[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5585 Referred in Senate (RFS)]
<DOC>
117th CONGRESS
2d Session
H. R. 5585
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 23, 2022
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To establish the Advanced Research Projects Agency-Health, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advanced Research Projects Agency-
Health Act'' or the ``ARPA-H Act''.
SEC. 2. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.
Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.)
is amended by adding at the end the following:
``PART J--ADVANCED RESEARCH PROJECTS AGENCY-HEALTH
``SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.
``(a) Establishment.--
``(1) In general.--There is established as an independent
operating division within the Department of Health and Human
Services, the Advanced Research Projects Agency-Health (in this
part referred to as `ARPA-H'). Not later than 180 days after
the date of enactment of this part, the Secretary shall
transfer all functions, personnel, missions, activities,
authorities, and funds of the Advanced Research Projects Agency
for Health within the National Institutes of Health, as in
existence on the date of enactment of this part, to ARPA-H
established by the preceding sentence.
``(2) Organization.--
``(A) In general.--There shall be within ARPA-H--
``(i) an Office of the Director;
``(ii) not more than 6 program offices; and
``(iii) such special project offices as the
Director may establish.
``(B) Program offices dedicated to research and
development.--Not fewer than two-thirds of the program
offices of ARPA-H shall be exclusively dedicated to
research and development.
``(b) Goals and Methods.--
``(1) Goals.--The goals of ARPA-H shall be to--
``(A) foster the development of new, breakthrough
capabilities, technologies, systems, and platforms to
accelerate innovations in health and medicine that are
not being met by Federal programs or private entities;
``(B) revolutionize detection, diagnosis,
mitigation, prevention, treatment, and curing of
serious diseases and medical conditions through the
development of transformative health technologies;
``(C) promote high-risk, high-reward innovation for
the development and translation of transformative
health technologies; and
``(D) contribute to ensuring the United States
maintains--
``(i) global leadership in science and
innovation;
``(ii) the highest quality of life and
health for its citizens; and
``(iii) an aggressive agenda for
innovations to address global health threats
that place United States citizens at risk.
``(2) Methods.--ARPA-H shall achieve the goals specified in
paragraph (1) by--
``(A) discovering, identifying, and promoting
revolutionary advances in health sciences;
``(B) translating scientific discoveries into
transformative health technologies;
``(C) providing resources and support to create
platform capabilities that draw on multiple
disciplines;
``(D) using researchers in a wide range of
disciplines, including the life sciences, the physical
sciences, engineering, and the computational sciences;
``(E) delivering advanced proofs of concept that
demonstrate potentially clinically meaningful advances;
``(F) developing new capabilities, advanced
computational tools, predictive models, or analytical
techniques to identify potential targets and
technological strategies for early disease detection
and intervention;
``(G) accelerating transformational technological
advances in areas with limited technical certainty; and
``(H) prioritizing investments based on such
considerations as--
``(i) scientific opportunity and uniqueness
of fit to the strategies and operating
practices of ARPA-H;
``(ii) the effect on disease burden,
including unmet patient need, quality and
disparity gaps, and the potential to preempt
progression of serious disease; and
``(iii) the effect on the fiscal liability
of the Federal Government with respect to
health care and the ability to reduce the cost
of care through innovation.
``(c) Director.--
``(1) In general.--The President shall appoint a director
of ARPA-H (in this part referred to as the `Director').
``(2) Qualifications.--The Director shall be an individual
who, by reason of professional background and experience, is
especially qualified to manage--
``(A) research and advanced development programs;
and
``(B) large-scale, high-risk initiatives with
respect to health research and technology development
across multiple sectors, including generating
transformative health technologies and improving health
outcomes for patients.
``(3) Relationship to secretary.--The Director shall report
directly to the Secretary.
``(4) Duties.--The duties of the Director shall include the
following:
``(A) Approve and terminate the projects and
programs of ARPA-H.
``(B) Set research and development priorities with
respect to the goals specified in subsection (b) and
manage the budget of ARPA-H.
``(C) Develop funding criteria and assess the
success of programs through the establishment of
technical milestones.
``(D) Advance the goals under subsection (b),
through consideration of the advice of the ARPA-H
Interagency Research Council established under
subsection (q).
``(E) Solicit data, as needed, from the National
Institutes of Health and other relevant entities.
``(F) Coordinate with the Director of the National
Institutes of Health to ensure that the programs of
ARPA-H build on, and are informed by, scientific
research supported by the National Institutes of
Health.
