On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860. The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028.
But not to worry, the user fees obviously can’t be paid until the rates are published and the FDA says, “Until those fee rates publish, the user fee cover sheet creation system will remain closed for ADUFA and AGDUFA submissions that require a fee payment prior to review. FDA will update this page when fee rates are available.” This will likely be on Monday. Get your checkbooks ready!
In today’s pre-publication of the Federal Register, the FY 2024 fee rates for animal drugs and animal generic drugs were announced (here) and they are reproduced below:
Animal Drug User Fees FY 2024
Generic Animal Drug User Fees FY 2024
The FR notices cited above discuss waiver possibilities for certain fees, which are fairly limited, and also describe how the FDA arrived at the fee figures for FY 2024. For those that have submitted their 2024 applications, payment should be made promptly as outlined in the FR notices. Fees for animal drugs rose slightly but fees for animal generic drugs dropped for all categories and some dropped considerably (unless there was an error in the FR notice)! See FY 2023 fees for comparison here.
