Act — H. R. 5585, Advanced Research Projects Agency–Health (ARPA–H) Act (117th Congress, passed House June 2022)
Summary
H. R. 5585, the Advanced Research Projects Agency–Health Act or ARPA–H Act, is an act to establish the Advanced Research Projects Agency-Health. It amends title IV of the Public Health Service Act to establish ARPA–H as an independent operating division within Health and Human Services. Not later than 180 days after enactment, the Secretary must transfer the functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health within the National Institutes of Health to ARPA–H. Not more than 15 percent of amounts made available for a fiscal year may be used for administrative expenses. The text ends with the line Passed the House of Representatives June 22, 2022.
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“Act — H. R. 5585, Advanced Research Projects Agency–Health (ARPA–H) Act (117th Congress, passed House June 2022).”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-117hr5585eh-bills-117hr5585eh/
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117TH CONGRESS
2D SESSION
H. R. 5585
AN ACT
To establish the Advanced Research Projects Agency-Health,
and for other purposes.
1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
2
1 SECTION 1. SHORT TITLE.
2 This Act may be cited as the ‘‘Advanced Research
3 Projects Agency–Health Act’’ or the ‘‘ARPA–H Act’’.
4 SEC. 2. ADVANCED RESEARCH PROJECTS AGENCY–
5 HEALTH.
6 Title IV of the Public Health Service Act (42 U.S.C.
7 281 et seq.) is amended by adding at the end the fol-
8 lowing:
9 ‘‘PART J—ADVANCED RESEARCH PROJECTS
10 AGENCY–HEALTH
11 ‘‘SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY–
12 HEALTH.
13 ‘‘(a) ESTABLISHMENT.—
14 ‘‘(1) IN GENERAL.—There is established as an
15 independent operating division within the Depart-
16 ment of Health and Human Services, the Advanced
17 Research Projects Agency–Health (in this part re-
18 ferred to as ‘ARPA–H’). Not later than 180 days
19 after the date of enactment of this part, the Sec-
20 retary shall transfer all functions, personnel, mis-
21 sions, activities, authorities, and funds of the Ad-
22 vanced Research Projects Agency for Health within
23 the National Institutes of Health, as in existence on
24 the date of enactment of this part, to ARPA–H es-
25 tablished by the preceding sentence.
26 ‘‘(2) ORGANIZATION.—
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1 ‘‘(A) IN GENERAL.—There shall be within
2 ARPA–H—
3 ‘‘(i) an Office of the Director;
4 ‘‘(ii) not more than 6 program offices;
5 and
6 ‘‘(iii) such special project offices as
7 the Director may establish.
8 ‘‘(B) PROGRAM OFFICES DEDICATED TO
9 RESEARCH AND DEVELOPMENT.—Not fewer
10 than two-thirds of the program offices of
11 ARPA–H shall be exclusively dedicated to re-
12 search and development.
13 ‘‘(b) GOALS AND METHODS.—
14 ‘‘(1) GOALS.—The goals of ARPA–H shall be
15 to—
16 ‘‘(A) foster the development of new, break-
17 through capabilities, technologies, systems, and
18 platforms to accelerate innovations in health
19 and medicine that are not being met by Federal
20 programs or private entities;
21 ‘‘(B) revolutionize detection, diagnosis,
22 mitigation, prevention, treatment, and curing of
23 serious diseases and medical conditions through
24 the development of transformative health tech-
25 nologies;
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1 ‘‘(C) promote high-risk, high-reward inno-
2 vation for the development and translation of
3 transformative health technologies; and
4 ‘‘(D) contribute to ensuring the United
5 States maintains—
6 ‘‘(i) global leadership in science and
7 innovation;
8 ‘‘(ii) the highest quality of life and
9 health for its citizens; and
10 ‘‘(iii) an aggressive agenda for innova-
11 tions to address global health threats that
12 place United States citizens at risk.
13 ‘‘(2) METHODS.—ARPA–H shall achieve the
14 goals specified in paragraph (1) by—
15 ‘‘(A) discovering, identifying, and pro-
16 moting revolutionary advances in health
17 sciences;
18 ‘‘(B) translating scientific discoveries into
19 transformative health technologies;
20 ‘‘(C) providing resources and support to
21 create platform capabilities that draw on mul-
22 tiple disciplines;
23 ‘‘(D) using researchers in a wide range of
24 disciplines, including the life sciences, the phys-
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1 ical sciences, engineering, and the computa-
2 tional sciences;
3 ‘‘(E) delivering advanced proofs of concept
4 that demonstrate potentially clinically meaning-
5 ful advances;
6 ‘‘(F) developing new capabilities, advanced
7 computational tools, predictive models, or ana-
8 lytical techniques to identify potential targets
9 and technological strategies for early disease
10 detection and intervention;
11 ‘‘(G) accelerating transformational techno-
12 logical advances in areas with limited technical
13 certainty; and
14 ‘‘(H) prioritizing investments based on
15 such considerations as—
16 ‘‘(i) scientific opportunity and unique-
17 ness of fit to the strategies and operating
18 practices of ARPA–H;
19 ‘‘(ii) the effect on disease burden, in-
20 cluding unmet patient need, quality and
21 disparity gaps, and the potential to pre-
22 empt progression of serious disease; and
23 ‘‘(iii) the effect on the fiscal liability
24 of the Federal Government with respect to
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1 health care and the ability to reduce the
2 cost of care through innovation.
