Advanced Research Projects Agency–Health Act
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This is House Report 117-365, Part 1, of the 117th Congress, 2d Session, titled Advanced Research Projects Agency–Health Act, from the Committee on Energy and Commerce, committed to the Committee of the Whole House on the State of the Union and ordered to be printed June 13, 2022. Mr. Pallone reports on H.R. 5585, to establish the Advanced Research Projects Agency–Health, which the Committee reports favorably with an amendment and recommends that the bill as amended do pass. The amendment text provides for establishing ARPA–H as an independent operating division within the Department of Health and Human Services and lists its goals and methods. It also provides that the President shall appoint a director of ARPA–H with the advice and consent of the Senate.
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Cite this document
“Advanced Research Projects Agency–Health Act.”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/crpt-crpt-117hrpt365-crpt-117hrpt365-pt1/
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117TH CONGRESS REPT. 117–365
" HOUSE OF REPRESENTATIVES !
2d Session Part 1
ADVANCED RESEARCH PROJECTS AGENCY–HEALTH ACT
JUNE 13, 2022.—Committed to the Committee of the Whole House on the State of
the Union and ordered to be printed
Mr. PALLONE, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 5585]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5585) to establish the Advanced Research Projects
Agency–Health, and for other purposes, having considered the
same, reports favorably thereon with an amendment and rec-
ommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary .................................................................................. 9
II. Background and Need for the Legislation ................................................... 9
III. Committee Hearings ...................................................................................... 11
IV. Committee Consideration .............................................................................. 11
V. Committee Votes ............................................................................................ 11
VI. Oversight Findings ........................................................................................ 13
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures 13
VIII. Federal Mandates Statement ....................................................................... 13
IX. Statement of General Performance Goals and Objectives .......................... 13
X. Duplication of Federal Programs .................................................................. 13
XI. Committee Cost Estimate ............................................................................. 13
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits .................. 13
XIII. Advisory Committee Statement .................................................................... 14
XIV. Applicability to Legislative Branch .............................................................. 14
XV. Section-by-Section Analysis of the Legislation ............................................ 14
XVI. Changes in Existing Law Made by the Bill, as Reported ........................... 15
The amendment is as follows:
Strike all after the enacting clause and insert the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Advanced Research Projects Agency–Health Act’’
or the ‘‘ARPA–H Act’’.
29–006
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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 func-
tions, personnel, missions, activities, authorities, and funds of the Advanced Re-
search 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 pre-
ceding sentence.
‘‘(b) GOALS AND METHODS.—
‘‘(1) GOALS.—The goals of ARPA–H shall be to—
‘‘(A) foster the development of new, breakthrough capabilities, tech-
nologies, 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 develop-
ment 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 tech-
nologies;
‘‘(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 techno-
logical 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, qual-
ity and disparity gaps, and the potential to preempt progression of seri-
ous 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 trans-
formative health technologies and improving health outcomes for patients.
‘‘(3) RELATIONSHIP TO SECRETARY.—The Director shall report directly to the
Secretary.
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‘‘(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 sub-
section (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, sci-
entific 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 recommenda-
tions, 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 rec-
ommendations, testimony, or comments to the Congress include a statement in-
dicating that the views expressed therein are those of the Director or such offi-
cer, and do not necessarily reflect the views of the President or another agency.
‘‘(7) DELEGATION OF AUTHORITY.—The Director may delegate to any duly au-
thorized 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 (com-
monly referred to as the ‘Paperwork Reduction Act’) with respect to the methods de-
scribed 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 commer-
cial 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 SERV-
ICES.—The Director shall timely share relevant information with the Administrator
of the Centers for Medicare & Medicaid Services that may help to expedite deter-
minations 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 pa-
tients and to expedite development of drugs, devices, and biological products, in-
cluding through—
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‘‘(A) helping to ensure that drug, device, or biological product develop-
ment 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 sec-
tion 505(i) of the Federal Food, Drug, and Cosmetic Act, review of investiga-
tional device exemptions under section 520(g) of such Act, and review of ap-
plications for approval, licensure, and clearance of drugs, devices, or biologi-
cal 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 au-
thority specified in paragraph (1) shall not be construed as limiting the author-
ity 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 prin-
ciples, 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 ad-
ministrative 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, condemna-
tion, 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 appropria-
tion, 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;
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‘‘(II) be available for maintenance, capital revitalization, and im-
provements of the real property assets and related personal prop-
erty under the jurisdiction of the Director; and
‘‘(III) remain available until expended; and
‘‘(ii) the remaining 65 percent shall be available to the respective cen-
ter or facility of ARPA–H engaged in the lease of nonexcess real prop-
erty, and shall remain available until expended for maintenance, cap-
ital revitalization, and improvements of the real property assets and re-
lated 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 lo-
cated on any part of the existing National Institutes of Health campuses.
