[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.

                          ____________________