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42 U.S. Code § 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 generalThere 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) GoalsThe 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) FunctionsARPA–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.