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Home Source documents Congressional Record, House, June 22, 2022 — H.R. 7666 and H.R. 5585 ARPA–H Act

Congressional Record, House, June 22, 2022 — H.R. 7666 and H.R. 5585 ARPA–H Act

Summary

Page H5795 of the House section of the Congressional Record for June 22, 2022, marked as a correction, in interleaved columns, from debate on H.R. 7666 and H.R. 5585. A speaker says only about 1 in 10 individuals with opioid use disorder receive medications such as buprenorphine, calling that a glaring systemic failure, and says H.R. 7666 takes a strong step to address it. Bill text establishes the Advanced Research Projects Agency-Health, ARPA-H, as an independent operating division within the Department of Health and Human Services. A vote is recorded with 387 yeas, 32 nays and 10 not voting.

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Cite this document

“Congressional Record, House, June 22, 2022 — H.R. 7666 and H.R. 5585 ARPA–H Act.” Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/crec-crec-2022-06-22-crec-2022-06-22-pt1-pgh5795-de04293ee1/, SHA-256 92a3e7fc1f32fb6a4f028af0c4ee94324ac2e14c34ed5cbe9eb0826e3d217fd9.

Full text

                                                         June 22, 2022                                      CONGRESSIONAL RECORD — HOUSE                                            CORRECTION                  H5795
                                                         treatment. Despite being recognized as                   guage. However, enacting this language                      ‘‘PART J—ADVANCED RESEARCH
                                                         the gold standard of care that can cut                   will be a huge policy change from the                          PROJECTS AGENCY–HEALTH
                                                         the risk of overdose in half, only about                 status quo.                                           ‘‘SEC. 499A. ADVANCED RESEARCH PROJECTS
                                                                                                                                                                                     AGENCY–HEALTH.
                                                         1 in 10 individuals with opioid use dis-                    Furthermore, States do regulate the
                                                                                                                                                                           ‘‘(a) ESTABLISHMENT.—There is established, as
                                                         order      received   medications     like               practice of medicine, and each State
                                                                                                                                                                        an independent operating division within the
                                                         buprenorphine to treat their addiction.                  has unique, individual regulations and                Department of Health and Human Services, the
                                                         That is a glaring systemic failure.                      procedures regarding the dispensing                   Advanced Research Projects Agency–Health (in
                                                           H.R. 7666 takes a strong step to ad-                   and the prescribing of scheduled nar-                 this part referred to as ‘ARPA–H’). Not later
                                                         dress that failure by expanding access                   cotics. States could use the additional               than 180 days after the date of enactment of this
                                                         to safe and effective addiction treat-                   time to update their laws with any                    part, the Secretary shall transfer all functions,
                                                         ment through eliminating the outdated                    changes they may want now that Fed-                   personnel, missions, activities, authorities, and
                                                         and    redundant      requirement    that                eral restrictions will be removed.                    funds of the Advanced Research Projects Agen-
                                                         healthcare providers obtain a special                                                                          cy for Health within the National Institutes of
                                                                                                                     This is exactly what Mr. GRIFFITH’s
                                                                                                                                                                        Health, as in existence on the date of enactment
                                                         waiver from the DEA to prescribe                         amendment does. It sets the implemen-                 of this part, to ARPA–H established by the pre-
                                                         buprenorphine for the treatment of ad-                   tation date for removing the X waiver                 ceding sentence.
                                                         diction.                                                 requirement to take effective on Janu-                   ‘‘(b) GOALS AND METHODS.—
                                                           Despite the lifesaving potential this                  ary 1, 2024.                                             ‘‘(1) GOALS.—The goals of ARPA–H shall be
                                                         legislation can bring, this amendment                       Madam Speaker, I support this com-                 to—
                                                         raises concerns about the impact the                     monsense amendment that will ensure                      ‘‘(A) foster the development of new, break-
                                                         MAT Act will have on safety, abuse,                                                                            through capabilities, technologies, systems, and
                                                                                                                  that the Mainstreaming Addiction
                                                                                                                                                                        platforms to accelerate innovations in health
                                                         and diversion, and I would take a mo-                    Treatment Act gets appropriately im-                  and medicine that are not being met by Federal
                                                         ment to directly address these con-                      plemented.                                            programs or private entities;
                                                         cerns.                                                      Mr. GRIFFITH. Madam Speaker, I                        ‘‘(B) revolutionize detection, diagnosis, miti-
                                                           Let’s start with the basic facts on                    yield back the balance of my time.                    gation, prevention, treatment, and curing of se-
                                                         safety.                                                     The SPEAKER pro tempore. Pursu-                    rious diseases and medical conditions through
                                                           Unlike heroin and fentanyl that are                    ant to House Resolution Number 1191,                  the development of transformative health tech-
                                                         causing           overdose        deaths,                the previous question is ordered on the               nologies;
                                                         buprenorphine is a safe medication                                                                                ‘‘(C) promote high-risk, high-reward innova-
                                                                                                                  amendment offered by the gentleman                    tion for the development and translation of
                                                         that is highly effective at protecting                   from Virginia (Mr. GRIFFITH).                         transformative health technologies; and
                                                         people from overdose.                                       The question is on the amendment.                     ‘‘(D) contribute to ensuring the United States
                                                           Due       to    its    ceiling   effect,                  The question was taken; and the                    maintains—
                                                         buprenorphine does not cause people to                   Speaker pro tempore announced that                       ‘‘(i) global leadership in science and innova-
                                                         feel high and is unlikely to result in                   the noes appeared to have it.                         tion;
                                                         substance use disorder or be a cause of                     Mr. GRIFFITH. Madam Speaker, on                       ‘‘(ii) the highest quality of life and health for
                                                         overdose deaths.                                                                                               its citizens; and
                                                                                                                  that I demand the yeas and nays.                         ‘‘(iii) an aggressive agenda for innovations to
                                                           With regard to diversion and abuse,                       The SPEAKER pro tempore. Pursu-                    address global health threats that place United
                                                         the DEA, which is responsible for polic-                 ant to section 3(s) of House Resolution               States citizens at risk.
                                                         ing illicit diversion, has specifically                  8, the yeas and nays are ordered.                        ‘‘(2) METHODS.—ARPA–H shall achieve the
                                                         looked at this issue and found that the                     Pursuant to clause 8 of rule XX, fur-              goals specified in paragraph (1) by—
                                                         primary reason for buprenorphine di-                     ther proceedings on this question are                    ‘‘(A) discovering, identifying, and promoting
                                                         version is the failure to access legiti-                 postponed.                                            revolutionary advances in health sciences;
                                                         mate treatment, and that increasing,                                                                              ‘‘(B) translating scientific discoveries into
                                                                                                                     Pursuant to clause 1(c) of rule XIX,               transformative health technologies;
                                                         not limiting, buprenorphine treatment                    further consideration of H.R. 7666 is                    ‘‘(C) providing resources and support to create
                                                         may be an effective response to diver-                   postponed.                                            platform capabilities that draw on multiple dis-
                                                         sion.                                                                                                          ciplines;
                                                                                                                                    f
                                                           Indeed, as buprenorphine access has                                                                             ‘‘(D) using researchers in a wide range of dis-
                                                         increased over the last 5 years through                   ADVANCED RESEARCH PROJECTS                           ciplines, including the life sciences, the physical
                                                         legislation passed by this Congress,                             AGENCY–HEALTH ACT                             sciences, engineering, and the computational
                                                         misuse of the medication has de-                                                                               sciences;
                                                                                                                    Mr. PALLONE. Mr. Speaker, pursu-                       ‘‘(E) delivering advanced proofs of concept
                                                         creased.
                                                                                                                  ant to House Resolution 1191, I call up               that demonstrate potentially clinically meaning-
                                                           So I would say that it is important
                                                                                                                  the bill (H.R. 5585) to establish the Ad-             ful advances;
                                                         for us to be responsible here. We are in                                                                          ‘‘(F) developing new capabilities, advanced
                                                                                                                  vanced Research Projects Agency–
                                                         the midst of a pandemic, an epidemic                                                                           computational tools, predictive models, or ana-
                                                                                                                  Health, and for other purposes, and ask
                                                         that is causing great pain, great suf-                                                                         lytical techniques to identify potential targets
                                                                                                                  for its immediate consideration in the
                                                         fering, great death, every day, every                                                                          and technological strategies for early disease de-
                                                                                                                  House.                                                tection and intervention;
                                                         week. Every moment we circumvent
                                                                                                                    The Clerk read the title of the bill.                  ‘‘(G) accelerating transformational techno-
                                                         our responsibilities, someone is paying
                                                                                                                    The SPEAKER pro tempore (Mr.                        logical advances in areas with limited technical
                                                         the price for that.
                                                                                                                  CARSON). Pursuant to House Resolution                 certainty; and
                                                           Madam Speaker, I strongly oppose                                                                                ‘‘(H) prioritizing investments based on such
                                                                                                                  1191, the amendment in the nature of a
                                                         this amendment.                                                                                                considerations as—
                                                                                                                  substitute recommended by the Com-
                                                           Mr. PALLONE. Madam Speaker, I                                                                                   ‘‘(i) scientific opportunity and uniqueness of
                                                                                                                  mittee on Energy and Commerce print-
                                                         yield back the balance of my time.                                                                             fit to the strategies and operating practices of
                                                           Mr. GRIFFITH. Madam Speaker, I                         ed in the bill is adopted, and the bill, as           ARPA–H;
                                                         yield 1 minute to the gentlewoman                        amended, is considered read.                             ‘‘(ii) the effect on disease burden, including
                                                         from Washington (Mrs. RODGERS).                            The text of the bill, as amended, is as             unmet patient need, quality and disparity gaps,
                                                           Mrs. RODGERS of Washington.                            follows:                                              and the potential to preempt progression of seri-
                                                                                                                                      H.R. 5585                         ous disease; and
                                                         Madam Speaker, I appreciate the gen-                                                                              ‘‘(iii) the effect on the fiscal liability of the
                                                         tleman for yielding.                                       Be it enacted by the Senate and House of Rep-




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                                                                                                                                                                        Federal Government with respect to health care
                                                           Madam Speaker, I rise in support of                    resentatives of the United States of America in
                                                                                                                                                                        and the ability to reduce the cost of care
                                                         the Griffith amendment which provides                    Congress assembled,
                                                                                                                                                                        through innovation.
                                                                                                                  SECTION 1. SHORT TITLE.
                                                         additional time for implementation of                                                                             ‘‘(c) DIRECTOR.—
                                                         the provisions of the Mainstreaming                        This Act may be cited as the ‘‘Advanced Re-            ‘‘(1) IN GENERAL.—The President shall appoint
                                                                                                                  search Projects Agency–Health Act’’ or the            with the advice and consent of the Senate, a di-
                                                         Addiction Treatment Act included in                      ‘‘ARPA–H Act’’.                                       rector of ARPA–H (in this part referred to as the
                                                         this bill.                                               SEC. 2. ADVANCED RESEARCH PROJECTS AGEN-              ‘Director’).
                                                           I supported the inclusion of this lan-                            CY–HEALTH.                                    ‘‘(2) QUALIFICATIONS.—The Director shall be
                                                         guage at committee, as I believe it will                   Title IV of the Public Health Service Act (42       an individual who, by reason of professional
                                                         help increase access to substance use                    U.S.C. 281 et seq.) is amended by adding at the       background and experience, is especially quali-
                                                         disorder treatment, the underlying lan-                  end the following:                                    fied to manage—




