H.R. 34 (114^th): 21st Century Cures Act

Identifying and funding areas of biomedical science that could realize significant advancements through a prize competition.

Improving health outcomes, particularly with respect to human diseases and conditions—

collect information on—

include the information collected under paragraph (1) in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032).

in paragraph (23), by striking and at the end;

in paragraph (24), by striking the period and inserting ; and; and

by inserting after paragraph (24) the following:

by amending the section heading to read as follows: Intramural loan repayment program;

in subsection (a)—

by redesignating subsection (b) as subsection (d);

by inserting after subsection (a), the following:

by adding at the end the following:

by amending the section heading to read as follows: Extramural loan repayment program;

in subsection (a)—

by redesignating subsections (b) and (c) as subsections (d) and (e), respectively;

by inserting after subsection (a), the following:

in subsection (d) (as so redesignated), by striking The provisions and inserting Applicability of certain provisions regarding obligated service.—The provisions; and

in subsection (e) (as so redesignated), by striking Amounts and inserting Availability of appropriations.—Amounts.

by striking section 464z–5 (42 U.S.C. 285t–2);

by striking section 487C (42 U.S.C. 288–3);

by striking section 487E (42 U.S.C. 288–5);

by striking section 487F (42 U.S.C. 288–5a), as added by section 205 of Public Law 106–505, relating to loan repayment for clinical researchers; and

by striking section 487F (42 U.S.C. 288–6), as added by section 1002(b) of Public Law 106–310 relating to pediatric research loan repayment.

in subsection (b)(5), by inserting before the semicolon the following: , and through the development, implementation, and updating of the strategic plan developed under subsection (m); and

by adding at the end the following:

describe the procedures in place to identify such duplicative research, including procedures for monitoring research applications and funded research awards to prevent unnecessary duplication;

describe the steps taken to improve the procedures described in paragraph (1), in response to relevant recommendations made by the Comptroller General of the United States;

describe how the Secretary operationally distinguishes necessary and appropriate scientific replication from unnecessary duplication; and

provide examples of instances where the Secretary has identified unnecessarily duplicative research and the steps taken to eliminate the unnecessary duplication.

In general

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall—

Considerations

In updating policies under paragraph (1)(B), the Secretary shall consider—

an exemption from subrecipient monitoring requirements, upon request from the primary awardees, provided that—

the implementation of alternative grant structures that obviate the need for subrecipient monitoring, which may include collaborative grant models allowing for multiple primary awardees.

identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;

take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and

take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.

Establishment

Not later than 1 year after the date of enactment of this Act, the Director of the Office of Management and Budget shall establish an advisory committee, to be known as the Research Policy Board (referred to in this subsection as the Board), to provide Federal Government officials with information on the effects of regulations related to Federal research requirements.

Membership

Purpose and responsibilities

The Board shall make recommendations regarding the modification and harmonization of regulations and policies having similar purposes across research funding agencies to ensure that the administrative burden of such research policy and regulation is minimized to the greatest extent possible and consistent with maintaining responsible oversight of federally funded research. Activities of the Board may include—

Expert subcommittees

The Board may form temporary expert subcommittees, as appropriate, to develop timely analysis on pressing issues and assist the Board in anticipating future regulatory challenges, including challenges emerging from new scientific advances.

Reporting requirements

Not later than 2 years after the date of enactment of this Act, and once thereafter, the Board shall submit a report to the Director of the Office of Management and Budget, the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the heads of relevant Federal departments and agencies, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives containing formal recommendations on the conceptualization, development, harmonization, and reconsideration of scientific research policy, including the regulatory benefits and burdens.

Sunset

The Board shall terminate on September 30, 2021.

