July 27, 2021
The U.S. Food and Drug Administration has announced in the Federal Register the fiscal year (FY) 2022 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).
ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013 and 2018, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), and 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 IV reauthorizes the FDA to collect user fees through FY 2023.
AGDUFA, originally signed into law in 2008 and reauthorized in 2013 and 2018, 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 III 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. The user fees for sponsors are prorated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA III reauthorizes the FDA to collect user fees through FY 2023.
In the period since Congress first passed ADUFA in 2003, the FDA has approved more than 489 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 more than 299 generic new animal drugs.
The 2018 reauthorizations of ADUFA and AGDUFA included several additions to the previous authorizations, including (in ADUFA) the expansion of the FDA’s conditional approval pathway for certain new animal drugs, reporting on the FDA’s progress in bringing all approved animal antimicrobial drugs that are medically important under veterinary oversight, and publicly listing of the number of pending petitions for food additives intended for use in animal food. In January 2021, the FDA announced the conditional approval of KBroVet-CA1 (potassium bromide chewable tablets), the first drug to receive conditional approval through the expanded pathway.
The tables below reflect the ADUFA IV and AGDUFA III fee rates for FY 2022.
ADUFA IV FY 2022 Fees
|Animal Drug User Fee Category||Fee Rate for FY 2022|
Animal Drug Application Fees:
|Product Fee||$ 10,787|
AGDUFA III FY 2022 Fees
|Generic New Animal Drug User Fee Category||Fee Rate for FY 2022|
|Abbreviated Application for a Generic New Animal Drug (except those subject to criteria in 21 U.S.C. 360b(d)(4))||$548,628|
|Abbreviated Application for a Generic New Animal Drug subject to criteria in 21 U.S.C. 360b(d)(4) (50% of application fee)||$274,314|
|Product Fee||$ 17,513|
100% (holds > 6 approved abbreviated applications)
In addition to announcing the ADUFA and AGDUFA user fee rates for FY 2022 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, 2021, until September 30, 2022. The FDA will issue invoices for FY 2022 product, establishment, and sponsor fees by December 31, 2021, and payment will be due by January 31, 2022. 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 2020 Financial and Performance Reports below.
- Federal Register Notice on ADUFA Fees
- Federal Register Notice on AGDUFA Fees
- FY 2020 ADUFA Financial Report
- FY 2020 AGDUFA Financial Report
- FY 2020 ADUFA Performance Report
- FY 2020 AGDUFA Performance Report
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.