Generic Drug User Fee Rates for Fiscal Year 2025

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-2024-N-3404] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2025 rates for GDUFA III fees. These fees are effective on October 1, 2024, and will remain in effect through September 30, 2025. FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903, 240-402-4989; or the User Fees Support Staff at OO-OFBAP-OFM-UFSS-Government@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background Sections 744A and 744B of the FD&C Act ( 21 U.S.C. 379j-41 and 379j-42 ), as amended by GDUFA III, authorize FDA to assess and collect fees associated with human generic drug products. Fees are assessed on: (1) certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) cer…