Federal Register #2026-15344

FDA Announces Fiscal Year 2027 OTC Monograph Drug User Fee Rates

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has published the user fee rates for Over-the-Counter (OTC) Monograph Drug facilities and order requests for Fiscal Year 2027. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs: - Not applicable (fees apply to all qualifying OTC drug manufacturers and facilities) - Products/Services Requested: - Annual user fee for OTC Monograph Drug Facilities (MDF): $47,891 - Annual user fee for Contract Manufacturing Organization (CMO) facilities: $31,927 - Fee for Tier 1 OTC Monograph Order Request (OMOR): $614,608 - Fee for Tier 2 OTC Monograph Order Request (OMOR): $122,921 - Notable Requirements: - Fees are assessed based on facility type and OMOR submission tier - Exemptions for facilities that ceased OTC monograph drug activities before January 1, 2026, and for certain safety-related OMORs - Payments must be made in U.S. currency via electronic methods - Non-payment may result in collection actions - Fees support FDA's OTC monograph drug regulatory activities - Period of Performance: - Fees cover the period from October 1, 2026, through September 30, 2027 - Facility fees are due in two equal installments; OMOR fees are due upon submission

Description

The Food and Drug Administration (FDA) is authorized under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II) to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OMUFA fee rates for fiscal year 2027, including facility fees for OTC monograph drug facilities and fees for OMOR submissions. The fees support FDA's OTC monograph drug activities and are effective from October 1, 2026, through September 30, 2027.

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