October 20, 2023
The U.S. Food and Drug Administration has announced in the Federal Register the fiscal year (FY) 2024 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023.
The Animal Drug User Fee Act (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.
The Animal Generic Drug User Fee Act (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 investigational new animal drug files, 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. The user fees for sponsors are prorated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA IV reauthorizes the FDA to collect user fees through FY 2028.
In the period since Congress first passed ADUFA in 2003 until September 30, 2023, 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 until September 30, 2023, the FDA has approved 354 generic new animal drugs.
The tables below reflect the ADUFA V and AGDUFA IV fee rates for FY 2024.
ADUFA V FY 2024 Fees
|Animal Drug User Fee Category||Fee Rate for FY 2024|
|Animal Drug Application Fees:
AGDUFA IV FY 2024 Fees
|Generic New Animal Drug User Fee Category||Fee Rate for FY 2024|
|Abbreviated Application for a Generic New Animal Drug (except those subject to criteria in 21 U.S.C. 360b(d)(4))||$126,582|
|Abbreviated Application for a Generic New Animal Drug subject to criteria in 21 U.S.C. 360b(d)(4) (50% of application fee)||$63,291|
|Generic Investigational New Animal Drug File Fee (JINAD)||$50,000|
100% (holds > 6 approved abbreviated applications)
75% (holds 2-6 approved abbreviated applications)
50% (holds 0-1 approved abbreviated applications)
In addition to announcing the ADUFA and AGDUFA user fee rates for FY 2024 and explaining how such rates were calculated, the Federal Register notices also provide details on how to submit payment of these fees to the FDA. The application fee rates are effective for applications received by the FDA’s Center for Veterinary Medicine from October 1, 2023, until September 30, 2024. The FDA will issue invoices for FY 2024 product, establishment, and sponsor fees by December 31, 2023, and payment will be due by January 31, 2024. The FDA will not accept an application for filing unless the FDA has received payment for all fees due from the sponsor.
For additional information regarding the financials and performance of ADUFA and AGDUFA, we have included a link for the FY 2022 Financial and Performance Reports below.
- Federal Register Notice; Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024
- Federal Register Notice; Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024
- ADUFA Financial Reports
- ADUFA Performance Reports
- AGDUFA Financial Reports
- AGDUFA Performance Reports
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.