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Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027
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Summary (from the Federal Register abstract)
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 type
- Notice
- Federal Register document number
- 2026-15341
- Published
- Jul 30, 2026
- Action
- Notice.
- Docket
- FDA-2026-N-7498
- Comments posted on Regulations.gov (at last check)
- 1
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-15341. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.