3 ‘‘(c) DIRECTOR.—
4 ‘‘(1) IN GENERAL.—The President shall ap-
5 point a director of ARPA–H (in this part referred
6 to as the ‘Director’).
7 ‘‘(2) QUALIFICATIONS.—The Director shall be
8 an individual who, by reason of professional back-
9 ground and experience, is especially qualified to
10 manage—
11 ‘‘(A) research and advanced development
12 programs; and
13 ‘‘(B) large-scale, high-risk initiatives with
14 respect to health research and technology devel-
15 opment across multiple sectors, including gener-
16 ating transformative health technologies and
17 improving health outcomes for patients.
18 ‘‘(3) RELATIONSHIP TO SECRETARY.—The Di-
19 rector shall report directly to the Secretary.
20 ‘‘(4) DUTIES.—The duties of the Director shall
21 include the following:
22 ‘‘(A) Approve and terminate the projects
23 and programs of ARPA–H.
24 ‘‘(B) Set research and development prior-
25 ities with respect to the goals specified in sub-
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1 section (b) and manage the budget of ARPA–
2 H.
3 ‘‘(C) Develop funding criteria and assess
4 the success of programs through the establish-
5 ment of technical milestones.
6 ‘‘(D) Advance the goals under subsection
7 (b), through consideration of the advice of the
8 ARPA–H Interagency Research Council estab-
9 lished under subsection (q).
10 ‘‘(E) Solicit data, as needed, from the Na-
11 tional Institutes of Health and other relevant
12 entities.
13 ‘‘(F) Coordinate with the Director of the
14 National Institutes of Health to ensure that the
15 programs of ARPA–H build on, and are in-
16 formed by, scientific research supported by the
17 National Institutes of Health.
18 ‘‘(G) Coordinate with the heads of Federal
19 agencies and, to the extent practicable, ensure
20 that the activities of ARPA–H supplement (and
21 do not supplant) the efforts of other Federal
22 agencies.
23 ‘‘(H) Ensure ARPA–H does not provide
24 funding for a project unless the program man-
•HR 5585 EH
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1 ager determines that the project meets the
2 goals described in subsection (b)(1).
3 ‘‘(5) TERM.—The Director—
4 ‘‘(A) shall be appointed for a 5-year term;
5 and
6 ‘‘(B) may be reappointed for 1 consecutive
7 5-year term.
8 ‘‘(6) AUTONOMY OF AGENCY REGARDING REC-
9 OMMENDATIONS AND TESTIMONY.—No officer or
10 agency of the United States shall have any authority
11 to require the Director or any other officer of
12 ARPA–H to submit legislative recommendations, or
13 testimony or comments on legislation, to any officer
14 or agency of the United States for approval, com-
15 ments, or review prior to the submission of such rec-
16 ommendations, testimony, or comments to the Con-
17 gress, if such recommendations, testimony, or com-
18 ments to the Congress include a statement indi-
19 cating that the views expressed therein are those of
20 the Director or such officer, and do not necessarily
21 reflect the views of the President or another agency.
22 ‘‘(7) DELEGATION OF AUTHORITY.—The Direc-
23 tor may delegate to any duly authorized employee,
24 representative, or agent any power vested in the Di-
25 rector by law, except that the Director may not dele-
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1 gate the power to appoint the Deputy Director
2 under paragraph (8).
3 ‘‘(8) DEPUTY DIRECTOR.—The Director shall
4 appoint a deputy director to serve as the first assist-
5 ant to the office.
6 ‘‘(d) APPLICATION OF PAPERWORK REDUCTION
7 ACT.—The Director may waive the requirements of sub-
8 chapter I of chapter 35 of title 44, United States Code
9 (commonly referred to as the ‘Paperwork Reduction Act’)
10 with respect to the methods described in subsection (b)(2).
