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

<DOC>





                                                 Union Calendar No. 277
117th CONGRESS
  2d Session
                                H. R. 5585

                          [Report No. 117-365]

  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

                             June 13, 2022

 Additional sponsors: Ms. Lofgren, Ms. Roybal-Allard, Mr. Thompson of 
 California, Mr. Huffman, Mr. Costa, Mr. Suozzi, Ms. Johnson of Texas, 
   Mr. Michael F. Doyle of Pennsylvania, Ms. Wasserman Schultz, Mr. 
McGovern, Mr. Cartwright, Mrs. Fletcher, Mr. Cardenas, Ms. Craig, Mrs. 
   Trahan, Mr. Pascrell, Mr. Courtney, Mr. Perlmutter, Ms. Ross, Mr. 
   McNerney, Mrs. Napolitano, Mr. Peters, Ms. Barragan, Mr. Levin of 
 California, Mr. Tonko, Ms. Schrier, Ms. Blunt Rochester, Mr. Khanna, 
   Ms. Chu, Mr. DeSaulnier, Mr. Schiff, Ms. Speier, Mr. Aguilar, Mr. 
   Trone, Ms. McCollum, Mr. Schrader, Ms. Jacobs of California, Mr. 
Quigley, Mr. Moulton, Mr. Welch, Mr. Rush, Ms. Schakowsky, Ms. Kuster, 
Ms. Kelly of Illinois, Mrs. Dingell, Ms. Matsui, Ms. Castor of Florida, 
 Mr. O'Halleran, Ms. DeGette, Mr. Upton, Ms. Sewell, Mr. Sarbanes, Ms. 
    Clarke of New York, Mr. Morelle, Mr. Grijalva, Mr. Nadler, Mr. 
     McEachin, Mr. Soto, Mr. Carbajal, Mr. Bishop of Georgia, Mr. 
    Fitzpatrick, Mr. Lawson of Florida, Mr. Burgess, Mr. Cohen, Ms. 
               Williams of Georgia, and Ms. Brown of Ohio

                             June 13, 2022

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on October 
                               15, 2021]