GAO report

Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out by the Board pursuant to this subsection and submit to the appropriate committees of Congress a report regarding the results of the independent evaluation. Such report shall review and assess the Board's activities with respect to the responsibilities described in paragraph (3).

by redesignating subparagraphs (C) through (L) as subparagraphs (D) through (M), respectively; and

by inserting after subparagraph (B), the following:

in paragraph (1), by striking phase IIA and inserting phase IIB; and

in paragraph (2)—

in subsection (c)—

by adding at the end the following:

by amending paragraph (4) to read as follows:

in paragraph (8)—

by striking biennial each place such term appears and inserting triennial;

by striking The advisory council and inserting the following:

by adding at the end the following:

In general

The Secretary, in collaboration with the Director of the National Institutes of Health, shall as appropriate—

National academy of medicine recommendations

In developing the measures described in paragraph (1)(A), the Secretary shall take into account recommendations made by the National Academy of Medicine.

by redesignating subsection (h), relating to interagency coordination, that follows subsection (j) as subsection (k); and

in subsection (k) (as so redesignated)—

Developing policies

Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health (referred to in this section as the Director of the National Institutes of Health), taking into consideration the recommendations developed under section 2039, shall develop policies for projects of basic research funded by National Institutes of Health to assess—

Revising policies

The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.

Consultation and outreach

In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—

Additional requirements

The Director of the National Institutes of Health shall—

In general

Not later than 1 year after the date of enactment of this Act, the Director of the National Institutes of Health, in consultation with the Director of the Office of Research on Women's Health and the Director of the National Institute on Minority Health and Health Disparities, shall update the guidelines established under section 492B(d) of Public Health Service Act (42 U.S.C. 289a–2(d)) in accordance with paragraph (2).

Requirements

The updated guidelines described in paragraph (1) shall—

Input from experts

Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on—

Policy updates

Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies—

Public Availability of Findings and Conclusions

The Director of the National Institutes of Health shall—

preclinical experiment design, including analysis of sex as a biological variable;

clinical experiment design, including—

applicable levels of rigor in statistical methods, methodology, and analysis;

data and information sharing in accordance with applicable privacy laws and regulations; and

any other matter the working group determines relevant.

in subsection (b), by striking conduct and support and inserting conduct, support, and coordination;

in subsection (c)(1)(C), by striking of the Center and inserting within the Center;

in subsection (d)—

in subsection (e)—

in subsection (f)(3)(B)—

by adding at the end the following:

in subsection (a), by striking In General.—; and

by striking subsection (b).

Establishment

Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall establish a task force, in accordance with the Federal Advisory Committee Act (5 U.S.C. App.), to be known as the Task Force on Research Specific to Pregnant Women and Lactating Women (in this section referred to as the Task Force).

Duties

The Task Force shall provide advice and guidance to the Secretary regarding Federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities.

Membership

Termination

Meetings

The Task Force shall meet not less than 2 times each year and shall convene public meetings, as appropriate, to fulfill its duties under paragraph (2).

Task force report to congress

Not later than 18 months after the date on which the Task Force is established under paragraph (1), the Task Force shall prepare and submit to the Secretary, 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 each of the following:

In general

Not later than 2 years after the date of enactment of this Act, the Secretary, considering any recommendations of the Task Force available at such time and in consultation with the heads of relevant agencies of the Department of Health and Human Services, shall, as appropriate, update regulations and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Criteria for excluding pregnant or lactating women

In updating any regulations or guidance described in paragraph (1), the Secretary shall consider any appropriate criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women or lactating women as a study population requiring additional protections from participating in human subject research.

by amending subparagraph (B) to read as follows:

in subparagraphs (D) and (E) by striking (B)(i) each place it appears and inserting (B).

by striking subsection (b);

by redesignating subsection (c) as subsection (b); and

in subsection (b) (as so redesignated), by striking subsections (a) and (b) and inserting subsection (a).

by striking subsection (b); and

by striking (a) Development of New Vaccines.—The Secretary and inserting The Secretary.

in the subsection heading, by striking Annual and inserting Biennial; and

in the matter preceding paragraph (1), by striking an annual report and inserting a report on a biennial basis.

Repeal

Section 404H of the Public Health Service Act (42 U.S.C. 283j) is repealed.

Conforming amendment

Section 399EE(c) of the Public Health Service Act (42 U.S.C. 280–4(c)) is amended by striking 399CC, 404H, and inserting 399CC.

by striking paragraph (2); and

by redesignating paragraph (3) as paragraph (2).

Repeal

Section 464Y of the Public Health Service Act (42 U.S.C. 285q–3) is repealed.

Conforming amendment

Section 464X(g) of the Public Health Service Act (42 U.S.C. 285q–2(g)) is amended by striking biennial report made under section 464Y, and inserting triennial report made under section 403.

