FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: OVER-THE-COUNTER MONOGRAPH DRUG USER FEE PROGRAM-FACILITY FEE RATES FOR FISCAL YEAR 2025

WASHINGTON, March 21 -- Food and Drug Administration has issued a notice called: Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025.

The notice was published in the Federal Register on March 21 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes t...