§ 290c. Advanced Research Projects Agency–Health

§ 290c. Advanced Research Projects Agency–Health

(a) Establishment

(1) In general There is established within the National Institutes of Health the Advanced Research Projects Agency–Health (referred to in this section as “ARPA–H”). Not later than 180 days after December 29, 2022, the Secretary shall transfer all functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health as in existence on December 29, 2022, to ARPA–H established by the preceding sentence.

(2) Organization

(A) In general There shall be within ARPA–H—

(i) an Office of the Director;

(ii) not more than 8 program offices; and

(iii) such special project offices as the Director may establish.

(B) Requirement Not fewer than two-thirds of the program offices of ARPA–H shall be exclusively dedicated to supporting research and development activities, consistent with the goals and functions described in subsection (b).

(C) Notification The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives if the Director determines that additional program offices are required to carry out this section.

(3) Exemption from certain policies of NIH

(A) In general Except as otherwise provided for in this section, and subject to subparagraph (B), in establishing ARPA–H pursuant to paragraph (1), the Secretary may exempt ARPA–H from policies and requirements of the National Institutes of Health that are in effect on the day before December 29, 2022, as necessary and appropriate to ensure ARPA–H can most effectively achieve the goals described in subsection (b)(1).

(B) Notice Not later than 90 days after December 29, 2022, the Secretary shall publish a notice in the Federal Register describing the specific policies and requirements of the National Institutes of Health from which the Secretary intends to exempt ARPA–H, including a rationale for such exemptions.

(b) Goals and functions

(1) Goals The goals of ARPA–H shall be to—

(A) foster the development of novel, breakthrough, and broadly applicable capabilities and technologies to accelerate transformative innovation in biomedical science and medicine in a manner that cannot be readily accomplished through traditional Federal biomedical research and development programs or commercial activity;

(B) revolutionize the detection, diagnosis, mitigation, prevention, treatment, and cure of diseases and health conditions by overcoming long-term and significant technological and scientific barriers to developing transformative health technologies;

(C) promote high-risk, high-reward innovation to enable the advancement of transformative health technologies; and

(D) contribute to ensuring the United States—

(i) pursues initiatives that aim to maintain global leadership in science and innovation; and

(ii) improves the health and wellbeing of its citizens by supporting the advancement of biomedical science and innovation.

(2) Functions ARPA–H shall achieve the goals specified in paragraph (1) by addressing specific scientific or technical questions by involving high-impact transformative, translational, applied, and advanced research in relevant areas of science, by supporting—

(A) discovery, identification, and promotion of revolutionary advancements in science;

(B) translation of scientific discoveries into transformative health technologies with potential application for biomedical science and medicine;

(C) creation of platform capabilities that draw on multiple disciplines;

(D) delivery of proofs of concept that demonstrate meaningful advances with potential clinical application;

(E) development of new capabilities and methods to identify potential targets and technological strategies for early disease detection and intervention, such as advanced computational tools and predictive models; and

(F) acceleration of transformational health technological advances in areas with limited technical certainty.

(c) Director

(1) In general The President shall appoint a director of ARPA–H (in this section referred to as the “Director”).

(2) Qualifications The Director shall be an individual who, by reason of professional background and experience—

(A) is especially qualified to advise the Secretary on, and manage—

(i) research and development programs; and

(ii) large-scale, high-risk initiatives with respect to health research and technology development across multiple sectors, including identifying and supporting potentially transformative health technologies; and

(B) has a demonstrated ability to identify and develop partnerships to address strategic needs in meeting the goals described in subsection (b)(1).

(3) Reporting The Director shall report to the Secretary of Health and Human Services.

(4) Duties The duties of the Director shall include the following:

(A) Establish strategic goals, objectives, and priorities for ARPA–H to advance the goals described in subsection (b)(1).

(B) Approve the projects and programs of ARPA–H and restructure, expand, or terminate any project or program within ARPA–H that is not achieving its goals.

(C) Develop funding criteria and assess the success of programs through the establishment of technical milestones.

(D) Request that applications for funding disclose current and previous research and development efforts related to such applications, as appropriate, and identify any challenges associated with such efforts, including any scientific or technical barriers encountered in the course of such efforts or challenges in securing sources of funding, as applicable.

