Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2027.
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-2026-N-7498] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2027. DATES: The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2026, and will remain in effect through September 30, 2027. The fee rates for requests to establish a JINAD file, and for certain submissions to JINAD files established prior to October 1, 2023, are effective on October 1, 2026, and will remain in effect through September 30, 2027. FOR FURTHER INFORMATION CONTACT: Visit FDA's website at: https://www.fda.gov/​industry/​fda-user-fee-programs/​animal-generic-drug-user-fee-act-agdufa . For general qu…
Citation: 91 FR 48149
