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

The Food and Drug Administration (FDA, the Agency, or we) is hosting 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. Under OMUFA, FDA collects 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 OMUFA for future fiscal years. Following negotiations with the regulated industry and consultation with interested members of the public, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish recommendations for the reauthorization of the OMUFA program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.