[Congressional Record Volume 168, Number 106 (Wednesday, June 22, 2022)]
[House]
[Pages H5795-H5803]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ADVANCED RESEARCH PROJECTS AGENCY-HEALTH ACT
Mr. PALLONE. Mr. Speaker, pursuant to House Resolution 1191, I call
up the bill (H.R. 5585) to establish the Advanced Research Projects
Agency-Health, and for other purposes, and ask for its immediate
consideration in the House.
=========================== NOTE ===========================
June 22, 2022, on page H5795, in the second column, the
following appeared: Mr. PALLONE. Mr. Speaker, pursuant to House
Resolution 1191, I call up the bill (H.R. 5595) to establish the
Advanced Research Projects Agency-Health, and for other purposes,
and ask for its immediate consideration in the House.
The online version has been corrected to read: Mr. PALLONE. Mr.
Speaker, pursuant to House Resolution 1191, I call up the bill
(H.R. 5585) to establish the Advanced Research Projects Agency-
Health, and for other purposes, and ask for its immediate
consideration in the House.
========================= END NOTE =========================
The Clerk read the title of the bill.
The SPEAKER pro tempore (Mr. Carson). Pursuant to House Resolution
1191, the amendment in the nature of a substitute recommended by the
Committee on Energy and Commerce printed in the bill is adopted, and
the bill, as amended, is considered read.
The text of the bill, as amended, is as follows:
H.R. 5585
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advanced Research Projects
Agency-Health Act'' or the ``ARPA-H Act''.
SEC. 2. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.
Title IV of the Public Health Service Act (42 U.S.C. 281 et
seq.) is amended by adding at the end the following:
``PART J--ADVANCED RESEARCH PROJECTS AGENCY-HEALTH
``SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY-HEALTH.
``(a) Establishment.--There is established, as an
independent operating division within the Department of
Health and Human Services, the Advanced Research Projects
Agency-Health (in this part referred to as `ARPA-H'). Not
later than 180 days after the date of enactment of this part,
the Secretary shall transfer all functions, personnel,
missions, activities, authorities, and funds of the Advanced
Research Projects Agency for Health within the National
Institutes of Health, as in existence on the date of
enactment of this part, to ARPA-H established by the
preceding sentence.
``(b) Goals and Methods.--
``(1) Goals.--The goals of ARPA-H shall be to--
``(A) foster the development of new, breakthrough
capabilities, technologies, systems, and platforms to
accelerate innovations in health and medicine that are not
being met by Federal programs or private entities;
``(B) revolutionize detection, diagnosis, mitigation,
prevention, treatment, and curing of serious diseases and
medical conditions through the development of transformative
health technologies;
``(C) promote high-risk, high-reward innovation for the
development and translation of transformative health
technologies; and
``(D) contribute to ensuring the United States maintains--
``(i) global leadership in science and innovation;
``(ii) the highest quality of life and health for its
citizens; and
``(iii) an aggressive agenda for innovations to address
global health threats that place United States citizens at
risk.
``(2) Methods.--ARPA-H shall achieve the goals specified in
paragraph (1) by--
``(A) discovering, identifying, and promoting revolutionary
advances in health sciences;
``(B) translating scientific discoveries into
transformative health technologies;
``(C) providing resources and support to create platform
capabilities that draw on multiple disciplines;
``(D) using researchers in a wide range of disciplines,
including the life sciences, the physical sciences,
engineering, and the computational sciences;
``(E) delivering advanced proofs of concept that
demonstrate potentially clinically meaningful advances;
``(F) developing new capabilities, advanced computational
tools, predictive models, or analytical techniques to
identify potential targets and technological strategies for
early disease detection and intervention;
``(G) accelerating transformational technological advances
in areas with limited technical certainty; and
``(H) prioritizing investments based on such considerations
as--
``(i) scientific opportunity and uniqueness of fit to the
strategies and operating practices of ARPA-H;
``(ii) the effect on disease burden, including unmet
patient need, quality and disparity gaps, and the potential
to preempt progression of serious disease; and
``(iii) the effect on the fiscal liability of the Federal
Government with respect to health care and the ability to
reduce the cost of care through innovation.
``(c) Director.--
``(1) In general.--The President shall appoint with the
advice and consent of the Senate, a director of ARPA-H (in
this part referred to as the `Director').
``(2) Qualifications.--The Director shall be an individual
who, by reason of professional background and experience, is
especially qualified to manage--
[[Page H5796]]
``(A) research and advanced development programs; and
``(B) large-scale, high-risk initiatives with respect to
health research and technology development across multiple
sectors, including generating transformative health
technologies and improving health outcomes for patients.
``(3) Relationship to secretary.--The Director shall report
directly to the Secretary.
``(4) Duties.--The duties of the Director shall include the
following:
``(A) Approve and terminate the projects and programs of
ARPA-H.
``(B) Set research and development priorities with respect
to the goals specified in subsection (b) and manage the
budget of ARPA-H.
``(C) Develop funding criteria and assess the success of
programs through the establishment of technical milestones.
``(D) Advance the goals under subsection (b), through
consideration of the advice of the ARPA-H Interagency
Research Council established under subsection (q).
``(E) Solicit data, as needed, from the National Institutes
of Health and other relevant entities.
``(F) Coordinate with the Director of the National
Institutes of Health to ensure that the programs of ARPA-H
build on, and are informed by, scientific research supported
by the National Institutes of Health.
``(G) Coordinate with the heads of Federal agencies and, to
the extent practicable, ensure that the activities of ARPA-H
supplement (and do not supplant) the efforts of other Federal
agencies.
``(H) Ensure ARPA-H does not provide funding for a project
unless the program manager determines that the project meets
the goals described in subsection (b)(1).
``(5) Term.--The Director--
``(A) shall be appointed for a 5-year term; and
``(B) may be reappointed for 1 consecutive 5-year term.
``(6) Autonomy of agency regarding recommendations and
testimony.--No officer or agency of the United States shall
have any authority to require the Director or any other
officer of ARPA-H to submit legislative recommendations, or
testimony or comments on legislation, to any officer or
agency of the United States for approval, comments, or review
prior to the submission of such recommendations, testimony,
or comments to the Congress, if such recommendations,
testimony, or comments to the Congress include a statement
indicating that the views expressed therein are those of the
Director or such officer, and do not necessarily reflect the
views of the President or another agency.
``(7) Delegation of authority.--The Director may delegate
to any duly authorized employee, representative, or agent any
power vested in the Director by law, except that the Director
may not delegate the power to appoint the Deputy Director
under paragraph (8).
``(8) Deputy director.--The Director shall appoint a deputy
director to serve as the first assistant to the office.
``(d) Application of Paperwork Reduction Act.--The Director
may waive the requirements of subchapter I of chapter 35 of
title 44, United States Code (commonly referred to as the
`Paperwork Reduction Act') with respect to the methods
described in subsection (b)(2).
``(e) Protection of Information.--The following types of
information collected by ARPA-H from recipients of financial
assistance awards shall be considered commercial and
financial information obtained from a person and privileged
or confidential and not subject to disclosure under section
552(b)(4) of title 5, United States Code:
``(1) Plans for commercialization of technologies developed
under the award, including business plans, technology-to
market plans, market studies, and cost and performance
models.