Applicable clinical trial

The term applicable clinical trial has the meaning given the term in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).

Secretary

The term Secretary means the Secretary of Health and Human Services.

In general

Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, the Secretary, acting through the Director of the National Institutes of Health and in collaboration with the Commissioner of Food and Drugs, 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—

Actions to enforce compliance

After the Secretary has undertaken the educational activities described in paragraph (1)(C), the Secretary shall include in subsequent reports submitted under paragraph (1) the number of actions taken by the Secretary during the period for which the report is being prepared to enforce compliance with data bank registration and results submission requirements.

Establishment

The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the Working Group), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.

Responsibilities

The working group shall—

Membership

The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:

Meetings

The Working Group shall meet not less than twice each year.

Reporting

Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall—

Applicability of FACA

The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).

Sunset

The Working Group under this section shall terminate 6 years after the date of enactment of this Act.

at a minimum, security and privacy safeguards, consistent with the requirements of the Rule, are maintained by the covered entity and the researcher; and

the protected health information is not copied or otherwise retained by the researcher.

Authorization for use and disclosure of health information

Clarification of the circumstances under which the authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes contains a sufficient description of the purpose of the use or disclosure, such as if the authorization—

Reminder of the right to revoke

Clarification of the circumstances under which it is appropriate to provide an individual with an annual notice or reminder that the individual has the right to revoke such authorization.

Revocation of authorization

Clarification of appropriate mechanisms by which an individual may revoke an authorization for future research purposes, such as described in paragraph (1)(C).

Establishment

Not later than 1 year after the date of enactment of this Act, the Secretary shall convene a working group to study and report on the uses and disclosures of protected health information for research purposes, under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191).

Members

The working group shall include representatives of—

Report

Not later than 1 year after the date on which the working group is convened under paragraph (1), the working group shall conduct a review and submit a report to the Secretary containing recommendations on whether the uses and disclosures of protected health information for research purposes should be modified to allow protected health information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge, while protecting individuals’ privacy rights. In conducting the review and making recommendations, the working group shall—

Report submission

The Secretary shall submit the report under paragraph (3) 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 shall post such report on the appropriate Internet website of the Department of Health and Human Services.

Termination

The working group convened under paragraph (1) shall terminate the day after the report under paragraph (3) is submitted to Congress and made public in accordance with paragraph (4).

The rule

References to the Rule refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).

Part 164

References to a specified section of part 164, refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section).

methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decisionmaking may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis;

methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease;

approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials;

methodologies, standards, and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking;

how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance to the Secretary;

the format and content required for submissions under this section to the Secretary, including with respect to the information described in paragraph (1);

how the Secretary intends to respond to submissions of information described in paragraph (1), if applicable, including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response; and

how the Secretary, if appropriate, anticipates using relevant patient experience data and related information, including with respect to the structured risk-benefit assessment framework described in section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory decisionmaking.

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall, in consultation with biomedical research consortia (as defined in subsection (e) of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—

Timing

Not later than 3 years after the date of the enactment of this Act, the Secretary shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.

Taxonomy

Meeting

Not later than 2 years after the date of the enactment of this Act, the Secretary shall convene a public meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

Report

Not later than 5 years after the date of the enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), information on—

The neglected tropical disease priority review voucher program under section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n).

The rare pediatric disease priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff).

The medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act, as added by section 3086.

for each drug for which a priority review voucher has been awarded as of initiation of the study—

for each drug for which a priority review voucher has been used—

an analysis of the priority review voucher programs described in subsection (a), including—

the term drug has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);

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)); and

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)).

In general

The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products.

Contents

The guidance under paragraph (1) shall address—

Public meeting

Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act.