_______________________________________________________________________

                                 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 Projects 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, as an independent 
operating division within the Department of Health and Human Services, 
the Advanced Research Projects Agency-Health (in this part referred to 
as `ARPA-H'). Not later than 180 days after the date of enactment of 
this part, the Secretary shall transfer all functions, personnel, 
missions, activities, authorities, and funds of the Advanced Research 
Projects Agency for Health within the National Institutes of Health, as 
in existence on the date of enactment of this part, to ARPA-H 
established by the preceding sentence.
    ``(b) Goals and Methods.--
            ``(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 that are 
                not being met by Federal programs or private entities;
                    ``(B) revolutionize detection, diagnosis, 
                mitigation, prevention, treatment, and curing of 
                serious diseases and medical conditions through the 
                development of transformative health technologies;
                    ``(C) promote high-risk, high-reward innovation for 
                the development and translation of transformative 
                health technologies; and
                    ``(D) contribute to ensuring the United States 
                maintains--
                            ``(i) global leadership in science and 
                        innovation;
                            ``(ii) the highest quality of life and 
                        health for its citizens; and
                            ``(iii) an aggressive agenda for 
                        innovations to address global health threats 
                        that place United States citizens at risk.
            ``(2) Methods.--ARPA-H shall achieve the goals specified in 
        paragraph (1) by--
                    ``(A) discovering, identifying, and promoting 
                revolutionary advances in health sciences;
                    ``(B) translating scientific discoveries into 
                transformative health technologies;
                    ``(C) providing resources and support to create 
                platform capabilities that draw on multiple 
                disciplines;
                    ``(D) using researchers in a wide range of 
                disciplines, including the life sciences, the physical 
                sciences, engineering, and the computational sciences;
                    ``(E) delivering advanced proofs of concept that 
                demonstrate potentially clinically meaningful advances;
                    ``(F) developing new capabilities, advanced 
                computational tools, predictive models, or analytical 
                techniques to identify potential targets and 
                technological strategies for early disease detection 
                and intervention;
                    ``(G) accelerating transformational technological 
                advances in areas with limited technical certainty; and
                    ``(H) 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, quality and 
                        disparity gaps, and the potential to preempt 
                        progression of serious disease; and
                            ``(iii) the effect on the fiscal liability 
                        of the Federal Government with respect to 
                        health care and the ability to reduce the cost 
                        of care through innovation.
    ``(c) Director.--
            ``(1) In general.--The President shall appoint with the 
        advice and consent of the Senate, a director of ARPA-H (in this 
        part 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 and technology development 
                across multiple sectors, including generating 
                transformative health technologies and improving health 
                outcomes for patients.
            ``(3) Relationship to secretary.--The Director shall report 
        directly 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 specified in 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 Research Council established under 
                subsection (q).
                    ``(E) Solicit data, as needed, from the National 
                Institutes of Health and other relevant entities.
                    ``(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.
                    ``(H) Ensure ARPA-H does not provide funding for a 
                project unless the program manager determines that the 
                project meets the goals described in subsection (b)(1).
            ``(5) Term.--The Director--
                    ``(A) shall be appointed for a 5-year term; and
                    ``(B) may be reappointed for 1 consecutive 5-year 
                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 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 the first assistant to the office.
    ``(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 methods described in subsection (b)(2).
    ``(e) Protection of Information.--The following types of 
information collected by ARPA-H from recipients of financial assistance 
awards shall be considered commercial and financial information 
obtained from a person and privileged or confidential and not subject 
to disclosure under section 552(b)(4) of title 5, United States Code:
            ``(1) Plans for commercialization of technologies developed 
        under the award, including business plans, technology-to market 
        plans, market studies, and cost and performance models.
            ``(2) Investments provided to an awardee from third parties 
        (such as venture capital firms, hedge funds, and private equity 
        firms), including amounts and the percentage of ownership of 
        the awardee provided in return for the investments.
            ``(3) Additional financial support that the awardee--
                    ``(A) plans to invest or has invested in the 
                technology developed under the award; or
                    ``(B) is seeking from third parties.
            ``(4) Revenue from the licensing or sale of new products or 
        services resulting from research conducted under the award.
    ``(f) Sharing Information With the Centers for Medicare & Medicaid 
Services.--The Director shall timely share relevant information with 
the Administrator of the Centers for Medicare & Medicaid Services that 
may help to expedite determinations of coverage of transformative 
health technologies developed by ARPA-H.
    ``(g) Expediting Breakthroughs Through Cooperation With the Food 
and Drug Administration.--
            ``(1) In general.--The Secretary, acting through the 