‘‘(B) CONSIDERATIONS.—In determining the location of facilities, the Direc-
tor 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 Di-
rector, up to the amount of annual compensation (excluding expenses) spec-
ified 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 administra-
tive, 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 sub-
section, the Director—
‘‘(A) may contract with private entities;
‘‘(B) shall make efforts to recruit and retain a diverse workforce, includ-
ing 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 rel-
evant 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, In-
dian 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 offi-
cers 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—
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‘‘(A) establish, in consultation with the Director or Deputy Director, re-
search and development goals for programs, including timelines and mile-
stones, 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 prom-
ise, especially in areas in which the private sector and the Federal Govern-
ment have not undertaken sufficient research;
‘‘(E) issue funding opportunity announcements, using uniform administra-
tive 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 iden-
tify 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 partner-
ships between or among awardees;
‘‘(J) identify innovative cost-sharing arrangements for ARPA–H projects;
‘‘(K) provide recommendations to expand, restructure, or terminate re-
search 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 appro-
priately 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 en-
actment 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 re-
spect 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 pro-
grams, including the provision of copies of all grants, contracts, or other
agreements related to such programs, and other supporting documenta-
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tion related to such programs, as a condition of receipt of Federal extra-
mural 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 Na-
tional Academies of Sciences, Engineering, and Medicine under which the
National Academies agree to study and evaluate whether ARPA–H is meet-
ing the goals specified in subsection (b).
‘‘(B) SUBMISSION OF RESULTS.—The agreement entered into under sub-
paragraph (A) shall require the National Academies of Sciences, Engineer-
ing, 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 in-
vestments 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 Depart-
ment 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 pro-
grams and projects; and
‘‘(2) to make recommendations regarding any potential reorganization, con-
solidation, 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, cooper-
ative agreements, contracts, prizes, and other transactions to individual persons
that do not have more than 3 ongoing concurrent grants, cooperative agree-
ments, 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 com-
mittee 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 fol-
lowing members, or designees:
‘‘(A) The Director of the National Institutes of Health.
‘‘(B) The Director of National Center for Advancing Translational
Sciences.
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‘‘(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 Administra-
tion.
‘‘(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 invest-
ment 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, reim-
bursement, and market barriers to commercialization or adoption of trans-
formative health technologies, including technologies intended to preempt
serious disease.
‘‘(4) ADVISORY NATURE.—The function of the Research Council shall be advi-
sory 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 Re-
search 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 produc-
tion contract or transaction to the participants in the transaction by ARPA–H
or another Federal agency. For purposes of this paragraph, such an other trans-
action 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 par-
ticipation 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 indi-
vidual 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.
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‘‘(5) OTHER AUTHORITIES.—Contracts and transactions entered into by ARPA–
H pursuant to this subsection may be awarded pursuant to division C of sub-
title I of title 41, United States Code, or under such procedures, terms, and con-
ditions 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 Regu-
lation’ 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 de-
vice—
‘‘(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, inter-
vention, 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.’’.
I. PURPOSE AND SUMMARY
H.R. 5585, the ‘‘Advanced Research Project Agency-Health Act’’
or the ‘‘ARPA–H Act,’’ authorizes the Advanced Research Projects
Agency for Health (ARPA–H) within the Department of Health and
Human Services (HHS) with the objective of accelerating innova-
tion in health and medicine in order to foster the development of
innovative transformative health technologies that are not being
developed by existing federal programs or the private sector. The
bill establishes a defined mission for the new agency, along with
specific goals and methods to address that mission, defines the role
and authorities of the director and program managers, creates a re-
search council and reporting mechanisms to determine whether
projects are meeting the agency’s goals, and authorizes hiring,
awards, cooperative agreements, and other transactions, among
other authorities. The bill authorizes appropriations of $500 million
for each of the fiscal years 2023 through 2027 to remain available
until expended.