``(G) Coordinate with the heads of Federal agencies
and, to the extent practicable, ensure that the
activities of ARPA-H supplement (and do not supplant)
the efforts of other Federal agencies.
``(H) Ensure ARPA-H does not provide funding for a
project unless the program manager determines that the
project meets the goals described in subsection (b)(1).
``(5) Term.--The Director--
``(A) shall be appointed for a 5-year term; and
``(B) may be reappointed for 1 consecutive 5-year
term.
``(6) Autonomy of agency regarding recommendations and
testimony.--No officer or agency of the United States shall
have any authority to require the Director or any other officer
of ARPA-H to submit legislative recommendations, or testimony
or comments on legislation, to any officer or agency of the
United States for approval, comments, or review prior to the
submission of such recommendations, testimony, or comments to
the Congress, if such recommendations, testimony, or comments
to the Congress include a statement indicating that the views
expressed therein are those of the Director or such officer,
and do not necessarily reflect the views of the President or
another agency.
``(7) Delegation of authority.--The Director may delegate
to any duly authorized employee, representative, or agent any
power vested in the Director by law, except that the Director
may not delegate the power to appoint the Deputy Director under
paragraph (8).
``(8) Deputy director.--The Director shall appoint a deputy
director to serve as the first assistant to the office.
``(d) Application of Paperwork Reduction Act.--The Director may
waive the requirements of subchapter I of chapter 35 of title 44,
United States Code (commonly referred to as the `Paperwork Reduction
Act') with respect to the methods described in subsection (b)(2).
``(e) Protection of Information.--The following types of
information collected by ARPA-H from recipients of financial assistance
awards shall be considered commercial and financial information
obtained from a person and privileged or confidential and not subject
to disclosure under section 552(b)(4) of title 5, United States Code:
``(1) Plans for commercialization of technologies developed
under the award, including business plans, technology-to market
plans, market studies, and cost and performance models.
``(2) Investments provided to an awardee from third parties
(such as venture capital firms, hedge funds, and private equity
firms), including amounts and the percentage of ownership of
the awardee provided in return for the investments.
``(3) Additional financial support that the awardee--
``(A) plans to invest or has invested in the
technology developed under the award; or
``(B) is seeking from third parties.
``(4) Revenue from the licensing or sale of new products or
services resulting from research conducted under the award.
``(f) Sharing Information With the Centers for Medicare & Medicaid
Services.--The Director shall timely share relevant information with
the Administrator of the Centers for Medicare & Medicaid Services that
may help to expedite determinations of coverage of transformative
health technologies developed by ARPA-H.
``(g) Expediting Breakthroughs Through Cooperation With the Food
and Drug Administration.--
``(1) In general.--The Secretary, acting through the
Commissioner of Food and Drugs and in consultation with the
Director, may take actions to facilitate translation of
transformative health technology into tangible solutions for
patients and to expedite development of drugs, devices, and
biological products, including through--
``(A) helping to ensure that drug, device, or
biological product development programs, in as
efficient a manner as possible, gather the nonclinical
and clinical data necessary to advancing the
development of such products and to obtaining their
approval, licensure, or clearance, as applicable, by
the Food and Drug Administration under sections 505,
510(k), and 515 of the Federal Food, Drug, and Cosmetic
Act and section 351 of this Act;
``(B) expediting review of investigational new drug
applications under section 505(i) of the Federal Food,
Drug, and Cosmetic Act, review of investigational
device exemptions under section 520(g) of such Act, and
review of applications for approval, licensure, and
clearance of drugs, devices, or biological products
under sections 505, 510(k), and 515 of such Act, and
section 351 of this Act; and
``(C) meeting at appropriate intervals with the
Director and any member of the ARPA-H Interagency
Research Council to discuss the development status of
drugs, devices, or biological products and projects
that are the highest priorities to ARPA-H, unless the
Director and the Commissioner of Food and Drugs
determine that any such meetings are not necessary.
``(2) Relation to otherwise authorized activities of the
fda.--The authority specified in paragraph (1) shall not be
construed as limiting the authority of the Secretary, acting
through the Commissioner of Food and Drugs, with respect to the
review and approval, clearance, authorization for emergency
use, or licensure of drugs, devices, or biological products
under the Federal Food, Drug, and Cosmetic Act or section 351
of this Act.
``(3) Reimbursement.--The Director, using funds made
available to ARPA-H, may reimburse the Food and Drug
Administration for expenditures made by the Food and Drug
Administration for activities carried out under this section
that have been identified by the Commissioner of Food and Drugs
and the Director as being carried out by the Food and Drug
Administration.