        Commissioner of Food and Drugs and in consultation with the 
        Director, may take actions to facilitate translation of 
        transformative health technology into tangible solutions for 
        patients and to expedite development of drugs, devices, and 
        biological products, including through--
                    ``(A) helping to ensure that drug, device, or 
                biological product development programs, in as 
                efficient a manner as possible, gather the nonclinical 
                and clinical data necessary to advancing the 
                development of such products and to obtaining their 
                approval, licensure, or clearance, as applicable, by 
                the Food and Drug Administration under sections 505, 
                510(k), and 515 of the Federal Food, Drug, and Cosmetic 
                Act and section 351 of this Act;
                    ``(B) expediting review of investigational new drug 
                applications under section 505(i) of the Federal Food, 
                Drug, and Cosmetic Act, review of investigational 
                device exemptions under section 520(g) of such Act, and 
                review of applications for approval, licensure, and 
                clearance of drugs, devices, or biological products 
                under sections 505, 510(k), and 515 of such Act, and 
                section 351 of this Act; and
                    ``(C) meeting at appropriate intervals with the 
                Director and any member of the ARPA-H Interagency 
                Research Council to discuss the development status of 
                drugs, devices, or biological products and projects 
                that are the highest priorities to ARPA-H, unless the 
                Director and the Commissioner of Food and Drugs 
                determine that any such meetings are not necessary.
            ``(2) Relation to otherwise authorized activities of the 
        fda.--The authority specified in paragraph (1) shall not be 
        construed as limiting the authority of the Secretary, acting 
        through the Commissioner of Food and Drugs, with respect to the 
        review and approval, clearance, authorization for emergency 
        use, or licensure of drugs, devices, or biological products 
        under the Federal Food, Drug, and Cosmetic Act or section 351 
        of this Act.
            ``(3) Reimbursement.--The Director, using funds made 
        available to ARPA-H, may reimburse the Food and Drug 
        Administration for expenditures made by the Food and Drug 
        Administration for activities carried out under this section 
        that have been identified by the Commissioner of Food and Drugs 
        and the Director as being carried out by the Food and Drug 
        Administration.
    ``(h) Awards.--
            ``(1) In general.--In carrying out this section, the 
        Director may make awards including--
                    ``(A) grants and cooperative agreements, which 
                shall--
                            ``(i) be subject to the uniform 
                        administrative requirements, cost principles, 
                        and audit requirements for Federal awards 
                        contained in part 200 of title 2, Code of 
                        Federal Regulations (or successor regulations); 
                        and
                            ``(ii) include the total line-item and 
                        itemized indirect facilities and administrative 
                        costs that shall be made publicly available and 
                        published in a machine-readable format;
                    ``(B) contracts subject to the Federal Acquisition 
                Regulation;
                    ``(C) multi-year contracts under section 3903 of 
                title 41, United States Code;
                    ``(D) prizes; and
                    ``(E) other transactions.
            ``(2) Exemptions for certain requirements.--Research funded 
        by ARPA-H shall not be subject to the requirements of section 
        406(a)(3)(A)(ii) or section 492.
    ``(i) Facilities Authority.--
            ``(1) In general.--The Director may acquire (by purchase, 
        lease, condemnation, or otherwise), construct, improve, repair, 
        operate, and maintain such real and personal property as may be 
        necessary to carry out this section.
            ``(2) Lease of nonexcess property.--The Director may enter 
        into a lease under this section with any person or entity 
        (including another department or agency of the Federal 
        Government or an entity of a State or local government) with 
        regard to any nonexcess real property and related personal 
        property under the jurisdiction of the Director.
            ``(3) Utilization of lease funds.--
                    ``(A) In general.--The Director may utilize, 
                without further appropriation, amounts of cash 
                consideration received for a lease entered into under 
                this subsection to cover the full costs to ARPA-H in 
                connection with the lease. Funds received as such cash 
                consideration shall remain available until expended.
                    ``(B) Capital revitalization and improvements.--Of 
                any amounts of cash consideration received under this 
                subsection that are not utilized in accordance with 
                subparagraph (A), without further appropriation--
                            ``(i) 35 percent shall--
                                    ``(I) be deposited in a capital 
                                asset account to be established by the 
                                Director;
                                    ``(II) be available for 
                                maintenance, capital revitalization, 
                                and improvements of the real property 
                                assets and related personal property 
                                under the jurisdiction of the Director; 
                                and
                                    ``(III) remain available until 
                                expended; and
                            ``(ii) the remaining 65 percent shall be 
                        available to the respective center or facility 
                        of ARPA-H engaged in the lease of nonexcess 
                        real property, and shall remain available until 
                        expended for maintenance, capital 
                        revitalization, and improvements of the real 
                        property assets and related personal property 
                        at the respective center or facility subject to 
                        the concurrence of the Director.
                    ``(C) No utilization for daily operating costs.--