II. BACKGROUND AND NEED FOR LEGISLATION
The American biomedical research enterprise is supported by the
world’s leading academic institutions, scientists, and commercial
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industries.1 The development of vaccines through the joint public-
private partnerships orchestrated by Operation Warp Speed to re-
spond to the coronavirus disease of 2019 (COVID–19) pandemic is
an example of America’s biomedical research leadership. Prior to
Operation Warp Speed, the fastest timeline for the development of
any vaccine from viral sampling to approval was four years.2 De-
veloping multiple vaccines within one year to effectively prevent se-
rious illness and death from COVID–19 infection was unprece-
dented.3 This outcome was made possible by significant federal in-
vestment and extensive collaboration with the private sector.4 For
example, years of fundamental research on related coronaviruses
that caused severe acute respiratory syndrome and Middle East
respiratory syndrome, funded by the National Institutes of Health
(NIH) and biotechnology companies, played a major role in the de-
velopment of COVID–19 vaccines.5 6
However, barriers and gaps exist within the public and private
biomedical research ecosystem, which can lead to the stalling or
failure of innovative projects.7 The priorities of the academic and
commercial sectors may result in ideas not being pursued that are
considered too high-risk, have a significant cost, or where the po-
tential commercial market would not support the cost, among other
reasons.8 H.R. 5585 seeks to address this gap by establishing a new
entity, ARPA–H, that will accelerate biomedical innovation in
health and medicine by supporting high-risk, high-reward research
projects. Projects taken on by ARPA–H will be subject to time-lim-
ited goals, benchmarks, and accountability initiatives.
ARPA–H is inspired by and builds on the model of the Defense
Advanced Research Projects Agency (DARPA).9 DARPA was
launched in 1958 with the goal of making pivotal investments in
breakthrough technologies for national security.10 Some of
DARPA’s important achievements include the development of the
internet, stealth aircraft, miniaturized Global Positioning System
technologies, flat-screen displays, and more.11 There are key fea-
tures of DARPA that have facilitated its success and that are in-
cluded in the design of ARPA–H, including its flexible hiring and
contracting authorities, streamlined and efficient leadership organi-
zation, milestone-based review, and focused mission.12
1 White House Office of Science and Technology Policy, Advanced Research Project Agency for
Health (ARPA–H): Concept Paper (June 2021) www.whitehouse.gov/wpcontent/uploads/2021/06/
ARPA–H-Concept-Paper.pdf).
2 Id.
3 Philip Ball, The Lightning-Fast Quest for COVID Vaccines—and What It Means for Other
Diseases, Nature (Dec. 18, 2020) (doi.org/10.1038/d41586-020-03626-1).
4 Id.
5 Id.
6 Amber Dance, Coronavirus Vaccines Get a Biotech Boost, Nature (July 21, 2020) (doi.org/
10.1038/d41586-020-02154-2).
7 Francis S. Collins et al., ARPA–H: Accelerating Biomedical Breakthroughs, Science, 373 (July
9, 2021) (doi.org/10.1126/science.abj8547).
8 Id.
9 Congressional Research Service, Advanced Research Agency for Health (ARPA–H): Potential
Questions for Consideration (Sept. 23, 2021). (www.crs.gov/Reports /R46901?source=search&guid
=c6ee36775a9 c4ed8a9239b678b 393e61&in dex=0).
10 Defense Advanced Research Projects Agency, About DARPA (www.darpa.mil/aboutus/about-
darpa) (accessed Jan. 30, 2022).
11 Defense Advanced Research Projects Agency, Innovation at DARPA (July 2016)
(www.darpa.mil/ attachments/ DARPA_Innovation_2016.pdf).
12 Defense Advanced Research Projects Agency, Contracting Managing (www.darpa.mil/work-
with-us/contract-management) (accessed Jan. 30, 2022).
