Reauthorization of the Over-the-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments

요약

The Food and Drug Administration (FDA, Agency, or we) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030. OMUFA authorizes FDA to assess and collect user fees to support OTC monograph drug activities. The current legislative authority for OMUFA expires September 30, 2025. At that time, new legislation will be required to reauthorize the OMUFA program for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with the public as part of the OMUFA reauthorization process. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2026 through 2030.