July 31, 2020
The U.S. Food and Drug Administration (FDA) has announced in the Federal Register the fiscal year (FY) 2021 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, 21 U.S.C. 321 et seq., and authorizes the FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources help support activities undertaken by the FDA to oversee 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 enhance the performance of the generic new animal drug review process, which enables the FDA to oversee 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 469 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 274 generic new animal drugs.
The tables below reflect the ADUFA IV and AGDUFA III fee rates for FY 2021.
ADUFA IV FY 2021 fees
|Animal Drug User Fee Category||Fee Rate for FY 2021|
Animal Drug Application Fees:
|Product Fee||$ 12,230|
AGDUFA III FY 2021 fees
|Generic New Animal Drug User Fee Category||Fee Rate for FY 2021|
|Abbreviated Application for a Generic New Animal Drug (except those subject to criteria in 21 U.S.C. 360b(d)(4))||$513,423|
|Abbreviated Application for a Generic New Animal Drug subject to criteria in 21 U.S.C. 360b(d)(4) (50% of application fee)||$256,712|
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 2021 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, 2020, until September 30, 2021. The FDA will issue invoices for FY 2021 product, establishment, and sponsor fees by December 31, 2020, and payment will be due by January 31, 2021. The FDA will not accept an application for filing unless the FDA has received payment for all fees due from the sponsor.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.