42 U.S.C. § 290c
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.
There shall be within ARPA-H-
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).
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.
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).
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.
The goals of ARPA-H shall be to-
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-
The President shall appoint a director of ARPA-H (in this section referred to as the "Director").
The Director shall be an individual who, by reason of professional background and experience-
The Director shall report to the Secretary of Health and Human Services.
The duties of the Director shall include the following:
Notwithstanding section 284(a)(2) of this title, the Director-
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.
The Director shall appoint a Deputy Director to serve as the principal assistant to the Director.
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.
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).
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.
If there have been requests under section 522 1 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-
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).
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.
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.
In carrying out this section, the Director may-
To the maximum extent practicable, competitive procedures shall be used when entering into other transactions under this section.
The authority of paragraph (1)(D) may be exercised for a project if the program manager-
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.
The Director is authorized, for administrative purposes, to-
ARPA-H, including its headquarters, shall not be located on any part of the existing National Institutes of Health campuses.
ARPA-H shall have offices or facilities in not less than 3 geographic areas.
In determining the location of each office or facility, the Director shall make a fair and open consideration of-
The Director may-
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).
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.
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).
The restriction provided under subparagraph (A) shall not apply to any individuals who are employed by ARPA-H on December 29, 2022.
In appointing personnel under this subsection, the Director-
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.
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.
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.
A program manager shall-
Beginning not later than 1 year after December 29, 2022, as part of the annual budget request submitted for each fiscal year, the Director shall submit a report on the actions undertaken, and the results generated, by ARPA-H, including-
The report under subparagraph (A) shall be submitted to-
Not later than 5 years after December 29, 2022, the Director shall seek to enter into an agreement with the National Academies under which the National Academies conducts an evaluation of whether ARPA-H is meeting the goals and functions specified in subsection (b).
The agreement entered into under subparagraph (A) shall require the National Academies to submit the evaluation conducted under such agreement to the Director, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, and make the report publicly available.
The Director shall establish and maintain records regarding the use of the authority under subsection (i)(1)(A), including-
Not later than 2 years after December 29, 2022, and annually thereafter for each fiscal year in which such authority is used, the Director shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under subsection (i) within the fiscal year and how the positions relate to the goals and functions of ARPA-H.
Not later than 2 years after December 29, 2022, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the use of the authority provided under subsection (i)(1)(A). Such report shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include information on-
Not later than 1 year after December 29, 2022, and every 3 years thereafter, the Director shall provide 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 a strategic plan describing how ARPA-H will carry out investments each fiscal year in the following 3-year period. The requirements regarding individual institute and center strategic plans under section 282(m) of this title, including paragraph (3) of such subsection, shall not apply to ARPA-H.
Not later than 1 year after December 29, 2022, and every 4 years thereafter, the Comptroller General of the United States shall conduct, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an independent review of the biomedical research and development portfolio of the Department of Health and Human Services, including ARPA-H, the National Institutes of Health, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority-
The Director shall-
In making an award under this section, the Director may waive the requirements of subparagraphs (A), (B), and (D) of paragraph (1) if such requirements cannot reasonably be met, and the proposed project has the potential to advance the goals described in subsection (b)(1). The Director shall provide notice to Congress not later than 30 days after waiving such requirements.
In carrying out this section, the Director may consult with-
There is established an ARPA-H Interagency Advisory Committee (referred to in this subsection as the "Advisory Committee") to coordinate efforts and provide advice and assistance on specific program or project tasks and the overall direction of ARPA-H.
The Advisory Committee established under paragraph (1) shall consist of the heads of the following agencies or their designees:
The Federal Advisory Committee Act (5 U.S.C. App.) 2 shall not apply to the Advisory Committee.
The functions of the Advisory Committee shall be advisory in nature, and nothing in this subsection shall be construed as granting such Committee authority over the activities authorized under this section.
The Director, in consultation with the Advisory Committee, shall develop a performance measures framework for programs or projects supported by ARPA-H in order to inform and facilitate the evaluation required under subsection (k)(2), including identification of any data needed to perform such evaluation,
The Director shall provide to the National Academies such performance measures and data necessary to perform the evaluation required under subsection (k)(2).
The authorities under this section, with respect to the Director, are additional authorities that do not supersede or modify any existing authorities.
In this section, the term "transformative health technology" means a novel, broadly applicable capability or technology-
To carry out this section, there is authorized to be appropriated $500,000,000 for each of the fiscal years 2024 through 2028, to remain available until expended.
Any budget request for ARPA-H shall propose a separate appropriation from the other accounts of the National Institutes of Health.
1 So in original. Probably should be "section 552".
2 See References in Text note below.
42 U.S.C. § 290c
EDITORIAL NOTES
REFERENCES IN TEXTThe Federal Advisory Committee Act, referred to in subsec. (p)(3), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, which was set out in the Appendix to Title 5, Government Organization and Employees, and was substantially repealed and restated in chapter 10 (§1001 et seq.) of Title 5 by Pub. L. 117-286, §§3(a), Dec. 27, 2022, 7, Dec. 27, 2022, 136 Stat. 4197, 4361. For disposition of sections of the Act into chapter 10 of Title 5, see Disposition Table preceding section 101 of Title 5.
PRIOR PROVISIONSA prior section 499A of act July 1, 1944, was renumbered section 499 by Pub. L. 103-43 and is classified to section 290b of this title.
- Advisory Committee
- The term "Advisory Committee" means the Green Building Advisory Committee established under section 484.1
- Service
- The term "Service" means the Public Health Service;
- practices
- The term "practices" means design, financing, permitting, construction, commissioning, operation and maintenance, and other practices that contribute to achieving zero-net-energy buildings or facilities.
- uniformed service
- The term "uniformed service" means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health Service, or National Oceanic and Atmospheric Administration.
- project
- The terms "federally assisted housing" and "project" mean-(A) a public housing project (as such term is defined in section 3(b) of the United States Housing Act of 1937 [42 U.S.C. 1437a(b)] );(B) housing for which project-based assistance is provided under section 8 of the United States Housing Act of 1937 [42 U.S.C. 1437f] ;(C) housing that is assisted under section 1701q of title 12;(D) housing that is assisted under section 1701q of title 12, as such section existed before November 28, 1990;(E) housing financed by a loan or mortgage insured under section 1715l(d)(3) of title 12 that bears interest at a rate determined under the proviso of section 1715l(d)(5) of title 12;(F) housing insured, assisted, or held by the Secretary or a State or State agency under section 1715z-1 of title 12;(G) housing constructed or substantially rehabilitated pursuant to assistance provided under section 8(b)(2) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(2)], as in effect before October 1, 1983, that is assisted under a contract for assistance under such section; and(H) housing that is assisted under section 8013 1 of this title.
- Director
- the term "Director" means the Chief Executive Officer of the Corporation for National and Community Service,
- Secretary
- the term "Secretary" means- (A) the Secretary of Education for purposes of subtitle A (other than section 3201),(B) the Secretary of Agriculture for purposes of the amendments made by section 3201, and(C) the Secretary of Health and Human Services for purposes of subtitle B,
- drug
- the term "drug" means- (A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,