``(h) Awards.--
``(1) In general.--In carrying out this section, the
Director may make awards including--
``(A) grants and cooperative agreements, which
shall--
``(i) be subject to the uniform
administrative requirements, cost principles,
and audit requirements for Federal awards
contained in part 200 of title 2, Code of
Federal Regulations (or successor regulations);
and
``(ii) include the total line-item and
itemized indirect facilities and administrative
costs that shall be made publicly available and
published in a machine-readable format;
``(B) contracts subject to the Federal Acquisition
Regulation;
``(C) multi-year contracts under section 3903 of
title 41, United States Code;
``(D) prizes; and
``(E) other transactions.
``(2) Exemptions for certain requirements.--Research funded
by ARPA-H shall not be subject to the requirements of section
406(a)(3)(A)(ii) or section 492.
``(i) Facilities Authority.--
``(1) In general.--The Director may acquire (by purchase,
lease, condemnation, or otherwise), construct, improve, repair,
operate, and maintain such real and personal property as may be
necessary to carry out this section.
``(2) Lease of nonexcess property.--The Director may enter
into a lease under this section with any person or entity
(including another department or agency of the Federal
Government or an entity of a State or local government) with
regard to any nonexcess real property and related personal
property under the jurisdiction of the Director.
``(3) Utilization of lease funds.--The Director shall
deposit amounts of cash consideration received for a lease
entered into under this subsection in the `Advanced Research
Projects Agency for Health' account as discretionary offsetting
collections, and such amounts shall be available only to the
extent and in the amounts provided in advance in appropriations
Acts--
``(A) to cover the full costs to ARPA-H in
connection with the lease;
``(B) for maintenance, capital revitalization, and
improvements of the real property assets and related
personal property under the jurisdiction of the
Director; and
``(C) for maintenance, capital revitalization, and
improvements of the real property assets and related
personal property at the respective center or facility
of ARPA-H engaged in the lease, subject to the
concurrence of the Director.
``(4) Locations.--
``(A) In general.--ARPA-H, including its
headquarters, shall not be located on any part of the
existing National Institutes of Health campuses.
``(B) Considerations.--In determining the location
of facilities, the Director shall make a fair and open
consideration of--
``(i) the characteristics of the intended
location; and
``(ii) the extent to which such location
will facilitate advancement of the goals and
methods specified in subsection (b).
``(j) Personnel.--
``(1) In general.--The Director may--
``(A) make and rescind appointments of scientific,
engineering, medical, and professional personnel, which
may include temporary or time-limited appointments as
determined by the Director to fulfill the mission of
ARPA-H, without regard to any provision in title 5,
United States Code, governing appointments and removals
under the civil service laws, and fix the base pay
compensation of such personnel at a rate to be
determined by the Director, up to the amount of annual
compensation (excluding expenses) specified in section
102 of title 3, United States Code; and
``(B) contract with private recruiting firms for
the hiring of qualified staff referenced in
subparagraph (A).
``(2) Additional staff.--The Director may use, to the same
extent and in the same manner as the Secretary, all authorities
in existence on the date of the enactment of this section that
are provided to the Secretary to hire administrative,
financial, contracts, legislative affairs, information
technology, ethics, and communications staff, and such other
staff as may be identified by the Director as necessary to
carry out this section.
``(3) Additional considerations.--In appointing personnel
under this subsection, the Director--
``(A) may contract with private entities;
``(B) shall make efforts to recruit and retain a
diverse workforce, including individuals
underrepresented in science and medicine and racial and
ethnic minorities (as long as such efforts comply with
applicable Federal civil rights law); and
``(C) shall recruit program managers with expertise
in a wide range of relevant disciplines, including life
sciences, the physical sciences, engineering, and the
computational sciences.
``(4) Additional hiring authority.--To the extent needed to
carry out the authorities vested by paragraph (1), the Director
may utilize hiring authorities under sections 3371 through 3376
of title 5, United States Code, to staff ARPA-H with employees
from other Federal agencies, State and local governments,
Indian Tribes and Tribal organizations, institutions of higher
education, and other organizations, as described in such
sections.
``(5) Existing authorities.--The authorities granted by
this section are--
``(A) in addition to existing authorities granted
to the Secretary; and
``(B) are not intended to supersede or modify any
existing authorities.