11 ‘‘(e) PROTECTION OF INFORMATION.—The following
12 types of information collected by ARPA–H from recipients
13 of financial assistance awards shall be considered commer-
14 cial and financial information obtained from a person and
15 privileged or confidential and not subject to disclosure
16 under section 552(b)(4) of title 5, United States Code:
17 ‘‘(1) Plans for commercialization of technologies
18 developed under the award, including business plans,
19 technology-to market plans, market studies, and cost
20 and performance models.
21 ‘‘(2) Investments provided to an awardee from
22 third parties (such as venture capital firms, hedge
23 funds, and private equity firms), including amounts
24 and the percentage of ownership of the awardee pro-
25 vided in return for the investments.
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1 ‘‘(3) Additional financial support that the
2 awardee—
3 ‘‘(A) plans to invest or has invested in the
4 technology developed under the award; or
5 ‘‘(B) is seeking from third parties.
6 ‘‘(4) Revenue from the licensing or sale of new
7 products or services resulting from research con-
8 ducted under the award.
9 ‘‘(f) SHARING INFORMATION WITH THE CENTERS
10 FOR MEDICARE & MEDICAID SERVICES.—The Director
11 shall timely share relevant information with the Adminis-
12 trator of the Centers for Medicare & Medicaid Services
13 that may help to expedite determinations of coverage of
14 transformative health technologies developed by ARPA–H.
15 ‘‘(g) EXPEDITING BREAKTHROUGHS THROUGH CO-
16 OPERATION WITH THE FOOD AND DRUG ADMINISTRA-
17 TION.—
18 ‘‘(1) IN GENERAL.—The Secretary, acting
19 through the Commissioner of Food and Drugs and
20 in consultation with the Director, may take actions
21 to facilitate translation of transformative health
22 technology into tangible solutions for patients and to
23 expedite development of drugs, devices, and biologi-
24 cal products, including through—
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1 ‘‘(A) helping to ensure that drug, device,
2 or biological product development programs, in
3 as efficient a manner as possible, gather the
4 nonclinical and clinical data necessary to ad-
5 vancing the development of such products and
6 to obtaining their approval, licensure, or clear-
7 ance, as applicable, by the Food and Drug Ad-
8 ministration under sections 505, 510(k), and
9 515 of the Federal Food, Drug, and Cosmetic
10 Act and section 351 of this Act;
11 ‘‘(B) expediting review of investigational
12 new drug applications under section 505(i) of
13 the Federal Food, Drug, and Cosmetic Act, re-
14 view of investigational device exemptions under
15 section 520(g) of such Act, and review of appli-
16 cations for approval, licensure, and clearance of
17 drugs, devices, or biological products under sec-
18 tions 505, 510(k), and 515 of such Act, and
19 section 351 of this Act; and
20 ‘‘(C) meeting at appropriate intervals with
21 the Director and any member of the ARPA–H
22 Interagency Research Council to discuss the de-
23 velopment status of drugs, devices, or biological
24 products and projects that are the highest pri-
25 orities to ARPA–H, unless the Director and the
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1 Commissioner of Food and Drugs determine
2 that any such meetings are not necessary.
3 ‘‘(2) RELATION TO OTHERWISE AUTHORIZED
4 ACTIVITIES OF THE FDA.—The authority specified in
5 paragraph (1) shall not be construed as limiting the
6 authority of the Secretary, acting through the Com-
7 missioner of Food and Drugs, with respect to the re-
8 view and approval, clearance, authorization for emer-
9 gency use, or licensure of drugs, devices, or biologi-
10 cal products under the Federal Food, Drug, and
11 Cosmetic Act or section 351 of this Act.
12 ‘‘(3) REIMBURSEMENT.—The Director, using
13 funds made available to ARPA–H, may reimburse
14 the Food and Drug Administration for expenditures
15 made by the Food and Drug Administration for ac-
16 tivities carried out under this section that have been
17 identified by the Commissioner of Food and Drugs
18 and the Director as being carried out by the Food
19 and Drug Administration.
20 ‘‘(h) AWARDS.—
21 ‘‘(1) IN GENERAL.—In carrying out this sec-
22 tion, the Director may make awards including—
23 ‘‘(A) grants and cooperative agreements,
24 which shall—
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1 ‘‘(i) be subject to the uniform admin-
2 istrative requirements, cost principles, and
3 audit requirements for Federal awards
4 contained in part 200 of title 2, Code of
5 Federal Regulations (or successor regula-
6 tions); and
7 ‘‘(ii) include the total line-item and
8 itemized indirect facilities and administra-
9 tive costs that shall be made publicly avail-
10 able and published in a machine-readable
11 format;
12 ‘‘(B) contracts subject to the Federal Ac-
13 quisition Regulation;
14 ‘‘(C) multi-year contracts under section
15 3903 of title 41, United States Code;
16 ‘‘(D) prizes; and
17 ‘‘(E) other transactions.
