Congress Tacks ARPA-H Authorization onto FY 2023 Spending Deal

The finalization of appropriations for fiscal year (FY) 2023 received plenty of attention by the research community for its investments in federal research agencies. However, another important provision was the authorization of the Advanced Research Projects Agency for Health (ARPA-H). Touted as a major priority for the Biden Administration, ARPA-H is a “high-risk, high-reward” advanced biomedical research agency established in 2022 after receiving initial funding in the FY 2022 appropriations bill. Despite receiving funds, it had not yet been authorized through legislation until it was attached to the FY 2023 appropriations omnibus last month (see COSSA’s analysis).

The long-awaited authorization of ARPA-H seeks to clarify questions regarding the agency’s independence and infrastructure. Originally established as an independent agency within the U.S. Department of Health and Human Services (HHS), ARPA-H was officially transferred to the National Institutes of Health (NIH) by HHS Secretary Xavier Becerra. This move into NIH received mixed responses among the research community; some voiced concerns about the new agency potentially sapping resources from the base NIH research activities while others asserted that ARPA-H should be stood up within NIH’s existing infrastructure. The debate over where ARPA-H should be housed spilled into Congress as well, as various proposals to authorize ARPA-H both within NIH and outside of NIH were proposed (see previous coverage). Most notable among them were the ARPA-H Act championed by Anna Eshoo (D-CA) – which would have established the agency independently within the HHS Department – and a section of the Cures 2.0 Act championed by Diana DeGette (D-CO) and Fred Upton (R-MI) – which would have housed the agency within NIH.

The final FY 2023 appropriations bill includes an authorization bill for ARPA-H that houses it within NIH, aligning with the Biden Administration’s initial transfer of the agency (Subtitle C, Chapter 4 of the bill). However, several provisions were included in the authorization that meaningfully assert ARPA-H’s independence from the rest of NIH, assuaging the concerns of Congressional detractors of the transfer. Notable provisions within the authorization include:

• ARPA-H will be organized with an Office of the Director and “no more than 8 program offices.” In addition, the Director of ARPA-H may establish “special project offices” as deemed necessary. At least two-thirds of the program offices are required to be dedicated exclusively to supporting R&D activities.
• The Director of ARPA-H is a presidentially appointed position but is not Senate confirmed (President Biden appointed the first director in September). The Director reports directly to the HHS Secretary and may serve up to two consecutive four-year terms. The Director may also appoint Program Managers for up to two three-year terms.
• The bill allows ARPA-H to be exempted from certain NIH policies “as necessary and appropriate” to achieve its goals. Exemptions are required to be published in the Federal Register for public inspection.
• The bill mandates that ARPA-H headquarters must not be located on any existing NIH campus. It also requires ARPA-H to have offices in at least three different geographic areas.
• Within five years of its authorization, ARPA-H shall be evaluated by the National Academies on whether it is meeting its stated goals and functions.
• Any budget request for ARPA-H is required to be submitted separately from the other NIH accounts.

COSSA will continue to report on updates to ARPA-H here.