Title: ARPA–H Act
Policy area: Health

Summary:
Advanced Research Project Agency-Health Act or the ARPA-H Act
This bill establishes within the Department of Health and Human Services (HHS) the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects. The bill also establishes an interagency committee to inform, and a fund in the Treasury to support, the agency's activities.
The director must designate personnel to serve as program managers who administer the agency's research programs, including by selecting projects to support, setting progress milestones for projects, and making recommendations about terminating or continuing projects.
The agency may use a variety of mechanisms to support the research projects, including grants, contracts, and prize competitions. The agency's budget is separate from that of HHS.
The agency must coordinate with the Food and Drug Administration and the Centers for Medicare & Medicaid Services to expedite development and coverage of high-need cures. Additionally, the agency may partner with other public and private entities, such as institutions of higher education and patient advocacy organizations.
The bill also requires the agency to develop and periodically update a strategic plan and annually report on its activities. Furthermore, the National Academies of Sciences, Engineering, and Medicine must evaluate the agency's performance.


[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5585 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 5585

  To establish the Advanced Research Projects Agency-Health, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 15, 2021

  Ms. Eshoo introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To establish the Advanced Research Projects Agency-Health, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advanced Research Project Agency-
Health Act'' or the ``ARPA-H Act''.

SEC. 2. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended by adding at the end the following:

           ``PART J--ADVANCED RESEARCH PROJECTS AGENCY-HEALTH

``SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.