                Amounts utilized under subparagraph (B) may not be 
                utilized for daily operating costs.
            ``(4) Locations.--
                    ``(A) In general.--ARPA-H, including its 
                headquarters, shall not be located on any part of the 
                existing National Institutes of Health campuses.
                    ``(B) Considerations.--In determining the location 
                of facilities, the Director shall make a fair and open 
                consideration of--
                            ``(i) the characteristics of the intended 
                        location; and
                            ``(ii) the extent to which such location 
                        will facilitate advancement of the goals and 
                        methods specified in subsection (b).
    ``(j) Personnel.--
            ``(1) In general.--The Director may--
                    ``(A) make and rescind appointments of scientific, 
                engineering, medical, and professional personnel, which 
                may include temporary or time-limited appointments as 
                determined by the Director to fulfill the mission of 
                ARPA-H, without regard to any provision in title 5, 
                United States Code, governing appointments and removals 
                under the civil service laws, and fix the base pay 
                compensation of such personnel at a rate to be 
                determined by the Director, up to the amount of annual 
                compensation (excluding expenses) specified in section 
                102 of title 3, United States Code; and
                    ``(B) contract with private recruiting firms for 
                the hiring of qualified staff referenced in 
                subparagraph (A).
            ``(2) Additional staff.--The Director may use, to the same 
        extent and in the same manner as the Secretary, all authorities 
        in existence on the date of the enactment of this section that 
        are provided to the Secretary to hire administrative, 
        financial, contracts, legislative affairs, information 
        technology, ethics, and communications staff, and such other 
        staff as may be identified by the Director as necessary to 
        carry out this section.
            ``(3) Additional considerations.--In appointing personnel 
        under this subsection, the Director--
                    ``(A) may contract with private entities;
                    ``(B) shall make efforts to recruit and retain a 
                diverse workforce, including individuals 
                underrepresented in science and medicine and racial and 
                ethnic minorities (as long as such efforts comply with 
                applicable Federal civil rights law); and
                    ``(C) shall recruit program managers with expertise 
                in a wide range of relevant disciplines, including life 
                sciences, the physical sciences, engineering, and the 
                computational sciences.
            ``(4) Additional hiring authority.--To the extent needed to 
        carry out the authorities vested by paragraph (1), the Director 
        may utilize hiring authorities under sections 3371 through 3376 
        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 such 
        sections.
            ``(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.
            ``(6) Authority to accept federal detailees.--The Director 
        may accept officers or employees of the United States or 
        members of the uniformed service on a detail from an element of 
        the Federal Government on a reimbursable or a nonreimbursable 
        basis, as jointly agreed to by the heads of the receiving and 
        detailing elements, for a period not to exceed 3 years.
    ``(k) Program Managers.--
            ``(1) In general.--The Director shall appoint program 
        managers for 3-year terms (and may reappoint such program 
        managers for 1 consecutive 3-year term) for the programs 
        carried out by ARPA-H.
            ``(2) Duties.--A program manager shall--
                    ``(A) establish, in consultation with the Director 
                or Deputy Director, research and development goals for 
                programs, including timelines and milestones, and make 
                such goals available to the public;
                    ``(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 gaps and opportunities;
                    ``(C) convene workshops and meetings, as needed, 
                with entities such as patients, patient advocacy 
                groups, practitioners, professional societies, and 
                other stakeholders to solicit input on programs and 
                goals;
                    ``(D) manage applications and proposals, through 
                the appropriate officials for making grants, 
                cooperative agreements, contracts, prizes, and other 
                transaction awards for advanced research that may show 
                particular promise, especially in areas in which the 
                private sector and the Federal Government have not 
                undertaken sufficient research;
                    ``(E) issue funding opportunity announcements, 
                using uniform administrative processes, as appropriate;
                    ``(F) select, on the basis of merit, each of the 
                projects to be supported under a program carried out by 
                ARPA-H, and taking into consideration--
                            ``(i) the scientific and technical merit of 
                        the proposed project;
                            ``(ii) the capabilities of the applicants 
                        to successfully carry out the proposed project;
                            ``(iii) the unmet needs or ability to 
                        improve health outcomes within patient 
                        populations;
                            ``(iv) future commercial applications of 
                        the project or the feasibility of partnering 
                        with one or more commercial entities;
                            ``(v) the potential for interdisciplinarity 
                        of the approach of the project; and
                            ``(vi) such other criteria as established 
                        by the Director;
                    ``(G) conduct project reviews within 18 months of 
                funding awards to identify milestones and monitor 
                progress of such milestones with respect to each 
                project and prior to disbursement of new funds;
                    ``(H) provide recommendations to the Director with 
                respect to advancing the goals specified in subsection 
                (b);
