October 2, 2023
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.
These two user fee programs enhance the FDA’s ability to maintain a predictable and timely animal drug review process, foster innovation in drug development, and expedite access to new therapies for food-producing and companion animals.
Fee rates and payment procedures for FY 2024 have not yet published in the Federal Register. 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.
ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013, 2018 and 2023, authorizes the FDA to collect fees for certain animal drug applications and supplemental applications, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources supplement funding provided by Congressional budget authority to enhance the performance of the drug review process ensuring that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. ADUFA V reauthorizes the FDA to collect user fees through FY 2028.
AGDUFA, originally signed into law in 2008 and reauthorized in 2013, 2018 and 2023, was designed to supplement the Congressional budget authority to enhance the performance of the generic new animal drug review process, which enables the FDA to ensure that generic new animal drug products are safe and effective. AGDUFA IV reauthorizes the FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. AGDUFA IV reauthorizes the FDA to collect user fees through FY 2028.
In the period since Congress first passed ADUFA in 2003, the FDA has approved 524 new animal drugs -- both original approvals and major enhancements to these approvals (e.g., new indications, new species). In the period since AGDUFA was passed in 2008, the FDA has approved 354 generic new animal drugs.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.