``(2) Investments provided to an awardee from third parties
(such as venture capital firms, hedge funds, and private
equity firms), including amounts and the percentage of
ownership of the awardee provided in return for the
investments.
``(3) Additional financial support that the awardee--
``(A) plans to invest or has invested in the technology
developed under the award; or
``(B) is seeking from third parties.
``(4) Revenue from the licensing or sale of new products or
services resulting from research conducted under the award.
``(f) Sharing Information With the Centers for Medicare &
Medicaid Services.--The Director shall timely share relevant
information with the Administrator of the Centers for
Medicare & Medicaid Services that may help to expedite
determinations of coverage of transformative health
technologies developed by ARPA-H.
``(g) Expediting Breakthroughs Through Cooperation With the
Food and Drug Administration.--
``(1) In general.--The Secretary, acting through the
Commissioner of Food and Drugs and in consultation with the
Director, may take actions to facilitate translation of
transformative health technology into tangible solutions for
patients and to expedite development of drugs, devices, and
biological products, including through--
``(A) helping to ensure that drug, device, or biological
product development programs, in as efficient a manner as
possible, gather the nonclinical and clinical data necessary
to advancing the development of such products and to
obtaining their approval, licensure, or clearance, as
applicable, by the Food and Drug Administration under
sections 505, 510(k), and 515 of the Federal Food, Drug, and
Cosmetic Act and section 351 of this Act;
``(B) expediting review of investigational new drug
applications under section 505(i) of the Federal Food, Drug,
and Cosmetic Act, review of investigational device exemptions
under section 520(g) of such Act, and review of applications
for approval, licensure, and clearance of drugs, devices, or
biological products under sections 505, 510(k), and 515 of
such Act, and section 351 of this Act; and
``(C) meeting at appropriate intervals with the Director
and any member of the ARPA-H Interagency Research Council to
discuss the development status of drugs, devices, or
biological products and projects that are the highest
priorities to ARPA-H, unless the Director and the
Commissioner of Food and Drugs determine that any such
meetings are not necessary.
``(2) Relation to otherwise authorized activities of the
fda.--The authority specified in paragraph (1) shall not be
construed as limiting the authority of the Secretary, acting
through the Commissioner of Food and Drugs, with respect to
the review and approval, clearance, authorization for
emergency use, or licensure of drugs, devices, or biological
products under the Federal Food, Drug, and Cosmetic Act or
section 351 of this Act.
``(3) Reimbursement.--The Director, using funds made
available to ARPA-H, may reimburse the Food and Drug
Administration for expenditures made by the Food and Drug
Administration for activities carried out under this section
that have been identified by the Commissioner of Food and
Drugs and the Director as being carried out by the Food and
Drug Administration.
``(h) Awards.--
``(1) In general.--In carrying out this section, the
Director may make awards including--
``(A) grants and cooperative agreements, which shall--
``(i) be subject to the uniform administrative
requirements, cost principles, and audit requirements for
Federal awards contained in part 200 of title 2, Code of
Federal Regulations (or successor regulations); and
``(ii) include the total line-item and itemized indirect
facilities and administrative costs that shall be made
publicly available and published in a machine-readable
format;
``(B) contracts subject to the Federal Acquisition
Regulation;
``(C) multi-year contracts under section 3903 of title 41,
United States Code;
``(D) prizes; and
``(E) other transactions.
``(2) Exemptions for certain requirements.--Research funded
by ARPA-H shall not be subject to the requirements of section
406(a)(3)(A)(ii) or section 492.
``(i) Facilities Authority.--
``(1) In general.--The Director may acquire (by purchase,
lease, condemnation, or otherwise), construct, improve,
repair, operate, and maintain such real and personal property
as may be necessary to carry out this section.
``(2) Lease of nonexcess property.--The Director may enter
into a lease under this section with any person or entity
(including another department or agency of the Federal
Government or an entity of a State or local government) with
regard to any nonexcess real property and related personal
property under the jurisdiction of the Director.
``(3) Utilization of lease funds.--
``(A) In general.--The Director may utilize, without
further appropriation, amounts of cash consideration received
for a lease entered into under this subsection to cover the
full costs to ARPA-H in connection with the lease. Funds
received as such cash consideration shall remain available
until expended.
``(B) Capital revitalization and improvements.--Of any
amounts of cash consideration received under this subsection
that are not utilized in accordance with subparagraph (A),
without further appropriation--
``(i) 35 percent shall--
``(I) be deposited in a capital asset account to be
established by the Director;
``(II) be available for maintenance, capital
revitalization, and improvements of the real property assets
and related personal property under the jurisdiction of the
Director; and
``(III) remain available until expended; and
``(ii) the remaining 65 percent shall be available to the
respective center or facility of ARPA-H engaged in the lease
of nonexcess real property, and shall remain available until
expended for maintenance, capital revitalization, and
improvements of the real property assets and related personal
property at the respective center or facility subject to the
concurrence of the Director.
``(C) No utilization for daily operating costs.--Amounts
utilized under subparagraph (B) may not be utilized for daily
operating costs.
``(4) Locations.--
``(A) In general.--ARPA-H, including its headquarters,
shall not be located on any part of the existing National
Institutes of Health campuses.
``(B) Considerations.--In determining the location of
facilities, the Director shall make a fair and open
consideration of--
``(i) the characteristics of the intended location; and
``(ii) the extent to which such location will facilitate
advancement of the goals and methods specified in subsection
(b).
``(j) Personnel.--
``(1) In general.--The Director may--
``(A) make and rescind appointments of scientific,
engineering, medical, and professional personnel, which may
include temporary or time-limited appointments as determined
by the Director to fulfill the mission of ARPA-H, without
regard to any provision in title 5, United States Code,
governing appointments and removals under the civil service
laws, and fix the base pay compensation of such personnel at
a rate to be determined by the Director, up to the amount of
annual compensation (excluding expenses) specified in section
102 of title 3, United States Code; and
``(B) contract with private recruiting firms for the hiring
of qualified staff referenced in subparagraph (A).
[[Page H5797]]
``(2) Additional staff.--The Director may use, to the same
extent and in the same manner as the Secretary, all
authorities in existence on the date of the enactment of this
section that are provided to the Secretary to hire
administrative, financial, contracts, legislative affairs,
information technology, ethics, and communications staff, and
such other staff as may be identified by the Director as
necessary to carry out this section.
``(3) Additional considerations.--In appointing personnel
under this subsection, the Director--
``(A) may contract with private entities;
``(B) shall make efforts to recruit and retain a diverse
workforce, including individuals underrepresented in science
and medicine and racial and ethnic minorities (as long as
such efforts comply with applicable Federal civil rights
law); and
``(C) shall recruit program managers with expertise in a
wide range of relevant disciplines, including life sciences,
the physical sciences, engineering, and the computational
sciences.
``(4) Additional hiring authority.--To the extent needed to
carry out the authorities vested by paragraph (1), the
Director may utilize hiring authorities under sections 3371
through 3376 of title 5, United States Code, to staff ARPA-H
with employees from other Federal agencies, State and local
governments, Indian Tribes and Tribal organizations,
institutions of higher education, and other organizations, as
described in such sections.
