Health and Human Services Department, Food and Drug Administration
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR)s for fiscal years 2026 through 2030. In this notice, FDA is announcing the OMOR fee rates for fiscal year (FY) 2026. FDA plans to announce the FY 2026 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of the OMUFA facility fee rate publication for prior FYs).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2025-N-6896] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as “OMUFA II”), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR)s for fiscal years 2026 through 2030. In this notice, FDA is announcing the OMOR fee rates for fiscal year (FY) 2026. FDA plans to announce the FY 2026 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of the OMUFA facility fee rate publication for prior FYs). DATES: These OMOR fees are effective on October 1, 2025, and will remain in effect through September 30, 2026. FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4989; or the User Fees Support Staff at OO-OFBA-OFM-UFSS-Government@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background Section 744M of the FD&C Act ( 21 U.S.C. 379j-72 ), as amended by OMUFA II,…
Citation: 90 FR 60719