18 ‘‘(2) EXEMPTIONS FOR CERTAIN REQUIRE-
19 MENTS.—Research funded by ARPA–H shall not be
20 subject to the requirements of section
21 406(a)(3)(A)(ii) or section 492.
22 ‘‘(i) FACILITIES AUTHORITY.—
23 ‘‘(1) IN GENERAL.—The Director may acquire
24 (by purchase, lease, condemnation, or otherwise),
25 construct, improve, repair, operate, and maintain
•HR 5585 EH
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1 such real and personal property as may be necessary
2 to carry out this section.
3 ‘‘(2) LEASE OF NONEXCESS PROPERTY.—The
4 Director may enter into a lease under this section
5 with any person or entity (including another depart-
6 ment or agency of the Federal Government or an en-
7 tity of a State or local government) with regard to
8 any nonexcess real property and related personal
9 property under the jurisdiction of the Director.
10 ‘‘(3) UTILIZATION OF LEASE FUNDS.—The Di-
11 rector shall deposit amounts of cash consideration
12 received for a lease entered into under this sub-
13 section in the ‘Advanced Research Projects Agency
14 for Health’ account as discretionary offsetting collec-
15 tions, and such amounts shall be available only to
16 the extent and in the amounts provided in advance
17 in appropriations Acts—
18 ‘‘(A) to cover the full costs to ARPA–H in
19 connection with the lease;
20 ‘‘(B) for maintenance, capital revitaliza-
21 tion, and improvements of the real property as-
22 sets and related personal property under the ju-
23 risdiction of the Director; and
24 ‘‘(C) for maintenance, capital revitaliza-
25 tion, and improvements of the real property as-
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1 sets and related personal property at the re-
2 spective center or facility of ARPA–H engaged
3 in the lease, subject to the concurrence of the
4 Director.
5 ‘‘(4) LOCATIONS.—
6 ‘‘(A) IN GENERAL.—ARPA–H, including
7 its headquarters, shall not be located on any
8 part of the existing National Institutes of
9 Health campuses.
10 ‘‘(B) CONSIDERATIONS.—In determining
11 the location of facilities, the Director shall
12 make a fair and open consideration of—
13 ‘‘(i) the characteristics of the intended
14 location; and
15 ‘‘(ii) the extent to which such location
16 will facilitate advancement of the goals and
17 methods specified in subsection (b).
18 ‘‘(j) PERSONNEL.—
19 ‘‘(1) IN GENERAL.—The Director may—
20 ‘‘(A) make and rescind appointments of
21 scientific, engineering, medical, and professional
22 personnel, which may include temporary or
23 time-limited appointments as determined by the
24 Director to fulfill the mission of ARPA–H,
25 without regard to any provision in title 5,
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1 United States Code, governing appointments
2 and removals under the civil service laws, and
3 fix the base pay compensation of such personnel
4 at a rate to be determined by the Director, up
5 to the amount of annual compensation (exclud-
6 ing expenses) specified in section 102 of title 3,
7 United States Code; and
8 ‘‘(B) contract with private recruiting firms
9 for the hiring of qualified staff referenced in
10 subparagraph (A).
11 ‘‘(2) ADDITIONAL STAFF.—The Director may
12 use, to the same extent and in the same manner as
13 the Secretary, all authorities in existence on the date
14 of the enactment of this section that are provided to
15 the Secretary to hire administrative, financial, con-
16 tracts, legislative affairs, information technology,
17 ethics, and communications staff, and such other
18 staff as may be identified by the Director as nec-
19 essary to carry out this section.
20 ‘‘(3) ADDITIONAL CONSIDERATIONS.—In ap-
21 pointing personnel under this subsection, the Direc-
22 tor—
23 ‘‘(A) may contract with private entities;
24 ‘‘(B) shall make efforts to recruit and re-
25 tain a diverse workforce, including individuals
•HR 5585 EH
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1 underrepresented in science and medicine and
2 racial and ethnic minorities (as long as such ef-
3 forts comply with applicable Federal civil rights
4 law); and
5 ‘‘(C) shall recruit program managers with
6 expertise in a wide range of relevant disciplines,
7 including life sciences, the physical sciences, en-
8 gineering, and the computational sciences.
9 ‘‘(4) ADDITIONAL HIRING AUTHORITY.—To the
10 extent needed to carry out the authorities vested by
11 paragraph (1), the Director may utilize hiring au-
12 thorities under sections 3371 through 3376 of title
13 5, United States Code, to staff ARPA–H with em-
14 ployees from other Federal agencies, State and local
15 governments, Indian Tribes and Tribal organiza-
16 tions, institutions of higher education, and other or-
17 ganizations, as described in such sections.