``(5) Existing authorities.--The authorities granted by
this section are--
``(A) in addition to existing authorities granted to the
Secretary; and
``(B) are not intended to supersede or modify any existing
authorities.
``(6) Authority to accept federal detailees.--The Director
may accept officers or employees of the United States or
members of the uniformed service on a detail from an element
of the Federal Government on a reimbursable or a
nonreimbursable basis, as jointly agreed to by the heads of
the receiving and detailing elements, for a period not to
exceed 3 years.
``(k) Program Managers.--
``(1) In general.--The Director shall appoint program
managers for 3-year terms (and may reappoint such program
managers for 1 consecutive 3-year term) for the programs
carried out by ARPA-H.
``(2) Duties.--A program manager shall--
``(A) establish, in consultation with the Director or
Deputy Director, research and development goals for programs,
including timelines and milestones, and make such goals
available to the public;
``(B) collaborate with experts from the National Institutes
of Health and other Federal agencies and experts in relevant
scientific fields to identify research and development gaps
and opportunities;
``(C) convene workshops and meetings, as needed, with
entities such as patients, patient advocacy groups,
practitioners, professional societies, and other stakeholders
to solicit input on programs and goals;
``(D) manage applications and proposals, through the
appropriate officials for making grants, cooperative
agreements, contracts, prizes, and other transaction awards
for advanced research that may show particular promise,
especially in areas in which the private sector and the
Federal Government have not undertaken sufficient research;
``(E) issue funding opportunity announcements, using
uniform administrative processes, as appropriate;
``(F) select, on the basis of merit, each of the projects
to be supported under a program carried out by ARPA-H, and
taking into consideration--
``(i) the scientific and technical merit of the proposed
project;
``(ii) the capabilities of the applicants to successfully
carry out the proposed project;
``(iii) the unmet needs or ability to improve health
outcomes within patient populations;
``(iv) future commercial applications of the project or the
feasibility of partnering with one or more commercial
entities;
``(v) the potential for interdisciplinarity of the approach
of the project; and
``(vi) such other criteria as established by the Director;
``(G) conduct project reviews within 18 months of funding
awards to identify milestones and monitor progress of such
milestones with respect to each project and prior to
disbursement of new funds;
``(H) provide recommendations to the Director with respect
to advancing the goals specified in subsection (b);
``(I) cultivate opportunities for the commercial
application or community use of successful projects,
including through the establishment of partnerships between
or among awardees;
``(J) identify innovative cost-sharing arrangements for
ARPA-H projects;
``(K) provide recommendations to expand, restructure, or
terminate research partnerships or projects; and
``(L) ensure that--
``(i) animal studies meet the Federal animal research
requirements pursuant of the Public Health Service Policy on
Humane Care and Use of Laboratory Animals; and
``(ii) applications apply statistical modeling approaches
and appropriately justify animal sample sizes to meet project
goals.
``(l) Reports and Evaluation.--
``(1) Annual report.--
``(A) In general.--Beginning not later than 1 year after
the date of enactment of this section, and each fiscal year
thereafter, the Director shall submit a report on the actions
undertaken, and results generated, by ARPA-H, including--
``(i) a description of projects supported by ARPA-H in the
previous fiscal year and whether such projects are meeting
the goals developed by the Director pursuant to subsection
(c)(4)(C);
``(ii) a description of projects terminated in the previous
fiscal year, and the reason for such termination;
``(iii) a description of programs starting in the next
fiscal year, as available;
``(iv) activities conducted in coordination with other
Federal agencies;
``(v) an analysis of the extent of coordination conducted
pursuant to subsections (c)(4)(F) and (f), including
successes and barriers with respect to achieving the goals
under subsection (b);
``(vi) a description of the demographic (including racial
and gender) diversity if available of direct recipients and
performers in funded projects and of the ARPA-H workforce;
and
``(vii) a disclosure by the reward recipients of whether
the principal investigators named on the award participate in
foreign talent programs, including the provision of copies of
all grants, contracts, or other agreements related to such
programs, and other supporting documentation related to such
programs, as a condition of receipt of Federal extramural
biomedical research funding awarded.
``(B) Submission to congress.--The report under
subparagraph (A) shall be submitted to--
``(i) the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives;
and
``(ii) the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate.
``(2) Evaluation.--
``(A) In general.--Not later than 5 years after the date of
the enactment of this section, the Secretary shall enter into
an agreement with the National Academies of Sciences,
Engineering, and Medicine under which the National Academies
agree to study and evaluate whether ARPA-H is meeting the
goals specified in subsection (b).
``(B) Submission of results.--The agreement entered into
under subparagraph (A) shall require the National Academies
of Sciences, Engineering, and Medicine to submit the results
of the evaluation conducted under such agreement to the
Secretary, the Committee on Energy and Commerce of the House
of Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate.
``(m) Strategic Plan.--Not later than 1 year after the date
of the enactment of this section, and every 3 years
thereafter, the Director shall provide to the relevant
committees of Congress a strategic plan describing how ARPA-H
will carry out investments each fiscal year in the following
3-year period.
``(n) Independent Review.--Not later than 1 year after the
date of the enactment of this section, and every 3 years
thereafter, the Comptroller General of the United States
shall conduct an independent review of the research portfolio
of the Department of Health and Human Services, including
ARPA-H, the National Institutes of Health, the Food and Drug
Administration, and the Biomedical Advanced Research and
Development Authority--
``(1) to assess the degree of unnecessary duplication of
existing Federal programs and projects; and
``(2) to make recommendations regarding any potential
reorganization, consolidation, or termination of such
programs and projects.
``(o) Prioritization.--The Director shall--
``(1) prioritize awarding grants, cooperative agreements,
contracts, prizes, and other transaction awards to domestic
recipients conducting the research on transformative health
technology in the United States;
``(2) as appropriate and practicable, ensure that
nondomestic recipients of any grants, cooperative agreements,
contracts, prizes, and other transactions under this section
are conducting research in collaboration with a domestic
recipient;
``(3) not award any grants, cooperative agreements,
contracts, prizes, and other transactions to nondomestic
recipients subject to malign foreign influence or organized
under the laws of a malign foreign country; and
``(4) in accordance with the requirements of chapter 33 of
title 41, United States Code, and the Federal Acquisition
Regulation, only award grants, cooperative agreements,
contracts, prizes, and other transactions to individual
persons that do not have more than 3 ongoing concurrent
grants, cooperative agreements, contracts, prizes, and other
transactions under this section.
``(p) Additional Consultation.--In carrying out this
section, the Director may consult with--
``(1) the President's Council of Advisors on Science and
Technology;
``(2) peers in the scientific community, including academia
and industry;
``(3) an existing advisory committee providing advice to
the Secretary or the head of any operating or staff division
of the Department;
``(4) a new interagency research council organized to
support the programs of ARPA-H and to provide advice and
assistance on--
``(A) specific program tasks; or
``(B) the overall direction of ARPA-H; and
``(5) any other entity the Director may deem appropriate.
``(q) ARPA-H Interagency Research Council.--
``(1) In general.--The Director shall establish an
interagency advisory committee to be known as the ARPA-H
Interagency Research Council (referred to in this subsection
as the `Research Council').