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III. COMMITTEE HEARINGS
For the purposes of section 3(c) of rule XIII of the Rules of the
House of Representatives, the following hearing was used to de-
velop or consider H.R. 5585:
The Subcommittee on Health held a hearing on February 8,
2022. The hearing was entitled, ‘‘ARPA–H: The Next Frontier of
Biomedical Research.’’ The Subcommittee received testimony from
the following witnesses:
• Keith R. Yamamoto, Vice Chancellor for Science Policy and
Strategy, University of California San Francisco;
• Esther Krofah, Executive Director, FasterCures and Cen-
ter for Public Health at the Milken Institute;
• Geoffrey Shiu Fei Ling, CEO, On Demand Pharma-
ceuticals, and Professor of Neurology, Johns Hopkins Medicine;
• Admiral Brett P. Giroir, Former Assistant Secretary for
Health, U.S. Department of Health and Human Services; and
• Brian James Miller, Professor of Medicine John Hopkins
Medicine.
IV. COMMITTEE CONSIDERATION
H.R. 5585, the ‘‘Advanced Research Project Agency-Health Act’’
or the ‘‘ARPA–H Act,’’ was introduced on October 15, 2021, by Rep-
resentative Anna Eshoo (D–CA) and was referred to the Committee
on Energy and Commerce. Subsequently, on October 18, 2021, the
bill was referred to the Subcommittee on Health.
On May 11, 2022, the Subcommittee on Health met in open
markup session, pursuant to notice, to consider H.R. 5585 and five
other bills. During consideration of the bill, no amendments were
offered. Upon conclusion of consideration of the bill, the Sub-
committee on Health agreed to report the bill favorably to the full
Committee, without amendment, by a voice vote.
On May 18, 2022, the full Committee met in open markup ses-
sion, pursuant to notice, to consider H.R. 5585 and five other bills.
An amendment in the nature of a substitute (AINS), offered by
Representative Eshoo, was agreed to by a voice vote. Upon conclu-
sion of consideration of the bill, the full Committee agreed to a mo-
tion on final passage offered by Representative Pallone, Chairman
of the Committee, to order H.R. 5585 reported favorably to the
House, amended, by a roll call vote of 53 yeas to 3 nays.
V. COMMITTEE VOTES
Clause 3(b) of rule XIII of the Rules of the House of Representa-
tives requires the Committee to list each record vote on the motion
to report legislation and amendments thereto. The Committee ad-
vises that there was one record vote taken on H.R. 5585, including
a motion by Mr. Pallone ordering H.R. 5585 favorably reported to
the House, amended. The motion on final passage of the bill was
approved by a record vote of 53 yeas to 3 nays. The following are
the record votes taken during Committee consideration, including
the names of those members voting for and against:
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Insert offset folio 15 here HR365P1.001
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VI. OVERSIGHT FINDINGS
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) of rule
X of the Rules of the House of Representatives, the oversight find-
ings and recommendations of the Committee are reflected in the
descriptive portion of the report.
VII. NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX
EXPENDITURES
Pursuant to 3(c)(2) of rule XIII of the Rules of the House of Rep-
resentatives, the Committee adopts as its own the estimate of new
budget authority, entitlement authority, or tax expenditures or rev-
enues contained in the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
The Committee has requested but not received from the Director
of the Congressional Budget Office a statement as to whether this
bill contains any new budget authority, spending authority, credit
authority, or an increase or decrease in revenues or tax expendi-
tures.
VIII. FEDERAL MANDATES STATEMENT
The Committee adopts as its own the estimate of Federal man-
dates prepared by the Director of the Congressional Budget Office
pursuant to section 423 of the Unfunded Mandates Reform Act.
IX. STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES
Pursuant to clause 3(c)(4) of rule XIII, the general performance
goal or objective of this legislation is to authorize ARPA–H within
HHS to accelerate innovation in health and medicine by investing
in high-risk, high-reward research projects. The bill authorizes ap-
propriations of $500 million for each of the fiscal years 2023
through 2027 to remain available until expended.
X. DUPLICATION OF FEDERAL PROGRAMS
Pursuant to clause 3(c)(5) of rule XIII, no provision of H.R. 5585
is known to be duplicative of another Federal program, including
any program that was included in a report to Congress pursuant
to section 21 of Public Law 111–139 or the most recent Catalog of
Federal Domestic Assistance.