                    ``(I) cultivate opportunities for the commercial 
                application or community use of successful projects, 
                including through the establishment of partnerships 
                between or among awardees;
                    ``(J) identify innovative cost-sharing arrangements 
                for ARPA-H projects;
                    ``(K) provide recommendations to expand, 
                restructure, or terminate research partnerships or 
                projects; and
                    ``(L) ensure that--
                            ``(i) animal studies meet the Federal 
                        animal research requirements pursuant of the 
                        Public Health Service Policy on Humane Care and 
                        Use of Laboratory Animals; and
                            ``(ii) applications apply statistical 
                        modeling approaches and appropriately justify 
                        animal sample sizes to meet project goals.
    ``(l) Reports and Evaluation.--
            ``(1) Annual report.--
                    ``(A) In general.--Beginning not later than 1 year 
                after the date of 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 programs starting 
                        in the next fiscal year, as available;
                            ``(iv) activities conducted in coordination 
                        with other Federal agencies;
                            ``(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);
                            ``(vi) a description of the demographic 
                        (including racial and gender) diversity if 
                        available of direct recipients and performers 
                        in funded projects and of the ARPA-H workforce; 
                        and
                            ``(vii) a disclosure by the reward 
                        recipients of whether the principal 
                        investigators named on the award participate in 
                        foreign talent programs, including the 
                        provision of copies of all grants, contracts, 
                        or other agreements related to such programs, 
                        and other supporting documentation related to 
                        such programs, as a condition of receipt of 
                        Federal extramural biomedical research funding 
                        awarded.
                    ``(B) Submission to congress.--The report under 
                subparagraph (A) shall be submitted to--
                            ``(i) the Committee on Energy and Commerce 
                        and the Committee on Appropriations of the 
                        House of Representatives; and
                            ``(ii) the Committee on Health, Education, 
                        Labor, and Pensions and the Committee on 
                        Appropriations of the Senate.
            ``(2) Evaluation.--
                    ``(A) In general.--Not later than 5 years after the 
                date of the enactment of this section, the Secretary 
                shall enter into an agreement with the National 
                Academies of Sciences, Engineering, and Medicine under 
                which the National Academies agree to study and 
                evaluate whether ARPA-H is meeting the goals specified 
                in 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.
    ``(m) Strategic Plan.--Not later than 1 year after the date of the 
enactment of this section, and every 3 years thereafter, the Director 
shall provide to the relevant committees of Congress a strategic plan 
describing how ARPA-H will carry out investments each fiscal year in 
the following 3-year period.
    ``(n) Independent Review.--Not later than 1 year after the date of 
the enactment of this section, and every 3 years thereafter, the 
Comptroller General of the United States shall conduct an independent 
review of the research portfolio of the Department of Health and Human 
Services, including ARPA-H, the National Institutes of Health, the Food 
and Drug Administration, and the Biomedical Advanced Research and 
Development Authority--
            ``(1) to assess the degree of unnecessary duplication of 
        existing Federal programs and projects; and
            ``(2) to make recommendations regarding any potential 
        reorganization, consolidation, or termination of such programs 
        and projects.
    ``(o) Prioritization.--The Director shall--
            ``(1) prioritize awarding grants, cooperative agreements, 
        contracts, prizes, and other transaction awards to domestic 
        recipients conducting the research on transformative health 
        technology in the United States;
            ``(2) as appropriate and practicable, ensure that 
        nondomestic recipients of any grants, cooperative agreements, 
        contracts, prizes, and other transactions under this section 
        are conducting research in collaboration with a domestic 
        recipient;
            ``(3) not award any grants, cooperative agreements, 
        contracts, prizes, and other transactions to nondomestic 
        recipients subject to malign foreign influence or organized 
        under the laws of a malign foreign country; and
            ``(4) in accordance with the requirements of chapter 33 of 
        title 41, United States Code, and the Federal Acquisition 
        Regulation, only award grants, cooperative agreements, 
        contracts, prizes, and other transactions to individual persons 
        that do not have more than 3 ongoing concurrent grants, 
        cooperative agreements, contracts, prizes, and other 
        transactions under this section.
    ``(p) Additional Consultation.--In carrying out this section, the 
Director may consult with--
            ``(1) the President's Council of Advisors on Science and 
        Technology;
            ``(2) peers in the scientific community, including academia 
        and industry;
            ``(3) an existing advisory committee providing advice to 
        the Secretary or the head of any operating or staff division of 
        the Department;
            ``(4) a new interagency research council organized to 
        support the programs of ARPA-H and to provide advice and 
        assistance on--
                    ``(A) specific program tasks; or
                    ``(B) the overall direction of ARPA-H; and
            ``(5) any other entity the Director may deem appropriate.
    ``(q) ARPA-H Interagency Research Council.--
            ``(1) In general.--The Director shall establish an 
        interagency advisory committee to be known as the ARPA-H 
        Interagency Research Council (referred to in this subsection as 
        the `Research Council').