18 ‘‘(5) EXISTING AUTHORITIES.—The authorities
19 granted by this section are—
20 ‘‘(A) in addition to existing authorities
21 granted to the Secretary; and
22 ‘‘(B) are not intended to supersede or
23 modify any existing authorities.
24 ‘‘(6) AUTHORITY TO ACCEPT FEDERAL
25 DETAILEES.—The Director may accept officers or
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1 employees of the United States or members of the
2 uniformed service on a detail from an element of the
3 Federal Government on a reimbursable or a nonre-
4 imbursable basis, as jointly agreed to by the heads
5 of the receiving and detailing elements, for a period
6 not to exceed 3 years.
7 ‘‘(k) PROGRAM MANAGERS.—
8 ‘‘(1) IN GENERAL.—The Director shall appoint
9 program managers for 3-year terms (and may re-
10 appoint such program managers for 1 consecutive 3-
11 year term) for the programs carried out by ARPA–
12 H.
13 ‘‘(2) DUTIES.—A program manager shall—
14 ‘‘(A) establish, in consultation with the Di-
15 rector or Deputy Director, research and devel-
16 opment goals for programs, including timelines
17 and milestones, and make such goals available
18 to the public;
19 ‘‘(B) collaborate with experts from the Na-
20 tional Institutes of Health and other Federal
21 agencies and experts in relevant scientific fields
22 to identify research and development gaps and
23 opportunities;
24 ‘‘(C) convene workshops and meetings, as
25 needed, with entities such as patients, patient
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1 advocacy groups, practitioners, professional so-
2 cieties, and other stakeholders to solicit input
3 on programs and goals;
4 ‘‘(D) manage applications and proposals,
5 through the appropriate officials for making
6 grants, cooperative agreements, contracts,
7 prizes, and other transaction awards for ad-
8 vanced research that may show particular
9 promise, especially in areas in which the private
10 sector and the Federal Government have not
11 undertaken sufficient research;
12 ‘‘(E) issue funding opportunity announce-
13 ments, using uniform administrative processes,
14 as appropriate;
15 ‘‘(F) select, on the basis of merit, each of
16 the projects to be supported under a program
17 carried out by ARPA–H, and taking into con-
18 sideration—
19 ‘‘(i) the scientific and technical merit
20 of the proposed project;
21 ‘‘(ii) the capabilities of the applicants
22 to successfully carry out the proposed
23 project;
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1 ‘‘(iii) the unmet needs or ability to
2 improve health outcomes within patient
3 populations;
4 ‘‘(iv) future commercial applications
5 of the project or the feasibility of
6 partnering with one or more commercial
7 entities;
8 ‘‘(v) the potential for
9 interdisciplinarity of the approach of the
10 project; and
11 ‘‘(vi) such other criteria as established
12 by the Director;
13 ‘‘(G) conduct project reviews within 18
14 months of funding awards to identify milestones
15 and monitor progress of such milestones with
16 respect to each project and prior to disburse-
17 ment of new funds;
18 ‘‘(H) provide recommendations to the Di-
19 rector with respect to advancing the goals speci-
20 fied in subsection (b);
21 ‘‘(I) cultivate opportunities for the com-
22 mercial application or community use of suc-
23 cessful projects, including through the establish-
24 ment of partnerships between or among award-
25 ees;
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1 ‘‘(J) identify innovative cost-sharing ar-
2 rangements for ARPA–H projects;
3 ‘‘(K) provide recommendations to expand,
4 restructure, or terminate research partnerships
5 or projects; and
6 ‘‘(L) ensure that—
7 ‘‘(i) animal studies meet the Federal
8 animal research requirements pursuant of
9 the Public Health Service Policy on Hu-
10 mane Care and Use of Laboratory Ani-
11 mals; and
12 ‘‘(ii) applications apply statistical
13 modeling approaches and appropriately
14 justify animal sample sizes to meet project
15 goals.