XI. COMMITTEE COST ESTIMATE
Pursuant to clause 3(d)(1) of rule XIII, the Committee adopts as
its own the cost estimate prepared by the Director of the Congres-
sional Budget Office pursuant to section 402 of the Congressional
Budget Act of 1974.
XII. EARMARKS, LIMITED TAX BENEFITS, AND LIMITED TARIFF
BENEFITS
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the Committee
finds that H.R. 5585 contains no earmarks, limited tax benefits, or
limited tariff benefits.
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XIII. ADVISORY COMMITTEE STATEMENT
No advisory committee within the meaning of section 5(b) of the
Federal Advisory Committee Act was created by this legislation.
XIV. APPLICABILITY TO LEGISLATIVE BRANCH
The Committee finds that the legislation does not relate to the
terms and conditions of employment or access to public services or
accommodations within the meaning of section 102(b)(3) of the Con-
gressional Accountability Act.
XV. SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION
Section. 1. Short title
Section 1 designates that the short title may be cited as the ‘‘Ad-
vanced Research Projects Agency–Health Act’’ or the ‘‘ARPA–H
Act.’’
Sec. 2. Advanced Research Projects Agency–Health
Section 2 amends Title IV of the Public Health Service Act to es-
tablish ARPA–H as an independent operating division within HHS.
This section establishes the goals of ARPA–H to foster the develop-
ment of new, breakthrough capabilities, technologies, systems, and
platforms to accelerate innovations in health and medicine that are
not being met by existing federal programs or private entities to
ensure the United States maintains global leadership in science
and the highest quality of life and health for its citizens. This sec-
tion also includes the methods by which ARPA–H shall achieve
these goals, including identifying, translating, accelerating,
prioritizing, and delivering transformative health technologies.
This section also specifies that investments will be prioritized
based on scientific opportunity, the effect on disease burden, in-
cluding unmet patient need, and the ability to reduce the cost of
care through innovation.
This section creates the position of a presidentially-appointed,
Senate-confirmed Director who shall report to the Secretary of
HHS and perform the duties of approving, setting, developing, and
advancing the goals and priorities of the Agency; coordinate with
NIH and other federal agencies, private entities, academia, non-
profit organizations, and international organizations to solicit data,
build on scientific research, and ensure that efforts supplement
(and do not supplant) those of other federal agencies; and appoint
a deputy director.
Under this section, the Director is authorized to submit autono-
mous agency recommendations and testimony to Congress, protect
certain ARPA–H information from disclosure, share information
with the Centers for Medicare and Medicaid Services, expedite
breakthroughs through cooperation with the Food and Drug Ad-
ministration, lease facilities and determine the location of ARPA–
H’s headquarters, hire personnel, and appoint program managers.
This section instructs the Director to prioritize awarding ARPA–H
funding to domestic recipients conducting research in the United
States. As appropriated and practicable, this section also specifies
that the Director shall ensure that nondomestic recipients conduct
research in collaboration with a domestic recipient and shall not
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award any funding to nondomestic recipients subject to malign for-
eign influence or organized under the laws of a malign foreign
country.
This section requires the Director to submit reports on the ac-
tions, results, and forthcoming strategic plans of ARPA–H to the
Congressional Committees in the House and Senate with appro-
priate jurisdiction. It also permits the Director to seek advice from
outside entities and to establish the ARPA–H Interagency Research
Council. Under this section, the Director may establish an Office of
Technology Transfer with ARPA–H to facilitate the transfer of fed-
erally owned or originated technology to recipients of ARPA–H
funding.
Under this section, the Comptroller General is required to con-
duct an independent review of the research portfolio of HHS, in-
cluding ARPA–H, to assess the degree of unnecessary duplication
and to make recommendations regarding potential reorganization,
coordination, or termination of such programs.
This section authorizes appropriations of $500 million for each of
the fiscal years 2023 through 2027 to remain available until ex-
pended.
