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1 1 (May 18, 2021)

handle is hein.crs/govedin0001 and id is 1 raw text is: Congressional SResearch Service Advanced Research Projects Agency for Health (ARPA-H): Considerations for Congress May 18, 2021 On April 9, 2021, the Office of Budget and Management (OMB) submitted President Biden's FY2022 discretionary budget request to Congress. This skinny budget request proposed the creation of an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH), an agency in the Department of Health and Human Services (HHS). The budget request included $6.5 billion for ARPA-H to drive transformational innovation in health research and speed application and implementation of health breakthroughs. Its initial focus would include cancer and other diseases such as diabetes and Alzheimer's. While the current publicly available information on the proposal lacks specifics, ARPA-H would likely follow the model of other ARPAs, especially the Defense Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency-Energy (ARPA-E). Stakeholders identify a number of DARPA model characteristics for ARPA-H, including a flat and nimble organizational structure, tenure-limited program managers with a high degree of autonomy to select and fund projects, and a milestone-based contract approach. In contrast, NIH relies predominantly, with some exceptions discussed below, 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 high-risk, high- reward projects. Novel approaches outside of the traditional peer-review process have been successful at funding medical research and development (R&D). Notably, DARPA invested in Moderna's mRNA vaccine technology- reportedly at a time when it was viewed with skepticism. The Biomedical Advanced Research and Development Authority (BARDA) has supported medical countermeasure R&D through flexible, innovation-focused R&D awards-including for Coronavirus Disease 2019 (COVID-19) products. NIH currently has programs with some DARPA model characteristics-the Common Fund for high-risk, short-term and milestone-driven innovative projects and the National Center for Advancing Translational Sciences (NCATS), which focuses on innovation in medical product development. Additionally, NIH has major drug R&D efforts involving private partners and other agencies for the diseases mentioned in the President's request-Alzheimer's disease, cancer, and diabetes-notably through the Alzheimer's disease Congressional Research Service https://crsreports. congress.gov IN11674 CRS INSIGHT Prepared for Members and Committees of Congress