``(2) Membership.--The Research Council may include any or
all of the following members, or designees:
``(A) The Director of the National Institutes of Health.
``(B) The Director of National Center for Advancing
Translational Sciences.
[[Page H5798]]
``(C) The Director of Office of Science and Technology
Policy.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the Biomedical Advanced Research and
Development Authority.
``(F) The Director of the Centers for Disease Control and
Prevention.
``(G) The Administrator of the Centers for Medicare &
Medicaid Services.
``(H) The Director of the Agency for Healthcare Research
and Quality.
``(I) The Director of the Office of Minority Health.
``(J) The Administrator of the Health Resources and
Services Administration.
``(K) The Director of the Defense Advanced Research
Projects Agency.
``(L) The Director of the National Science Foundation.
``(M) The Director of the Office of Science of the
Department of Energy.
``(N) The Director of the Advanced Research Projects
Agency-Energy.
``(O) The Assistant Secretary for Preparedness and
Response.
``(P) Representatives of any Federal agency with subject
matter expertise that the Director determines is necessary
for the successful completion of a project carried out
pursuant to this section.
``(Q) Any other entity the Director may deem appropriate.
``(3) Duties.--The Research Council shall advise the
Director, including by--
``(A) making recommendations on--
``(i) research priorities that will provide the greatest
return on investment with respect to improving human health;
``(ii) avoiding duplication of efforts in the Federal
Government; and
``(iii) improving coordination with other Federal agencies;
and
``(B) identifying and developing strategies to address
regulatory, reimbursement, and market barriers to
commercialization or adoption of transformative health
technologies, including technologies intended to preempt
serious disease.
``(4) Advisory nature.--The function of the Research
Council shall be advisory in nature. Nothing in this
subsection shall be construed as granting the Research
Council authority over any activities or functions of ARPA-H.
``(5) Meetings.--Not later than 1 year after the date of
the enactment of this section, and every fiscal year
thereafter, the Director shall convene meetings of the
Research Council, including conferences or workshops, as
needed. The Research Council may function through established
or ad hoc committees, task forces, or interagency groups to--
``(A) share information on health innovations funded by
ARPA-H; and
``(B) receive input on areas of particular promise for
ARPA-H projects.
``(r) Technology Transfer Office.--The Director may
establish within ARPA-H an Office of Technology Transfer to
facilitate, where appropriate, the transfer of federally-
owned or federally-originated technology to recipients of an
award under this section (other than Federal Government
entities).
``(s) Follow-on Production Award Authority.--
``(1) In general.--An other transaction entered into by the
Director under subsection (h)(1) for a project may provide
for the award of a follow-on production contract or
transaction to the participants in the transaction by ARPA-H
or another Federal agency. For purposes of this paragraph,
such an other transaction includes all individual subprojects
awarded under the transaction to a consortium of United
States industry and academic institutions.
``(2) Relation to competitive procedures.--A follow-on
production contract or transaction under paragraph (1) may be
awarded to the participants in the transaction without the
use of competitive procedures (as defined in section 152 of
title 41, United States Code), notwithstanding the
requirements of division C of subtitle I of such title 41,
if--
``(A) competitive procedures were used for the selection of
parties for participation in the other transaction; and
``(B) the participants in the other transaction
successfully completed the project provided for in the
transaction.
``(3) Precondition.--A follow-on production contract or
transaction may be awarded pursuant to this subsection when
the Director determines that an individual project or
subproject as part of a consortium is successfully completed
by the participants.
``(4) Clarification.--Award of a follow-on production
contract or transaction pursuant to this subsection shall not
be made contingent upon the successful completion of all
activities within a consortium as a condition for an award
for follow-on production of a successfully completed project
or subproject within that consortium.
``(5) Other authorities.--Contracts and transactions
entered into by ARPA-H pursuant to this subsection may be
awarded pursuant to division C of subtitle I of title 41,
United States Code, or under such procedures, terms, and
conditions as the Director or head of such agency may
establish by regulation.
``(t) Rule of Construction.--The authorities under this
section, with respect to the Director, are additional
authorities that do not supersede or modify any existing
authorities.
``(u) Definitions.--In this part:
``(1) Advanced proofs of concept.--The term `advanced
proofs of concept' means data, a prototype, or other
experimental evidence that--
``(A) may precede the development of transformative health
technologies; and
``(B) demonstrates the feasibility of a new concept.
``(2) Biological product.--The term `biological product'
has the meaning given such term in section 351(i).
``(3) Department.--The term `Department' means the
Department of Health and Human Services.
``(4) Drug; device.--The terms `drug' and `device' have the
meanings given such terms in section 201 of the Federal Food,
Drug, and Cosmetic Act.
``(5) Federal acquisition regulation.--The term `Federal
Acquisition Regulation' means the Federal Acquisition
Regulation issued pursuant to section 1303(a)(1) of title 41,
United States Code.
``(6) Federal agency.--The term `Federal agency' has the
meaning given such term in section 3371 of title 5, United
States Code.
``(7) Prize.--The term `prize' means a prize as such term
is used in section 24 of the Stevenson-Wydler Technology
Innovation Act of 1980.
``(8) Transformative health technology.--The term
`transformative health technology' means a drug, biological
product, intervention, platform, tool, or device--
``(A) that should be prioritized to detect, diagnose,
mitigate, prevent, cure, or treat a serious disease or
medical condition for which there are unmet needs; and
``(B) for which--
``(i) significant scientific uncertainty and regulatory
risk exist; or
``(ii) incentives in the commercial market are unlikely to
result in the adequate or timely development of such drug,
biological product, intervention, platform, tool, or device.
``(v) Authorization of Appropriations.--There is authorized
to be appropriated $500,000,000 for each of fiscal years 2023
through 2027, to remain available until expended.''.
The SPEAKER pro tempore. The bill, as amended, shall be debatable for
1 hour equally divided and controlled by the Chair and ranking minority
member of the Committee on Energy and Commerce or their respective
designees.
After 1 hour of debate, it shall be in order to consider the further
amendment printed in part C of House Report 117-381, if offered by the
Member designated in the report, which shall be considered read, shall
be separately debatable for the time specified in the report equally
divided and controlled by the proponent and an opponent, and shall not
be subject to a demand for a division of the question.
The gentleman from New Jersey (Mr. Pallone), and the gentleman from
Kentucky (Mr. Guthrie), each will control 30 minutes.
The Chair recognizes the gentleman from New Jersey (Mr. Pallone).
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include any extraneous material on H.R. 5585.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise to speak in support of H.R. 5585, the Advance
Research Projects Agency-Health Act, or ARPA-H Act.
In February, the Energy and Commerce Committee's Health Subcommittee
held a hearing to discuss the Biden administration's proposal to
establish the Advance Research Projects Agency for Health, better known
as ARPA-H.
The agency is modeled after the Defense Advanced Research Projects
Agency, or DARPA. The mission of ARPA-H is to translate fundamental
biomedical research into breakthrough platform technologies that would
change healthcare as we know it.
ARPA-H would focus on the highest-risk, highest-reward issues in
disease research. It will attempt to solve the problems that the
private and public sectors have not been able to conquer. The
expectations we have for this agency are justifiably high.