(E) Coordinate with the heads of relevant Federal departments and agencies to facilitate sharing of data and information, as applicable and appropriate, and ensure that research supported by ARPA–H is informed by and supplements, not supplants, the activities of such departments and agencies and is free of unnecessary duplication of effort.

(F) Ensure ARPA–H does not provide funding for a project unless the program manager determines that the project aligns with the goals described in subsection (b)(1).

(G) Prioritize investments based on considerations such as—

(i) scientific opportunity and potential impact, especially in areas that fit within the strategies and operating practices of ARPA–H and require public-private partnerships to effectively advance research and development activities; and

(ii) the potential applications that an innovation may have to address areas of currently unmet need in medicine and health, including health disparities and the potential to prevent progression to serious disease.

(H) Encourage strategic collaboration and partnerships with a broad range of entities, which may include institutions of higher education, minority-serving institutions (defined, for the purposes of this section, as institutions and programs described in section 1063b(e)(1) of title 20 and institutions described in section 1067q(a) of title 20), industry, nonprofit organizations, Federally funded research and development centers, or consortia of such entities.

(5) Term Notwithstanding section 284(a)(2) of this title, the Director—

(A) shall be appointed for a 4-year term; and

(B) may be reappointed for 1 consecutive 4-year term.

(6) Autonomy of Agency regarding recommendations and testimony No office or agency of the United States shall have authority to require the Director to submit legislative recommendations, or testimony or comments on legislation, to any officer or agency of the United States for approval, comments, or review prior to the submission of such recommendations, testimony or comments to Congress, if such recommendations, testimony, or comments to Congress include a statement indicating that the views expressed therein are those of the Director and do not necessarily reflect the views of the President or another Federal department, agency, or office.

(7) Deputy Director The Director shall appoint a Deputy Director to serve as the principal assistant to the Director.

(8) Nonapplication of certain provision The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) related to consultants and individual scientists appointed for limited periods of time shall not apply to the Director appointed under this subsection.

(d) Application of certain flexibilities The flexibilities provided to the National Institutes of Health under section 241(g) of this title shall apply to ARPA–H with respect to the functions described in subsection (b)(2).

(e) Protection of information

(1) No authorization for disclosure Nothing in this section shall be construed as authorizing the Director to disclose any information that is a trade secret or other privileged or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(2) Reporting If there have been requests under section 522 11 So in original. Probably should be “section 552”. of title 5 or the Secretary has used such authority to withhold information within the preceding year, not later than 1 year after December 29, 2022, and annually thereafter, the Director shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—

(A) the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure; and

(B) the nature of any request under section 552 of title 5 or section 1905 of title 18 that was denied using such authority.

(3) Clarification The protections for trade secrets or other privileged or confidential information described in paragraph (1) shall not be construed to limit the availability or disclosure of information necessary to inform and facilitate the evaluation required under subsection (k)(2). Any such information made available to members of the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the “National Academies”) for such evaluation shall be kept confidential by such members and shall not be used for any purposes other than informing and facilitating the evaluation required under subsection (k)(2).

(f) Cooperation with the Food and Drug Administration

(1) In general In order to facilitate the enhanced collaboration and communication with respect to the most current priorities of ARPA–H, the Food and Drug Administration may meet with ARPA–H and any other Federal partners at appropriate intervals to discuss the development status, and actions that may be taken to facilitate the development, of medical products and projects that are the highest priorities to ARPA–H.

(2) Reimbursement Utilizing interagency agreements or other appropriate resource allocation mechanisms available, the Director shall reimburse, using funds made available to ARPA–H, the Food and Drug Administration, as appropriate, for activities identified by the Commissioner of Food and Drugs and the Director as being conducted by the Food and Drug Administration under the authority of this subsection.

(g) Awards

(1) In general In carrying out this section, the Director may—

(A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs;

(B) award contracts, which may include multi-year contracts subject to section 3903 of title 41;

(C) award cash prizes, utilizing the authorities and processes established under section 3719 of title 15; and

(D) enter into other transactions, as defined by section 247d–7e(a)(3) of this title, subject to paragraph (2).

(2) Limitations on entering into other transactions

(A) Use of competitive procedures To the maximum extent practicable, competitive procedures shall be used when entering into other transactions under this section.

