Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Requests Fee Rates for Fiscal Year 2024

Issuing agencies

Abstract

The Food and Drug Administration (FDA or the Agency) is announcing the over-the-counter (OTC) monograph order request (OMOR) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. 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 OMORs. This notice publishes the OMOR fee rates under OMUFA for FY 2024. FDA plans to publish the FY 2024 OMUFA facility fee rates in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of OMUFA facility fee rate publication for prior fiscal years).