Our hope is that within 5 years of operations, ARPA-H will have led
to the development of cutting-edge treatments and cures for cancer,
diabetes, autoimmune disorders, and mental health conditions.
In order to be truly successful, we must ensure that all Americans
have access to these innovations. Equity and promoting the health of
all Americans must also be part of ARPA-H's mission.
The fiscal year 2022 omnibus appropriations law provided the
Department of Health and Human Services with $1 billion to get ARPA-H
off the ground. We must now provide the necessary and appropriate
authorities to make ARPA-H successful, to clarify its mission and its
organizational structure,
[[Page H5799]]
and ensure that the work at ARPA-H is not duplicative or redundant.
H.R. 5585 does just that.
ARPA-H will be led by a director and cadre of program managers with
the autonomy and authority to develop high-risk, high-reward
portfolios. This will be coupled with the appropriate contracting,
hiring, and procurement authorities that will pull from the best minds
and resources in the biomedical research ecosystem.
This legislation authorizes $500 million annually for 5 fiscal years.
ARPA-H projects will be time- and milestone-limited, ensuring that each
project delivers real and measurable results. The ARPA-H Act includes
reporting requirements to ensure proper compliance and avoid the
redundancy. The director will be required to submit reports on the
actions, results, and forthcoming strategic plans of ARPA-H to Congress
so that we can confirm that the agency is meeting our intent.
So last month, the Committee on Energy and Commerce advanced H.R.
5585 by an overwhelming bipartisan vote of 55-3. This was a tremendous
achievement and demonstrates Congress' ability to come together and
find solutions that will improve the health of all Americans.
I thank Health Subcommittee Chairwoman Eshoo, who is the author of
this legislation, along with Health Subcommittee Ranking Member
Guthrie, our full committee Ranking Member Rodgers, and also
Representatives DeGette and Upton for their work on this important
bill.
Mr. Speaker, I strongly urge my colleagues to support H.R. 5585, and
I reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise to speak in support of the Advanced Research
Projects Agency-Health Act, or ARPA-H Act. I know this has been an
important priority for researchers, industry, and, most importantly,
patients who are waiting for life-changing medical technology to
improve or even save their lives.
This legislation will authorize the establishment of ARPA-H within
the U.S. Department of Health and Human Services. The agency will
specifically be charged with helping to foster high-risk, high-reward
treatments and cures for diseases with clinically unmet needs.
Some of my colleagues may be concerned about a new agency, and that
is where a number of Republicans on the Committee on Energy and
Commerce were early in October when this legislation was introduced.
ARPA-H was funded at $1 billion in the previous appropriations bill
in 2021. To ensure that funding was used for the best possible result,
the Committee on Energy and Commerce for the past several months has
worked hard to ensure that ARPA-H has a clear mission. As a result, it
passed out of committee with a strong 55-to-3 vote.
{time} 1615
We most notably ensure this newly created agency remains separate
from the NIH. We limit administration costs associated with setting up
ARPA-H to maximize research investments, which would require a
strategic plan and transparent reporting on projects; define the number
of offices; and require that the majority of offices within the
organization be exclusively devoted to biomedical research and
development.
In order to ensure this agency is fostering the development of
innovative, transformative health technologies that are not being met
by Federal programs or private industry, the technologies the agency
should pursue are very explicitly defined in the legislation before us
today.
The legislation puts guardrails in place to ensure that priority
access is granted to U.S. researchers over researchers abroad. There
are additional requirements for international researchers to work in
collaboration with a U.S. counterpart if they receive ARPA-H funding.
Importantly, the bill makes clear that funding is prohibited from
going to nondomestic recipients of a malign foreign country, most
notably Chinese research labs or Russian research labs. This is a
significant step to ensure the United States' intellectual property
isn't being stolen by our adversaries and to ensure we remain the world
leader in biomedical research and innovation.
As the Republican leader on the Health Subcommittee, I am leading
efforts to strengthen oversight of NIH-funded research. It is
unacceptable that some Federal grants have been supporting foreign
researchers with ties to governments of adversarial nations like China.
We must prevent this from happening moving forward.
Mr. Speaker, I emphasize the need to pass this bill. The funding has
already been appropriated in a previous year. If we don't pass this
bill and don't authorize this agency to move forward, then this will
erode our oversight role in Congress. Funding decisions made by ARPA-H
must require diligence to ensure that resources are being spent as
appropriately and as effectively as possible.
The Biden administration ARPA-H organizational chart, without this
bill, has 14 offices, less than half of which are actually dedicated to
research. This gives us insight into how the Biden administration would
manage this new agency without congressional guidance. It is just
appropriate that the legislative branch sets up the way this money is
being spent.
That is what the bill before us today does. It puts ARPA-H on the
right track, gives Congress the opportunity to set high standards, and
promotes greater biomedical research and innovation for patients.
Mr. Speaker, I thank the majority for working together. I thank our
staff for the excellent work they have done. I encourage the passage of
this because if we don't pass it, the money is still going to be spent
but without congressional guardrails.
Mr. Speaker, I support this bill, and I reserve the balance of my
time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
California (Ms. Eshoo), the Health Subcommittee chair and the author of
this legislation.
Ms. ESHOO. Mr. Speaker, I thank the chairman of the full committee
for his full support of this legislation from the very beginning.
Mr. Speaker, this has been somewhat of a long journey. It began in
March of last year, 2021, when a group of Members, bipartisan and
bicameral, were invited to the White House to meet with President
Biden. When we gathered there, he spoke about his vision for creating
ARPA-H, an advanced research project for health.
It is modeled after DARPA, the highly innovative and successful small
agency that was created many years ago. I think one of its chief assets
is its autonomy, and its successes are extraordinary because of the way
it is shaped. They have produced the internet, GPS navigation, and
Moderna's mRNA vaccines.
This bill is shaped to maximize the promise of ARPA-H.
All of us have a relative or someone in our family, extended family,
and our communities that when receiving a diagnosis, it is a death
sentence. That is what the mission of ARPA-H is directed to address. I
have full confidence that, the way this legislation is shaped, it can
meet that challenge.
It will be a place where highly innovative ideas are tested, and if
the approaches fail because these are high-risk undertakings, then the
agency will quickly move on to new ones and redirect the money. It will
be flat and small like DARPA, but it has a mighty mission.
Mr. Speaker, I thank all the members of the Energy and Commerce
Committee on the majority and the minority side. We have really worked
hard together on this to shape something that is worthy of the American
people and has the ability to produce. From the chairman of the full
committee to the ranking member, Mrs. McMorris Rodgers, to the ranking
member of the subcommittee, Mr. Guthrie, ideas kept coming forward. We
polished them, added them to the legislation, and, in some instances,
dropped other parts of the draft.
Mr. Speaker, I acknowledge the work of my staffer, Aisling McDonough,
who has given her all on this; the staff of the committee; the
scientists, because well over 100 of them leaned in and gave us their
ideas and advice on how best to create a small agency that would be
nimble but highly effective; and the patient advocates. So many of them
have cheered us on and given us their best input, as well.