Timing

The Secretary shall update or issue a draft version of the guidance required by paragraph (1) not later than 18 months after the date of the public meeting required by paragraph (3) and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes.

make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary—

ensure that human subject research that is subject to the HHS Human Subject Regulations and to the FDA Human Subject Regulations may—

Human subject regulations

In this section:

Institutional review board defined

In this section, the term institutional review board has the meaning that applies to the term institutional review board under the HHS Human Subject Regulations.

in subparagraph (D), by striking except where subject to such conditions as the Secretary may prescribe, the investigator and inserting the following: “except where, subject to such conditions as the Secretary may prescribe—

in the matter following subparagraph (D), by striking subparagraph (D) and inserting subparagraph (D)(ii).

by transferring subsection (e) (relating to construction) so that it appears before subsection (f) (relating to awareness efforts); and

by adding at the end the following:

to approve drugs pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262) as authorized prior to the date of enactment of the 21st Century Cures Act, including the standards of evidence, and applicable conditions, for approval under such Acts; or

to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior to the date of enactment of the 21st Century Cures Act.

how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;

what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device;

when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and

application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

the number and type of applications for approval of regenerative advanced therapies filed, approved or licensed as applicable, withdrawn, or denied; and

how many of such applications or therapies, as applicable, were granted accelerated approval or priority review.

by striking paragraph (3);

by redesignating paragraph (2) as paragraph (7);

by redesignating paragraphs (4) and (5) as paragraphs (8) and (9), respectively;

by striking (g)(1) and all that follows through the end of paragraph (1) and inserting the following:

in paragraph (8) (as redesignated by paragraph (3))—

in paragraph (9) (as redesignated by paragraph (3))—

in subparagraph (A), by striking Any information and inserting “Subject to subparagraph (C), any information”; and

by adding at the end the following new subparagraph:

by redesignating subsections (f) and (g) as subsections (l) and (m), respectively; and

by inserting after subsection (e), the following:

Repeal of prior related authority

Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d–5a), relating to identification of clinically susceptible concentrations of antimicrobials, is repealed.

Addition to categories of misbranded drugs

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

Recognition of interpretive criteria standard as device standard

Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting after the Secretary shall, by publication in the Federal Register the following: (or, with respect to a susceptibility test interpretive criteria standard under section 511A, by posting on the Interpretive Criteria Website in accordance with such section).

In general

Section 515(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is amended—

Conforming amendment

Section 737(5) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by striking 515(d)(6) and inserting 515(d)(5).

on the program under section 515C of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in bringing safe and effective devices included in such program to patients as soon as possible; and

that includes recommendations, if any, to strengthen the program to better meet patient device needs in a manner as timely as possible.

in paragraph (1) by striking fewer than 4,000 and inserting not more than 8,000;

in paragraph (2)(A) by striking fewer than 4,000 and inserting not more than 8,000; and

in paragraph (6)(A)(ii), by striking 4,000 and inserting 8,000.

in paragraph (1), by inserting after subparagraph (B) the following new subparagraphs:

by adding at the end the following:

by striking A report under subsection (k) and inserting (1) A report under subsection (k); and

by adding at the end the following new paragraph:

by striking (m)(1) and all that follows through by the Secretary. and inserting the following:

in paragraph (2)—

by striking (5) and inserting (5)(A); and

by adding at the end the following:

in subparagraph (A)(iii), by inserting before the period at the end , including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided; and

by striking subparagraph (B) and inserting the following new subparagraph:

revises Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy of the guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices and dated January 30, 2008; and

includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.

includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;

examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a)); and

summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions.

in the section heading, by inserting and Biomedical Product Assessment after Research;

in subsection (a)—

in subsection (b)—

in subsection (d)(2), by striking and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code and inserting and shall not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code;

by striking subsection (e); and

by redesignating subsections (f) and (g) as subsections (e) and (f), respectively.

In general

The Comptroller General of the United States shall conduct a study of the effectiveness of the amendments to section 228 of the Public Health Service Act (42 U.S.C. 237) made by subsection (a) and the impact of such amendments, if any, on all agencies or departments of the Department of Health and Human Services, and, not later than 4 years after the date of enactment of this Act, shall submit a report based on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

Content of study and report

The study and report under paragraph (1) shall include an examination of the extent to which recruitment and retention of outstanding and qualified scientific, medical, or technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment have improved or otherwise have been affected by the amendments to section 228 of the Public Health Service Act (42 U.S.C. 237) made by subsection (a), including by determining, during the period between the date of enactment of this Act and the completion of the study—

