September 25, 2018
The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 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 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 support the FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals, as well as ensuring the safety of food from treated animals. 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 and enable the FDA to more efficiently 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 pro-rated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA III reauthorizes FDA to collect user fees through FY 2023.
ADUFA IV FY 2019 fees
|Animal Drug Application||$449,348|
|Supplemental Animal Drug Application requiring safety or effectiveness data and Animal Drug Application subject to criteria in 21 U.S.C. 360b(d)(4))||$224,674|
AGDUFA III FY 2019 fees
|Abbreviated Generic New Animal Drug Application (except those subject to criteria in 21 U.S.C. 360b(d)(4))||$424,444|
|Abbreviated Generic New Animal Drug Application subject to criteria in 21 U.S.C. 360b(d)(4) (50% of application fee)||$212,222|
100% (holds > 6 approved abbreviated applications)
75% (holds 2-6 approved abbreviated applications)
50% (holds 0-1 approved abbreviated applications)
The Federal Register notices provide details on how to submit payment for the FY 2019 user fees. The application fee rates are effective for applications received by the FDA’s Center for Veterinary Medicine from October 1, 2018, until September 30, 2019. The FDA will issue invoices for FY 2019 product, establishment, and sponsor fees by December 31, 2018, and payment will be due by January 31, 2019. The FDA will not accept an application for filing unless the sponsor has paid all fees due.
For questions, Contact CVM.