Today is the day. The House is poised. I urge all of my colleagues to
[[Page H5800]]
support this because when this mission is executed, I think even if one
deadly disease is addressed and cured, we will have succeeded. I think
we are going to do better than that.
Mr. GUTHRIE. Mr. Speaker, I yield 5 minutes to the gentlewoman from
Washington (Mrs. Rodgers), who is the Republican leader of the full
committee.
Mrs. RODGERS of Washington. Mr. Speaker, America is the envy of the
world for our leadership in biomedical innovation. People from all over
the world have an incredible amount of hope in the promise of our
lifesaving, breakthrough research for more cures and treatments.
That is why I have been a longtime supporter of NIH and projects like
the BRAIN Initiative intended to speed scientific research necessary to
accelerate cures for neurologic diseases.
When the concept of ARPA-H was first proposed to me, I expressed a
healthy dose of skepticism.
First, I was concerned about a clear and targeted strategic mission.
I was concerned an unfocused agenda would not be a recipe for success.
The second was the issue of duplication. The Federal Government has
several agencies that advance biomedical innovation. Within the
National Institutes of Health alone, we already have the National
Center for Advancing Translational Science, the Cures Acceleration
Network, the Common Fund, and the Foundation for NIH's Accelerating
Medicines Partnership Program, to name a few.
Third, I was concerned that the creation of a new agency would lack
sufficient transparency and oversight. My questions to supporters of
ARPA-H included:
How will projects be selected?
How will the public be kept informed of projects and project funding?
Who will be assessing for duplication of Federal programs, and how
will it be managed?
What measure will be used to define success?
What are the guardrails to ensure that we are supporting American
innovators?
These concerns were validated earlier this year when the
administration began implementing the $1 billion that was appropriated
to set up ARPA-H with little to no congressional direction. The Biden
administration proposed 14 offices within ARPA-H. DARPA has six to
eight. They also placed ARPA-H within NIH, which has its own issues in
lacking transparency and accountability related to federally funded
research and the origins of COVID-19.
We needed to ensure proper oversight and provide guardrails through
congressional direction, so we plowed the hard ground necessary to
legislate through the Energy and Commerce Committee. Chairman Frank
Pallone and Health Subcommittee Chairwoman Anna Eshoo listened to my
concerns. We had very productive negotiations to properly define ARPA-
H's mission and place strong safeguards for transparency and
accountability.
This bill defines ARPA-H's mission so that it is laser-focused on
high-risk breakthrough technologies in health and medicine that are not
being addressed by the private sector or current Federal programs.
This bill also prohibits Federal funding to China, Russia, and other
recipients subject to malign foreign influence.
It moves the agency back outside of NIH.
We are also making sure ARPA-H sets the right priorities. The
director must provide Congress with a strategic plan within 1 year of
enactment and every 3 years on how ARPA-H will carry out projects.
Projects will be evaluated every 18 months, and those not meeting
milestones are expected to be terminated.
We placed guardrails on ARPA-H to prioritize projects that provide
the greatest return on investment to improve human health and lower
healthcare costs.
This bill also keeps the focus on lifesaving research. The director
will have the power to hire and make appointments based on merit and
expertise, not based on provisions that reward government bureaucrats.
We require those who receive ARPA-H funding to provide a public
itemized report on indirect facilities and administrative costs.
To further cut down on duplication and mission creep, we limited the
number of offices to 6, not the 14 proposed by the administration. Of
those offices, at least four must be exclusively focused on R&D. In
addition, not more than 15 percent of the total agency funding is
allowed to go to administrative costs.
Mr. Speaker, I will close by thanking my colleagues for working
together on this. I especially recognize the leadership of Chairman
Pallone, Health Subcommittee Chairwoman Eshoo, Health Subcommittee
Republican leader Brett Guthrie, as well as the 21st Century Cures
leaders Fred Upton and Diana DeGette.
I am pleased we were able to come together. We put ARPA-H on the
right path with a targeted mission, increased accountability and
transparency, and a laser focus on promoting American innovators. It is
a strong example of E&C's bipartisan record of success in moving
legislation that will continue America's global leadership in
biomedical research.
Mr. Speaker, before I close, I want to applaud and thank the members
of my team: Grace Graham, Kristen Shatynski, Seth Gold, Kristin Flukey,
and Kristin Ashford.
They say that Energy and Commerce has the best staff on the Hill, and
that is certainly evident through their service to deliver hope and
healing, both through this bill and through the package just before us
with the mental health package. At every step of the way, I am grateful
for their hard work and passion.
Mr. Speaker, I urge a ``yes'' vote on H.R. 5585, the Advanced
Research Projects Agency-Health Act.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. DeGette), the chair of our Energy and Commerce Oversight
and Investigations Subcommittee who has also worked on ARPA-H in the
very beginning.
Ms. DeGETTE. Mr. Speaker, I am so honored to stand here today in
support of this legislation, which will revolutionize how our Nation
researches and develops new cures and treatments for some of the
world's most difficult diseases.
There is not a person in this room or in this Capitol who hasn't been
impacted in some way by a devastating disease--cancer, Alzheimer's, or
something else. These diseases don't care if you are a Democrat or a
Republican. They affect all of us. It needs to be our collective
mission to cure all of them immediately.
The ripple effect that they have on our communities is immeasurable.
The pain and suffering that they cause, not just to those who become
ill but to their families, friends, and loved ones, is irreparable.
They place significant strain on our public health systems and
significant strain on our economy.
For years, scientists and researchers, both here in the U.S. and
around the world, have been searching for ways to prevent and treat
these devastating illnesses.
{time} 1630
I see my friend and colleague Fred Upton here on the floor with us
today. Fred and I worked on the 21st Century Cures bill in 2016 which
has revolutionized the way we do a lot of this discovery and
development. But what we need more of now is an all-hands-on-deck
approach to end these illnesses, and that is exactly why this
legislation was developed.
As Ms. Eshoo, Mr. Pallone, and others said, it will create a new
Advanced Research Projects Agency for Health, ARPA-H, which will bring
together some of the world's greatest minds and give them access to the
Federal Government's seemingly unlimited resources to make the
impossible possible.
Mr. Speaker, modeled after the DARPA program, as you heard, the new
agency will be lean and it will be mean. It will be targeted at
specifically researching and finding cures for some of the most
intractable diseases that we have.
It is going to be run by a small number of program managers, and it
will be able to take on the high-risk, high-reward projects that others
simply cannot. It will not substitute for the basic research at the NIH
or the research at our great universities or in private
[[Page H5801]]
business. It will supplement it by targeting these tough issues, and it
will reshape the future of biomedical research in this country for
many, many years to come.
As I said, this legislation is an opportunity. It is an opportunity
to put our country on track to ending cancer as we know it. It is an
opportunity to save millions of lives. If we cure cancer, and if we
save lives and improve the health and well-being of our constituents,
isn't that what we came here for?
Mr. Speaker, I urge everyone to vote ``yes.''
Mr. GUTHRIE. Mr. Speaker, as the chair of this committee, Mr. Upton
made his signature issue the 21st Century Cures, and not just passing
that which has changed people's lives already but being able to work
with Ms. DeGette and all the others to say that this is something we
all need to work on together in a bipartisan way and make a big
difference.