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                                            H5796                                              CONGRESSIONAL RECORD — HOUSE                                                             June 22, 2022
                                               ‘‘(A) research and advanced development pro-         hedge funds, and private equity firms), includ-        shall be made publicly available and published
                                            grams; and                                              ing amounts and the percentage of ownership of         in a machine-readable format;
                                               ‘‘(B) large-scale, high-risk initiatives with re-    the awardee provided in return for the invest-            ‘‘(B) contracts subject to the Federal Acquisi-
                                            spect to health research and technology devel-          ments.                                                 tion Regulation;
                                            opment across multiple sectors, including gener-           ‘‘(3) Additional financial support that the            ‘‘(C) multi-year contracts under section 3903
                                            ating transformative health technologies and            awardee—                                               of title 41, United States Code;
                                            improving health outcomes for patients.                    ‘‘(A) plans to invest or has invested in the           ‘‘(D) prizes; and
                                               ‘‘(3) RELATIONSHIP TO SECRETARY.—The Direc-          technology developed under the award; or                  ‘‘(E) other transactions.
                                            tor shall report directly to the Secretary.                ‘‘(B) is seeking from third parties.                   ‘‘(2) EXEMPTIONS FOR CERTAIN REQUIRE-
                                               ‘‘(4) DUTIES.—The duties of the Director shall          ‘‘(4) Revenue from the licensing or sale of new     MENTS.—Research funded by ARPA–H shall not
                                            include the following:                                  products or services resulting from research con-      be subject to the requirements of section
                                               ‘‘(A) Approve and terminate the projects and         ducted under the award.                                406(a)(3)(A)(ii) or section 492.
                                            programs of ARPA–H.                                        ‘‘(f) SHARING INFORMATION WITH THE CENTERS             ‘‘(i) FACILITIES AUTHORITY.—
                                               ‘‘(B) Set research and development priorities        FOR MEDICARE & MEDICAID SERVICES.—The Di-                 ‘‘(1) IN GENERAL.—The Director may acquire
                                            with respect to the goals specified in subsection       rector shall timely share relevant information         (by purchase, lease, condemnation, or other-
                                            (b) and manage the budget of ARPA–H.                    with the Administrator of the Centers for Medi-        wise), construct, improve, repair, operate, and
                                               ‘‘(C) Develop funding criteria and assess the        care & Medicaid Services that may help to expe-        maintain such real and personal property as
                                            success of programs through the establishment           dite determinations of coverage of trans-              may be necessary to carry out this section.
                                            of technical milestones.                                formative health technologies developed by                ‘‘(2) LEASE OF NONEXCESS PROPERTY.—The Di-
                                               ‘‘(D) Advance the goals under subsection (b),        ARPA–H.                                                rector may enter into a lease under this section
                                            through consideration of the advice of the                 ‘‘(g) EXPEDITING BREAKTHROUGHS THROUGH              with any person or entity (including another
                                            ARPA–H Interagency Research Council estab-              COOPERATION WITH THE FOOD AND DRUG AD-                 department or agency of the Federal Govern-
                                            lished under subsection (q).                            MINISTRATION.—                                         ment or an entity of a State or local govern-
                                               ‘‘(E) Solicit data, as needed, from the Na-             ‘‘(1) IN GENERAL.—The Secretary, acting             ment) with regard to any nonexcess real prop-
                                            tional Institutes of Health and other relevant          through the Commissioner of Food and Drugs             erty and related personal property under the ju-
                                            entities.                                               and in consultation with the Director, may take        risdiction of the Director.
                                               ‘‘(F) Coordinate with the Director of the Na-        actions to facilitate translation of trans-               ‘‘(3) UTILIZATION OF LEASE FUNDS.—
                                            tional Institutes of Health to ensure that the          formative health technology into tangible solu-           ‘‘(A) IN GENERAL.—The Director may utilize,
                                            programs of ARPA–H build on, and are in-                tions for patients and to expedite development of      without further appropriation, amounts of cash
                                            formed by, scientific research supported by the         drugs, devices, and biological products, includ-       consideration received for a lease entered into
                                            National Institutes of Health.                          ing through—                                           under this subsection to cover the full costs to
                                               ‘‘(G) Coordinate with the heads of Federal              ‘‘(A) helping to ensure that drug, device, or       ARPA–H in connection with the lease. Funds
                                            agencies and, to the extent practicable, ensure         biological product development programs, in as         received as such cash consideration shall remain
                                            that the activities of ARPA–H supplement (and           efficient a manner as possible, gather the non-        available until expended.
                                            do not supplant) the efforts of other Federal           clinical and clinical data necessary to advanc-           ‘‘(B) CAPITAL REVITALIZATION AND IMPROVE-
                                                                                                                                                           MENTS.—Of any amounts of cash consideration
                                            agencies.                                               ing the development of such products and to ob-
                                               ‘‘(H) Ensure ARPA–H does not provide fund-           taining their approval, licensure, or clearance,       received under this subsection that are not uti-
                                            ing for a project unless the program manager            as applicable, by the Food and Drug Adminis-           lized in accordance with subparagraph (A),
                                            determines that the project meets the goals de-         tration under sections 505, 510(k), and 515 of the     without further appropriation—
                                            scribed in subsection (b)(1).                                                                                     ‘‘(i) 35 percent shall—
                                                                                                    Federal Food, Drug, and Cosmetic Act and sec-             ‘‘(I) be deposited in a capital asset account to
                                               ‘‘(5) TERM.—The Director—                            tion 351 of this Act;
                                               ‘‘(A) shall be appointed for a 5-year term; and                                                             be established by the Director;
                                                                                                       ‘‘(B) expediting review of investigational new         ‘‘(II) be available for maintenance, capital re-
                                               ‘‘(B) may be reappointed for 1 consecutive 5-        drug applications under section 505(i) of the
                                            year term.                                                                                                     vitalization, and improvements of the real prop-
                                                                                                    Federal Food, Drug, and Cosmetic Act, review           erty assets and related personal property under
                                               ‘‘(6) AUTONOMY OF AGENCY REGARDING REC-              of investigational device exemptions under sec-
                                            OMMENDATIONS AND TESTIMONY.—No officer or                                                                      the jurisdiction of the Director; and
                                                                                                    tion 520(g) of such Act, and review of applica-           ‘‘(III) remain available until expended; and
                                            agency of the United States shall have any au-          tions for approval, licensure, and clearance of           ‘‘(ii) the remaining 65 percent shall be avail-
                                            thority to require the Director or any other offi-      drugs, devices, or biological products under sec-      able to the respective center or facility of
                                            cer of ARPA–H to submit legislative rec-                tions 505, 510(k), and 515 of such Act, and sec-       ARPA–H engaged in the lease of nonexcess real
                                            ommendations, or testimony or comments on leg-          tion 351 of this Act; and                              property, and shall remain available until ex-
                                            islation, to any officer or agency of the United           ‘‘(C) meeting at appropriate intervals with the     pended for maintenance, capital revitalization,
                                            States for approval, comments, or review prior to       Director and any member of the ARPA–H Inter-           and improvements of the real property assets
                                            the submission of such recommendations, testi-          agency Research Council to discuss the develop-        and related personal property at the respective
                                            mony, or comments to the Congress, if such rec-         ment status of drugs, devices, or biological prod-     center or facility subject to the concurrence of
                                            ommendations, testimony, or comments to the             ucts and projects that are the highest priorities      the Director.
                                            Congress include a statement indicating that the        to ARPA–H, unless the Director and the Com-               ‘‘(C) NO UTILIZATION FOR DAILY OPERATING
                                            views expressed therein are those of the Director       missioner of Food and Drugs determine that any         COSTS.—Amounts utilized under subparagraph
                                            or such officer, and do not necessarily reflect         such meetings are not necessary.                       (B) may not be utilized for daily operating costs.
                                            the views of the President or another agency.              ‘‘(2) RELATION TO OTHERWISE AUTHORIZED AC-             ‘‘(4) LOCATIONS.—
                                               ‘‘(7) DELEGATION OF AUTHORITY.—The Direc-            TIVITIES OF THE FDA.—The authority specified              ‘‘(A) IN GENERAL.—ARPA–H, including its
                                            tor may delegate to any duly authorized em-             in paragraph (1) shall not be construed as lim-        headquarters, shall not be located on any part
                                            ployee, representative, or agent any power vest-        iting the authority of the Secretary, acting           of the existing National Institutes of Health
                                            ed in the Director by law, except that the Direc-       through the Commissioner of Food and Drugs,            campuses.
                                            tor may not delegate the power to appoint the           with respect to the review and approval, clear-           ‘‘(B) CONSIDERATIONS.—In determining the lo-
                                            Deputy Director under paragraph (8).                    ance, authorization for emergency use, or licen-       cation of facilities, the Director shall make a
                                               ‘‘(8) DEPUTY DIRECTOR.—The Director shall            sure of drugs, devices, or biological products         fair and open consideration of—
                                            appoint a deputy director to serve as the first         under the Federal Food, Drug, and Cosmetic                ‘‘(i) the characteristics of the intended loca-
                                            assistant to the office.                                Act or section 351 of this Act.                        tion; and
                                               ‘‘(d) APPLICATION OF PAPERWORK REDUCTION                ‘‘(3) REIMBURSEMENT.—The Director, using               ‘‘(ii) the extent to which such location will fa-
                                            ACT.—The Director may waive the requirements            funds made available to ARPA–H, may reim-              cilitate advancement of the goals and methods
                                            of subchapter I of chapter 35 of title 44, United       burse the Food and Drug Administration for ex-         specified in subsection (b).
                                            States Code (commonly referred to as the ‘Pa-           penditures made by the Food and Drug Admin-               ‘‘(j) PERSONNEL.—
                                            perwork Reduction Act’) with respect to the             istration for activities carried out under this sec-      ‘‘(1) IN GENERAL.—The Director may—
                                            methods described in subsection (b)(2).                 tion that have been identified by the Commis-             ‘‘(A) make and rescind appointments of sci-
                                               ‘‘(e) PROTECTION OF INFORMATION.—The fol-            sioner of Food and Drugs and the Director as           entific, engineering, medical, and professional
                                            lowing types of information collected by ARPA–          being carried out by the Food and Drug Admin-          personnel, which may include temporary or
                                            H from recipients of financial assistance awards        istration.                                             time-limited appointments as determined by the
                                            shall be considered commercial and financial in-           ‘‘(h) AWARDS.—                                      Director to fulfill the mission of ARPA–H, with-
                                            formation obtained from a person and privileged            ‘‘(1) IN GENERAL.—In carrying out this sec-         out regard to any provision in title 5, United
                                            or confidential and not subject to disclosure           tion, the Director may make awards including—          States Code, governing appointments and re-
                                            under section 552(b)(4) of title 5, United States          ‘‘(A) grants and cooperative agreements,            movals under the civil service laws, and fix the
                                            Code:                                                   which shall—                                           base pay compensation of such personnel at a




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                                               ‘‘(1) Plans for commercialization of tech-              ‘‘(i) be subject to the uniform administrative      rate to be determined by the Director, up to the
                                            nologies developed under the award, including           requirements, cost principles, and audit require-      amount of annual compensation (excluding ex-
                                            business plans, technology-to market plans,             ments for Federal awards contained in part 200         penses) specified in section 102 of title 3, United
                                            market studies, and cost and performance mod-           of title 2, Code of Federal Regulations (or suc-       States Code; and
                                            els.                                                    cessor regulations); and                                  ‘‘(B) contract with private recruiting firms for
                                               ‘‘(2) Investments provided to an awardee from           ‘‘(ii) include the total line-item and itemized     the hiring of qualified staff referenced in sub-
                                            third parties (such as venture capital firms,           indirect facilities and administrative costs that      paragraph (A).




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                                            June 22, 2022                                      CONGRESSIONAL RECORD — HOUSE                                                                       H5797
                                               ‘‘(2) ADDITIONAL STAFF.—The Director may                ‘‘(ii) the capabilities of the applicants to suc-      ‘‘(B) SUBMISSION OF RESULTS.—The agreement
                                            use, to the same extent and in the same manner          cessfully carry out the proposed project;               entered into under subparagraph (A) shall re-
                                            as the Secretary, all authorities in existence on          ‘‘(iii) the unmet needs or ability to improve        quire the National Academies of Sciences, Engi-
                                            the date of the enactment of this section that          health outcomes within patient populations;             neering, and Medicine to submit the results of
                                            are provided to the Secretary to hire administra-          ‘‘(iv) future commercial applications of the         the evaluation conducted under such agreement
                                            tive, financial, contracts, legislative affairs, in-    project or the feasibility of partnering with one       to the Secretary, the Committee on Energy and
                                            formation technology, ethics, and communica-            or more commercial entities;                            Commerce of the House of Representatives, and
                                            tions staff, and such other staff as may be iden-          ‘‘(v) the potential for interdisciplinarity of the   the Committee on Health, Education, Labor,
                                            tified by the Director as necessary to carry out        approach of the project; and                            and Pensions of the Senate.
                                            this section.                                              ‘‘(vi) such other criteria as established by the       ‘‘(m) STRATEGIC PLAN.—Not later than 1 year
                                               ‘‘(3) ADDITIONAL CONSIDERATIONS.—In ap-              Director;                                               after the date of the enactment of this section,
                                            pointing personnel under this subsection, the              ‘‘(G) conduct project reviews within 18 months       and every 3 years thereafter, the Director shall
                                            Director—                                               of funding awards to identify milestones and            provide to the relevant committees of Congress a
                                               ‘‘(A) may contract with private entities;            monitor progress of such milestones with respect        strategic plan describing how ARPA–H will
                                               ‘‘(B) shall make efforts to recruit and retain a     to each project and prior to disbursement of new        carry out investments each fiscal year in the fol-
                                            diverse workforce, including individuals under-         funds;                                                  lowing 3-year period.
                                            represented in science and medicine and racial             ‘‘(H) provide recommendations to the Director          ‘‘(n) INDEPENDENT REVIEW.—Not later than 1
                                            and ethnic minorities (as long as such efforts          with respect to advancing the goals specified in        year after the date of the enactment of this sec-
                                            comply with applicable Federal civil rights law);       subsection (b);                                         tion, and every 3 years thereafter, the Comp-
                                            and                                                        ‘‘(I) cultivate opportunities for the commercial     troller General of the United States shall con-
                                               ‘‘(C) shall recruit program managers with ex-        application or community use of successful              duct an independent review of the research
                                            pertise in a wide range of relevant disciplines,        projects, including through the establishment of        portfolio of the Department of Health and
                                            including life sciences, the physical sciences, en-     partnerships between or among awardees;                 Human Services, including ARPA–H, the Na-
                                            gineering, and the computational sciences.                 ‘‘(J) identify innovative cost-sharing arrange-      tional Institutes of Health, the Food and Drug
                                               ‘‘(4) ADDITIONAL HIRING AUTHORITY.—To the            ments for ARPA–H projects;                              Administration, and the Biomedical Advanced
                                            extent needed to carry out the authorities vested          ‘‘(K) provide recommendations to expand, re-         Research and Development Authority—
                                            by paragraph (1), the Director may utilize hir-         structure, or terminate research partnerships or          ‘‘(1) to assess the degree of unnecessary dupli-
                                            ing authorities under sections 3371 through 3376        projects; and                                           cation of existing Federal programs and
                                            of title 5, United States Code, to staff ARPA–H            ‘‘(L) ensure that—                                   projects; and
                                            with employees from other Federal agencies,                ‘‘(i) animal studies meet the Federal animal           ‘‘(2) to make recommendations regarding any
                                            State and local governments, Indian Tribes and          research requirements pursuant of the Public            potential reorganization, consolidation, or ter-
                                            Tribal organizations, institutions of higher edu-       Health Service Policy on Humane Care and Use            mination of such programs and projects.
                                            cation, and other organizations, as described in        of Laboratory Animals; and                                ‘‘(o) PRIORITIZATION.—The Director shall—
                                            such sections.                                             ‘‘(ii) applications apply statistical modeling         ‘‘(1) prioritize awarding grants, cooperative
                                               ‘‘(5) EXISTING AUTHORITIES.—The authorities          approaches and appropriately justify animal             agreements, contracts, prizes, and other trans-
                                            granted by this section are—                            sample sizes to meet project goals.                     action awards to domestic recipients conducting
                                               ‘‘(A) in addition to existing authorities grant-        ‘‘(l) REPORTS AND EVALUATION.—                       the research on transformative health tech-
                                            ed to the Secretary; and                                   ‘‘(1) ANNUAL REPORT.—                                nology in the United States;
                                               ‘‘(B) are not intended to supersede or modify           ‘‘(A) IN GENERAL.—Beginning not later than 1           ‘‘(2) as appropriate and practicable, ensure
                                            any existing authorities.                               year after the date of enactment of this section,       that nondomestic recipients of any grants, coop-
                                               ‘‘(6)   AUTHORITY      TO    ACCEPT     FEDERAL      and each fiscal year thereafter, the Director           erative agreements, contracts, prizes, and other
                                            DETAILEES.—The Director may accept officers or          shall submit a report on the actions undertaken,        transactions under this section are conducting
                                            employees of the United States or members of            and results generated, by ARPA–H, including—            research in collaboration with a domestic recipi-
                                            the uniformed service on a detail from an ele-             ‘‘(i) a description of projects supported by         ent;
                                            ment of the Federal Government on a reimburs-           ARPA–H in the previous fiscal year and wheth-             ‘‘(3) not award any grants, cooperative agree-
                                            able or a nonreimbursable basis, as jointly             er such projects are meeting the goals developed        ments, contracts, prizes, and other transactions
                                            agreed to by the heads of the receiving and de-         by the Director pursuant to subsection (c)(4)(C);       to nondomestic recipients subject to malign for-
                                            tailing elements, for a period not to exceed 3             ‘‘(ii) a description of projects terminated in       eign influence or organized under the laws of a
                                            years.                                                  the previous fiscal year, and the reason for such       malign foreign country; and
                                               ‘‘(k) PROGRAM MANAGERS.—                             termination;                                              ‘‘(4) in accordance with the requirements of
                                               ‘‘(1) IN GENERAL.—The Director shall appoint            ‘‘(iii) a description of programs starting in the    chapter 33 of title 41, United States Code, and
                                            program managers for 3-year terms (and may re-          next fiscal year, as available;                         the Federal Acquisition Regulation, only award
                                            appoint such program managers for 1 consecu-               ‘‘(iv) activities conducted in coordination with     grants, cooperative agreements, contracts,
                                            tive 3-year term) for the programs carried out by       other Federal agencies;                                 prizes, and other transactions to individual per-
                                            ARPA–H.                                                    ‘‘(v) an analysis of the extent of coordination      sons that do not have more than 3 ongoing con-
                                               ‘‘(2) DUTIES.—A program manager shall—               conducted pursuant to subsections (c)(4)(F) and         current grants, cooperative agreements, con-
                                               ‘‘(A) establish, in consultation with the Direc-     (f), including successes and barriers with respect      tracts, prizes, and other transactions under this
                                            tor or Deputy Director, research and develop-           to achieving the goals under subsection (b);            section.
                                            ment goals for programs, including timelines               ‘‘(vi) a description of the demographic (in-           ‘‘(p) ADDITIONAL CONSULTATION.—In carrying
                                            and milestones, and make such goals available           cluding racial and gender) diversity if available       out this section, the Director may consult with—
                                            to the public;                                          of direct recipients and performers in funded             ‘‘(1) the President’s Council of Advisors on
                                               ‘‘(B) collaborate with experts from the Na-          projects and of the ARPA–H workforce; and               Science and Technology;
                                            tional Institutes of Health and other Federal              ‘‘(vii) a disclosure by the reward recipients of       ‘‘(2) peers in the scientific community, includ-
                                            agencies and experts in relevant scientific fields      whether the principal investigators named on            ing academia and industry;
                                            to identify research and development gaps and           the award participate in foreign talent pro-              ‘‘(3) an existing advisory committee providing
                                            opportunities;                                          grams, including the provision of copies of all         advice to the Secretary or the head of any oper-
                                               ‘‘(C) convene workshops and meetings, as             grants, contracts, or other agreements related to       ating or staff division of the Department;
                                            needed, with entities such as patients, patient         such programs, and other supporting docu-                 ‘‘(4) a new interagency research council orga-
                                            advocacy groups, practitioners, professional so-        mentation related to such programs, as a condi-         nized to support the programs of ARPA–H and
                                            cieties, and other stakeholders to solicit input        tion of receipt of Federal extramural biomedical        to provide advice and assistance on—
                                            on programs and goals;                                  research funding awarded.                                 ‘‘(A) specific program tasks; or
                                               ‘‘(D) manage applications and proposals,                ‘‘(B) SUBMISSION TO CONGRESS.—The report               ‘‘(B) the overall direction of ARPA–H; and
                                            through the appropriate officials for making            under subparagraph (A) shall be submitted to—             ‘‘(5) any other entity the Director may deem
                                            grants, cooperative agreements, contracts,                 ‘‘(i) the Committee on Energy and Commerce           appropriate.
                                            prizes, and other transaction awards for ad-            and the Committee on Appropriations of the                ‘‘(q) ARPA–H INTERAGENCY RESEARCH COUN-
                                            vanced research that may show particular                House of Representatives; and                           CIL.—
                                            promise, especially in areas in which the private          ‘‘(ii) the Committee on Health, Education,             ‘‘(1) IN GENERAL.—The Director shall establish
                                            sector and the Federal Government have not un-          Labor, and Pensions and the Committee on Ap-            an interagency advisory committee to be known
                                            dertaken sufficient research;                           propriations of the Senate.                             as the ARPA–H Interagency Research Council
                                               ‘‘(E) issue funding opportunity announce-               ‘‘(2) EVALUATION.—                                   (referred to in this subsection as the ‘Research
                                            ments, using uniform administrative processes,             ‘‘(A) IN GENERAL.—Not later than 5 years             Council’).




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                                            as appropriate;                                         after the date of the enactment of this section,          ‘‘(2) MEMBERSHIP.—The Research Council
                                               ‘‘(F) select, on the basis of merit, each of the     the Secretary shall enter into an agreement with        may include any or all of the following mem-
                                            projects to be supported under a program car-           the National Academies of Sciences, Engineer-           bers, or designees:
                                            ried out by ARPA–H, and taking into consider-           ing, and Medicine under which the National                ‘‘(A) The Director of the National Institutes of
                                            ation—                                                  Academies agree to study and evaluate whether           Health.
                                               ‘‘(i) the scientific and technical merit of the      ARPA–H is meeting the goals specified in sub-             ‘‘(B) The Director of National Center for Ad-
                                            proposed project;                                       section (b).                                            vancing Translational Sciences.




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                                            H5798                                              CONGRESSIONAL RECORD — HOUSE                                                           June 22, 2022
                                              ‘‘(C) The Director of Office of Science and           the use of competitive procedures (as defined in       ber of the Committee on Energy and
                                            Technology Policy.                                      section 152 of title 41, United States Code), not-     Commerce or their respective des-
                                              ‘‘(D) The Commissioner of Food and Drugs.             withstanding the requirements of division C of         ignees.
                                              ‘‘(E) The Director of the Biomedical Advanced         subtitle I of such title 41, if—
                                            Research and Development Authority.
                                                                                                                                                             After 1 hour of debate, it shall be in
                                                                                                      ‘‘(A) competitive procedures were used for the
                                              ‘‘(F) The Director of the Centers for Disease         selection of parties for participation in the other    order to consider the further amend-
                                            Control and Prevention.                                 transaction; and                                       ment printed in part C of House Report
                                              ‘‘(G) The Administrator of the Centers for              ‘‘(B) the participants in the other transaction      117–381, if offered by the Member des-
                                            Medicare & Medicaid Services.                           successfully completed the project provided for        ignated in the report, which shall be
                                              ‘‘(H) The Director of the Agency for                  in the transaction.                                    considered read, shall be separately de-
                                            Healthcare Research and Quality.                          ‘‘(3) PRECONDITION.—A follow-on production           batable for the time specified in the re-
                                              ‘‘(I) The Director of the Office of Minority          contract or transaction may be awarded pursu-
                                            Health.
                                                                                                                                                           port equally divided and controlled by
                                                                                                    ant to this subsection when the Director deter-
                                              ‘‘(J) The Administrator of the Health Re-             mines that an individual project or subproject as
                                                                                                                                                           the proponent and an opponent, and
                                            sources and Services Administration.                    part of a consortium is successfully completed         shall not be subject to a demand for a
                                              ‘‘(K) The Director of the Defense Advanced            by the participants.                                   division of the question.
                                            Research Projects Agency.                                 ‘‘(4) CLARIFICATION.—Award of a follow-on              The gentleman from New Jersey (Mr.
                                              ‘‘(L) The Director of the National Science            production contract or transaction pursuant to         PALLONE), and the gentleman from
                                            Foundation.                                             this subsection shall not be made contingent           Kentucky (Mr. GUTHRIE), each will con-
                                              ‘‘(M) The Director of the Office of Science of        upon the successful completion of all activities       trol 30 minutes.
                                            the Department of Energy.                               within a consortium as a condition for an
                                              ‘‘(N) The Director of the Advanced Research
                                                                                                                                                             The Chair recognizes the gentleman
                                                                                                    award for follow-on production of a successfully
                                            Projects Agency–Energy.                                                                                        from New Jersey (Mr. PALLONE).
                                                                                                    completed project or subproject within that con-
                                              ‘‘(O) The Assistant Secretary for Preparedness        sortium.                                                                 GENERAL LEAVE
                                            and Response.                                             ‘‘(5) OTHER AUTHORITIES.—Contracts and                 Mr. PALLONE. Mr. Speaker, I ask
                                              ‘‘(P) Representatives of any Federal agency           transactions entered into by ARPA–H pursuant           unanimous consent that all Members
                                            with subject matter expertise that the Director         to this subsection may be awarded pursuant to          may have 5 legislative days in which to
                                            determines is necessary for the successful com-         division C of subtitle I of title 41, United States    revise and extend their remarks and in-
                                            pletion of a project carried out pursuant to this       Code, or under such procedures, terms, and con-
                                            section.                                                                                                       clude any extraneous material on H.R.
                                                                                                    ditions as the Director or head of such agency
                                              ‘‘(Q) Any other entity the Director may deem                                                                 5585.
                                                                                                    may establish by regulation.
                                            appropriate.                                              ‘‘(t) RULE OF CONSTRUCTION.—The authorities            The SPEAKER pro tempore. Is there
                                              ‘‘(3) DUTIES.—The Research Council shall ad-          under this section, with respect to the Director,      objection to the request of the gen-
                                            vise the Director, including by—                        are additional authorities that do not supersede       tleman from New Jersey?
                                              ‘‘(A) making recommendations on—                      or modify any existing authorities.                      There was no objection.
                                              ‘‘(i) research priorities that will provide the         ‘‘(u) DEFINITIONS.—In this part:                       Mr. PALLONE. Mr. Speaker, I yield
                                            greatest return on investment with respect to im-         ‘‘(1) ADVANCED PROOFS OF CONCEPT.—The                myself such time as I may consume.
                                            proving human health;                                   term ‘advanced proofs of concept’ means data, a
                                              ‘‘(ii) avoiding duplication of efforts in the
                                                                                                                                                             Mr. Speaker, I rise to speak in sup-
                                                                                                    prototype, or other experimental evidence that—        port of H.R. 5585, the Advance Research
                                            Federal Government; and                                   ‘‘(A) may precede the development of trans-
                                              ‘‘(iii) improving coordination with other Fed-        formative health technologies; and
                                                                                                                                                           Projects Agency–Health Act, or ARPA–
                                            eral agencies; and                                        ‘‘(B) demonstrates the feasibility of a new          H Act.
                                              ‘‘(B) identifying and developing strategies to        concept.                                                 In February, the Energy and Com-
                                            address regulatory, reimbursement, and market             ‘‘(2) BIOLOGICAL PRODUCT.—The term ‘biologi-         merce     Committee’s     Health   Sub-
                                            barriers to commercialization or adoption of            cal product’ has the meaning given such term in        committee held a hearing to discuss
                                            transformative health technologies, including           section 351(i).                                        the Biden administration’s proposal to
                                            technologies intended to preempt serious dis-             ‘‘(3) DEPARTMENT.—The term ‘Department’
                                            ease.
                                                                                                                                                           establish    the    Advance    Research
                                                                                                    means the Department of Health and Human               Projects Agency for Health, better
                                              ‘‘(4) ADVISORY NATURE.—The function of the            Services.
                                            Research Council shall be advisory in nature.             ‘‘(4) DRUG; DEVICE.—The terms ‘drug’ and ‘de-        known as ARPA–H.
                                            Nothing in this subsection shall be construed as        vice’ have the meanings given such terms in sec-         The agency is modeled after the De-
                                            granting the Research Council authority over            tion 201 of the Federal Food, Drug, and Cos-           fense Advanced Research Projects
                                            any activities or functions of ARPA–H.                  metic Act.                                             Agency, or DARPA. The mission of
                                              ‘‘(5) MEETINGS.—Not later than 1 year after             ‘‘(5) FEDERAL ACQUISITION REGULATION.—The            ARPA–H is to translate fundamental
                                            the date of the enactment of this section, and          term ‘Federal Acquisition Regulation’ means the        biomedical research into breakthrough
                                            every fiscal year thereafter, the Director shall        Federal Acquisition Regulation issued pursuant
                                            convene meetings of the Research Council, in-
                                                                                                                                                           platform technologies that would
                                                                                                    to section 1303(a)(1) of title 41, United States       change healthcare as we know it.
                                            cluding conferences or workshops, as needed.            Code.
                                            The Research Council may function through es-             ‘‘(6) FEDERAL AGENCY.—The term ‘Federal
                                                                                                                                                             ARPA–H would focus on the highest-
                                            tablished or ad hoc committees, task forces, or         agency’ has the meaning given such term in sec-        risk, highest-reward issues in disease
                                            interagency groups to—                                  tion 3371 of title 5, United States Code.              research. It will attempt to solve the
                                              ‘‘(A) share information on health innovations           ‘‘(7) PRIZE.—The term ‘prize’ means a prize as       problems that the private and public
                                            funded by ARPA–H; and                                   such term is used in section 24 of the Stevenson-      sectors have not been able to conquer.
                                              ‘‘(B) receive input on areas of particular            Wydler Technology Innovation Act of 1980.              The expectations we have for this agen-
                                            promise for ARPA–H projects.                              ‘‘(8) TRANSFORMATIVE HEALTH TECHNOLOGY.—
                                              ‘‘(r) TECHNOLOGY TRANSFER OFFICE.—The Di-                                                                    cy are justifiably high.
                                                                                                    The term ‘transformative health technology’              Our hope is that within 5 years of op-
                                            rector may establish within ARPA–H an Office            means a drug, biological product, intervention,
                                            of Technology Transfer to facilitate, where ap-         platform, tool, or device—
                                                                                                                                                           erations, ARPA–H will have led to the
                                            propriate, the transfer of federally-owned or             ‘‘(A) that should be prioritized to detect, diag-    development of cutting-edge treat-
                                            federally-originated technology to recipients of        nose, mitigate, prevent, cure, or treat a serious      ments and cures for cancer, diabetes,
                                            an award under this section (other than Federal         disease or medical condition for which there are       autoimmune disorders, and mental
                                            Government entities).                                   unmet needs; and                                       health conditions.
                                              ‘‘(s) FOLLOW-ON PRODUCTION AWARD AUTHOR-                ‘‘(B) for which—                                       In order to be truly successful, we
                                            ITY.—                                                     ‘‘(i) significant scientific uncertainty and reg-
                                              ‘‘(1) IN GENERAL.—An other transaction en-
                                                                                                                                                           must ensure that all Americans have
                                                                                                    ulatory risk exist; or                                 access to these innovations. Equity and
                                            tered into by the Director under subsection               ‘‘(ii) incentives in the commercial market are
                                            (h)(1) for a project may provide for the award of       unlikely to result in the adequate or timely de-
                                                                                                                                                           promoting the health of all Americans
                                            a follow-on production contract or transaction          velopment of such drug, biological product,            must also be part of ARPA–H’s mis-
                                            to the participants in the transaction by ARPA–         intervention, platform, tool, or device.               sion.
                                            H or another Federal agency. For purposes of              ‘‘(v) AUTHORIZATION OF APPROPRIATIONS.—                The fiscal year 2022 omnibus appro-
                                            this paragraph, such an other transaction in-           There is authorized to be appropriated                 priations law provided the Department




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                                            cludes all individual subprojects awarded under         $500,000,000 for each of fiscal years 2023 through     of Health and Human Services with $1
                                            the transaction to a consortium of United States        2027, to remain available until expended.’’.           billion to get ARPA–H off the ground.
                                            industry and academic institutions.
                                              ‘‘(2) RELATION TO COMPETITIVE PROCE-                    The SPEAKER pro tempore. The bill,                   We must now provide the necessary
                                            DURES.—A follow-on production contract or               as amended, shall be debatable for 1                   and appropriate authorities to make
                                            transaction under paragraph (1) may be award-           hour equally divided and controlled by                 ARPA–H successful, to clarify its mis-
                                            ed to the participants in the transaction without       the Chair and ranking minority mem-                    sion and its organizational structure,



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                                            June 22, 2022                                      CONGRESSIONAL RECORD — HOUSE                                                                 H5799
                                            and ensure that the work at ARPA–H is                                     b 1615                               I encourage the passage of this because
                                            not duplicative or redundant. H.R. 5585                   We most notably ensure this newly                    if we don’t pass it, the money is still
                                            does just that.                                         created agency remains separate from                   going to be spent but without congres-
                                              ARPA–H will be led by a director and                  the NIH. We limit administration costs                 sional guardrails.
                                            cadre of program managers with the                      associated with setting up ARPA–H to                     Mr. Speaker, I support this bill, and
                                            autonomy and authority to develop                       maximize research investments, which                   I reserve the balance of my time.
                                            high-risk, high-reward portfolios. This                                                                          Mr. PALLONE. Mr. Speaker, I yield 3
                                                                                                    would require a strategic plan and
                                            will be coupled with the appropriate                                                                           minutes to the gentlewoman from Cali-
                                                                                                    transparent reporting on projects; de-
                                            contracting, hiring, and procurement                                                                           fornia (Ms. ESHOO), the Health Sub-
                                                                                                    fine the number of offices; and require
                                            authorities that will pull from the best                                                                       committee chair and the author of this
                                                                                                    that the majority of offices within the
                                            minds and resources in the biomedical                                                                          legislation.
                                                                                                    organization be exclusively devoted to                   Ms. ESHOO. Mr. Speaker, I thank the
                                            research ecosystem.                                     biomedical research and development.
                                              This legislation authorizes $500 mil-                                                                        chairman of the full committee for his
                                                                                                      In order to ensure this agency is fos-
                                            lion annually for 5 fiscal years. ARPA–                                                                        full support of this legislation from the
                                                                                                    tering the development of innovative,
                                            H projects will be time- and milestone-                                                                        very beginning.
                                                                                                    transformative health technologies                       Mr. Speaker, this has been somewhat
                                            limited, ensuring that each project de-                 that are not being met by Federal pro-
                                            livers real and measurable results. The                                                                        of a long journey. It began in March of
                                                                                                    grams or private industry, the tech-                   last year, 2021, when a group of Mem-
                                            ARPA–H Act includes reporting re-                       nologies the agency should pursue are
                                            quirements to ensure proper compli-                                                                            bers, bipartisan and bicameral, were in-
                                                                                                    very explicitly defined in the legisla-                vited to the White House to meet with
                                            ance and avoid the redundancy. The di-                  tion before us today.                                  President Biden. When we gathered
                                            rector will be required to submit re-                     The legislation puts guardrails in                   there, he spoke about his vision for cre-
                                            ports on the actions, results, and forth-               place to ensure that priority access is                ating ARPA–H, an advanced research
                                            coming strategic plans of ARPA–H to                     granted to U.S. researchers over re-                   project for health.
                                            Congress so that we can confirm that                    searchers abroad. There are additional                   It is modeled after DARPA, the high-
                                            the agency is meeting our intent.                       requirements for international re-                     ly innovative and successful small
                                              So last month, the Committee on En-                   searchers to work in collaboration with                agency that was created many years
                                            ergy and Commerce advanced H.R. 5585                    a U.S. counterpart if they receive                     ago. I think one of its chief assets is its
                                            by an overwhelming bipartisan vote of                   ARPA–H funding.                                        autonomy, and its successes are ex-
                                            55–3. This was a tremendous achieve-                      Importantly, the bill makes clear                    traordinary because of the way it is
                                            ment and demonstrates Congress’ abil-                   that funding is prohibited from going                  shaped. They have produced the inter-
                                            ity to come together and find solutions                 to nondomestic recipients of a malign                  net, GPS navigation, and Moderna’s
                                            that will improve the health of all                     foreign country, most notably Chinese                  mRNA vaccines.
                                            Americans.                                              research labs or Russian research labs.                  This bill is shaped to maximize the
                                              I thank Health Subcommittee Chair-                    This is a significant step to ensure the               promise of ARPA–H.
                                            woman ESHOO, who is the author of                       United States’ intellectual property                     All of us have a relative or someone
                                            this legislation, along with Health Sub-                isn’t being stolen by our adversaries                  in our family, extended family, and our
                                            committee Ranking Member GUTHRIE,                       and to ensure we remain the world                      communities that when receiving a di-
                                            our full committee Ranking Member                       leader in biomedical research and inno-                agnosis, it is a death sentence. That is
                                            RODGERS, and also Representatives                       vation.                                                what the mission of ARPA–H is di-
                                            DeGette and Upton for their work on                       As the Republican leader on the                      rected to address. I have full con-
                                            this important bill.                                    Health Subcommittee, I am leading ef-                  fidence that, the way this legislation is
                                              Mr. Speaker, I strongly urge my col-                  forts to strengthen oversight of NIH-                  shaped, it can meet that challenge.
                                            leagues to support H.R. 5585, and I re-                 funded research. It is unacceptable                      It will be a place where highly inno-
                                            serve the balance of my time.                           that some Federal grants have been                     vative ideas are tested, and if the ap-
                                              Mr. GUTHRIE. Mr. Speaker, I yield                     supporting foreign researchers with                    proaches fail because these are high-
                                            myself such time as I may consume.                      ties to governments of adversarial na-                 risk undertakings, then the agency will
                                              Mr. Speaker, I rise to speak in sup-                  tions like China. We must prevent this                 quickly move on to new ones and redi-
                                            port of the Advanced Research Projects                  from happening moving forward.                         rect the money. It will be flat and
                                            Agency-Health Act, or ARPA–H Act. I                       Mr. Speaker, I emphasize the need to                 small like DARPA, but it has a mighty
                                            know this has been an important pri-                    pass this bill. The funding has already                mission.
                                            ority for researchers, industry, and,                   been appropriated in a previous year. If                 Mr. Speaker, I thank all the members
                                            most importantly, patients who are                      we don’t pass this bill and don’t au-                  of the Energy and Commerce Com-
                                            waiting for life-changing medical tech-                 thorize this agency to move forward,                   mittee on the majority and the minor-
                                            nology to improve or even save their                    then this will erode our oversight role                ity side. We have really worked hard
                                            lives.                                                  in Congress. Funding decisions made                    together on this to shape something
                                              This legislation will authorize the es-               by ARPA–H must require diligence to                    that is worthy of the American people
                                            tablishment of ARPA–H within the                        ensure that resources are being spent                  and has the ability to produce. From
                                            U.S. Department of Health and Human                     as appropriately and as effectively as                 the chairman of the full committee to
                                            Services. The agency will specifically                  possible.                                              the ranking member, Mrs. McMorris
                                            be charged with helping to foster high-                   The Biden administration ARPA–H                      Rodgers, to the ranking member of the
                                            risk, high-reward treatments and cures                  organizational chart, without this bill,               subcommittee, Mr. GUTHRIE, ideas kept
                                            for diseases with clinically unmet                      has 14 offices, less than half of which                coming forward. We polished them,
                                            needs.                                                  are actually dedicated to research.                    added them to the legislation, and, in
                                              Some of my colleagues may be con-                     This gives us insight into how the                     some instances, dropped other parts of
                                            cerned about a new agency, and that is                  Biden administration would manage                      the draft.
                                            where a number of Republicans on the                    this new agency without congressional                    Mr. Speaker, I acknowledge the work
                                            Committee on Energy and Commerce                        guidance. It is just appropriate that                  of my staffer, Aisling McDonough, who
                                            were early in October when this legis-                  the legislative branch sets up the way                 has given her all on this; the staff of
                                            lation was introduced.                                  this money is being spent.                             the committee; the scientists, because
                                              ARPA–H was funded at $1 billion in                      That is what the bill before us today                well over 100 of them leaned in and
                                            the previous appropriations bill in 2021.               does. It puts ARPA–H on the right                      gave us their ideas and advice on how
                                            To ensure that funding was used for the                 track, gives Congress the opportunity                  best to create a small agency that




ctelli on DSK11ZRN23PROD with HOUSE
                                            best possible result, the Committee on                  to set high standards, and promotes                    would be nimble but highly effective;
                                            Energy and Commerce for the past sev-                   greater biomedical research and inno-                  and the patient advocates. So many of
                                            eral months has worked hard to ensure                   vation for patients.                                   them have cheered us on and given us
                                            that ARPA–H has a clear mission. As a                     Mr. Speaker, I thank the majority                    their best input, as well.
                                            result, it passed out of committee with                 for working together. I thank our staff                  Today is the day. The House is
                                            a strong 55-to-3 vote.                                  for the excellent work they have done.                 poised. I urge all of my colleagues to



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                                            H5800                                              CONGRESSIONAL RECORD — HOUSE                                                       June 22, 2022
                                            support this because when this mission                  We had very productive negotiations to                 age just before us with the mental
                                            is executed, I think even if one deadly                 properly define ARPA–H’s mission and                   health package. At every step of the
                                            disease is addressed and cured, we will                 place strong safeguards for trans-                     way, I am grateful for their hard work
                                            have succeeded. I think we are going to                 parency and accountability.                            and passion.
                                            do better than that.                                      This bill defines ARPA–H’s mission                     Mr. Speaker, I urge a ‘‘yes’’ vote on
                                              Mr. GUTHRIE. Mr. Speaker, I yield 5                   so that it is laser-focused on high-risk               H.R. 5585, the Advanced Research
                                            minutes to the gentlewoman from                         breakthrough technologies in health                    Projects Agency-Health Act.
                                            Washington (Mrs. RODGERS), who is the                   and medicine that are not being ad-                      Mr. PALLONE. Mr. Speaker, I yield 3
                                            Republican leader of the full com-                      dressed by the private sector or current               minutes to the gentlewoman from Col-
                                            mittee.                                                 Federal programs.                                      orado (Ms. DEGETTE), the chair of our
                                              Mrs. RODGERS of Washington. Mr.                         This bill also prohibits Federal fund-               Energy and Commerce Oversight and
                                            Speaker, America is the envy of the                     ing to China, Russia, and other recipi-                Investigations Subcommittee who has
                                            world for our leadership in biomedical                  ents subject to malign foreign influ-                  also worked on ARPA–H in the very be-
                                            innovation. People from all over the                    ence.                                                  ginning.
                                            world have an incredible amount of                        It moves the agency back outside of                    Ms. DEGETTE. Mr. Speaker, I am so
                                            hope in the promise of our lifesaving,                  NIH.                                                   honored to stand here today in support
                                            breakthrough research for more cures                      We are also making sure ARPA–H                       of this legislation, which will revolu-
                                            and treatments.                                         sets the right priorities. The director                tionize how our Nation researches and
                                              That is why I have been a longtime                    must provide Congress with a strategic                 develops new cures and treatments for
                                            supporter of NIH and projects like the                  plan within 1 year of enactment and                    some of the world’s most difficult dis-
                                            BRAIN Initiative intended to speed sci-                 every 3 years on how ARPA–H will                       eases.
                                            entific research necessary to accelerate                carry out projects. Projects will be                     There is not a person in this room or
                                            cures for neurologic diseases.                          evaluated every 18 months, and those                   in this Capitol who hasn’t been im-
                                              When the concept of ARPA–H was                        not meeting milestones are expected to                 pacted in some way by a devastating
                                            first proposed to me, I expressed a                     be terminated.                                         disease—cancer, Alzheimer’s, or some-
                                            healthy dose of skepticism.                               We placed guardrails on ARPA–H to                    thing else. These diseases don’t care if
                                              First, I was concerned about a clear                  prioritize projects that provide the                   you are a Democrat or a Republican.
                                            and targeted strategic mission. I was                   greatest return on investment to im-                   They affect all of us. It needs to be our
                                            concerned an unfocused agenda would                     prove    human     health    and    lower              collective mission to cure all of them
                                            not be a recipe for success.                            healthcare costs.                                      immediately.
                                              The second was the issue of duplica-                    This bill also keeps the focus on life-                The ripple effect that they have on
                                            tion. The Federal Government has sev-                   saving research. The director will have                our communities is immeasurable. The
                                            eral agencies that advance biomedical                   the power to hire and make appoint-                    pain and suffering that they cause, not
                                            innovation. Within the National Insti-                  ments based on merit and expertise,                    just to those who become ill but to
                                            tutes of Health alone, we already have                  not based on provisions that reward                    their families, friends, and loved ones,
                                            the National Center for Advancing                       government bureaucrats.                                is irreparable. They place significant
                                            Translational Science, the Cures Accel-                   We require those who receive ARPA–                   strain on our public health systems
                                            eration Network, the Common Fund,                       H funding to provide a public itemized                 and significant strain on our economy.
                                            and the Foundation for NIH’s Accel-                     report on indirect facilities and admin-                 For years, scientists and researchers,
                                            erating Medicines Partnership Pro-                      istrative costs.                                       both here in the U.S. and around the
                                            gram, to name a few.                                      To further cut down on duplication                   world, have been searching for ways to
                                              Third, I was concerned that the cre-                  and mission creep, we limited the num-                 prevent and treat these devastating ill-
                                            ation of a new agency would lack suffi-                 ber of offices to 6, not the 14 proposed               nesses.
                                            cient transparency and oversight. My                    by the administration. Of those offices,
                                                                                                    at least four must be exclusively fo-                                    b 1630
                                            questions to supporters of ARPA–H in-
                                            cluded:                                                 cused on R&D. In addition, not more                      I see my friend and colleague FRED
                                              How will projects be selected?                        than 15 percent of the total agency                    UPTON here on the floor with us today.
                                              How will the public be kept informed                  funding is allowed to go to administra-                Fred and I worked on the 21st Century
                                            of projects and project funding?                        tive costs.                                            Cures bill in 2016 which has revolution-
                                              Who will be assessing for duplication                   Mr. Speaker, I will close by thanking                ized the way we do a lot of this dis-
                                            of Federal programs, and how will it be                 my colleagues for working together on                  covery and development. But what we
                                            managed?                                                this. I especially recognize the leader-               need more of now is an all-hands-on-
                                              What measure will be used to define                   ship of Chairman PALLONE, Health Sub-                  deck approach to end these illnesses,
                                            success?                                                committee Chairwoman ESHOO, Health                     and that is exactly why this legislation
                                              What are the guardrails to ensure                     Subcommittee       Republican      leader              was developed.
                                            that we are supporting American                         BRETT GUTHRIE, as well as the 21st Cen-                  As Ms. ESHOO, Mr. PALLONE, and oth-
                                            innovators?                                             tury Cures leaders FRED UPTON and                      ers said, it will create a new Advanced
                                              These concerns were validated earlier                 DIANA DEGETTE.                                         Research Projects Agency for Health,
                                            this year when the administration                         I am pleased we were able to come to-                ARPA–H, which will bring together
                                            began implementing the $1 billion that                  gether. We put ARPA–H on the right                     some of the world’s greatest minds and
                                            was appropriated to set up ARPA–H                       path with a targeted mission, increased                give them access to the Federal Gov-
                                            with little to no congressional direc-                  accountability and transparency, and a                 ernment’s seemingly unlimited re-
                                            tion. The Biden administration pro-                     laser focus on promoting American                      sources to make the impossible pos-
                                            posed 14 offices within ARPA–H.                         innovators. It is a strong example of                  sible.
                                            DARPA has six to eight. They also                       E&C’s bipartisan record of success in                    Mr. Speaker, modeled after the
                                            placed ARPA–H within NIH, which has                     moving legislation that will continue                  DARPA program, as you heard, the
                                            its own issues in lacking transparency                  America’s global leadership in bio-                    new agency will be lean and it will be
                                            and accountability related to federally                 medical research.                                      mean. It will be targeted at specifically
                                            funded research and the origins of                        Mr. Speaker, before I close, I want to               researching and finding cures for some
                                            COVID–19.                                               applaud and thank the members of my                    of the most intractable diseases that
                                              We needed to ensure proper oversight                  team:     Grace      Graham,     Kristen               we have.
                                            and provide guardrails through con-                     Shatynski, Seth Gold, Kristin Flukey,                    It is going to be run by a small num-




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                                            gressional direction, so we plowed the                  and Kristin Ashford.                                   ber of program managers, and it will be
                                            hard ground necessary to legislate                        They say that Energy and Commerce                    able to take on the high-risk, high-re-
                                            through the Energy and Commerce                         has the best staff on the Hill, and that               ward projects that others simply can-
                                            Committee. Chairman FRANK PALLONE                       is certainly evident through their serv-               not. It will not substitute for the basic
                                            and Health Subcommittee Chairwoman                      ice to deliver hope and healing, both                  research at the NIH or the research at
                                            ANNA ESHOO listened to my concerns.                     through this bill and through the pack-                our great universities or in private



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                                            June 22, 2022                                      CONGRESSIONAL RECORD — HOUSE                                                               H5801
                                            business. It will supplement it by tar-                 Research Projects entity—that was our                    We do. We are the Energy and Com-
                                            geting these tough issues, and it will                  goal—DARPA. It is going to be game-                    merce Committee, and we are going to
                                            reshape the future of biomedical re-                    changing,      health    research.  Like               find a cure for these diseases. This bill
                                            search in this country for many, many                   DARPA, this entity is going to be fo-                  is a step in that direction.
                                            years to come.                                          cused on producing research on things                    Mr. GUTHRIE. Mr. Speaker, I reserve
                                               As I said, this legislation is an oppor-             that, frankly, may be too risky for the                the balance of my time.
                                            tunity. It is an opportunity to put our                 private sector. It is going to move at a                 Mr. PALLONE. Mr. Speaker, I must
                                            country on track to ending cancer as                    faster pace than the current structure.                say that for many years we had a Con-
                                            we know it. It is an opportunity to save                There may be a high failure rate, but                  gressman Brown on the committee who
                                            millions of lives. If we cure cancer, and               its successes are going to have the po-                contributed a lot, particularly on
                                            if we save lives and improve the health                 tential       to       be      absolutely              healthcare issues. He chaired the
                                            and well-being of our constituents,                     groundbreaking, answering the prayers                  Health Subcommittee. So it is an
                                            isn’t that what we came here for?                       of millions.                                           honor to hear from Ms. BROWN of Ohio.
                                               Mr. Speaker, I urge everyone to vote                   It really is a follow-up to what we did              We have another Congresswoman
                                            ‘‘yes.’’                                                in this body with the 21st Century                     BROWN from Ohio.
                                               Mr. GUTHRIE. Mr. Speaker, as the                     Cures with the UPTON and DEGETTE ef-                     Mr. Speaker, I yield 3 minutes to the
                                            chair of this committee, Mr. UPTON                      fort that passed our committee 53–0,                   gentlewoman from Ohio (Ms. BROWN).
                                            made his signature issue the 21st Cen-                  then passed here on the House floor                      Ms. BROWN of Ohio. Mr. Speaker, I
                                            tury Cures, and not just passing that                   392–26.                                                thank Chairman PALLONE for yielding,
                                            which has changed people’s lives al-                      There has been a lot of debate on                    and I thank Congresswoman ESHOO for
                                            ready but being able to work with Ms.                   where ARPA–H is going to be housed.                    her leadership on this bill.
                                            DEGETTE and all the others to say that                    Should it be in NIH?                                   I applaud President Biden for having
                                            this is something we all need to work                     Should it be in HHS or someplace                     the foresight to propose the creation of
                                            on together in a bipartisan way and                     else?                                                  an Advanced Research Projects Agency
                                                                                                      Wherever this entity is finally lo-                  for Health, also known as ARPA–H, an
                                            make a big difference.
                                                                                                    cated, we need to make sure that it is                 agency tasked with driving break-
                                               Now as chair emeritus, this is, I
                                                                                                    lean, that it is independent and nimble,               throughs in cancer, diabetes, Alz-
                                            think, his signature piece. He may
                                                                                                    and that there are the appropriate                     heimer’s, and other difficult diseases.
                                            have other pieces of legislation, too,
                                                                                                    guardrails to keep other agencies from                   The new science moonshot agency is
                                            but this is the one that I have worked
                                                                                                    mission creep and siphoning that fund-                 modeled on the successes of the De-
                                            on with him in the very beginning in
                                                                                                    ing. The legislation that was intro-                   fense Advanced Research Projects
                                            the Oval Office with the President. We
                                                                                                    duced did a very good job of that and I                Agency, also known as DARPA. For
                                            worked together to say: Can we do
                                                                                                    am pleased to see that these protec-                   decades DARPA has driven advances in
                                            something big that is really going to
                                                                                                    tions were strengthened in the final                   technologies that have changed our
                                            change the lives of people in this coun-
                                                                                                    product that we are going to be voting                 lives for the better. Yet, there are so
                                            try?
                                               He has done it. He has done it his en-               on this afternoon.                                     many things that we take for granted,
                                                                                                      My partner in 21st Century Cures,                    things like the internet and flat-screen
                                            tire career. He is a mentor of mine,
                                                                                                    DIANA DEGETTE, and really everybody                    displays. I am confident the same will
                                            and, unfortunately, at the end of this
                                                                                                    on our committee were happy to in-                     be true for ARPA–H as it seeks to ac-
                                            year he is going to do something dif-
                                                                                                    clude language for ARPA–H in our                       celerate advancements in health and
                                            ferent than being here in Congress. He
                                                                                                    Cures 2.0 bill that we introduced more                 medicine. Thanks to President Biden’s
                                            will be missed for his voice and being a
                                                                                                    than a year ago. We thought that it                    leadership, my colleagues in Congress
                                            champion of this issue.
                                                                                                    was a great follow-up to the work that                 funded ARPA–H in March for the cur-
                                               Mr. Speaker, I am going to yield to
                                                                                                    we did to enhance basic research on the                rent fiscal year.
                                            him so that he can speak on this bill
                                                                                                    first Cures bill which added $45 bil-                    Yet in order to successfully carry out
                                            for himself. The gentleman certainly
                                                                                                    lion—paid for—in additional health re-                 its mission, ARPA–H needs long-term
                                            has left a legacy here with the previous
                                                                                                    search.                                                resources and authorities. That is ex-
                                            legislation and this piece of legislation.                Funding for the NIH and the FDA in-
                                            So let’s work together to move it for-                                                                         actly what this bill does. The ARPA–H
                                                                                                    cluded many important things such as
                                            ward.                                                                                                          legislation would authorize the agency
                                                                                                    the Cancer Moonshot and the Brain
                                               Mr. Speaker, I yield 3 minutes to the                                                                       for 5 years and create the structure it
                                                                                                    Initiative.
                                            gentleman from Michigan (Mr. UPTON).                      We are still in a pandemic. We have                  needs to successfully drive break-
                                               Mr. UPTON. Mr. Speaker, I thank my                   awful diseases that need cures, whether                throughs that would otherwise die in
                                            very good friend, and I certainly appre-                it be cancer, Alzheimer’s, lupus, or dia-              the commercial market.
                                            ciate his kind words. The good news is                                                                           Yet ARPA–H not only needs long-
                                                                                                    betes that strike literally every single
                                            I am not done yet. We have a lot of                                                                            term funding but also a long-term
                                                                                                    family.
                                            work to do, and this is yet one more                      The SPEAKER pro tempore. The                         home. ARPA–H’s mission is centered
                                            piece that we are going to be driving                   time of the gentleman has expired.                     around high-risk, high-reward re-
                                            forward. But, certainly, I rise in sup-                   Mr. GUTHRIE. Mr. Speaker, I yield                    search, which is a charge that Cleve-
                                            port of this legislation, the ARPA–H                    the gentleman from Michigan an addi-                   land has historically proven it is pre-
                                            authorization bill.                                     tional 1 minute.                                       pared to lead. With world-class
                                               While I have been a longtime sup-                      Mr. UPTON. This bill, ARPA–H, can                    healthcare systems, top-tier institu-
                                            porter of many different versions of                    provide the breakthroughs necessary to                 tions of higher education, advanced
                                            this bill, I thank, in particular, Chair-               find cures for those diseases. The Presi-              biomedical companies, and a highly
                                            man PALLONE, my Republican Leader                       dent has already signed $1 billion for                 skilled     manufacturing     workforce,
                                            RODGERS, certainly ANNA ESHOO—who                       this program into law. So what we need                 Cleveland has a long track record of
                                            is my good friend—and BRETT GUTHRIE                     now is bipartisan authorization to                     bringing cutting-edge innovations from
                                            for their leadership on working to-                     complete the work. This bill certainly                 discovery all the way to production.
                                            gether on language with the goal of                     accomplishes that goal.                                This includes groundbreaking medical
                                            really making this issue bipartisan and                   Mr. Speaker, I urge all of my col-                   advancements like the first face trans-
                                            one that is going to work.                              leagues, like we did before, to vote for               plant in America as well as the region’s
                                               I am glad that we came together to                   this bill a little bit later this after-               cutting-edge cancer research.
                                            add even more important guardrails to                   noon. Again, I just want to commend                      Now, wherever the agency lands, it




ctelli on DSK11ZRN23PROD with HOUSE
                                            ensure that this bill, ARPA–H, works                    our great staff. As our leader, Con-                   will have a meaningful impact on the
                                            as it was intended as well as, hopefully,               gresswoman RODGERS, said: We have                      lives of Americans nationwide for gen-
                                            have a very strong bipartisan vote a                    the best staff there is.                               erations to come. Creating ARPA–H
                                            little bit later this afternoon.                          Is there any objection to that?                      with 1 year of funding was a good first
                                               This bill is going to establish an enti-               Hearing     none—sorry,     Ways   and               step, but it is time to put this new
                                            ty not unlike the Defense Advanced                      Means; sorry appropriators.                            breakthrough agency on firm footing



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                                            H5802                                              CONGRESSIONAL RECORD — HOUSE                                                           June 22, 2022
                                            and in a firm location so we can truly                  have spoken and everybody else who is                   printed in part C of House Report 117–
                                            start to revolutionize how we prevent,                  working on this together on our staff.                  381.
                                            treat, and cure a range of diseases.                       Mr. Speaker, I think it is important                   Ms. ESHOO. Mr. Speaker, I have an
                                              Mr. Speaker, I thank Chairman PAL-                    that we pass this bill. I urge my col-                  amendment at the desk made in order
                                            LONE again for his leadership, and I                    leagues to vote for the bill tonight, and               under the rule.
                                            urge my colleagues to support the bill.                 I yield back the balance of my time.                      The SPEAKER pro tempore. The
                                              Mr. GUTHRIE. Mr. Speaker, I reserve                      Mr. PALLONE. Mr. Speaker, I yield                    Clerk will designate the amendment.
                                            the balance of my time.                                 myself the balance of my time to close.                   The text of the amendment is as fol-
                                              Mr. PALLONE. Mr. Speaker, I yield 3                      Mr. Speaker, I just want to say in                   lows:
                                            minutes to the gentleman from Massa-                    closing that I think you can feel the
                                                                                                                                                              Page 3, line 13, strike ‘‘There is estab-
                                            chusetts (Mr. AUCHINCLOSS), who is also                 real enthusiasm and the hope that is                    lished’’ and insert the following:
                                            very much involved in healthcare                        involved with both the sponsors of this                   (1) IN GENERAL.—There is established
                                            issues with regard to the pharma-                       bill and those who spoke on both sides                    Page 3, after line 23, insert the following:
                                            ceutical industry and so many other                     of the aisle.                                             (2) ORGANIZATION.—
                                            health issues.                                             We consider ourselves, the Energy                      (A) IN GENERAL.—There shall be within
                                              Mr. AUCHINCLOSS. Mr. Speaker, I                       and Commerce Committee, the innova-                     ARPA–H—
                                            strongly support Chairwoman ESHOO’s                     tion committee, and I think this is a                     (i) an Office of the Director;
                                            bill to create an Advanced Research                     prime example of the type of innova-                      (ii) not more than 6 program offices; and
                                            Projects Agency. This bill will ensure                  tion that we see for the future and the                   (iii) such special project offices as the Di-
                                                                                                    hope in ARPA–H.                                         rector may establish.
                                            that ARPA–H can address the limita-                                                                               (B) PROGRAM OFFICES DEDICATED TO RE-
                                            tions of commercial markets and tack-                      Mr. Speaker, I would ask for every-
                                                                                                                                                            SEARCH AND DEVELOPMENT.—Not fewer than
                                            le high-risk, high-reward biomedical                    one on a bipartisan basis to vote for
                                                                                                                                                            two-thirds of the program offices of ARPA–H
                                            research in oncology, neuroscience, di-                 this, so we have a strong vote, and I                   shall be exclusively dedicated to research
                                            abetes, artificial intelligence, mRNA                   yield back the balance of my time.                      and development.
                                            and RNA, cell and gene therapy, and so                     Mr. COLE. Mr. Speaker, I support H.R.
                                                                                                                                                              Page 6, line 16, strike ‘‘with the advice and
                                            much more.                                              5585, the Advanced Research Projects Agen-              consent of the Senate,’’.
                                              As the global epicenter of break-                     cy—Health Act. During my time in Congress,                Page 14, strike line 19, and all that follows
                                            through science, Massachusetts is a top                 I have been a strong supporter of basic med-            through page 16, line 6, and insert the fol-
                                            candidate to host the headquarters of                   ical research, and I recognize the potential            lowing:
                                            ARPA–H. Not only are we home to the                     translational medical research holds when it              ‘‘(3) UTILIZATION OF LEASE FUNDS.—The Di-
                                            highest proportion of top-ranked re-                    builds off this prior research. The discoveries         rector shall deposit amounts of cash consid-
                                                                                                    made by our scientists at NIH and at NIH-               eration received for a lease entered into
                                            search universities in the world, but we                                                                        under this subsection in the ‘Advanced Re-
                                                                                                    funded universities across the nation have the
                                            also have the best and brightest in in-                                                                         search Projects Agency for Health’ account
                                                                                                    potential to transform the delivery of health
                                            dustry, healthcare, and academia.                                                                               as discretionary offsetting collections, and
                                              We have also invested in infrastruc-                  care and the prevention, treatment, and ulti-
                                                                                                                                                            such amounts shall be available only to the
                                            ture to support the needs of ARPA–H.                    mately curing of disease.                               extent and in the amounts provided in ad-
                                                                                                       That support for research and its potential to       vance in appropriations Acts—
                                            Over the past decade, we have delivered
                                                                                                    transform the delivery of health care led me to           ‘‘(A) to cover the full costs to ARPA–H in
                                            21.6 million square feet of lab space, in               be an initial supporter of ARPA–H. In collabo-
                                            addition to over 100 incubators, accel-                                                                         connection with the lease;
                                                                                                    ration with my colleagues on the Appropria-               ‘‘(B) for maintenance, capital revitaliza-
                                            erators, and co-working spaces.                         tions Committee, we provided ARPA–H with                tion, and improvements of the real property
                                              This bill specifically directs ARPA–H
                                                                                                    some initial funding in the Fiscal Year 2022            assets and related personal property under
                                            to advance early disease detection,                     omnibus.                                                the jurisdiction of the Director; and
                                            translational research, and health                         However, we are appropriators, not author-             ‘‘(C) for maintenance, capital revitaliza-
                                            technologies. It realizes President                     izers, and many of the basic decisions about            tion, and improvements of the real property
                                            Biden’s goal of driving breakthroughs                   the structure and functions of the agency had           assets and related personal property at the
                                            in cancer, Alzheimer’s, diabetes, and                                                                           respective center or facility of ARPA–H en-
                                                                                                    to be left unmade and instead be delegated to
                                            infectious disease. From pre-competi-                                                                           gaged in the lease, subject to the concur-
                                                                                                    the Secretary of Health and Human Services.             rence of the Director.’’.
                                            tive Alzheimer’s research at the Massa-                 As I mentioned to him when he came before                 Page 26, lines 15 through 19, amend para-
                                            chusetts General Hospital to Vertex’s                   my subcommittee this spring, Congress still             graph (3) to read as follows:
                                            work to utilize stem cell therapies to                  did not know how grants would be made or                  ‘‘(3) not award any grants, cooperative
                                            treat diabetes, we are aligned with and                 funded or how ARPA–H would interface with               agreements, contracts, prizes, and other
                                            deeply committed to ARPA–H’s goal in                    NIH.                                                    transactions to nondomestic recipients orga-
                                            the Commonwealth.                                          I am pleased that this bill from the House           nized under the laws of a covered foreign
                                              I am proud to represent a State that                  Energy and Commerce Committee answers                   country (as defined in section 119C of the Na-
                                            is deeply invested in the success of                    these questions and provides Congress the               tional Security Act of 1947); and
                                            ARPA–H.                                                 opportunity to shape this agency in line with             Page 34, lines 23 and 24, strike ‘‘There is
                                              Mr. Speaker, I urge my colleagues to                                                                          authorized’’ and insert the following:
                                                                                                    our original intent. I am especially pleased that         (1) IN GENERAL.—To carry out this section,
                                            support this legislation.                               the resulting bill is fiscally responsible and will     there is authorized
                                              Mr. GUTHRIE. Mr. Speaker, I yield                     ensure proper oversight of ARPA–H as it im-               Page 35, after line 2 (but before the close
                                            myself the balance of my time.                          plements this new research arm. H.R. 5585               quotation mark and second period) insert the
                                              Mr. Speaker, it is important we are                   establishes ARPA–H as an independent agen-              following:
                                            here today.                                             cy within HHS—separate from NIH—and pro-                  (2) ADMINISTRATIVE EXPENSES.—Not more
                                              I thank the chair of the other sub-                   vides its director with independence from NIH.          than 15 percent of the amounts made avail-
                                            committee whom I have the privilege                     It also establishes clear agency goals and              able to carry out this section for any fiscal
                                            to work alongside as the Republican                     mission and provides a framework for coordi-            year may be used for administrative ex-
                                            leader. She has been a champion of                      nation to ensure ARPA–H’s efforts will not du-          penses to operate ARPA–H.
                                            ARPA–H as it first came out and at the                  plicate or cannibalize the research efforts of            The SPEAKER pro tempore. Pursu-
                                            first meeting at the White House. We                    other federal agencies, particularly NIH. Impor-        ant to House Resolution 1191, the gen-
                                            have discussed quite a bit about where                  tantly, it also prohibits awards being made to          tlewoman from California (Ms. ESHOO)
                                            it should be and what the guardrails                    foreign researchers and entities operating at           and a Member opposed each will con-
                                            should be.                                              behest of or in concert with our adversaries.           trol 5 minutes.
                                              I know the funding got out in front of                   I urge my colleagues to support this legisla-          The Chair recognizes the gentle-
                                            it. We all really wanted Congress to                    tion.                                                   woman from California.




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                                            have a say in how this agency operated                     The SPEAKER pro tempore. All time
                                            and not the executive branch the way,                   for debate on the bill has expired.                                      b 1645
                                            unfortunately, getting in front of au-                       AMENDMENT NO. 1 OFFERED BY MS. ESHOO OF              Ms. ESHOO. Mr. Speaker, I yield my-
                                            thorization does.                                                         CALIFORNIA                            self such time as I may consume.
                                              I appreciate the hard work. I appre-                    The SPEAKER pro tempore. It is now                      I offer this bipartisan manager’s
                                            ciate the work of the colleagues who                    in order to consider amendment No. 1                    amendment to improve and strengthen



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                                            June 22, 2022                                      CONGRESSIONAL RECORD — HOUSE                                                                         H5803
                                            the bill. I thank my Republican col-                       Mrs. BOEBERT. Mr. Speaker, on that                                     [Roll No. 281]
                                            leagues on the Health Subcommittee,                     I demand the yeas and nays.                                                YEAS—387
                                            including Ranking Member MCMORRIS                          The SPEAKER pro tempore. Pursu-                      Adams             Deutch            Kelly (PA)
                                            RODGERS, Ranking Member GUTHRIE,                        ant to section 3(s) of House Resolution                 Aderholt          Diaz-Balart       Khanna
                                            and Dr. BURGESS for working closely                     8, the yeas and nays are ordered.                       Aguilar           Dingell           Kildee
                                                                                                                                                            Allen             Doggett           Kilmer
                                            with me on this bill over the last sev-                    Pursuant to clause 8 of rule XX, fur-                Allred            Doyle, Michael    Kim (CA)
                                            eral weeks.                                             ther proceedings on this question are                   Amodei              F.              Kim (NJ)
                                              This manager’s amendment makes                        postponed.                                              Armstrong         Duncan            Kind
                                            sure that the structure of ARPA–H will                                                                          Arrington         Dunn              Kinzinger
                                                                                                       Pursuant to clause 1(c) of rule XIX,                 Auchincloss       Ellzey            Kirkpatrick
                                            help the Agency achieve success. Spe-                   further consideration of H.R. 5585 is                   Axne              Emmer             Krishnamoorthi
                                            cifically, the amendment requires:                      postponed.                                              Babin             Escobar           Kuster
                                            First, two-thirds of the ARPA–H pro-                                                                            Bacon             Eshoo             Kustoff
                                            gram offices be exclusively dedicated                                      f                                    Baird             Espaillat         LaHood
                                                                                                                                                            Balderson         Estes             LaMalfa
                                            to research and development; number                     ANNOUNCEMENT BY THE SPEAKER                             Barr              Evans             Lamb
                                            two, not more than 15 percent of the                                PRO TEMPORE                                 Barragán         Feenstra          Lamborn
                                            ARPA–H budget to be used on adminis-                                                                            Bass              Ferguson          Langevin
                                            trative expenses; and, thirdly, removes                   The SPEAKER pro tempore. Pro-                         Beatty            Fischbach         Larsen (WA)
                                            the requirement of Senate confirma-                     ceedings will resume on questions pre-                  Bentz             Fitzgerald        Larson (CT)
                                                                                                    viously postponed. Votes will be taken                  Bera              Fitzpatrick       Latta
                                            tion of the ARPA–H director.                                                                                    Bergman           Fleischmann       LaTurner
                                              I think these are commonsense provi-                  in the following order:                                 Beyer             Fletcher          Lawrence
                                            sions that improve the bill and, ulti-                    The following questions on H.R. 7666:                 Bice (OK)         Flores            Lawson (FL)
                                                                                                      En bloc amendments No. 1;                             Bilirakis         Foster            Lee (CA)
                                            mately, strengthen ARPA–H and its                                                                               Bishop (GA)       Frankel, Lois     Lee (NV)
                                            mission; and it is why I urge my col-                     En bloc amendments No. 2;                             Blumenauer        Franklin, C.      Leger Fernandez
                                            leagues to support this amendment.                        Amendment No. 4 by Mrs. DEMINGS of                    Blunt Rochester     Scott           Lesko
                                              Mr. Speaker, I yield back the balance                 Florida;                                                Bonamici          Fulcher           Letlow
                                                                                                      Amendment No. 6 by Mrs. RODGERS of                    Bost              Gallagher         Levin (CA)
                                            of my time.                                                                                                     Bourdeaux         Gallego           Levin (MI)
                                              Mr. GUTHRIE. Mr. Speaker, I claim                     Washington;                                             Bowman            Garamendi         Lieu
                                            the time in opposition, even though I                     Amendment No. 8 by Mr. GRIFFITH of                    Boyle, Brendan    Garbarino         Lofgren
                                            am not opposed to the bill.                             Virginia;                                                 F.              Garcia (CA)       Long
                                              The SPEAKER pro tempore. Without                                                                              Brady             Garcı́a (IL)      Lowenthal
                                                                                                      Motion to recommit, if offered;                       Brown (MD)        Garcia (TX)       Lucas
                                            objection, the gentleman from Ken-                        Passage of the bill, if ordered;                      Brown (OH)        Gibbs             Luetkemeyer
                                            tucky is recognized for 5 minutes.                        The following questions on H.R. 5585:                 Brownley          Gimenez           Luria
                                              There was no objection.                                 Amendment No. 1 by Ms. ESHOO of                       Buchanan          Gohmert           Lynch
                                              Mr. GUTHRIE. Mr. Speaker, the                         California;
                                                                                                                                                            Bucshon           Golden            Mace
                                            Chair of the subcommittee kind of                                                                               Budd              Gomez             Malinowski
                                                                                                      Motion to recommit, if offered;                       Burgess           Gonzales, Tony    Malliotakis
                                            went through what the amendment                                                                                 Bush              Gonzalez (OH)     Maloney,
                                                                                                      Passage of the bill, if ordered; and
                                            says. Another thing that we need to                                                                             Bustos            Gonzalez,           Carolyn B.
                                                                                                      The motion to suspend the rules and
                                            make sure is reinforced is that the                                                                             Butterfield         Vicente         Maloney, Sean
                                                                                                    pass H.R. 6538.                                         Calvert           Gottheimer        Mann
                                            amendment would ensure that agency
                                                                                                      The first electronic vote will be con-                Cammack           Granger           Manning
                                            and precious U.S. taxpayer dollars can                                                                          Carbajal          Graves (LA)       Matsui
                                            never go to nondomestic recipients or-                  ducted as a 15-minute vote. Pursuant
                                                                                                                                                            Cárdenas         Graves (MO)       McBath
                                            ganized under the laws of a covered for-                to clause 9 of rule XX, remaining elec-                 Carey             Green (TN)        McCarthy
                                            eign entity as defined by the National                  tronic votes will be conducted as 5-                    Carl              Green, Al (TX)    McCaul
                                                                                                    minute votes.                                           Carson            Griffith          McClain
                                            Security Act of 1947. This includes                                                                             Carter (GA)       Grijalva          McCollum
                                            China, Russia, Iran, and North Korea.                                      f                                    Carter (LA)       Grothman          McEachin
                                            So I want to make sure we understand                                                                            Carter (TX)       Guest             McGovern
                                            that.                                                   RESTORING HOPE FOR MENTAL                               Cartwright        Guthrie           McHenry
                                                                                                      HEALTH AND WELL-BEING ACT                             Case              Harder (CA)       McKinley
                                              I said this on the debate on the bill                                                                         Casten            Harris            McNerney
                                            that the Chair and I were talking back                    OF 2022                                               Castor (FL)       Harshbarger       Meeks
                                            and forth. And I understood the mis-                      The SPEAKER pro tempore. Pursu-                       Castro (TX)       Hartzler          Meijer
                                                                                                                                                            Cawthorn          Hayes             Meng
                                            sion of what we wanted to accomplish                    ant to clause 1(c) of rule XIX, further                 Chabot            Hern              Meuser
                                            with ARPA–H, but I was concerned                        consideration of the bill (H.R. 7666) to                Cheney            Herrell           Mfume
                                            about the application of it and how it                  amend the Public Health Service Act                     Cherfilus-        Herrera Beutler   Miller (WV)
                                            would actually be put into place. We                    to reauthorize certain programs relat-                    McCormick       Higgins (LA)      Miller-Meeks
                                                                                                                                                            Chu               Higgins (NY)      Moolenaar
                                            had a lot of discussions based on that.                 ing to mental health and substance use                  Cicilline         Himes             Mooney
                                              This amendment really does define as                  disorders, and for other purposes will                  Clark (MA)        Hinson            Moore (UT)
                                            best as we can define in legislation,                   now resume.                                             Clarke (NY)       Hollingsworth     Moore (WI)
                                            without vague terms, what we want                         The Clerk read the title of the bill.                 Cleaver           Horsford          Morelle
                                            ARPA–H to do. This amendment en-                                                                                Clyburn           Houlahan          Moulton
                                                                                                         AMENDMENTS EN BLOC NO. 1 OFFERED BY MR.            Cohen             Hoyer             Mrvan
                                            sures that 85 percent of the money goes                             PALLONE OF NEW JERSEY                       Cole              Hudson            Mullin
                                            to research and not to administration                                                                           Comer             Huffman           Murphy (FL)
                                                                                                      The SPEAKER pro tempore. Pursu-                       Connolly          Huizenga          Murphy (NC)
                                            and growing an agency. We think that
                                                                                                    ant to clause 8 of rule XX, the unfin-                  Cooper            Issa              Nadler
                                            this really does narrow and, as we said
                                                                                                    ished business is the question on                       Correa            Jackson           Napolitano
                                            earlier, put guardrails. This amend-                                                                            Costa             Jackson Lee       Neal
                                                                                                    amendments en bloc No. 1, printed in
                                            ment is what accomplishes that with                                                                             Courtney          Jacobs (CA)       Neguse
                                                                                                    part E of House Report 117–381, on                      Craig             Jacobs (NY)       Newhouse
                                            the bill. I am for this amendment, and
                                                                                                    which further proceedings were post-                    Crawford          Jayapal           Newman
                                            I encourage its adoption.                                                                                       Crenshaw          Jeffries          O’Halleran
                                              Mr. Speaker, I yield back the balance                 poned and on which the yeas and nays
                                                                                                                                                            Crist             Johnson (GA)      Obernolte
                                            of my time.                                             were ordered.                                           Crow              Johnson (LA)      Ocasio-Cortez
                                              The SPEAKER pro tempore. Pursu-                         The Clerk will redesignate the                        Cuellar           Johnson (OH)      Omar
                                            ant to the rule, the previous question                  amendments en bloc.                                     Curtis            Johnson (SD)      Owens
                                                                                                      The Clerk redesignated the amend-                     Davids (KS)       Johnson (TX)      Palazzo
                                            is ordered on the bill and the amend-                                                                           Davis, Danny K.   Jones             Pallone
                                            ment offered by the gentlewoman from                    ments en bloc.                                          Davis, Rodney     Joyce (OH)        Palmer
                                            California (Ms. ESHOO).                                   The SPEAKER pro tempore. The                          Dean              Joyce (PA)        Panetta




ctelli on DSK11ZRN23PROD with HOUSE
                                                                                                    question is on the amendments en bloc                   DeFazio           Kahele            Pappas
                                              The question is on the amendment                                                                              DeGette           Kaptur            Pascrell
                                            offered by the gentlewoman from Cali-                   offered by the gentleman from New                       DeLauro           Katko             Payne
                                            fornia (Ms. ESHOO).                                     Jersey (Mr. PALLONE).                                   DelBene           Keating           Perlmutter
                                              The question was taken; and the                         The vote was taken by electronic de-                  Demings           Keller            Pfluger
                                                                                                    vice, and there were—yeas 387, nays 32,                 DeSaulnier        Kelly (IL)        Phillips
                                            Speaker pro tempore announced that                                                                              DesJarlais        Kelly (MS)        Pingree
                                            the ayes appeared to have it.                           not voting 10, as follows:



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