(B) Written determination required The authority of paragraph (1)(D) may be exercised for a project if the program manager—

(i) submits a request to the Director for each individual use of such authority before conducting or supporting a program, including an explanation of why the use of such authority is essential to promoting the success of the project;

(ii) receives approval for the use of such authority from the Director; and

(iii) for each year in which the program manager has used such authority in accordance with this paragraph, submits a report to the Director on the activities of the program related to such project.

(3) Exemptions from certain requirements Research funded by ARPA–H shall not be subject to the requirements of section 284a(a)(3)(A)(ii) of this title or section 289a of this title.

(h) Facilities authority

(1) In general The Director is authorized, for administrative purposes, to—

(A) acquire (by purchase, lease, condemnation or otherwise), construct, improve, repair, operate, and maintain such real and personal property as are necessary to carry out this section; and

(B) lease an interest in property for not more than 20 years, notwithstanding section 1341(a)(1) of title 31.

(2) Locations

(A) In general ARPA–H, including its headquarters, shall not be located on any part of the existing National Institutes of Health campuses.

(B) Number of locations ARPA–H shall have offices or facilities in not less than 3 geographic areas.

(C) Considerations In determining the location of each office or facility, the Director shall make a fair and open consideration of—

(i) the characteristics of the intended location; and

(ii) the extent to which such location will facilitate advancement of the goals and functions specified in subsection (b).

(i) Personnel

(1) In general The Director may—

(A) appoint and remove scientific, engineering, medical, and professional personnel, which may include temporary or term-limited appointments as determined by the Director to fulfill the mission of ARPA–H, without regard to any provision in title 5 governing appointments and removals under the civil service laws;

(B) notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, fix the base pay compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in section 102 of title 3; and

(C) contract with private recruiting firms for assistance in identifying highly qualified candidates for technical positions needed to carry out this section.

(2) Support staff The Director may use authorities in existence on December 29, 2022, that are provided to the Secretary to hire administrative, financial, clerical, and other staff necessary to carry out functions that support the goals and functions described in subsection (b).

(3) Number of personnel The Director may appoint not more than 210 personnel under this section. The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives if the Director determines that additional personnel are required to carry out this section.

(4) Clarification on previous positions

(A) In general Except as provided in subparagraph (B), the Director shall ensure that the personnel who are appointed to staff or support ARPA–H are individuals who, at the time of appointment and for 3 years prior to such appointment, were not employed by the National Institutes of Health. The Director may grant an exemption only for individuals who are uniquely qualified, by way of professional background and expertise, to advance the goals and functions specified in subsection (b).

(B) Nonapplication of provision The restriction provided under subparagraph (A) shall not apply to any individuals who are employed by ARPA–H on December 29, 2022.

(5) Additional considerations In appointing personnel under this subsection, the Director—

(A) may contract with private entities for the purposes of recruitment services;

(B) shall make efforts to recruit a diverse workforce, including individuals underrepresented in science, engineering, and medicine, including racial and ethnic minorities, provided such efforts do not conflict with applicable Federal civil rights law, and individuals with a variety of professional experiences or backgrounds; and

(C) shall recruit program managers with demonstrated expertise in a wide range of scientific disciplines and management skills.

(6) Use of Intergovernmental Personnel Act To the extent needed to carry out the authorities under paragraph (1) and the goals and functions specified in subsection (b), the Director may utilize hiring authorities under sections 3371 through 3376 of title 5.

(7) Authority to accept Federal detailees The Director may accept officers or employees of the United States or members of the uniformed service on a detail from an element of the Federal Government, on a reimbursable or a nonreimbursable basis, as jointly agreed to by the heads of the receiving and detailing elements, for a period not to exceed 3 years.

(j) Program managers

(1) In general The Director shall appoint program managers for 3-year terms (and may reappoint such program managers for 1 additional consecutive 3-year term) for the programs carried out by ARPA–H.

(2) Duties A program manager shall—

(A) establish, in consultation with the Director, research and development goals for programs, including timelines and milestones, and make such goals available to the public;

(B) manage applications and proposals, through the appropriate officials, for making awards as described in subsection (g) for activities consistent with the goals and functions described in subsection (b);

(C) issue funding opportunity announcements, using uniform administrative processes, as appropriate;