Now as chair emeritus, this is, I think, his signature piece. He may
have other pieces of legislation, too, but this is the one that I have
worked on with him in the very beginning in the Oval Office with the
President. We worked together to say: Can we do something big that is
really going to change the lives of people in this country?
He has done it. He has done it his entire career. He is a mentor of
mine, and, unfortunately, at the end of this year he is going to do
something different than being here in Congress. He will be missed for
his voice and being a champion of this issue.
Mr. Speaker, I am going to yield to him so that he can speak on this
bill for himself. The gentleman certainly has left a legacy here with
the previous legislation and this piece of legislation. So let's work
together to move it forward.
Mr. Speaker, I yield 3 minutes to the gentleman from Michigan (Mr.
Upton).
Mr. UPTON. Mr. Speaker, I thank my very good friend, and I certainly
appreciate his kind words. The good news is I am not done yet. We have
a lot of work to do, and this is yet one more piece that we are going
to be driving forward. But, certainly, I rise in support of this
legislation, the ARPA-H authorization bill.
While I have been a longtime supporter of many different versions of
this bill, I thank, in particular, Chairman Pallone, my Republican
Leader Rodgers, certainly Anna Eshoo--who is my good friend--and Brett
Guthrie for their leadership on working together on language with the
goal of really making this issue bipartisan and one that is going to
work.
I am glad that we came together to add even more important guardrails
to ensure that this bill, ARPA-H, works as it was intended as well as,
hopefully, have a very strong bipartisan vote a little bit later this
afternoon.
This bill is going to establish an entity not unlike the Defense
Advanced Research Projects entity--that was our goal--DARPA. It is
going to be game-changing, health research. Like DARPA, this entity is
going to be focused on producing research on things that, frankly, may
be too risky for the private sector. It is going to move at a faster
pace than the current structure. There may be a high failure rate, but
its successes are going to have the potential to be absolutely
groundbreaking, answering the prayers of millions.
It really is a follow-up to what we did in this body with the 21st
Century Cures with the Upton and DeGette effort that passed our
committee 53-0, then passed here on the House floor 392-26.
There has been a lot of debate on where ARPA-H is going to be housed.
Should it be in NIH?
Should it be in HHS or someplace else?
Wherever this entity is finally located, we need to make sure that it
is lean, that it is independent and nimble, and that there are the
appropriate guardrails to keep other agencies from mission creep and
siphoning that funding. The legislation that was introduced did a very
good job of that and I am pleased to see that these protections were
strengthened in the final product that we are going to be voting on
this afternoon.
My partner in 21st Century Cures, Diana DeGette, and really everybody
on our committee were happy to include language for ARPA-H in our Cures
2.0 bill that we introduced more than a year ago. We thought that it
was a great follow-up to the work that we did to enhance basic research
on the first Cures bill which added $45 billion--paid for--in
additional health research.
Funding for the NIH and the FDA included many important things such
as the Cancer Moonshot and the Brain Initiative.
We are still in a pandemic. We have awful diseases that need cures,
whether it be cancer, Alzheimer's, lupus, or diabetes that strike
literally every single family.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. GUTHRIE. Mr. Speaker, I yield the gentleman from Michigan an
additional 1 minute.
Mr. UPTON. This bill, ARPA-H, can provide the breakthroughs necessary
to find cures for those diseases. The President has already signed $1
billion for this program into law. So what we need now is bipartisan
authorization to complete the work. This bill certainly accomplishes
that goal.
Mr. Speaker, I urge all of my colleagues, like we did before, to vote
for this bill a little bit later this afternoon. Again, I just want to
commend our great staff. As our leader, Congresswoman Rodgers, said: We
have the best staff there is.
Is there any objection to that?
Hearing none--sorry, Ways and Means; sorry appropriators.
We do. We are the Energy and Commerce Committee, and we are going to
find a cure for these diseases. This bill is a step in that direction.
Mr. GUTHRIE. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I must say that for many years we had a
Congressman Brown on the committee who contributed a lot, particularly
on healthcare issues. He chaired the Health Subcommittee. So it is an
honor to hear from Ms. Brown of Ohio. We have another Congresswoman
Brown from Ohio.
Mr. Speaker, I yield 3 minutes to the gentlewoman from Ohio (Ms.
Brown).
Ms. BROWN of Ohio. Mr. Speaker, I thank Chairman Pallone for
yielding, and I thank Congresswoman Eshoo for her leadership on this
bill.
I applaud President Biden for having the foresight to propose the
creation of an Advanced Research Projects Agency for Health, also known
as ARPA-H, an agency tasked with driving breakthroughs in cancer,
diabetes, Alzheimer's, and other difficult diseases.
The new science moonshot agency is modeled on the successes of the
Defense Advanced Research Projects Agency, also known as DARPA. For
decades DARPA has driven advances in technologies that have changed our
lives for the better. Yet, there are so many things that we take for
granted, things like the internet and flat-screen displays. I am
confident the same will be true for ARPA-H as it seeks to accelerate
advancements in health and medicine. Thanks to President Biden's
leadership, my colleagues in Congress funded ARPA-H in March for the
current fiscal year.
Yet in order to successfully carry out its mission, ARPA-H needs
long-term resources and authorities. That is exactly what this bill
does. The ARPA-H legislation would authorize the agency for 5 years and
create the structure it needs to successfully drive breakthroughs that
would otherwise die in the commercial market.
Yet ARPA-H not only needs long-term funding but also a long-term
home. ARPA-H's mission is centered around high-risk, high-reward
research, which is a charge that Cleveland has historically proven it
is prepared to lead. With world-class healthcare systems, top-tier
institutions of higher education, advanced biomedical companies, and a
highly skilled manufacturing workforce, Cleveland has a long track
record of bringing cutting-edge innovations from discovery all the way
to production. This includes groundbreaking medical advancements like
the first face transplant in America as well as the region's cutting-
edge cancer research.
Now, wherever the agency lands, it will have a meaningful impact on
the lives of Americans nationwide for generations to come. Creating
ARPA-H with 1 year of funding was a good first step, but it is time to
put this new breakthrough agency on firm footing
[[Page H5802]]
and in a firm location so we can truly start to revolutionize how we
prevent, treat, and cure a range of diseases.
Mr. Speaker, I thank Chairman Pallone again for his leadership, and I
urge my colleagues to support the bill.
Mr. GUTHRIE. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
Massachusetts (Mr. Auchincloss), who is also very much involved in
healthcare issues with regard to the pharmaceutical industry and so
many other health issues.
Mr. AUCHINCLOSS. Mr. Speaker, I strongly support Chairwoman Eshoo's
bill to create an Advanced Research Projects Agency. This bill will
ensure that ARPA-H can address the limitations of commercial markets
and tackle high-risk, high-reward biomedical research in oncology,
neuroscience, diabetes, artificial intelligence, mRNA and RNA, cell and
gene therapy, and so much more.
As the global epicenter of breakthrough science, Massachusetts is a
top candidate to host the headquarters of ARPA-H. Not only are we home
to the highest proportion of top-ranked research universities in the
world, but we also have the best and brightest in industry, healthcare,
and academia.
