Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027
Published Date: 7/30/2026
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.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
FY2027 Animal-Drug Fee Schedule Set
FDA set FY2027 user fees for generic new animal drugs. Application fees are $132,614 (or $66,307 for certain 50% cases), JINAD file fees are $50,000, product fees are $15,670, and annual sponsor fees are $264,009 (100%), $198,007 (75%), or $132,005 (50%). These application and JINAD fee rates apply to submissions made on or after October 1, 2026 through September 30, 2027.
Invoices and Payment Deadlines
FDA will issue invoices for FY2027 product and sponsor fees by December 31, 2026, and payment will be due by January 31, 2027. FDA will not accept an application, a request to establish a JINAD file, or certain JINAD submissions for review or action until it has received full payment of all applicable AGDUFA fees.
Waivers, Reductions, and Removed Exemption
Fee waivers or reductions remain available for abbreviated applications intended solely for a minor use or minor species indication. However, after September 30, 2023, there is no longer an exemption for submissions that are supplemental abbreviated applications submitted solely to add the application number to labeling as described in section 502(w)(3).
How You Must Pay FY2027 Fees
Payments for FY2027 fees must be in U.S. dollars drawn on a U.S. bank and can be made online via Pay.gov using ACH (eCheck) or credit card, or by wire transfer. Credit card payments are allowed only for balances under $25,000; ACH (eCheck) is required for larger balances, and wire transfers must include the unique user fee ID or invoice number so FDA can apply the payment.
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Previous: 2026-15339, Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2027.
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