16 ‘‘(l) REPORTS AND EVALUATION.—
17 ‘‘(1) ANNUAL REPORT.—
18 ‘‘(A) IN GENERAL.—Beginning not later
19 than 1 year after the date of enactment of this
20 section, and each fiscal year thereafter, the Di-
21 rector shall submit a report on the actions un-
22 dertaken, and results generated, by ARPA–H,
23 including—
24 ‘‘(i) a description of projects sup-
25 ported by ARPA–H in the previous fiscal
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1 year and whether such projects are meet-
2 ing the goals developed by the Director
3 pursuant to subsection (c)(4)(C);
4 ‘‘(ii) a description of projects termi-
5 nated in the previous fiscal year, and the
6 reason for such termination;
7 ‘‘(iii) a description of programs start-
8 ing in the next fiscal year, as available;
9 ‘‘(iv) activities conducted in coordina-
10 tion with other Federal agencies;
11 ‘‘(v) an analysis of the extent of co-
12 ordination conducted pursuant to sub-
13 sections (c)(4)(F) and (f), including suc-
14 cesses and barriers with respect to achiev-
15 ing the goals under subsection (b);
16 ‘‘(vi) a description of the demographic
17 (including racial and gender) diversity if
18 available of direct recipients and per-
19 formers in funded projects and of the
20 ARPA–H workforce; and
21 ‘‘(vii) a disclosure by the reward re-
22 cipients of whether the principal investiga-
23 tors named on the award participate in
24 foreign talent programs, including the pro-
25 vision of copies of all grants, contracts, or
•HR 5585 EH
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1 other agreements related to such pro-
2 grams, and other supporting documenta-
3 tion related to such programs, as a condi-
4 tion of receipt of Federal extramural bio-
5 medical research funding awarded.
6 ‘‘(B) SUBMISSION TO CONGRESS.—The re-
7 port under subparagraph (A) shall be submitted
8 to—
9 ‘‘(i) the Committee on Energy and
10 Commerce and the Committee on Appro-
11 priations of the House of Representatives;
12 and
13 ‘‘(ii) the Committee on Health, Edu-
14 cation, Labor, and Pensions and the Com-
15 mittee on Appropriations of the Senate.
16 ‘‘(2) EVALUATION.—
17 ‘‘(A) IN GENERAL.—Not later than 5 years
18 after the date of the enactment of this section,
19 the Secretary shall enter into an agreement
20 with the National Academies of Sciences, Engi-
21 neering, and Medicine under which the National
22 Academies agree to study and evaluate whether
23 ARPA–H is meeting the goals specified in sub-
24 section (b).
•HR 5585 EH
24
1 ‘‘(B) SUBMISSION OF RESULTS.—The
2 agreement entered into under subparagraph (A)
3 shall require the National Academies of
4 Sciences, Engineering, and Medicine to submit
5 the results of the evaluation conducted under
6 such agreement to the Secretary, the Com-
7 mittee on Energy and Commerce of the House
8 of Representatives, and the Committee on
9 Health, Education, Labor, and Pensions of the
10 Senate.
11 ‘‘(m) STRATEGIC PLAN.—Not later than 1 year after
12 the date of the enactment of this section, and every 3
13 years thereafter, the Director shall provide to the relevant
14 committees of Congress a strategic plan describing how
15 ARPA–H will carry out investments each fiscal year in
16 the following 3-year period.
17 ‘‘(n) INDEPENDENT REVIEW.—Not later than 1 year
18 after the date of the enactment of this section, and every
19 3 years thereafter, the Comptroller General of the United
20 States shall conduct an independent review of the research
21 portfolio of the Department of Health and Human Serv-
22 ices, including ARPA–H, the National Institutes of
23 Health, the Food and Drug Administration, and the Bio-
24 medical Advanced Research and Development Authority—
•HR 5585 EH
25
1 ‘‘(1) to assess the degree of unnecessary dupli-
2 cation of existing Federal programs and projects;
3 and
4 ‘‘(2) to make recommendations regarding any
5 potential reorganization, consolidation, or termi-
6 nation of such programs and projects.
7 ‘‘(o) PRIORITIZATION.—The Director shall—
8 ‘‘(1) prioritize awarding grants, cooperative
9 agreements, contracts, prizes, and other transaction
10 awards to domestic recipients conducting the re-
11 search on transformative health technology in the
12 United States;
13 ‘‘(2) as appropriate and practicable, ensure that
14 nondomestic recipients of any grants, cooperative
15 agreements, contracts, prizes, and other transactions
16 under this section are conducting research in col-
17 laboration with a domestic recipient;
18 ‘‘(3) not award any grants, cooperative agree-
19 ments, contracts, prizes, and other transactions to
20 nondomestic recipients organized under the laws of
21 a covered foreign country (as defined in section
22 119C of the National Security Act of 1947); and
23 ‘‘(4) in accordance with the requirements of
24 chapter 33 of title 41, United States Code, and the
25 Federal Acquisition Regulation, only award grants,
•HR 5585 EH
26
1 cooperative agreements, contracts, prizes, and other
2 transactions to individual persons that do not have
3 more than 3 ongoing concurrent grants, cooperative
4 agreements, contracts, prizes, and other transactions
5 under this section.
