‘‘(iii) the unmet needs or ability to im-
prove health outcomes within patient popu-
lations; 
‘‘(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 re-
spect to each project and prior to disbursement 
of new funds; 
‘‘(H) provide recommendations to the Direc-
tor with respect to advancing the goals specified 
in subsection (b); 
‘‘(I) cultivate opportunities for the commer-
cial application or community use of successful 
projects, including through the establishment of 
partnerships between or among awardees; 
‘‘(J) identify innovative cost-sharing ar-
rangements for ARPA–H projects; 
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‘‘(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 Hu-
mane Care and Use of Laboratory Animals; 
and 
‘‘(ii) applications apply statistical 
modeling approaches and appropriately jus-
tify 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 Di-
rector shall submit a report on the actions un-
dertaken, and results generated, by ARPA–H, in-
cluding— 
‘‘(i) a description of projects supported 
by ARPA–H in the previous fiscal year and 
whether such projects are meeting the goals 
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developed by the Director pursuant to sub-
section (c)(4)(C); 
‘‘(ii) a description of projects termi-
nated in the previous fiscal year, and the 
reason for such termination; 
‘‘(iii) a description of programs start-
ing in the next fiscal year, as available; 
‘‘(iv) activities conducted in coordina-
tion with other Federal agencies; 
‘‘(v) an analysis of the extent of coordi-
nation 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 re-
cipients of whether the principal investiga-
tors named on the award participate in for-
eign talent programs, including the provi-
sion of copies of all grants, contracts, or 
other agreements related to such programs, 
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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 re-
port under subparagraph (A) shall be submitted 
to— 
‘‘(i) the Committee on Energy and 
Commerce and the Committee on Appro-
priations of the House of Representatives; 
and 
‘‘(ii) the Committee on Health, Edu-
cation, Labor, and Pensions and the Com-
mittee 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 Acad-
emies agree to study and evaluate whether 
ARPA–H is meeting the goals specified in sub-
section (b). 
‘‘(B) SUBMISSION OF RESULTS.—The agree-
ment entered into under subparagraph (A) shall 
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require the National Academies of Sciences, En-
gineering, 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 commit-
tees 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 Ad-
vanced Research and Development Authority— 
‘‘(1) to assess the degree of unnecessary duplica-
tion of existing Federal programs and projects; and 
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‘‘(2) to make recommendations regarding any 
potential reorganization, consolidation, or termi-
nation 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 collabo-
ration with a domestic recipient; 
‘‘(3) not award any grants, cooperative agree-
ments, contracts, prizes, and other transactions to 
nondomestic recipients subject to malign foreign in-
fluence or organized under the laws of a malign for-
eign 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 
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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 orga-
nized 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 ap-
propriate. 
‘‘(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’). 
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‘‘(2) MEMBERSHIP.—The Research Council may 
include any or all of the following members, or des-
ignees: 
‘‘(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 Ad-
vanced 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 Re-
sources and Services Administration. 
‘‘(K) The Director of the Defense Advanced 
Research Projects Agency. 
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‘‘(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 Prepared-
ness and Response. 
‘‘(P) Representatives of any Federal agency 
with subject matter expertise that the Director 
determines is necessary for the successful comple-
tion of a project carried out pursuant to this sec-
tion. 
‘‘(Q) Any other entity the Director may 
deem appropriate. 
‘‘(3) DUTIES.—The Research Council shall ad-
vise the Director, including by— 
‘‘(A) making recommendations on— 
‘‘(i) research priorities that will pro-
vide 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 
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‘‘(B) identifying and developing strategies 
to address regulatory, reimbursement, and mar-
ket 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 work-
shops, as needed. The Research Council may function 
through established or ad hoc committees, task forces, 
or interagency groups to— 
‘‘(A) share information on health innova-
tions 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 fed-
erally-owned or federally-originated technology to recipients 
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of an award under this section (other than Federal Govern-
ment 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 pro-
duction contract or transaction to the participants in 
the transaction by ARPA–H or another Federal agen-
cy. For purposes of this paragraph, such an other 
transaction includes all individual subprojects award-
ed under the transaction to a consortium of United 
States industry and academic institutions. 
‘‘(2) 
RELATION
TO
COMPETITIVE
PROCE-
DURES.—A follow-on production contract or trans-
action 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 re-
quirements 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 
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‘‘(B) the participants in the other trans-
action 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 consor-
tium is successfully completed by the participants. 
‘‘(4) CLARIFICATION.—Award of a follow-on pro-
duction contract or transaction pursuant to this sub-
section shall not be made contingent upon the success-
ful 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 reg-
ulation. 
‘‘(t) RULE OF CONSTRUCTION.—The authorities under 
this section, with respect to the Director, are additional au-
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thorities that do not supersede or modify any existing au-
thorities. 
‘‘(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 trans-
formative health technologies; and 
‘‘(B) demonstrates the feasibility of a new 
concept. 
‘‘(2) BIOLOGICAL PRODUCT.—The term ‘biologi-
cal product’ has the meaning given such term in sec-
tion 351(i). 
‘‘(3) DEPARTMENT.—The term ‘Department’ 
means the Department of Health and Human Serv-
ices. 
‘‘(4) DRUG; DEVICE.—The terms ‘drug’ and ‘de-
vice’ 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 Fed-
eral Acquisition Regulation issued pursuant to sec-
tion 1303(a)(1) of title 41, United States Code. 
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‘‘(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, di-
agnose, 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 ade-
quate 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 fis-
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cal years 2023 through 2027, to remain available until ex-
pended.’’. 
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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 Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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