Sec. 31031. Funding for Advanced Research Projects for Health
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In addition to amounts otherwise available, there is appropriated to the Secretary for fiscal year 2022, out of any money in the Treasury not otherwise appropriated, $3,000,000,000, to remain available until expended, to establish the Advanced Research Projects Agency for Health (in this section referred to as the ARPA–H ) for purposes of making pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform important areas of medicine and health for the benefit of all individuals and that cannot readily be accomplished through traditional biomedical research or commercial activity.
Amounts made available by subsection
(a)shall be used to— hire a Director to head the ARPA–H (for a term of no more than 5 years subject to one renewal period); and acting through the Director of the ARPA–H, in consultation, as applicable, with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the Director of the Biomedical Advanced Research and Development Authority, the Deputy Assistant Secretary for Minority Health, and the heads of other agencies, shall— ensure to the maximum extent practicable that the projects and activities of the ARPA–H funded by subsection
(a)are coordinated with, and do not duplicate the efforts of, programs within, or research conducted or supported by, the Department of Health and Human Services; and in using amounts made available by subsection (a), expedite the development, application, and implementation of health breakthroughs to prevent, detect, and treat serious or life-threatening diseases, including— providing awards in the form of grants, contracts, cooperative agreements, prizes, and other transactions (as defined under section 402(n) of the Public Health Service Act ( 42 U.S.C. 282(n) )) to entities to carry out advanced research projects for health, including through multiyear contracts (subject to the availability of funds) and prize competitions; developing funding criteria and evaluation criteria to assess projects funded under clause (i); establishing metrics or criteria to prioritize investments and research that should be funded under clause (i), including the novelty, scientific, and technical merit of proposed projects, the future commercial applications of projects, and the unmet need within patient populations; identifying and promoting potential advances in basic research that will assist in carrying out advanced health research and development; identifying areas of research and innovation that are high-risk, high-reward or where the incentives of the commercial market are unlikely to result in adequate or timely development; supporting collaboration and communication among other Federal agencies, including both health and scientific agencies, institutions of higher education, private or public research institutions, private entities, including biotechnology and pharmaceutical companies, and nonprofit organizations, including patient advocacy groups, including soliciting data, if applicable; translating scientific discoveries into technological innovations, including through— collaboration with the Food and Drug Administration on the development of medical products to facilitate transformation of breakthroughs in biomedicine into tangible solutions for patients; and ensuring that medical product development programs gather nonclinical and clinical data necessary for approval as efficiently as practicable; hiring and appointing personnel necessary to carry out activities described in this section, including— making and rescinding appointments of scientific, medical, and professional personnel; designating personnel to serve as program managers (for terms of no more than 3 years subject to one renewal period) to establish research and development goals for the ARPA–H, provide project oversight and management of strategic initiatives, recommend restructure, expansion, or termination of research projects under this section, as necessary and appropriate, and carry out other activities described in this subsection; recruiting and retaining a diverse workforce, including individuals underrepresented in science and medicine and, racial and ethnic minorities; and hiring and appointing administrative, financial, and information technology staff as necessary to carry out this subsection; compensating personnel at a rate to be determined by the Director of the ARPA–H; acquiring (by purchase, lease, condemnation, or otherwise), constructing, improving, repairing, operating, and maintaining such real and personal property as are necessary to carry out this section; and entering into or terminating contracts, including multiyear contracts, as appropriate to support advanced research projects for health. Research funded by amounts made available under this section shall not be subject to the requirements of section 406(a)(3)(A)(ii) or 492 of the Public Health Service Act ( 42 U.S.C. 284a(a)(3)(A)(ii) , 289a). Funds appropriated by this section shall be used to supplement and not supplant any appropriations for institutes and centers of the National Institutes of Health.
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