6 ‘‘(p) ADDITIONAL CONSULTATION.—In carrying out
7 this section, the Director may consult with—
8 ‘‘(1) the President’s Council of Advisors on
9 Science and Technology;
10 ‘‘(2) peers in the scientific community, includ-
11 ing academia and industry;
12 ‘‘(3) an existing advisory committee providing
13 advice to the Secretary or the head of any operating
14 or staff division of the Department;
15 ‘‘(4) a new interagency research council orga-
16 nized to support the programs of ARPA–H and to
17 provide advice and assistance on—
18 ‘‘(A) specific program tasks; or
19 ‘‘(B) the overall direction of ARPA–H; and
20 ‘‘(5) any other entity the Director may deem
21 appropriate.
22 ‘‘(q) ARPA–H INTERAGENCY RESEARCH COUN-
23 CIL.—
24 ‘‘(1) IN GENERAL.—The Director shall establish
25 an interagency advisory committee to be known as
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27
1 the ARPA–H Interagency Research Council (re-
2 ferred to in this subsection as the ‘Research Coun-
3 cil’).
4 ‘‘(2) MEMBERSHIP.—The Research Council
5 may include any or all of the following members, or
6 designees:
7 ‘‘(A) The Director of the National Insti-
8 tutes of Health.
9 ‘‘(B) The Director of National Center for
10 Advancing Translational Sciences.
11 ‘‘(C) The Director of Office of Science and
12 Technology Policy.
13 ‘‘(D) The Commissioner of Food and
14 Drugs.
15 ‘‘(E) The Director of the Biomedical Ad-
16 vanced Research and Development Authority.
17 ‘‘(F) The Director of the Centers for Dis-
18 ease Control and Prevention.
19 ‘‘(G) The Administrator of the Centers for
20 Medicare & Medicaid Services.
21 ‘‘(H) The Director of the Agency for
22 Healthcare Research and Quality.
23 ‘‘(I) The Director of the Office of Minority
24 Health.
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1 ‘‘(J) The Administrator of the Health Re-
2 sources and Services Administration.
3 ‘‘(K) The Director of the Defense Ad-
4 vanced Research Projects Agency.
5 ‘‘(L) The Director of the National Science
6 Foundation.
7 ‘‘(M) The Director of the Office of Science
8 of the Department of Energy.
9 ‘‘(N) The Director of the Advanced Re-
10 search Projects Agency–Energy.
11 ‘‘(O) The Assistant Secretary for Pre-
12 paredness and Response.
13 ‘‘(P) Representatives of any Federal agen-
14 cy with subject matter expertise that the Direc-
15 tor determines is necessary for the successful
16 completion of a project carried out pursuant to
17 this section.
18 ‘‘(Q) Any other entity the Director may
19 deem appropriate.
20 ‘‘(3) DUTIES.—The Research Council shall ad-
21 vise the Director, including by—
22 ‘‘(A) making recommendations on—
23 ‘‘(i) research priorities that will pro-
24 vide the greatest return on investment with
25 respect to improving human health;
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1 ‘‘(ii) avoiding duplication of efforts in
2 the Federal Government; and
3 ‘‘(iii) improving coordination with
4 other Federal agencies; and
5 ‘‘(B) identifying and developing strategies
6 to address regulatory, reimbursement, and mar-
7 ket barriers to commercialization or adoption of
8 transformative health technologies, including
9 technologies intended to preempt serious dis-
10 ease.
11 ‘‘(4) ADVISORY NATURE.—The function of the
12 Research Council shall be advisory in nature. Noth-
13 ing in this subsection shall be construed as granting
14 the Research Council authority over any activities or
15 functions of ARPA–H.
16 ‘‘(5) MEETINGS.—Not later than 1 year after
17 the date of the enactment of this section, and every
18 fiscal year thereafter, the Director shall convene
19 meetings of the Research Council, including con-
20 ferences or workshops, as needed. The Research
21 Council may function through established or ad hoc
22 committees, task forces, or interagency groups to—
23 ‘‘(A) share information on health innova-
24 tions funded by ARPA–H; and
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30
1 ‘‘(B) receive input on areas of particular
2 promise for ARPA–H projects.
3 ‘‘(r) TECHNOLOGY TRANSFER OFFICE.—The Direc-
4 tor may establish within ARPA–H an Office of Technology
5 Transfer to facilitate, where appropriate, the transfer of
6 federally-owned or federally-originated technology to re-
7 cipients of an award under this section (other than Fed-
8 eral Government entities).
9 ‘‘(s) FOLLOW-ON PRODUCTION AWARD AUTHOR-
10 ITY.—
11 ‘‘(1) IN GENERAL.—An other transaction en-
12 tered into by the Director under subsection (h)(1)
13 for a project may provide for the award of a follow-
14 on production contract or transaction to the partici-
15 pants in the transaction by ARPA–H or another
16 Federal agency. For purposes of this paragraph,
17 such an other transaction includes all individual sub-
18 projects awarded under the transaction to a consor-
19 tium of United States industry and academic institu-
20 tions.
