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Advanced Research Projects Agency for Health (ARPA-H): Congressional Action and Selected Policy Issues (31 pages)

Through FY2022 appropriations (P.L. 117-103), Congress provided $1 billion to the Department of Health and Human Services (HHS) to establish the Advanced Research Projects Agency for Health (ARPA-H). The law provided funding to a new ARPA-H account at HHS, available until September 30, 2024, and allowed the HHS Secretary to place the new agency anywhere within the department within 30 days of enactment. On March 30, 2022, HHS Secretary Xavier Becerra submitted a notice to the appropriations committees that ARPA-H is to reside within the National
Institutes of Health (NIH), while the ARPA-H Director is to report directly to the HHS Secretary.

The Biden Administration originally proposed ARPA-H as part of the President’s FY2022 budget request for the NIH. The budget request sought $6.5 billion for ARPA-H over three years to “drive transformational health research innovation and speed medical breakthroughs by tackling ambitious challenges requiring large-scale, sustained, and cross-sector coordination.” As proposed by the Biden Administration, the initial focus of ARPA-H would have included building platforms and capabilities to try to deliver cures for diseases such as cancer, Alzheimer’s disease, and diabetes.

Absent additional legislation, the FY2022 appropriation gives HHS considerable flexibility to design and structure the new agency. As proposed by the Biden Administration, ARPA-H is modelled after other “ARPAs,” especially the Defense Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency-Energy (ARPA-E). The “ARPA model” involves an organizational structure designed to be flat and nimble, staffed by tenure-limited program managers with a high degree of autonomy to select and fund research projects using a milestone-based contract approach. In contrast, NIH relies predominantly on the scientific peer review process to award most of its funding. Some evidence
suggests that this investigator-driven and consensus-based process is less likely to fund transformative or “high-risk, high￾reward” projects. Supporters of the proposal argue that high-risk, high-reward biomedical research may lead to health breakthroughs on a faster timeline and is critical to ensuring U.S. competitiveness and addressing societal challenges.
Several bills are being considered in the 117th Congress that would codify and further delineate ARPA-H’s goals, structure, placement, activities, and authorities. A Senate proposal, S. 3819, was incorporated into the PREVENT Pandemics Act (S. 3799), in an amendment in the nature of a substitute, and ordered to be reported by the Senate Committee on Health, Education, Labor, and Pensions (HELP) on March 15, 2022. Meanwhile, the Advanced Research Projects Agency for Health Act (H.R. 5585) passed the House on June 22, 2022. As Congress continues its deliberations on ARPA-H, several policy debates remain. Such debates include (1) where to place ARPA-H within the federal government and how to facilitate its independence and autonomy, (2) what the appropriate goals are for ARPA-H and how to prevent its activities and programs
from duplicating the efforts of other federal agencies and the private sector, and (3) what the appropriate current and future appropriations levels are for ARPA-H.  

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