``(6) Authority to accept federal detailees.--The Director
may accept officers or employees of the United States or
members of the uniformed service on a detail from an element of
the Federal Government on a reimbursable or a nonreimbursable
basis, as jointly agreed to by the heads of the receiving and
detailing elements, for a period not to exceed 3 years.
``(k) Program Managers.--
``(1) In general.--The Director shall appoint program
managers for 3-year terms (and may reappoint such program
managers for 1 consecutive 3-year term) for the programs
carried out by ARPA-H.
``(2) Duties.--A program manager shall--
``(A) establish, in consultation with the Director
or Deputy Director, research and development goals for
programs, including timelines and milestones, and make
such goals available to the public;
``(B) collaborate with experts from the National
Institutes of Health and other Federal agencies and
experts in relevant scientific fields to identify
research and development gaps and opportunities;
``(C) convene workshops and meetings, as needed,
with entities such as patients, patient advocacy
groups, practitioners, professional societies, and
other stakeholders to solicit input on programs and
goals;
``(D) manage applications and proposals, through
the appropriate officials for making grants,
cooperative agreements, contracts, prizes, and other
transaction awards for advanced research that may show
particular promise, especially in areas in which the
private sector and the Federal Government have not
undertaken sufficient research;
``(E) issue funding opportunity announcements,
using uniform administrative processes, as appropriate;
``(F) select, on the basis of merit, each of the
projects to be supported under a program carried out by
ARPA-H, and taking into consideration--
``(i) the scientific and technical merit of
the proposed project;
``(ii) the capabilities of the applicants
to successfully carry out the proposed project;
``(iii) the unmet needs or ability to
improve health outcomes within patient
populations;
``(iv) future commercial applications of
the project or the feasibility of partnering
with one or more commercial entities;
``(v) the potential for interdisciplinarity
of the approach of the project; and
``(vi) such other criteria as established
by the Director;
``(G) conduct project reviews within 18 months of
funding awards to identify milestones and monitor
progress of such milestones with respect to each
project and prior to disbursement of new funds;
``(H) provide recommendations to the Director with
respect to advancing the goals specified in subsection
(b);
``(I) cultivate opportunities for the commercial
application or community use of successful projects,
including through the establishment of partnerships
between or among awardees;
``(J) identify innovative cost-sharing arrangements
for ARPA-H projects;
``(K) provide recommendations to expand,
restructure, or terminate research partnerships or
projects; and
``(L) ensure that--
``(i) animal studies meet the Federal
animal research requirements pursuant of the
Public Health Service Policy on Humane Care and
Use of Laboratory Animals; and
``(ii) applications apply statistical
modeling approaches and appropriately justify
animal sample sizes to meet project goals.
``(l) Reports and Evaluation.--
``(1) Annual report.--
``(A) In general.--Beginning not later than 1 year
after the date of enactment of this section, and each
fiscal year thereafter, the Director shall submit a
report on the actions undertaken, and results
generated, by ARPA-H, including--
``(i) a description of projects supported
by ARPA-H in the previous fiscal year and
whether such projects are meeting the goals
developed by the Director pursuant to
subsection (c)(4)(C);
``(ii) a description of projects terminated
in the previous fiscal year, and the reason for
such termination;
``(iii) a description of programs starting
in the next fiscal year, as available;
``(iv) activities conducted in coordination
with other Federal agencies;
``(v) an analysis of the extent of
coordination conducted pursuant to subsections
(c)(4)(F) and (f), including successes and
barriers with respect to achieving the goals
under subsection (b);
``(vi) a description of the demographic
(including racial and gender) diversity if
available of direct recipients and performers
in funded projects and of the ARPA-H workforce;
and
``(vii) a disclosure by the reward
recipients of whether the principal
investigators named on the award participate in
foreign talent programs, including the
provision of copies of all grants, contracts,
or other agreements related to such programs,
and other supporting documentation related to
such programs, as a condition of receipt of
Federal extramural biomedical research funding
awarded.
``(B) Submission to congress.--The report under
subparagraph (A) shall be submitted to--
``(i) the Committee on Energy and Commerce
and the Committee on Appropriations of the
House of Representatives; and
``(ii) the Committee on Health, Education,
Labor, and Pensions and the Committee on
Appropriations of the Senate.
``(2) Evaluation.--
``(A) In general.--Not later than 5 years after the
date of the enactment of this section, the Secretary
shall enter into an agreement with the National
Academies of Sciences, Engineering, and Medicine under
which the National Academies agree to study and
evaluate whether ARPA-H is meeting the goals specified
in subsection (b).