    ``(a) Establishment.--There is established the Advanced Research 
Projects Agency-Health (in this part referred to as `ARPA-H') within 
the Department of Health and Human Services.
    ``(b) Goals and Activities.--
            ``(1) Goals.--The goals of ARPA-H shall be to--
                    ``(A) foster the development of new, breakthrough 
                capabilities, technologies, systems, and platforms to 
                accelerate innovations in health and medicine;
                    ``(B) revolutionize diagnosis, mitigation, 
                prevention, and treatment of diseases through the 
                development of transformative health technologies and 
                high-need cures;
                    ``(C) promote high-risk, high-reward innovation to 
                develop high-need cures; and
                    ``(D) ensure the United States maintains--
                            ``(i) global leadership in science and 
                        innovation; and
                            ``(ii) the highest quality of life and 
                        health for its citizens.
            ``(2) Means.--ARPA-H shall achieve the goals under 
        paragraph (1) by--
                    ``(A) identifying and promoting revolutionary 
                advances in health sciences;
                    ``(B) translating scientific discoveries into 
                technological innovations and high-need cures;
                    ``(C) providing resources and support to create 
                platform capabilities that draw on multiple 
                disciplines;
                    ``(D) delivering advanced proofs of concept that 
                demonstrate clinically meaningful advances;
                    ``(E) accelerating transformational technological 
                advances in areas with limited funding or technical 
                certainty; and
                    ``(F) prioritizing investments based on such 
                considerations as--
                            ``(i) scientific opportunity and uniqueness 
                        of fit to the strategies and operating 
                        practices of ARPA-H;
                            ``(ii) the effect on disease burden, 
                        including unmet patient need and the fiscal 
                        liability of the Federal Government with 
                        respect to health care; and
                            ``(iii) potential opportunities to advance 
                        health equity.
    ``(c) Director.--
            ``(1) In general.--The President shall appoint in the 
        Department of Health and Human Services a director of ARPA-H 
        (in this section referred to as the `Director').
            ``(2) Qualifications.--The Director shall be an individual 
        who, by reason of professional background and experience, is 
        especially qualified to manage--
                    ``(A) research and advanced development programs; 
                and
                    ``(B) large-scale, high-risk initiatives with 
                respect to health research across multiple sectors, 
                including generating high-need cures.
            ``(3) Relationship to secretary.--The Director shall report 
        to the Secretary.
            ``(4) Duties.--The duties of the Director shall include the 
        following:
                    ``(A) Approve and terminate the projects and 
                programs of ARPA-H.
                    ``(B) Set research and development priorities with 
                respect to the goals under subsection (b) and manage 
                the budget of ARPA-H.
                    ``(C) Develop funding criteria and assess the 
                success of programs through the establishment of 
                technical milestones.
                    ``(D) Advance the goals under subsection (b), 
                through consideration of the advice of the ARPA-H 
                Interagency Advisory Committee established under 
                subsection (l).
                    ``(E) Solicit data, as needed, from the National 
                Institutes of Health and other relevant Federal 
                agencies, private entities, academia, nonprofit 
                organizations, and international organizations.
                    ``(F) Coordinate with the Director of the National 
                Institutes of Health to ensure that the programs of 
                ARPA-H build on and are informed by scientific research 
                supported by the National Institutes of Health.
                    ``(G) Coordinate with the heads of Federal agencies 
                and, to the extent practicable, ensure that the 
                activities of ARPA-H supplement (and do not supplant) 
                the efforts of other Federal agencies.
            ``(5) Term.--The Director--
                    ``(A) shall be appointed for a 5-year term; and
                    ``(B) may be reappointed for 1 consecutive term.
            ``(6) Autonomy of agency regarding recommendations and 
        testimony.--No officer or agency of the United States shall 
        have any authority to require the Director or any other officer 
        of ARPA-H to submit legislative recommendations, or testimony 
        or comments on legislation, to any officer or agency of the 
        United States for approval, comments, or review prior to the 
        submission of such recommendations, testimony, or comments to 
        the Congress, if such recommendations, testimony, or comments 
        to the Congress include a statement indicating that the views 
        expressed therein are those of the Director or such officer, 
        and do not necessarily reflect the views of the President or 
        another agency.
            ``(7) Delegation of authority.--The Director may delegate 
        to any duly authorized employee, representative, or agent any 
        power vested in the Director or ARPA-H by law, except that the 
        Director may not delegate the power to appoint the Deputy 
        Director under paragraph (8).
            ``(8) Deputy director.--The Director shall appoint a deputy 
        director to serve as acting Director in the absence or 
        unavailability of the Director (notwithstanding section 3345 of 
        title 5, United States Code).
    ``(d) Application of Paperwork Reduction Act.--The Director may 
waive the requirements of subchapter I of chapter 35 of title 44, 
United States Code (commonly referred to as the `Paperwork Reduction 
Act') with respect to the activities described under subsection 
(c)(3)(F).
    ``(e) Partnerships.--In carrying out this section, the Director may 