XVI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In compliance with clause 3(e) of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the bill,
as reported, are shown as follows (new matter is printed in italics
and existing law in which no change is proposed is shown in
roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE IV—NATIONAL RESEARCH INSTITUTES
* * * * * * *
PART J—ADVANCED RESEARCH PROJECTS
AGENCY–HEALTH
SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY–HEALTH.
(a) ESTABLISHMENT.—There is established, as an independent op-
erating division within the Department of Health and Human Serv-
ices, the Advanced Research Projects Agency–Health (in this part re-
ferred 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 Ad-
vanced Research Projects Agency for Health within the National In-
stitutes 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 capabili-
ties, technologies, systems, and platforms to accelerate inno-
vations in health and medicine that are not being met by
Federal programs or private entities;
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(B) revolutionize detection, diagnosis, mitigation, preven-
tion, 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 de-
velopment and translation of transformative health tech-
nologies; 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 citi-
zens; 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, in-
cluding the life sciences, the physical sciences, engineering,
and the computational sciences;
(E) delivering advanced proofs of concept that dem-
onstrate 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 dis-
ease 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 pa-
tient need, quality and disparity gaps, and the poten-
tial 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 es-
pecially 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 sec-
tors, including generating transformative health tech-
nologies and improving health outcomes for patients.
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(3) RELATIONSHIP TO SECRETARY.—The Director shall report
directly to the Secretary.
(4) DUTIES.—The duties of the Director shall include the fol-
lowing:
(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 mile-
stones.
(D) Advance the goals under subsection (b), through con-
sideration of the advice of the ARPA–H Interagency Re-
search 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 Insti-
tutes 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 of-
ficer of ARPA–H to submit legislative recommendations, or tes-
timony 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 com-
ments 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 an-
other 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 Reduc-
tion Act’’) with respect to the methods described in subsection (b)(2).
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(e) PROTECTION OF INFORMATION.—The following types of infor-
mation 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 sub-
ject 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 mar-
ket 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 de-
veloped 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 in-
formation with the Administrator of the Centers for Medicare &
Medicaid Services that may help to expedite determinations of cov-
erage 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 Commis-
sioner 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 ex-
pedite 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 ob-
taining their approval, licensure, or clearance, as applica-
ble, by the Food and Drug Administration under sections
505, 510(k), and 515 of the Federal Food, Drug, and Cos-
metic Act and section 351 of this Act;
(B) expediting review of investigational new drug appli-
cations 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 pri-
orities to ARPA–H, unless the Director and the Commis-
sioner of Food and Drugs determine that any such meetings
are not necessary.
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(2) RELATION TO OTHERWISE AUTHORIZED ACTIVITIES OF THE
FDA.—The authority specified in paragraph (1) shall not be con-
strued 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 li-
censure of drugs, devices, or biological products under the Fed-
eral Food, Drug, and Cosmetic Act or section 351 of this Act.
(3) REIMBURSEMENT.—The Director, using funds made avail-
able to ARPA–H, may reimburse the Food and Drug Adminis-
tration for expenditures made by the Food and Drug Adminis-
tration 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 Adminis-
tration.
(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 require-
ments, cost principles, and audit requirements for Fed-
eral 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-read-
able format;
(B) contracts subject to the Federal Acquisition Regula-
tion;
(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 (includ-
ing 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 fur-
ther 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 sub-
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section that are not utilized in accordance with subpara-
graph (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 revital-
ization, and improvements of the real property as-
sets and related personal property under the juris-
diction 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 revi-
talization, and improvements of the real property as-
sets and related personal property at the respective cen-
ter or facility subject to the concurrence of the Director.
(C) NO UTILIZATION FOR DAILY OPERATING COSTS.—
Amounts utilized under subparagraph (B) may not be uti-
lized 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 In-
stitutes of Health campuses.
(B) CONSIDERATIONS.—In determining the location of fa-
cilities, the Director shall make a fair and open consider-
ation 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, engi-
neering, medical, and professional personnel, which may
include temporary or time-limited appointments as deter-
mined 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 ex-
tent 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, con-
tracts, 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;
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(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, In-
dian Tribes and Tribal organizations, institutions of higher
education, and other organizations, as described in such sec-
tions.