``(B) Submission of results.--The agreement entered
into under subparagraph (A) shall require the National
Academies of Sciences, Engineering, and Medicine to
submit the results of the evaluation conducted under
such agreement to the Secretary, the Committee on
Energy and Commerce of the House of Representatives,
and the Committee on Health, Education, Labor, and
Pensions of the Senate.
``(m) Strategic Plan.--Not later than 1 year after the date of the
enactment of this section, and every 3 years thereafter, the Director
shall provide to the relevant committees of Congress a strategic plan
describing how ARPA-H will carry out investments each fiscal year in
the following 3-year period.
``(n) Independent Review.--Not later than 1 year after the date of
the enactment of this section, and every 3 years thereafter, the
Comptroller General of the United States shall conduct an independent
review of the research portfolio of the Department of Health and Human
Services, including ARPA-H, the National Institutes of Health, the Food
and Drug Administration, and the Biomedical Advanced Research and
Development Authority--
``(1) to assess the degree of unnecessary duplication of
existing Federal programs and projects; and
``(2) to make recommendations regarding any potential
reorganization, consolidation, or termination of such programs
and projects.
``(o) Prioritization.--The Director shall--
``(1) prioritize awarding grants, cooperative agreements,
contracts, prizes, and other transaction awards to domestic
recipients conducting the research on transformative health
technology in the United States;
``(2) as appropriate and practicable, ensure that
nondomestic recipients of any grants, cooperative agreements,
contracts, prizes, and other transactions under this section
are conducting research in collaboration with a domestic
recipient;
``(3) not award any grants, cooperative agreements,
contracts, prizes, and other transactions to nondomestic
recipients organized under the laws of a covered foreign
country (as defined in section 119C of the National Security
Act of 1947); and
``(4) in accordance with the requirements of chapter 33 of
title 41, United States Code, and the Federal Acquisition
Regulation, only award grants, cooperative agreements,
contracts, prizes, and other transactions to individual persons
that do not have more than 3 ongoing concurrent grants,
cooperative agreements, contracts, prizes, and other
transactions under this section.
``(p) Additional Consultation.--In carrying out this section, the
Director may consult with--
``(1) the President's Council of Advisors on Science and
Technology;
``(2) peers in the scientific community, including academia
and industry;
``(3) an existing advisory committee providing advice to
the Secretary or the head of any operating or staff division of
the Department;
``(4) a new interagency research council organized to
support the programs of ARPA-H and to provide advice and
assistance on--
``(A) specific program tasks; or
``(B) the overall direction of ARPA-H; and
``(5) any other entity the Director may deem appropriate.
``(q) ARPA-H Interagency Research Council.--
``(1) In general.--The Director shall establish an
interagency advisory committee to be known as the ARPA-H
Interagency Research Council (referred to in this subsection as
the `Research Council').
``(2) Membership.--The Research Council may include any or
all of the following members, or designees:
``(A) The Director of the National Institutes of
Health.
``(B) The Director of National Center for Advancing
Translational Sciences.
``(C) The Director of Office of Science and
Technology Policy.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the Biomedical Advanced
Research and Development Authority.
``(F) The Director of the Centers for Disease
Control and Prevention.
``(G) The Administrator of the Centers for Medicare
& Medicaid Services.
``(H) The Director of the Agency for Healthcare
Research and Quality.
``(I) The Director of the Office of Minority
Health.
``(J) The Administrator of the Health Resources and
Services Administration.
``(K) The Director of the Defense Advanced Research
Projects Agency.
``(L) The Director of the National Science
Foundation.
``(M) The Director of the Office of Science of the
Department of Energy.
``(N) The Director of the Advanced Research
Projects Agency-Energy.
``(O) The Assistant Secretary for Preparedness and
Response.
``(P) Representatives of any Federal agency with
subject matter expertise that the Director determines
is necessary for the successful completion of a project
carried out pursuant to this section.
``(Q) Any other entity the Director may deem
appropriate.
``(3) Duties.--The Research Council shall advise the
Director, including by--
``(A) making recommendations on--
``(i) research priorities that will provide
the greatest return on investment with respect
to improving human health;
``(ii) avoiding duplication of efforts in
the Federal Government; and
``(iii) improving coordination with other
Federal agencies; and
``(B) identifying and developing strategies to
address regulatory, reimbursement, and market barriers
to commercialization or adoption of transformative
health technologies, including technologies intended to
preempt serious disease.