partner with public and private entities, including--
            ``(1) other Federal agencies;
            ``(2) institutions of higher education;
            ``(3) private or public research institutions;
            ``(4) federally funded research and development centers;
            ``(5) private entities, including biotechnology, and 
        pharmaceutical, medical device, and other health entities; and
            ``(6) nonprofit organizations, including patient advocacy 
        groups.
    ``(f) Coordination on High-Need Cures.--The Director shall 
coordinate with the Commissioner of Food and Drugs and the 
Administrator of the Centers for Medicare & Medicaid Services to 
expedite the development, application, coverage, and implementation of 
high-need cures.
    ``(g) Awards.--In carrying out this section, the Director may make 
awards in the form of grants, contracts, cooperative agreements, 
prizes, and other transactions, including--
            ``(1) grants and cooperative agreements subject to the 
        uniform administrative requirements, cost principles, and audit 
        requirements for Federal awards contained in part 200 of title 
        2 of the Code of Federal Regulations;
            ``(2) contracts subject to chapter 1 of title 48, Code of 
        Federal Regulations (or successor regulations) (commonly 
        referred to as the `Federal Acquisition Regulation') but exempt 
        from the regulations specified in chapter 3 of title 48, Code 
        of Federal Regulations (or successor regulations);
            ``(3) multi-year contracts under section 3903 of title 41, 
        United States Code;
            ``(4) prize competitions; and
            ``(5) other transactions or prototype projects that are 
        directly relevant to enhancing such goals.
    ``(h) Facilities Authority.--The Director may--
            ``(1) acquire (by purchase, lease, condemnation or 
        otherwise), construct, improve, repair, operate, and maintain 
        such real and personal property necessary to carry out this 
        section; and
            ``(2) lease an interest in property for not more than 20 
        years, notwithstanding section 1341(a)(1) of title 31, United 
        States Code.
    ``(i) Personnel.--
            ``(1) In general.--The Director of ARPA-H shall have the 
        authority to--
                    ``(A) hire personnel under section 207(f) and 
                establish governing criteria to recruit, appoint, and 
                compensate personnel under this section without regard 
                to any provision in title 5, United States Code, 
                governing appointments under the civil service laws and 
                fix the compensation of such personnel at a rate to be 
                determined by the Director, up to the amount of annual 
                compensation (excluding expenses) specified in section 
                102 of title 3, United States Code, notwithstanding 
                section 202 of the Department of Health and Human 
                Services Appropriations Act, 1993 (Public Law 102-394) 
                or any provision of title 5, United States Code, 
                governing the rates of pay or classification of 
                employees in the executive branch;
                    ``(B) make additional appointments of scientific, 
                medical, and professional personnel under this section 
                without regard to any provision in title 5, United 
                States Code, governing appointments under the civil 
                service laws and fix the compensation of such personnel 
                at a rate to be determined by the Director, up to the 
                amount of annual compensation (excluding expenses) 
                specified in section 102 of title 3, United States 
                Code, notwithstanding section 202 of Department of 
                Health and Human Services Appropriations Act, 1993 
                (Public Law 102-394) or any provision of title 5, 
                United States Code, governing the rates of pay or 
                classification of employees in the executive branch; 
                and
                    ``(C) make appointments to positions of 
                administration or management of ARPA-H without regard 
                to any provision in title 5, United States Code, 
                governing appointments under the civil service laws and 
                fix the compensation of such personnel at a rate to be 
                determined by the Director, up to the amount of annual 
                compensation (excluding expenses) specified in section 
                102 of title 3, United States Code, notwithstanding 
                section 202 of Department of Health and Human Services 
                Appropriations Act, 1993 (Public Law 102-394) or any 
                provision of title 5, United States Code, governing the 
                rates of pay or classification of employees in the 
                executive branch.
            ``(2) Additional staff.--The Director of ARPA-H may use all 
        authorities in existence on the date of enactment of this 
        section that are provided to the Secretary to hire 
        administrative, financial, legal, contracts, legislative 
        affairs, and information technology staff, and such other staff 
        as may be identified by the Director as necessary to carry out 
        this section.
            ``(3) Additional considerations.--In appointing qualified 
        personnel under this subsection, the Director--
                    ``(A) may contract with private entities; and
                    ``(B) shall make efforts to recruit and retain a 
                diverse workforce, including individuals 
                underrepresented in science and medicine and racial and 
                ethnic minorities.
            ``(4) Additional hiring authority.--To the extent needed to 
        carry out the duties in paragraph (1), the Director is 
        authorized to utilize hiring authorities under section 3372 of 
        title 5, United States Code, to staff ARPA-H with employees 
        from other Federal agencies, State and local governments, 
        Indian Tribes and Tribal organizations, institutions of higher 
        education, and other organizations, as described in that 
        section, in the same manner and subject to the same conditions, 
        that apply to such individuals utilized to accomplish other 
        purposes.
            ``(5) Existing authorities.--The authorities granted by 
        this section are--
                    ``(A) in addition to existing authorities granted 