In general

The Comptroller General of the United States shall conduct a study of the ability of the Food and Drug Administration to hire, train, and retain qualified scientific, technical, and professional staff, not including contractors, necessary to fulfill the mission of the Food and Drug Administration to protect and promote public health. Not later than January 1, 2022, the Comptroller General shall submit a report on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

Contents of study

The Comptroller General shall include in the study and report under paragraph (1)—

by redesignating section 1012 as section 1013; and

by redesignating the second section 1011 (with respect to improving the training of State, local, territorial, and tribal food safety officials), as added by section 209(a) of the FDA Food Safety Modernization Act (Public Law 111–353), as section 1012.

shall not be considered conferences for the purposes of complying with Federal reporting requirements contained in annual appropriations Acts or in this section; and

shall not be considered conferences for purposes of a restriction contained in an annual appropriations Act, based on Office of Management and Budget Memorandum M-12-12 or any other regulation restricting travel to such meeting.

general information concerning the scientific meeting activities involved;

information concerning the total amount expended for such meetings;

a description of all such meetings that were attended by scientific or medical personnel, or other professionals, of each such operating division where the total amount expended by the operating division associated with each such meeting were in excess of $30,000, including—

with respect to any such meeting where the total expenses to the operating division exceeded $150,000, a description of the exceptional circumstances that necessitated the expenditure of such amounts.

in subparagraph (A), by striking , bi-weekly screening and inserting screenings;

in subparagraph (B), as redesignated by section 2074(1)(C), by striking the period at the end and inserting ; and; and

by adding at the end the following:

in the matter preceding subparagraph (A), by inserting or other advisory committee after (or successor committee); and

in subparagraph (B), by striking at least annually, and inserting periodically.

Composition and size

Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) is amended—

Federal employees allowed to serve on Board

Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by paragraph (1)(A), is amended by adding at the end the following: For purposes of this section, the term employee of the Federal Government does not include a special Government employee, as that term is defined in section 202(a) of title 18, United States Code..

Staggered terms

Subparagraph (A) of section 770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended to read as follows:

in subsection (a)(2)—

in subsection (b)(4), by striking the second comma after determination;

in subsection (e)(3)(B), by striking section 503(b) and inserting subsection (b) or (f) of section 503 or under section 504;

in subsection (f)(2)—

in subsection (g)(1), by inserting conditional approval under section 571, after approval,;

in subsection (h)(1), by striking or section 520(g)and inserting 512(j), or 520(g); and

in subsection (k), by striking section 520(g),and inserting 512(j), or 520(g).

in subparagraph (B), by striking or at the end;

in subparagraph (C), by striking the period and inserting ; or; and

by inserting after subparagraph (C) the following:

in subsection (a)(1)(A), by inserting , conditionally approved under section 571, after chapter; and

in subsection (d), by striking sections 503(b) and 520(e) and inserting subsections (b) and (f) of section 503, section 504, and section 520(e).

in subparagraph (A)—

in subparagraph (B), by striking or 520 and inserting 512, or 520.

are designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) and licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); or

could be used in a public health emergency.

the criteria used to evaluate new and existing vaccines, including the identification of any areas for which flexibility in evaluating such criteria is necessary and the reason for such flexibility;

the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and

the extent to which the processes used by the work groups of the Advisory Committee on Immunization Practices are consistent among such groups, including the identification of reasons for any variation.

In general

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), in collaboration with appropriate agencies or offices within the Department of Health and Human Services, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority, 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 post publicly on the Internet website of the Department of Health and Human Services, a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious disease.

Contents

The report described in paragraph (1) shall review the current status of vaccine development and, as appropriate—

Consultation

In preparing the report under this subsection, the Secretary may consult with—

Additional vaccines

Section 2114(e) of the Public Health Service Act (42 U.S.C. 300aa–14(e)) is amended by adding at the end the following:

Petition content

Section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) is amended by adding at the end the following:

Petitioners

Section 2111(b)(2) of the Public Health Service Act (42 U.S.C. 300aa–11(b)(2)) is amended by adding A covered vaccine administered to a pregnant woman shall constitute more than one administration, one to the mother and one to each child (as such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine. at the end.

References

Except as otherwise expressly provided, whenever in this subsection an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

Amendments