(5) EXISTING AUTHORITIES.—The authorities granted by this
section are—
(A) in addition to existing authorities granted to the Sec-
retary; 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 mem-
bers 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 de-
tailing elements, for a period not to exceed 3 years.
(k) PROGRAM MANAGERS.—
(1) IN GENERAL.—The Director shall appoint program man-
agers for 3-year terms (and may reappoint such program man-
agers 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, in-
cluding 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 rel-
evant scientific fields to identify research and development
gaps and opportunities;
(C) convene workshops and meetings, as needed, with en-
tities such as patients, patient advocacy groups, practi-
tioners, professional societies, and other stakeholders to so-
licit input on programs and goals;
(D) manage applications and proposals, through the ap-
propriate officials for making grants, cooperative agree-
ments, contracts, prizes, and other transaction awards for
advanced research that may show particular promise, espe-
cially in areas in which the private sector and the Federal
Government have not undertaken sufficient research;
(E) issue funding opportunity announcements, using uni-
form administrative processes, as appropriate;
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(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 out-
comes within patient populations;
(iv) future commercial applications of the project or
the feasibility of partnering with one or more commer-
cial entities;
(v) the potential for interdisciplinarity of the ap-
proach 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 dis-
bursement 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 award-
ees;
(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 Ani-
mals; and
(ii) applications apply statistical modeling ap-
proaches 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, includ-
ing—
(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 pre-
vious 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;
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(v) an analysis of the extent of coordination con-
ducted pursuant to subsections (c)(4)(F) and (f), includ-
ing successes and barriers with respect to achieving the
goals under subsection (b);
(vi) a description of the demographic (including ra-
cial and gender) diversity if available of direct recipi-
ents 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 par-
ticipate in foreign talent programs, including the provi-
sion of copies of all grants, contracts, or other agree-
ments related to such programs, and other supporting
documentation related to such programs, as a condi-
tion of receipt of Federal extramural biomedical re-
search funding awarded.
(B) SUBMISSION TO CONGRESS.—The report under sub-
paragraph (A) shall be submitted to—
(i) the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Rep-
resentatives; 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, En-
gineering, and Medicine under which the National Acad-
emies 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 sub-
mit 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 Com-
mittee 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 inde-
pendent 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 duplication of existing
Federal programs and projects; and
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(2) to make recommendations regarding any potential reorga-
nization, consolidation, or termination of such programs and
projects.
(o) PRIORITIZATION.—The Director shall—
(1) prioritize awarding grants, cooperative agreements, con-
tracts, prizes, and other transaction awards to domestic recipi-
ents conducting the research on transformative health tech-
nology 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 Regula-
tion, only award grants, cooperative agreements, contracts,
prizes, and other transactions to individual persons that do not
have more than 3 ongoing concurrent grants, cooperative agree-
ments, contracts, prizes, and other transactions under this sec-
tion.
(p) ADDITIONAL CONSULTATION.—In carrying out this section, the
Director may consult with—
(1) the President’s Council of Advisors on Science and Tech-
nology;
(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 ‘‘Re-
search 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 Pol-
icy.
(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.
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(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 Serv-
ices 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 Depart-
ment of Energy.
(N) The Director of the Advanced Research Projects Agen-
cy–Energy.
(O) The Assistant Secretary for Preparedness and Re-
sponse.
(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 pursu-
ant 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 agen-
cies; and
(B) identifying and developing strategies to address regu-
latory, reimbursement, and market barriers to commer-
cialization or adoption of transformative health tech-
nologies, 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 en-
actment of this section, and every fiscal year thereafter, the Di-
rector shall convene meetings of the Research Council, includ-
ing 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-origi-
nated technology to recipients of an award under this section (other
than Federal Government entities).
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(s) FOLLOW-ON PRODUCTION AWARD AUTHORITY.—
(1) IN GENERAL.—An other transaction entered into by the Di-
rector 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 trans-
action includes all individual subprojects awarded under the
transaction to a consortium of United States industry and aca-
demic 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 divi-
sion 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 trans-
action 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 partici-
pants.
(4) CLARIFICATION.—Award of a follow-on production con-
tract 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 experi-
mental 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 Depart-
ment 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 Regula-
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27
tion 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 Innova-
tion 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, miti-
gate, 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.
* * * * * * *
Æ
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