21 ‘‘(2) RELATION TO COMPETITIVE PROCE-
22 DURES.—A follow-on production contract or trans-
23 action under paragraph (1) may be awarded to the
24 participants in the transaction without the use of
25 competitive procedures (as defined in section 152 of
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1 title 41, United States Code), notwithstanding the
2 requirements of division C of subtitle I of such title
3 41, if—
4 ‘‘(A) competitive procedures were used for
5 the selection of parties for participation in the
6 other transaction; and
7 ‘‘(B) the participants in the other trans-
8 action successfully completed the project pro-
9 vided for in the transaction.
10 ‘‘(3) PRECONDITION.—A follow-on production
11 contract or transaction may be awarded pursuant to
12 this subsection when the Director determines that
13 an individual project or subproject as part of a con-
14 sortium is successfully completed by the partici-
15 pants.
16 ‘‘(4) CLARIFICATION.—Award of a follow-on
17 production contract or transaction pursuant to this
18 subsection shall not be made contingent upon the
19 successful completion of all activities within a con-
20 sortium as a condition for an award for follow-on
21 production of a successfully completed project or
22 subproject within that consortium.
23 ‘‘(5) OTHER AUTHORITIES.—Contracts and
24 transactions entered into by ARPA–H pursuant to
25 this subsection may be awarded pursuant to division
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32
1 C of subtitle I of title 41, United States Code, or
2 under such procedures, terms, and conditions as the
3 Director or head of such agency may establish by
4 regulation.
5 ‘‘(t) RULE OF CONSTRUCTION.—The authorities
6 under this section, with respect to the Director, are addi-
7 tional authorities that do not supersede or modify any ex-
8 isting authorities.
9 ‘‘(u) DEFINITIONS.—In this part:
10 ‘‘(1) ADVANCED PROOFS OF CONCEPT.—The
11 term ‘advanced proofs of concept’ means data, a
12 prototype, or other experimental evidence that—
13 ‘‘(A) may precede the development of
14 transformative health technologies; and
15 ‘‘(B) demonstrates the feasibility of a new
16 concept.
17 ‘‘(2) BIOLOGICAL PRODUCT.—The term ‘bio-
18 logical product’ has the meaning given such term in
19 section 351(i).
20 ‘‘(3) DEPARTMENT.—The term ‘Department’
21 means the Department of Health and Human Serv-
22 ices.
23 ‘‘(4) DRUG; DEVICE.—The terms ‘drug’ and
24 ‘device’ have the meanings given such terms in sec-
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33
1 tion 201 of the Federal Food, Drug, and Cosmetic
2 Act.
3 ‘‘(5) FEDERAL ACQUISITION REGULATION.—
4 The term ‘Federal Acquisition Regulation’ means
5 the Federal Acquisition Regulation issued pursuant
6 to section 1303(a)(1) of title 41, United States
7 Code.
8 ‘‘(6) FEDERAL AGENCY.—The term ‘Federal
9 agency’ has the meaning given such term in section
10 3371 of title 5, United States Code.
11 ‘‘(7) PRIZE.—The term ‘prize’ means a prize as
12 such term is used in section 24 of the Stevenson-
13 Wydler Technology Innovation Act of 1980.
14 ‘‘(8) TRANSFORMATIVE HEALTH TECH-
15 NOLOGY.—The term ‘transformative health tech-
16 nology’ means a drug, biological product, interven-
17 tion, platform, tool, or device—
18 ‘‘(A) that should be prioritized to detect,
19 diagnose, mitigate, prevent, cure, or treat a se-
20 rious disease or medical condition for which
21 there are unmet needs; and
22 ‘‘(B) for which—
23 ‘‘(i) significant scientific uncertainty
24 and regulatory risk exist; or
•HR 5585 EH
34
1 ‘‘(ii) incentives in the commercial
2 market are unlikely to result in the ade-
3 quate or timely development of such drug,
4 biological product, intervention, platform,
5 tool, or device.
6 ‘‘(v) AUTHORIZATION OF APPROPRIATIONS.—
7 ‘‘(1) IN GENERAL.—To carry out this section,
8 there is authorized to be appropriated $500,000,000
9 for each of fiscal years 2023 through 2027, to re-
10 main available until expended.
11 ‘‘(2) ADMINISTRATIVE EXPENSES.—Not more
12 than 15 percent of the amounts made available to
13 carry out this section for any fiscal year may be
14 used for administrative expenses to operate ARPA–
15 H.’’.
Passed the House of Representatives June 22, 2022.
Attest:
Clerk.
•HR 5585 EH
117TH CONGRESS
2D SESSION H. R. 5585
AN ACT
To establish the Advanced Research Projects
Agency-Health, and for other purposes.
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