                to the Secretary; and
                    ``(B) are not intended to supersede or modify any 
                existing authorities.
    ``(j) Program Managers.--
            ``(1) In general.--The Director shall designate employees 
        of ARPA-H to serve as program managers for the programs carried 
        out by ARPA-H.
            ``(2) Duties.--A program manager shall--
                    ``(A) establish research and development goals for 
                programs in accordance with guidance from the Director;
                    ``(B) collaborate with experts from the National 
                Institutes of Health and other Federal agencies and 
                experts in relevant scientific fields to identify 
                research and development opportunities;
                    ``(C) convene workshops, as needed, with relevant 
                Federal agencies, institutions of higher education, 
                nonprofit research institutions, companies, venture 
                capital firms, and nonprofit organizations for the 
                development of high-need cures;
                    ``(D) issue funding opportunity announcements;
                    ``(E) select, on the basis of merit, each of the 
                projects to be supported under a program carried out by 
                ARPA-H, taking into consideration--
                            ``(i) the novelty and scientific and 
                        technical merit of the proposed projects;
                            ``(ii) the demonstrated capabilities of the 
                        applicants to successfully carry out the 
                        proposed project;
                            ``(iii) the unmet needs within patient 
                        populations;
                            ``(iv) the consideration by the applicant 
                        of future commercial applications of the 
                        project, including the feasibility of 
                        partnering with one or more commercial 
                        entities; and
                            ``(v) such other criteria as are 
                        established by the Director;
                    ``(F) identify milestones and monitor progress of 
                such milestones with respect to each project;
                    ``(G) provide recommendations to the Director with 
                respect to advancing the goals under subsection (b);
                    ``(H) identify opportunities for the commercial 
                application of successful projects, including through 
                the establishment of partnerships between or among 
                awardees; and
                    ``(I) provide recommendations to expand, 
                restructure, or terminate research partnerships or 
                projects.
            ``(3) Term.--A program manager may serve not greater than 2 
        terms for a period of 3 years each.
    ``(k) Reports and Evaluation.--
            ``(1) Annual report.--
                    ``(A) In general.--Beginning not later than 1 year 
                after the date of the enactment of this section, and 
                each fiscal year thereafter, the Director shall submit 
                a report on the actions undertaken, and results 
                generated, by ARPA-H, including--
                            ``(i) a description of projects supported 
                        by ARPA-H in the previous fiscal year and 
                        whether such projects are meeting the goals 
                        developed by the Director pursuant to 
                        subsection (c)(4)(C);
                            ``(ii) a description of projects terminated 
                        in the previous fiscal year, and the reason for 
                        such termination;
                            ``(iii) a description of projects starting 
                        in the next fiscal year, as available;
                            ``(iv) activities conducted in coordination 
                        with other Federal agencies; and
                            ``(v) an analysis of the extent of 
                        coordination conducted pursuant to subsections 
                        (c)(4)(F) and (f), including successes and 
                        barriers with respect to achieving the goals 
                        under subsection (b).
                    ``(B) Submission to congress.--The report under 
                subsection (a) shall be submitted to--
                            ``(i) the Committee on Energy and Commerce 
                        and the Committee on Appropriations of the 
                        House of Representatives; and
                            ``(ii) the Committee on Health, Education, 
                        Labor, and Pensions and the Committee on 
                        Appropriations of the Senate.
            ``(2) Evaluation.--
                    ``(A) In general.--Not later than 8 years after the 
                date of the enactment of this section, the Secretary 
                shall enter into an agreement with the National 
                Academies of Sciences, Engineering, and Medicine to 
                study and evaluate whether ARPA-H has met the goals 
                under subsection (b).
                    ``(B) Submission of results.--The agreement entered 
                into under subparagraph (A) shall require the National 
                Academies of Sciences, Engineering, and Medicine to 
                submit the results of the evaluation conducted under 
                such agreement to the Secretary, the Committee on 
                Energy and Commerce of the House of Representatives and 
                the Committee on Health, Education, Labor, and Pensions 
                of the Senate.
    ``(l) Strategic Plan.--Not later than 1 year after the date of the 
enactment of this section, and every 4 years thereafter, the Director 
shall provide to the relevant committees of Congress a strategic plan 
describing how ARPA-H will carry out investments each fiscal year in 
the next 4-year period.
    ``(m) Additional Advice.--In carrying out this section, the 
Director may seek advice from--
            ``(1) the President's Committee of Advisors on Science and 
        Technology;
            ``(2) peers in the scientific community, including academia 
        and industry;
            ``(3) experts in other Federal agencies;
            ``(4) any professional or scientific organization with 
        expertise technologies under development by ARPA-H or a 
        relevant scientific discipline; and