            ``(2) Membership.--The Research Council 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 Food and Drugs.
                    ``(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) The Director of the Advanced Research 
                Projects Agency-Energy.
                    ``(O) The Assistant Secretary for Preparedness and 
                Response.
                    ``(P) Representatives of any Federal agency with 
                subject matter expertise that the Director determines 
                is necessary for the successful completion of a project 
                carried out pursuant to this section.
                    ``(Q) Any other entity the Director may deem 
                appropriate.
            ``(3) Duties.--The Research Council 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 regulatory, reimbursement, and market barriers 
                to commercialization or adoption of transformative 
                health technologies, including technologies intended to 
                preempt serious disease.
            ``(4) Advisory nature.--The function of the Research 
        Council shall be advisory in nature. Nothing in this subsection 
        shall be construed as granting the Research Council authority 
        over any activities or functions of ARPA-H.
            ``(5) Meetings.--Not later than 1 year after the date of 
        the enactment of this section, and every fiscal year 
        thereafter, the Director shall convene meetings of the Research 
        Council, including conferences or workshops, as needed. The 
        Research Council may function through established or ad hoc 
        committees, task forces, or interagency groups to--
                    ``(A) share information on health innovations 
                funded by ARPA-H; and
                    ``(B) receive input on areas of particular promise 
                for ARPA-H projects.
    ``(r) Technology Transfer Office.--The Director may establish 
within ARPA-H an Office of Technology Transfer to facilitate, where 
appropriate, the transfer of federally-owned or federally-originated 
technology to recipients of an award under this section (other than 
Federal Government entities).
    ``(s) Follow-on Production Award Authority.--
            ``(1) In general.--An other transaction entered into by the 
        Director under subsection (h)(1) for a project may provide for 
        the award of a follow-on production contract or transaction to 
        the participants in the transaction by ARPA-H or another 
        Federal agency. For purposes of this paragraph, such an other 
        transaction includes all individual subprojects awarded under 
        the transaction to a consortium of United States industry and 
        academic institutions.
            ``(2) Relation to competitive procedures.--A follow-on 
        production contract or transaction under paragraph (1) may be 
        awarded to the participants in the transaction without the use 
        of competitive procedures (as defined in section 152 of title 
        41, United States Code), notwithstanding the requirements of 
        division C of subtitle I of such title 41, if--
                    ``(A) competitive procedures were used for the 
                selection of parties for participation in the other 
                transaction; and
                    ``(B) the participants in the other transaction 
                successfully completed the project provided for in the 
                transaction.
            ``(3) Precondition.--A follow-on production contract or 
        transaction may be awarded pursuant to this subsection when the 
        Director determines that an individual project or subproject as 
        part of a consortium is successfully completed by the 
        participants.
            ``(4) Clarification.--Award of a follow-on production 
        contract or transaction pursuant to this subsection shall not 
        be made contingent upon the successful completion of all 
        activities within a consortium as a condition for an award for 
        follow-on production of a successfully completed project or 
        subproject within that consortium.
            ``(5) Other authorities.--Contracts and transactions 
        entered into by ARPA-H pursuant to this subsection may be 
        awarded pursuant to division C of subtitle I of title 41, 
        United States Code, or under such procedures, terms, and 
        conditions as the Director or head of such agency may establish 
        by regulation.
    ``(t) 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.
    ``(u) Definitions.--In this part:
            ``(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 transformative 
                health technologies; and
                    ``(B) demonstrates the feasibility of a new 
                concept.
            ``(2) Biological product.--The term `biological product' 
        has the meaning given such term in section 351(i).
            ``(3) Department.--The term `Department' means the 
        Department of Health and Human Services.
            ``(4) Drug; device.--The terms `drug' and `device' have the 
        meanings given such terms 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) Federal agency.--The term `Federal agency' has the 
        meaning given such term in section 3371 of title 5, United 
        States Code.
            ``(7) Prize.--The term `prize' means a prize as such term 
        is used in section 24 of the Stevenson-Wydler Technology 
        Innovation Act of 1980.
            ``(8) Transformative health technology.--The term 
        `transformative health technology' means a drug, biological 
        product, intervention, platform, tool, or device--
                    ``(A) that should be prioritized to detect, 
                diagnose, mitigate, prevent, cure, or treat a serious 
                disease or medical condition for which there are unmet 
                needs; and
                    ``(B) for which--
                            ``(i) significant scientific uncertainty 
                        and regulatory risk exist; or
                            ``(ii) incentives in the commercial market 
                        are unlikely to result in the adequate or 
                        timely development of such drug, biological 
                        product, intervention, platform, tool, or 
                        device.
    ``(v) Authorization of Appropriations.--There is authorized to be 
appropriated $500,000,000 for each of fiscal years 2023 through 2027, 
to remain available until expended.''.
                                                 Union Calendar No. 277

117th CONGRESS

  2d Session

                               H. R. 5585

                          [Report No. 117-365]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             June 13, 2022

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed