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S. 3819, Advanced Research Project Authority for Health Act

Summary

Senate bill 3819, the Advanced Research Project Authority for Health Act, is a bill to establish an Advanced Research Projects Authority for Health within the National Institutes of Health. Murray introduced it with Burr, and it was read twice and referred to the Committee on Health, Education, Labor, and Pensions. The bill provides that the Authority is headed by a Director appointed by the President, who reports to the Director of NIH and serves for a period of 4 years, with an extension of up to 4 additional years. It authorizes such sums as may be necessary for each of fiscal years 2023 through 2027 and requires that any budget request for the Authority be separate from the other National Institutes of Health budget requests.

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Congressional materials
Document type
Bills Bills 117S3819Is Bills 117S3819Is
Case
Bills Bills 117S3819Is Bills 117S3819Is

Cite this document

“S. 3819, Advanced Research Project Authority for Health Act.” Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-117s3819is-bills-117s3819is/, SHA-256 4a0190a8654512eda2dcf5ccd15d539b873b33ba81f695130e724d9f9e90998c.

Full text

                                                                                                                                                                          II




                                                                       117TH CONGRESS
                                                                          2D SESSION
                                                                                                              S. 3819
                                                                             To establish an Advanced Research Projects Authority for Health within
                                                                                                the National Institutes of Health.




                                                                                   IN THE SENATE OF THE UNITED STATES
                                                                                      MARCH 10 (legislative day, MARCH 7), 2022
                                                                       Mrs. MURRAY (for herself and Mr. BURR) introduced the following bill; which
                                                                           was read twice and referred to the Committee on Health, Education,
                                                                           Labor, and Pensions




                                                                                                                 A BILL
                                                                          To establish an Advanced Research Projects Authority for
                                                                               Health within the National Institutes of Health.

                                                                         1              Be it enacted by the Senate and House of Representa-
                                                                         2 tives of the United States of America in Congress assembled,
                                                                         3     SECTION 1. SHORT TITLE.

                                                                         4              This Act may be cited as the ‘‘Advanced Research
                                                                         5 Project Authority for Health Act’’ or the ‘‘ARPA–H Act’’.
                                                                         6     SEC. 2. ADVANCED RESEARCH PROJECTS AUTHORITY FOR

                                                                         7                             HEALTH.

                                                                         8              Part E of title IV of the Public Health Service Act




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                                                                         9 (42 U.S.C. 287 et seq.) is amended by inserting after sub-
                                                                       10 part 2 of such part the following:


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                                                                         1         ‘‘Subpart 3—Advanced Research Projects Authority

                                                                         2                                                for Health

                                                                         3     ‘‘SEC. 483. ADVANCED RESEARCH PROJECTS AUTHORITY

                                                                         4                             FOR HEALTH.

                                                                         5              ‘‘(a) DEFINITIONS.—In this section:
                                                                         6                        ‘‘(1) ARPA–H.—The term ‘ARPA–H’ means
                                                                         7              the Advanced Research Projects Authority for
                                                                         8              Health established under subsection (b).
                                                                         9                        ‘‘(2) DIRECTOR.—The term ‘Director’ means
                                                                       10               the Director of ARPA–H appointed under sub-
                                                                       11               section (c).
                                                                       12                         ‘‘(3) OTHER TRANSACTIONS.—The term ‘other
                                                                       13               transactions’ has the meaning given such term in
                                                                       14               section 319L(a)(3).
                                                                       15               ‘‘(b) ESTABLISHMENT                            OF       THE        ADVANCED RE-
                                                                       16      SEARCH PROJECTS AUTHORITY FOR HEALTH.—There is

                                                                       17 established within the National Institutes of Health the
                                                                       18 Advanced Research Projects Authority for Health, for
                                                                       19 purposes of—
                                                                       20                         ‘‘(1) supporting high-impact, cutting-edge re-
                                                                       21               search in biomedicine and broadly applicable break-
                                                                       22               through technologies that have the potential to sig-
                                                                       23               nificantly transform and advance areas of biomedical




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                                                                       24               science and medicine in a manner that cannot read-
                                                                       25               ily be accomplished through traditional biomedical
                                                                       26               research or commercial activity; and
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                                                                         1                        ‘‘(2) overcoming long-term and significant tech-
                                                                         2              nological and scientific barriers to advancing such
                                                                         3              technologies in order to improve the prevention, di-
                                                                         4              agnosis, mitigation, treatment, and cure of health
                                                                         5              conditions.
                                                                         6              ‘‘(c) DIRECTOR.—
                                                                         7                        ‘‘(1) IN GENERAL.—ARPA–H shall be headed
                                                                         8              by a Director, who shall be appointed by the Presi-
                                                                         9              dent. The Director shall report to the Director of
                                                                       10               NIH.
                                                                       11                         ‘‘(2) QUALIFICATIONS.—The Director shall be
                                                                       12               an individual who, by reason of professional back-
                                                                       13               ground and experience, is especially qualified to ad-
                                                                       14               vise the Secretary on, and manage, research pro-
                                                                       15               grams that advance the purposes of ARPA–H in
                                                                       16               promoting biomedical and novel technology innova-
                                                                       17               tion pursuant to this section, and who has a dem-
                                                                       18               onstrated ability to identify and develop partnerships
                                                                       19               to address strategic needs in meeting such purposes.
                                                                       20                         ‘‘(3) APPOINTMENT.—Notwithstanding section
                                                                       21               405(a)(2), the Director shall be appointed for a pe-
                                                                       22               riod of 4 years. The President may extend the term
                                                                       23               of a Director for a period of up to 4 additional




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                                                                       24               years.
                                                                       25                         ‘‘(4) DUTIES.—The Director shall—


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                                                                         1                                 ‘‘(A) establish strategic goals, objectives,
                                                                         2                        and priorities for ARPA–H, pursuant to the
                                                                         3                        purposes of ARPA–H described in subsection
                                                                         4                        (b);
                                                                         5                                 ‘‘(B) approve all new programs within
                                                                         6                        ARPA–H and terminate any program within
                                                                         7                        ARPA–H that is not achieving its goals;
                                                                         8                                 ‘‘(C) establish criteria for funding and as-
                                                                         9                        sessing the success of programs through the es-
                                                                       10                         tablishment of technical milestones;
                                                                       11                                  ‘‘(D) ensure that applications for funding
                                                                       12                         disclose current and previous research and de-
                                                                       13                         velopment efforts, and identify any challenges
                                                                       14                         associated with such efforts, including any sci-
                                                                       15                         entific or technical barriers encountered in the
                                                                       16                         course of such efforts or challenges in securing
                                                                       17                         sources of funding, as applicable and appro-
                                                                       18                         priate, in pursuit of the technology area for
                                                                       19                         which funding is requested;
                                                                       20                                  ‘‘(E) facilitate coordination between the
                                                                       21                         Department of Health and Human Services,
                                                                       22                         relevant agencies within such Department, and
                                                                       23                         other relevant Federal departments and agen-




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                                                                       24                         cies, with respect to research supported by
                                                                       25                         ARPA–H;


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                                                                         1                                 ‘‘(F) support transformative, translational,
                                                                         2                        applied, and advanced research in areas of bio-
                                                                         3                        medical science to address specific technical or
                                                                         4                        scientific questions by—
                                                                         5                                         ‘‘(i) prioritizing investments based on
                                                                         6                                 scientific potential and impact on the field
                                                                         7                                 of biomedicine, as described in subsection
                                                                         8                                 (b), especially in areas that require public-
                                                                         9                                 private partnerships in order to effectively
                                                                       10                                  advance research and development activi-
                                                                       11                                  ties;
                                                                       12                                          ‘‘(ii) translating scientific discoveries
                                                                       13                                  and cutting-edge innovation into techno-
                                                                       14                                  logical advancements;
                                                                       15                                          ‘‘(iii) encouraging opportunities to de-
                                                                       16                                  velop broadly applicable technologies, using
                                                                       17                                  a multi-disciplinary approach; and
                                                                       18                                          ‘‘(iv) making investments in high-risk,
                                                                       19                                  high-reward research related to broadly ap-
                                                                       20                                  plicable technologies, capabilities, and plat-
                                                                       21                                  forms that may have an application for
                                                                       22                                  medicine and health;
                                                                       23                                  ‘‘(G) encourage strategic collaboration and




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                                                                       24                         partnerships with a broad range of entities, in-
                                                                       25                         cluding institutions of higher education, indus-


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                                                                         1                        try, nonprofit organizations, or consortia of
                                                                         2                        such entities, which may include federally fund-
                                                                         3                        ed research and development centers; and
                                                                         4                                 ‘‘(H) ensure that the United States main-
                                                                         5                        tains global leadership in researching and devel-
                                                                         6                        oping health technologies.
                                                                         7              ‘‘(d) PERSONNEL.—
                                                                         8                        ‘‘(1) IN GENERAL.—The Director shall establish
                                                                         9              and maintain within ARPA–H a staff with appro-
                                                                       10               priate qualifications and expertise to enable ARPA–
                                                                       11               H to carry out the responsibilities under this section.
                                                                       12                         ‘‘(2) PROGRAM MANAGERS.—
                                                                       13                                  ‘‘(A) IN          GENERAL.—The                         Director shall
                                                                       14                         designate employees to serve as program man-
                                                                       15                         agers for the programs established or supported
                                                                       16                         pursuant to subsection (c)(4).
                                                                       17                                  ‘‘(B)         RESPONSIBILITIES.—A                              program
                                                                       18                         manager shall—
                                                                       19                                          ‘‘(i) establish, in consultation with the
                                                                       20                                  Director, research and development goals
                                                                       21                                  for the program, including timelines and
                                                                       22                                  milestones, and make such goals available
                                                                       23                                  to the public;




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                                                                         1                                        ‘‘(ii) provide project oversight and
                                                                         2                                 management of strategic initiatives to ad-
                                                                         3                                 vance the purpose of the program;
                                                                         4                                        ‘‘(iii) encourage research collabora-
                                                                         5                                 tions, including by identifying and sup-
                                                                         6                                 porting applicable public-private partner-
                                                                         7                                 ships;
                                                                         8                                        ‘‘(iv) select the projects to be sup-
                                                                         9                                 ported under the program after consid-
                                                                       10                                  ering—
                                                                       11                                                  ‘‘(I) the novelty, scientific, and
                                                                       12                                         technical             merit          of         the     proposed
                                                                       13                                         projects;
                                                                       14                                                  ‘‘(II) the demonstrated capabili-
                                                                       15                                         ties of the applicants to successfully
                                                                       16                                         carry out the proposed project and
                                                                       17                                         achieve designated milestones within
                                                                       18                                         the applicable timeline;
                                                                       19                                                  ‘‘(III) the potential future com-
                                                                       20                                         mercial applications of the project
                                                                       21                                         proposed by the applicant;
                                                                       22                                                  ‘‘(IV) the degree to which the
                                                                       23                                         project addresses a scientific or tech-




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                                                                       24                                         nical question pursuant to subsection
                                                                       25                                         (c)(4)(F) and has the potential to


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                                                                         1                                        transform biomedicine, as described in
                                                                         2                                        subsection (b); and
                                                                         3                                                 ‘‘(V) other criteria as established
                                                                         4                                        by the Director;
                                                                         5                                        ‘‘(v) recommend program restructure,
                                                                         6                                 expansion, or termination of research
                                                                         7                                 projects or whole projects, as necessary
                                                                         8                                 and appropriate; and
                                                                         9                                        ‘‘(vi) communicate with leaders in the
                                                                       10                                  health care and biomedical research and
                                                                       11                                  development fields, including from both the
                                                                       12                                  public and private sectors, representatives
                                                                       13                                  of patient organizations, institutions of
                                                                       14                                  higher education, and nonprofit organiza-
                                                                       15                                  tions, to identify areas of need and sci-
                                                                       16                                  entific opportunity with the potential to
                                                                       17                                  transform biomedicine as described in sub-
                                                                       18                                  section (b).
                                                                       19                                  ‘‘(C) TERM.—The term of a program man-
                                                                       20                         ager shall be not more than 3 years, and, at the
                                                                       21                         discretion of the Director, may be renewed for
                                                                       22                         one additional period of up to 3 years.
                                                                       23                         ‘‘(3) CONSIDERATIONS.—The Director—




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                                                                       24                                  ‘‘(A) in designating employees to serve as
                                                                       25                         program managers under paragraph (1), shall


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                                                                         1                        consider, as appropriate, individuals with dem-
                                                                         2                        onstrated scientific expertise and management
                                                                         3                        skills required to advance the purposes of
                                                                         4                        ARPA–H, and who represent a diverse set of
                                                                         5                        professional experiences or backgrounds, includ-
                                                                         6                        ing individuals with experience in academia, in-
                                                                         7                        dustry, government, nonprofit organizations, or
                                                                         8                        other sectors; and
                                                                         9                                 ‘‘(B) in making appointments of personnel
                                                                       10                         to staff or support ARPA–H, may consider
                                                                       11                         other factors, as appropriate, such as popu-
                                                                       12                         lations that are traditionally underrepresented
                                                                       13                         in the biomedical research enterprise.
                                                                       14                         ‘‘(4) HIRING.—
                                                                       15                                  ‘‘(A) IN GENERAL.—The Director may—
                                                                       16                                         ‘‘(i) make or rescind appointments of
                                                                       17                                  scientific, medical, and professional per-
                                                                       18                                  sonnel, without regard to any provision of
                                                                       19                                  title 5, United States Code governing ap-
                                                                       20                                  pointments under the civil service laws and
                                                                       21                                  notwithstanding section 202 of the Depart-
                                                                       22                                  ment of Health and Human Services Ap-
                                                                       23                                  propriations Act, 1993 (Public Law 102–




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                                                                       24                                  394); and




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                                                                         1                                        ‘‘(ii) fix the compensation of such per-
                                                                         2                                 sonnel at a rate to be determined by the
                                                                         3                                 Director, up to the amount of annual com-
                                                                         4                                 pensation (excluding expenses) specified in
                                                                         5                                 section 102 of title 3, United States Code.
                                                                         6                                 ‘‘(B) REPORTING.—The Director shall es-
                                                                         7                        tablish and maintain records regarding the use
                                                                         8                        of the authority under subparagraph (A)(i), in-
                                                                         9                        cluding—
                                                                       10                                         ‘‘(i) the number of positions filled
                                                                       11                                  through such authority;
                                                                       12                                         ‘‘(ii) the types of appointments of
                                                                       13                                  such positions;
                                                                       14                                         ‘‘(iii) the titles, occupational series,
                                                                       15                                  and grades of such positions;
                                                                       16                                         ‘‘(iv) the number of positions publicly
                                                                       17                                  noticed to be filled under such authority;
                                                                       18                                         ‘‘(v) the number of qualified appli-
                                                                       19                                  cants who apply for such positions;
                                                                       20                                         ‘‘(vi) the qualification criteria for such
                                                                       21                                  positions; and
                                                                       22                                         ‘‘(vii) the demographic information of
                                                                       23                                  individuals appointed to such positions.




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                                                                       24                                  ‘‘(C) REPORTS TO CONGRESS.—Not later
                                                                       25                         than one year after the date of enactment of


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                                                                         1                        the Advanced Research Project Authority for
                                                                         2                        Health Act, and annually thereafter for each
                                                                         3                        fiscal year in which such authority is used, the
                                                                         4                        Director shall submit to the Committee on
                                                                         5                        Health, Education, Labor, and Pensions of the
                                                                         6                        Senate and the Committee on Energy and Com-
                                                                         7                        merce of the House of Representatives a report
                                                                         8                        describing the total number of appointments
                                                                         9                        filled under this subsection within the fiscal
                                                                       10                         year and how the positions relate to the pur-
                                                                       11                         poses of ARPA–H.
                                                                       12                                  ‘‘(D) PRIVATE RECRUITING FIRMS.—The
                                                                       13                         Director may contract with private recruiting
                                                                       14                         firms for the hiring of qualified technical staff
                                                                       15                         to carry out this section.
                                                                       16                                  ‘‘(E) CLARIFICATIONS.—
                                                                       17                                         ‘‘(i) PREVIOUS POSITIONS.—The Di-
                                                                       18                                  rector shall ensure that the personnel who
                                                                       19                                  are appointed to staff or support ARPA–
                                                                       20                                  H are individuals who, at the time of ap-
                                                                       21                                  pointment and for 3 years prior to such
                                                                       22                                  appointment, were not employed by the
                                                                       23                                  National Institutes of Health.




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                                                                       24                                         ‘‘(ii) NUMBER OF PERSONNEL.—The
                                                                       25                                  Director may appoint not more than 120


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                                                                         1                                 personnel under this section. The Director
                                                                         2                                 shall submit a notification to Congress if
                                                                         3                                 the Director determines that additional
                                                                         4                                 personnel are required to carry out this
                                                                         5                                 section.
                                                                         6                                 ‘‘(F) GAO              REPORT.—Not                     later than 2
                                                                         7                        years after the date of enactment of the Ad-
                                                                         8                        vanced Research Project Authority for Health
                                                                         9                        Act, the Comptroller General of the United
                                                                       10                         States shall submit to the Committee on
                                                                       11                         Health, Education, Labor, and Pensions of the
                                                                       12                         Senate and the Committee on Energy and Com-
                                                                       13                         merce of the House of Representatives a report
                                                                       14                         on the use of the authority provided under sub-
                                                                       15                         paragraph (A)(i). Such report shall, in a man-
                                                                       16                         ner that protects personal privacy, to the extent
                                                                       17                         required by applicable Federal and State pri-
                                                                       18                         vacy law, at a minimum, include information
                                                                       19                         on—
                                                                       20                                         ‘‘(i) the number of positions publicly
                                                                       21                                  noticed and filled under the authority
                                                                       22                                  under this subsection;
                                                                       23                                         ‘‘(ii) the occupational series, grades,




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                                                                       24                                  and types of appointments of such posi-
                                                                       25                                  tions;


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                                                                         1                                        ‘‘(iii) how such positions related to ad-
                                                                         2                                 vancing the purposes of ARPA–H;
                                                                         3                                        ‘‘(iv) how the Director made appoint-
                                                                         4                                 ment decisions under this subsection;
                                                                         5                                        ‘‘(v) sources used to identify can-
                                                                         6                                 didates for filling such positions;
                                                                         7                                        ‘‘(vi) the number of individuals ap-
                                                                         8                                 pointed;
                                                                         9                                        ‘‘(vii) aggregated demographic infor-
                                                                       10                                  mation related to individuals appointed;
                                                                       11                                  and
                                                                       12                                         ‘‘(viii) any challenges, limitations, or
                                                                       13                                  gaps related to the use of the authority
                                                                       14                                  under this subsection and any related rec-
                                                                       15                                  ommendations to address such challenges,
                                                                       16                                  limitations, or gaps.
                                                                       17               ‘‘(e) FUNDING AWARDS.—
                                                                       18                         ‘‘(1) IN GENERAL.—In carrying out this sec-
                                                                       19               tion, the Director may award grants, contracts, co-
                                                                       20               operative agreements, cash prizes, and enter into
                                                                       21               other transactions, as described in paragraph (2).
                                                                       22                         ‘‘(2) OTHER TRANSACTIONS.—
                                                                       23                                  ‘‘(A) LIMITATIONS                      ON       ENTERING       INTO




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                                                                       24                         OTHER TRANSACTIONS.—




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                                                                         1                                         ‘‘(i) IN GENERAL.—To the maximum
                                                                         2                                 extent practicable, competitive procedures
                                                                         3                                 shall be used when entering into other
                                                                         4                                 transactions to carry out projects under
                                                                         5                                 this section.
                                                                         6                                 ‘‘(B)        WRITTEN                DETERMINATIONS             RE-

                                                                         7                        QUIRED.—The authority of this paragraph may

                                                                         8                        be exercised for a project if the project man-
                                                                         9                        ager—
                                                                       10                                          ‘‘(i) submits a proposal to the Direc-
                                                                       11                                  tor for each individual use of such author-
                                                                       12                                  ity before conducting or supporting a
                                                                       13                                  project, including why the use of such au-
                                                                       14                                  thority is essential to promoting the suc-
                                                                       15                                  cess of the project;
                                                                       16                                          ‘‘(ii) receives approval for the use of
                                                                       17                                  such authority from the Director; and
                                                                       18                                          ‘‘(iii) for each year in which the pro-
                                                                       19                                  gram manager has used such authority in
                                                                       20                                  accordance with this paragraph, submits a
                                                                       21                                  report to the Director on the activities of
                                                                       22                                  the program relating to such project.
                                                                       23                         ‘‘(3) PRIZE COMPETITIONS.—The Director may




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                                                                       24               utilize the authorities and processes established
                                                                       25               under section 24 of the Stevenson-Wydler Tech-


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                                                                         1              nology Innovation Act of 1980 (15 U.S.C. 3719) to
                                                                         2              support prize competitions, in accordance with this
                                                                         3              section.
                                                                         4                        ‘‘(4) FEDERAL                    DEMONSTRATION                      OF   TECH-

                                                                         5              NOLOGIES.—The Director may seek opportunities to

                                                                         6              partner with procurement programs of Federal agen-
                                                                         7              cies to demonstrate technologies resulting from ac-
                                                                         8              tivities funded through ARPA–H.
                                                                         9                        ‘‘(5) CLARIFICATIONS.—Research supported by
                                                                       10               this section shall not be subject to the requirements
                                                                       11               of section 406(a)(3)(A)(ii) or 492.
                                                                       12               ‘‘(f) COORDINATION, COLLABORATION, NONDUPLICA-
                                                                       13      TION, AND CONSULTATION.—

                                                                       14                         ‘‘(1) COORDINATION.—To the maximum extent
                                                                       15               practicable, the Director shall ensure that the activi-
                                                                       16               ties of ARPA–H are coordinated with, and do not
                                                                       17               duplicate the efforts of—
                                                                       18                                  ‘‘(A) other programs within, or research
                                                                       19                         conducted or supported by, the Department of
                                                                       20                         Health and Human Services, including the Na-
                                                                       21                         tional Institutes of Health and the Biomedical
                                                                       22                         Advanced Research and Development Authority;
                                                                       23                         and




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                                                                       24                                  ‘‘(B) other relevant efforts or research and
                                                                       25                         development programs operated or overseen by


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                                                                         1                        other departments, agencies, or offices of the
                                                                         2                        Federal Government.
                                                                         3                        ‘‘(2) FUNDING DETERMINATIONS.—The Direc-
                                                                         4              tor shall ensure that ARPA–H does not provide
                                                                         5              funding for a research program or project unless the
                                                                         6              applicant for such funding demonstrates that—
                                                                         7                                 ‘‘(A)(i) such applicant has made sufficient
                                                                         8                        unsuccessful attempts to secure private financ-
                                                                         9                        ing, and that there is a lack of significant pri-
                                                                       10                         vate support for the program or project; or
                                                                       11                                  ‘‘(ii) such program or project is in the best
                                                                       12                         interests of the United States; and
                                                                       13                                  ‘‘(B) such program or project has the po-
                                                                       14                         tential to significantly transform and advance
                                                                       15                         the field of biomedicine, as described in sub-
                                                                       16                         section (b).
                                                                       17                         ‘‘(3) CONSULTATION.—In carrying out this sec-
                                                                       18               tion, the Director may seek input from—
                                                                       19                                  ‘‘(A) the President’s Council of Advisors
                                                                       20                         on Science and Technology;
                                                                       21                                  ‘‘(B) representatives of professional or sci-
                                                                       22                         entific organizations with expertise in specific
                                                                       23                         technologies under consideration or development




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                                                                       24                         by ARPA–H; and




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                                                                         1                                 ‘‘(C) representatives of patient organiza-
                                                                         2                        tions, public health, innovators, and other pub-
                                                                         3                        lic and private entities.
                                                                         4                        ‘‘(4) ENHANCED COLLABORATION AND COMMU-
                                                                         5              NICATION.—

                                                                         6                                 ‘‘(A) IN GENERAL.—In order to facilitate
                                                                         7                        enhanced collaboration and communication with
                                                                         8                        respect to the most current priorities of ARPA–
                                                                         9                        H, the Food and Drug Administration may
                                                                       10                         meet with ARPA–H and any other appropriate
                                                                       11                         Federal partners, such as the Biomedical Ad-
                                                                       12                         vanced Research and Development Authority, at
                                                                       13                         appropriate intervals, to discuss the develop-
                                                                       14                         ment status, and actions that may be taken to
                                                                       15                         facilitate the development, of medical products
                                                                       16                         and projects that are the highest priorities to
                                                                       17                         ARPA–H.
                                                                       18                                  ‘‘(B) RELATION TO OTHERWISE AUTHOR-
                                                                       19                         IZED ACTIVITIES OF THE FOOD AND DRUG AD-

                                                                       20                         MINISTRATION.—Utilizing                             interagency         agree-
                                                                       21                         ments or other appropriate resource allocation
                                                                       22                         mechanisms available, the Director shall reim-
                                                                       23                         burse the Food and Drug Administration, as




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                                                                       24                         appropriate, for activities identified by the
                                                                       25                         Commissioner of Food and Drugs and the Di-


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                                                                         1                        rector as being conducted by the Food and
                                                                         2                        Drug Administration under the authority of
                                                                         3                        this section, using funds made available to
                                                                         4                        ARPA–H.
                                                                         5              ‘‘(g) ADVISORY COMMITTEE.—
                                                                         6                        ‘‘(1) IN         GENERAL.—There                        is established an
                                                                         7              ARPA–H Interagency Advisory Committee (referred
                                                                         8              to in this subsection as the ‘Advisory Committee’) to
                                                                         9              coordinate efforts and provide advice and assistance
                                                                       10               on specific program or project tasks and the overall
                                                                       11               direction of ARPA–H.
                                                                       12                         ‘‘(2) MEMBERS.—The Advisory Committee es-
                                                                       13               tablished under paragraph (1) shall consist of the
                                                                       14               heads of the following agencies or their designees:
                                                                       15                                  ‘‘(A) The National Institutes of Health.
                                                                       16                                  ‘‘(B) The Centers for Disease Control and
                                                                       17                         Prevention.
                                                                       18                                  ‘‘(C) The Food and Drug Administration.
                                                                       19                                  ‘‘(D) The Office of the Assistant Secretary
                                                                       20                         for Preparedness and Response.
                                                                       21                                  ‘‘(E) The Office of the Assistant Secretary
                                                                       22                         of Health.
                                                                       23                                  ‘‘(F) The Defense Advanced Research




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                                                                       24                         Projects Agency.




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                                                                         1                                 ‘‘(G) The Office of Science of the Depart-
                                                                         2                        ment of Energy.
                                                                         3                                 ‘‘(H) The National Science Foundation.
                                                                         4                                 ‘‘(I) Any other agency with subject matter
                                                                         5                        expertise that the Director of ARPA–H deter-
                                                                         6                        mines appropriate to advance programs or
                                                                         7                        projects under this section.
                                                                         8                        ‘‘(3) NONAPPLICABILITY OF FACA.—The Fed-
                                                                         9              eral Advisory Committee Act (5 U.S.C. App.) shall
                                                                       10               not apply to the Advisory Committee.
                                                                       11                         ‘‘(4) ADVISORY NATURE.—The functions of the
                                                                       12               Advisory Committee shall be advisory in nature, and
                                                                       13               nothing in this subsection shall be construed as
                                                                       14               granting such Committee authority over the activi-
                                                                       15               ties authorized under this section.
                                                                       16                         ‘‘(5) PERFORMANCE MEASURES FRAMEWORK.—
                                                                       17               The Director, in consultation with the Advisory
                                                                       18               Committee, shall develop a performance measures
                                                                       19               framework for programs or projects supported by
                                                                       20               ARPA–H in order to inform and facilitate the eval-
                                                                       21               uation required under subsection (m), including
                                                                       22               identification of any data needed to perform such
                                                                       23               evaluation, consistent with subsection (l).




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                                                                       24               ‘‘(h) FACILITIES.—




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                                                                         1                        ‘‘(1) AUTHORITIES.—The Director is author-
                                                                         2              ized to—
                                                                         3                                 ‘‘(A) acquire (by purchase, lease, con-
                                                                         4                        demnation or otherwise), construct, improve, re-
                                                                         5                        pair, operate, and maintain such real and per-
                                                                         6                        sonal property as are necessary to carry out
                                                                         7                        this section; and
                                                                         8                                 ‘‘(B) lease an interest in property for not
                                                                         9                        more than 20 years, notwithstanding section
                                                                       10                         1341(a)(1) of title 31, United States Code.
                                                                       11                         ‘‘(2) LOCATIONS.—
                                                                       12                                  ‘‘(A) IN GENERAL.—ARPA–H, including
                                                                       13                         its headquarters, shall not be located, including
                                                                       14                         headquartered, inside of, or in close proximity
                                                                       15                         to, the National Capital region, and shall not be
                                                                       16                         located on any part of the National Institutes
                                                                       17                         of Health campuses.
                                                                       18                                  ‘‘(B) CONSIDERATIONS.—In determining
                                                                       19                         the location of facilities, the Director shall con-
                                                                       20                         sider the characteristics of the intended location
                                                                       21                         and the extent to which such location will facili-
                                                                       22                         tate advancement of the ARPA–H purposes
                                                                       23                         pursuant to subsection (b).




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                                                                       24               ‘‘(i) RULE              OF       CONSTRUCTION.—The authorities
                                                                       25 granted by this section—


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                                                                         1                        ‘‘(1) are in addition to existing authorities
                                                                         2              granted to the Secretary; and
                                                                         3                        ‘‘(2) shall not be construed to modify or super-
                                                                         4              sede any existing authorities.
                                                                         5              ‘‘(j) PROTECTION OF INFORMATION.—
                                                                         6                        ‘‘(1) IN         GENERAL.—Nothing                          in this section
                                                                         7              shall be construed as authorizing the Secretary to
                                                                         8              disclose any information that is a trade secret, or
                                                                         9              other privileged or confidential information subject
                                                                       10               to section 552(b)(4) of title 5, United States Code,
                                                                       11               or section 1905 of title 18, United States Code.
                                                                       12                         ‘‘(2) REPORTING.—One year after the date of
                                                                       13               enactment of the Advanced Research Project Au-
                                                                       14               thority for Health Act, and annually thereafter, the
                                                                       15               Director shall report to the Committee on Health,
                                                                       16               Education, Labor, and Pensions of the Senate and
                                                                       17               the Committee on Energy and Commerce of the
                                                                       18               House of Representatives on—
                                                                       19                                  ‘‘(A) the number of instances in which the
                                                                       20                         Secretary has used the authority under this
                                                                       21                         subsection to withhold information from disclo-
                                                                       22                         sure; and
                                                                       23                                  ‘‘(B) the nature of any request under sec-




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                                                                       24                         tion 552 of title 5, United States Code, or sec-




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                                                                         1                        tion 1905 of title 18, United States Code, that
                                                                         2                        was denied using such authority.
                                                                         3              ‘‘(k) REPORTS AND STRATEGIC PLANS.—
                                                                         4                        ‘‘(1) ANNUAL REPORT.—As part of the annual
                                                                         5              budget request submitted for each fiscal year, the
                                                                         6              Director shall provide to the Committee on Health,
                                                                         7              Education, Labor, and Pensions and the Committee
                                                                         8              on Appropriations of the Senate and the Committee
                                                                         9              on Energy and Commerce and the Committee on
                                                                       10               Appropriations of the House of Representatives a re-
                                                                       11               port that describes—
                                                                       12                                  ‘‘(A) projects supported by ARPA–H dur-
                                                                       13                         ing the previous fiscal year, and, with respect to
                                                                       14                         each such project, the stage of development and
                                                                       15                         details as to whether the project is meeting
                                                                       16                         project milestones;
                                                                       17                                  ‘‘(B) projects supported by ARPA–H in
                                                                       18                         the previous fiscal year that were terminated,
                                                                       19                         and the reasons for termination;
                                                                       20                                  ‘‘(C) projects supported by ARPA–H dur-
                                                                       21                         ing the previous fiscal year that examine topics
                                                                       22                         and technologies closely related to other activi-
                                                                       23                         ties funded by the Department of Health and




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                                                                       24                         Human Services, including an analysis of
                                                                       25                         whether in supporting such projects, the Direc-


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                                                                         1                        tor is in compliance with the requirements of
                                                                         2                        this section; and
                                                                         3                                 ‘‘(D)       current,           proposed,               and     planned
                                                                         4                        projects to be carried out.
                                                                         5                        ‘‘(2) STRATEGIC PLAN.—Not later than 180
                                                                         6              days after the appointment of the first Director pur-
                                                                         7              suant to subsection (c), and every 4 years thereafter,
                                                                         8              the Director shall provide to the Committee on
                                                                         9              Health, Education, Labor, and Pensions and the
                                                                       10               Committee on Appropriations of the Senate and the
                                                                       11               Committee on Energy and Commerce and the Com-
                                                                       12               mittee on Appropriations of the House of Represent-
                                                                       13               atives a plan describing the strategic plan that
                                                                       14               ARPA–H will use to guide future investments over
                                                                       15               the following 4 fiscal years. Every 2 years after the
                                                                       16               date of submission of the initial plan, the Director
                                                                       17               shall submit a supplemental strategic plan that de-
                                                                       18               tails any changes to such strategic vision, as appro-
                                                                       19               priate. The requirements regarding individual insti-
                                                                       20               tute and center strategic plans under section
                                                                       21               402(m), including paragraph (3) of such subsection,
                                                                       22               shall not apply to ARPA–H.
                                                                       23               ‘‘(l) NATIONAL ACADEMIES OF SCIENCES, ENGI-




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                                                                       24      NEERING, AND MEDICINE EVALUATION.—




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                                                                         1                        ‘‘(1) IN GENERAL.—Not later than 3 years
                                                                         2              after the date of enactment of the Advanced Re-
                                                                         3              search Project Authority for Health Act, the Direc-
                                                                         4              tor shall seek to enter into a contract with the Na-
                                                                         5              tional Academies of Sciences, Engineering, and Med-
                                                                         6              icine under which the National Academies conducts
                                                                         7              an evaluation of ARPA–H regarding the goals and
                                                                         8              purposes of ARPA–H and the degree to which the
                                                                         9              activities of ARPA–H support, and align with, such
                                                                       10               goals and purposes.
                                                                       11                         ‘‘(2) INCLUSIONS.—The evaluation under para-
                                                                       12               graph (1) may include—
                                                                       13                                  ‘‘(A) recommendations on how to improve
                                                                       14                         upon the operation of, and projects carried out
                                                                       15                         by, ARPA–H, which may include lessons
                                                                       16                         learned from other advanced research and de-
                                                                       17                         velopment agencies or authorities within the
                                                                       18                         Department of Health and Human Services and
                                                                       19                         in other departments, agencies, or offices of the
                                                                       20                         Federal Government;
                                                                       21                                  ‘‘(B) a description of lessons learned from
                                                                       22                         the establishment and operation of ARPA–H,
                                                                       23                         and the manner in which those lessons may




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                                                                       24                         apply to the operation of other programs of the




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                                                                         1                        Department of Health and Human Services;
                                                                         2                        and
                                                                         3                                 ‘‘(C) an analysis of whether any projects
                                                                         4                        supported by ARPA–H were duplicative of
                                                                         5                        other research programs supported by the De-
                                                                         6                        partment of Health and Human Services or
                                                                         7                        other another relevant Federal department or
                                                                         8                        agency.
                                                                         9                        ‘‘(3) AVAILABILITY.—Upon completion of the
                                                                       10               evaluation, the evaluation shall be submitted by the
                                                                       11               Director to the Committee on Health, Education,
                                                                       12               Labor, and Pensions and the Committee on Appro-
                                                                       13               priations of the Senate and the Committee on En-
                                                                       14               ergy and Commerce and the Committee on Appro-
                                                                       15               priations of the House of Representatives and made
                                                                       16               publicly available.
                                                                       17               ‘‘(m) AUTHORIZATION                            OF       APPROPRIATIONS.—To
                                                                       18 carry out this section, there are authorized to be appro-
                                                                       19 priated such sums as may be necessary for each of fiscal
                                                                       20 years 2023 through 2027.
                                                                       21               ‘‘(n) ADDITIONAL BUDGET CLARIFICATION.—Any
                                                                       22 budget request for ARPA–H shall be separate from the
                                                                       23 other budget requests of the National Institutes of




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                                                                       24 Health.’’.
                                                                                                                                  Æ

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