``(4) Advisory nature.--The function of the Research
Council shall be advisory in nature. Nothing in this subsection
shall be construed as granting the Research Council authority
over any activities or functions of ARPA-H.
``(5) Meetings.--Not later than 1 year after the date of
the enactment of this section, and every fiscal year
thereafter, the Director shall convene meetings of the Research
Council, including conferences or workshops, as needed. The
Research Council may function through established or ad hoc
committees, task forces, or interagency groups to--
``(A) share information on health innovations
funded by ARPA-H; and
``(B) receive input on areas of particular promise
for ARPA-H projects.
``(r) Technology Transfer Office.--The Director may establish
within ARPA-H an Office of Technology Transfer to facilitate, where
appropriate, the transfer of federally-owned or federally-originated
technology to recipients of an award under this section (other than
Federal Government entities).
``(s) Follow-on Production Award Authority.--
``(1) In general.--An other transaction entered into by the
Director under subsection (h)(1) for a project may provide for
the award of a follow-on production contract or transaction to
the participants in the transaction by ARPA-H or another
Federal agency. For purposes of this paragraph, such an other
transaction includes all individual subprojects awarded under
the transaction to a consortium of United States industry and
academic institutions.
``(2) Relation to competitive procedures.--A follow-on
production contract or transaction under paragraph (1) may be
awarded to the participants in the transaction without the use
of competitive procedures (as defined in section 152 of title
41, United States Code), notwithstanding the requirements of
division C of subtitle I of such title 41, if--
``(A) competitive procedures were used for the
selection of parties for participation in the other
transaction; and
``(B) the participants in the other transaction
successfully completed the project provided for in the
transaction.
``(3) Precondition.--A follow-on production contract or
transaction may be awarded pursuant to this subsection when the
Director determines that an individual project or subproject as
part of a consortium is successfully completed by the
participants.
``(4) Clarification.--Award of a follow-on production
contract or transaction pursuant to this subsection shall not
be made contingent upon the successful completion of all
activities within a consortium as a condition for an award for
follow-on production of a successfully completed project or
subproject within that consortium.
``(5) Other authorities.--Contracts and transactions
entered into by ARPA-H pursuant to this subsection may be
awarded pursuant to division C of subtitle I of title 41,
United States Code, or under such procedures, terms, and
conditions as the Director or head of such agency may establish
by regulation.
``(t) Rule of Construction.--The authorities under this section,
with respect to the Director, are additional authorities that do not
supersede or modify any existing authorities.
``(u) Definitions.--In this part:
``(1) Advanced proofs of concept.--The term `advanced
proofs of concept' means data, a prototype, or other
experimental evidence that--
``(A) may precede the development of transformative
health technologies; and
``(B) demonstrates the feasibility of a new
concept.
``(2) Biological product.--The term `biological product'
has the meaning given such term in section 351(i).
``(3) Department.--The term `Department' means the
Department of Health and Human Services.
``(4) Drug; device.--The terms `drug' and `device' have the
meanings given such terms in section 201 of the Federal Food,
Drug, and Cosmetic Act.
``(5) Federal acquisition regulation.--The term `Federal
Acquisition Regulation' means the Federal Acquisition
Regulation issued pursuant to section 1303(a)(1) of title 41,
United States Code.
``(6) Federal agency.--The term `Federal agency' has the
meaning given such term in section 3371 of title 5, United
States Code.
``(7) Prize.--The term `prize' means a prize as such term
is used in section 24 of the Stevenson-Wydler Technology
Innovation Act of 1980.
``(8) Transformative health technology.--The term
`transformative health technology' means a drug, biological
product, intervention, platform, tool, or device--
``(A) that should be prioritized to detect,
diagnose, mitigate, prevent, cure, or treat a serious
disease or medical condition for which there are unmet
needs; and
``(B) for which--
``(i) significant scientific uncertainty
and regulatory risk exist; or
``(ii) incentives in the commercial market
are unlikely to result in the adequate or
timely development of such drug, biological
product, intervention, platform, tool, or
device.
``(v) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there is
authorized to be appropriated $500,000,000 for each of fiscal
years 2023 through 2027, to remain available until expended.
``(2) Administrative expenses.--Not more than 15 percent of
the amounts made available to carry out this section for any
fiscal year may be used for administrative expenses to operate
ARPA-H.''.
Passed the House of Representatives June 22, 2022.
Attest:
CHERYL L. JOHNSON,
Clerk.
By Kevin McCumber,
Deputy Clerk.