Act, the Secretary shall submit a report on workforce planning 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 examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including—

“(A) an analysis of the workforce needs at the Food and Drug Administration and the Secretary’s strategic plan for addressing such needs, including through use of the authority under this section; and

“(B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—

“(i) recruitment through nongovernmental recruitment or placement agencies;

“(ii) recruitment through academic institutions;

“(iii) recruitment or hiring bonuses, if applicable;

“(iv) recruitment using targeted direct hiring authorities; and

“(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.

“(2) Recommendations.—The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.”

“SEC. 1014. FOOD AND DRUG ADMINISTRATION INTERCENTER INSTITUTES.

“(a) In General.—The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an ‘Institute’) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the ‘Centers’). Such activities may include—

“(1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute;

“(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 505, 510(k), 513(f)(2), and 515 of this Act and section 351 of the Public Health Service Act, and other applicable authorities;

“(3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute;

“(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute;

“(5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and

“(6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.

“(b) Public Process.—The Secretary shall provide a period for public comment during the time that each Institute is being implemented.

“(c) Timing.—The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after the date of enactment of the 21st Century Cures Act.

“(d) Termination of Institutes.—The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination.”

“(3) Utilization guidelines.—The Secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products (as defined in section 319F–3), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.”

; and

“(5) Clarification on contracting authority.—The Secretary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement of security countermeasures under subsection (c) and for carrying out section 319L), including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and section 319L.”

“(E) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.”