We have also invested in infrastructure to support the needs of ARPA-
H. Over the past decade, we have delivered 21.6 million square feet of
lab space, in addition to over 100 incubators, accelerators, and co-
working spaces.
This bill specifically directs ARPA-H to advance early disease
detection, translational research, and health technologies. It realizes
President Biden's goal of driving breakthroughs in cancer, Alzheimer's,
diabetes, and infectious disease. From pre-competitive Alzheimer's
research at the Massachusetts General Hospital to Vertex's work to
utilize stem cell therapies to treat diabetes, we are aligned with and
deeply committed to ARPA-H's goal in the Commonwealth.
I am proud to represent a State that is deeply invested in the
success of ARPA-H.
Mr. Speaker, I urge my colleagues to support this legislation.
Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, it is important we are here today.
I thank the chair of the other subcommittee whom I have the privilege
to work alongside as the Republican leader. She has been a champion of
ARPA-H as it first came out and at the first meeting at the White
House. We have discussed quite a bit about where it should be and what
the guardrails should be.
I know the funding got out in front of it. We all really wanted
Congress to have a say in how this agency operated and not the
executive branch the way, unfortunately, getting in front of
authorization does.
I appreciate the hard work. I appreciate the work of the colleagues
who have spoken and everybody else who is working on this together on
our staff.
Mr. Speaker, I think it is important that we pass this bill. I urge
my colleagues to vote for the bill tonight, and I yield back the
balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time to
close.
Mr. Speaker, I just want to say in closing that I think you can feel
the real enthusiasm and the hope that is involved with both the
sponsors of this bill and those who spoke on both sides of the aisle.
We consider ourselves, the Energy and Commerce Committee, the
innovation committee, and I think this is a prime example of the type
of innovation that we see for the future and the hope in ARPA-H.
Mr. Speaker, I would ask for everyone on a bipartisan basis to vote
for this, so we have a strong vote, and I yield back the balance of my
time.
Mr. COLE. Mr. Speaker, I support H.R. 5585, the Advanced Research
Projects Agency--Health Act. During my time in Congress, I have been a
strong supporter of basic medical research, and I recognize the
potential translational medical research holds when it builds off this
prior research. The discoveries made by our scientists at NIH and at
NIH-funded universities across the nation have the potential to
transform the delivery of health care and the prevention, treatment,
and ultimately curing of disease.
That support for research and its potential to transform the delivery
of health care led me to be an initial supporter of ARPA-H. In
collaboration with my colleagues on the Appropriations Committee, we
provided ARPA-H with some initial funding in the Fiscal Year 2022
omnibus.
However, we are appropriators, not authorizers, and many of the basic
decisions about the structure and functions of the agency had to be
left unmade and instead be delegated to the Secretary of Health and
Human Services. As I mentioned to him when he came before my
subcommittee this spring, Congress still did not know how grants would
be made or funded or how ARPA-H would interface with NIH.
I am pleased that this bill from the House Energy and Commerce
Committee answers these questions and provides Congress the opportunity
to shape this agency in line with our original intent. I am especially
pleased that the resulting bill is fiscally responsible and will ensure
proper oversight of ARPA-H as it implements this new research arm. H.R.
5585 establishes ARPA-H as an independent agency within HHS--separate
from NIH--and provides its director with independence from NIH. It also
establishes clear agency goals and mission and provides a framework for
coordination to ensure ARPA-H's efforts will not duplicate or
cannibalize the research efforts of other federal agencies,
particularly NIH. Importantly, it also prohibits awards being made to
foreign researchers and entities operating at behest of or in concert
with our adversaries.
I urge my colleagues to support this legislation.
The SPEAKER pro tempore. All time for debate on the bill has expired.
Amendment No. 1 Offered by Ms. Eshoo of California
The SPEAKER pro tempore. It is now in order to consider amendment No.
1 printed in part C of House Report 117-381.
Ms. ESHOO. Mr. Speaker, I have an amendment at the desk made in order
under the rule.
The SPEAKER pro tempore. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 3, line 13, strike ``There is established'' and insert
the following:
(1) In general.--There is established
Page 3, after line 23, insert the following:
(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.
Page 6, line 16, strike ``with the advice and consent of
the Senate,''.
Page 14, strike line 19, and all that follows through page
16, line 6, and insert the following:
``(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.''.
Page 26, lines 15 through 19, amend paragraph (3) to read
as follows:
``(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
Page 34, lines 23 and 24, strike ``There is authorized''
and insert the following:
(1) In general.--To carry out this section, there is
authorized
Page 35, after line 2 (but before the close quotation mark
and second period) insert the following:
(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.
The SPEAKER pro tempore. Pursuant to House Resolution 1191, the
gentlewoman from California (Ms. Eshoo) and a Member opposed each will
control 5 minutes.
The Chair recognizes the gentlewoman from California.
{time} 1645
Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
I offer this bipartisan manager's amendment to improve and strengthen
[[Page H5803]]
the bill. I thank my Republican colleagues on the Health Subcommittee,
including Ranking Member McMorris Rodgers, Ranking Member Guthrie, and
Dr. Burgess for working closely with me on this bill over the last
several weeks.
This manager's amendment makes sure that the structure of ARPA-H will
help the Agency achieve success. Specifically, the amendment requires:
First, two-thirds of the ARPA-H program offices be exclusively
dedicated to research and development; number two, not more than 15
percent of the ARPA-H budget to be used on administrative expenses;
and, thirdly, removes the requirement of Senate confirmation of the
ARPA-H director.
I think these are commonsense provisions that improve the bill and,
ultimately, strengthen ARPA-H and its mission; and it is why I urge my
colleagues to support this amendment.
Mr. Speaker, I yield back the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I claim the time in opposition, even though
I am not opposed to the bill.
The SPEAKER pro tempore. Without objection, the gentleman from
Kentucky is recognized for 5 minutes.
There was no objection.
Mr. GUTHRIE. Mr. Speaker, the Chair of the subcommittee kind of went
through what the amendment says. Another thing that we need to make
sure is reinforced is that the amendment would ensure that agency and
precious U.S. taxpayer dollars can never go to nondomestic recipients
organized under the laws of a covered foreign entity as defined by the
National Security Act of 1947. This includes China, Russia, Iran, and
North Korea. So I want to make sure we understand that.
I said this on the debate on the bill that the Chair and I were
talking back and forth. And I understood the mission of what we wanted
to accomplish with ARPA-H, but I was concerned about the application of
it and how it would actually be put into place. We had a lot of
discussions based on that.
This amendment really does define as best as we can define in
legislation, without vague terms, what we want ARPA-H to do. This
amendment ensures that 85 percent of the money goes to research and not
to administration and growing an agency. We think that this really does
narrow and, as we said earlier, put guardrails. This amendment is what
accomplishes that with the bill. I am for this amendment, and I
encourage its adoption.
Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. Pursuant to the rule, the previous question
is ordered on the bill and the amendment offered by the gentlewoman
from California (Ms. Eshoo).
The question is on the amendment offered by the gentlewoman from
California (Ms. Eshoo).
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mrs. BOEBERT. Mr. Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this question
are postponed.
Pursuant to clause 1(c) of rule XIX, further consideration of H.R.
5585 is postponed.
____________________