            ``(5) representatives of patient communities.
    ``(n) ARPA-H Advisory Committee.--
            ``(1) In general.--The Director shall establish an 
        interagency advisory committee to be known as the ARPA-H 
        Interagency Advisory Committee (referred to in this subsection 
        as the `Advisory Committee').
            ``(2) Membership.--The Advisory Committee may include any 
        or all of the following members, or designees:
                    ``(A) The Director of the National Institutes of 
                Health.
                    ``(B) The Director of National Center for Advancing 
                Translational Sciences.
                    ``(C) The Director of Office of Science and 
                Technology Policy.
                    ``(D) The Commissioner of the Food and Drug 
                Administration.
                    ``(E) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(F) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(G) The Administrator of the Centers for Medicare 
                & Medicaid Services.
                    ``(H) The Director of the Agency for Healthcare 
                Research and Quality.
                    ``(I) The Director of the Office of Minority 
                Health.
                    ``(J) The Administrator of the Health Resources and 
                Services Administration.
                    ``(K) The Director of the Defense Advanced Research 
                Projects Agency.
                    ``(L) The Director of the National Science 
                Foundation.
                    ``(M) The Director of the Office of Science of the 
                Department of Energy.
                    ``(N) Representatives of any Federal agency with 
                subject matter expertise that the Director of ARPA-H 
                determines is necessary for the successful completion 
                of a project carried out pursuant to this section.
            ``(3) Duties.--The Advisory Committee shall advise the 
        Director, including by--
                    ``(A) making recommendations on--
                            ``(i) research priorities that will provide 
                        the greatest return on investment with respect 
                        to improving human health;
                            ``(ii) avoiding duplication of efforts in 
                        the Federal Government; and
                            ``(iii) improving coordination with other 
                        Federal agencies; and
                    ``(B) identifying and developing strategies to 
                address market barriers to commercialization or 
                adoption of high-need cures.
            ``(4) Non-applicability of faca.--The Federal Advisory 
        Committee Act (5 U.S.C. App.) shall not apply to the Advisory 
        Committee.
            ``(5) Advisory nature.--The function of the Committee shall 
        be advisory in nature. Nothing in this section shall be 
        construed as giving the Committee authority over the activities 
        authorized under this section.
    ``(o) Rule of Construction.--The authorities under this section, 
with respect to the Director, are additional authorities that do not 
supersede or modify any existing authorities.
    ``(p) Definitions.--In this section:
            ``(1) Advanced proofs of concept.--The term `advanced 
        proofs of concept' means data, a prototype, or other 
        experimental evidence that--
                    ``(A) may precede the development of a high-need 
                cure or health technology; and
                    ``(B) demonstrates the feasibility of a new 
                concept.
            ``(2) Biological product.--The term `biological product' 
        has the meaning given such term in section 262 of the Federal 
        Food, Drug, and Cosmetic Act.
            ``(3) Drug.--The term `drug' has the meaning given such 
        term in section 201 of the Federal Food, Drug, and Cosmetic 
        Act.
            ``(4) Device.--The term `device' has the meaning given such 
        term in section 201 of the Federal Food, Drug, and Cosmetic 
        Act.
            ``(5) Federal acquisition regulation.--The term `Federal 
        Acquisition Regulation' means the Federal Acquisition 
        Regulation issued pursuant to section 1303(a)(1) of title 41, 
        United States Code.
            ``(6) High-need cure.--The term `high-need cure' means a 
        drug, biological product, or device--
                    ``(A) that should be prioritized to detect, 
                diagnose, mitigate, prevent, or treat any disease or 
                medical condition; and
                    ``(B) for which incentives in commercial market are 
                unlikely to result in the adequate or timely 
                development of such drug, biological product, or 
                device.
            ``(7) Prize competitions.--The term `prize competitions' 
        has the meaning given such term in section 24 of the Stevenson-
        Wydler Technology Innovation Act of 1980 (15 U.S.C. 3719).

``SEC. 499B. HEALTH ADVANCED RESEARCH AND DEVELOPMENT FUND.

    ``(a) Establishment.--There is established in the Treasury a fund 
to be known as the Health Advanced Research and Development Fund (in 
this section referred to as the `Fund') which shall be administered by 
the Director of ARPA-H for the purposes of carrying out section 499A.
    ``(b) Separate Budget Request.--The annual budget request for ARPA-
H shall be separate from the rest of the budget for the Department of 
Health and Human Services. The Director of ARPA-H shall prepare and 
submit directly to the President for review and transmittal to 
Congress, an annual budget for ARPA-H after reasonable opportunity for 
comment (but without change) by the Secretary.
    ``(c) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to the Fund, $3,000,000,000 for fiscal year 2022, to remain 
        available until expended.
            ``(2) Advance appropriations.--For each fiscal year 
        beginning with fiscal year 2022, discretionary new budget 
        authority provided in an appropriations Act for ARPA-H shall--
                    ``(A) be made available for that fiscal year; and
                    ``(B) include advance discretionary new budget 
                authority that first becomes available for the first 
                fiscal year following the budget year.
            ``(3) Separate appropriations.--Appropriations to the Fund 
        shall be separate and distinct from other appropriations for 
        the Department.''.
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