The US Food and Drug Administration (FDA) announced in the Federal Register the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).
ADUFA, originally signed into law in 2003 and reauthorized in 2008 and 2013, amends the Federal Food, Drug, and Cosmetic Act and authorizes 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 FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals that produce food for consumption. ADUFA III reauthorizes FDA to collect user fees through FY 2018.
AGDUFA, originally signed into law in 2008 and reauthorized in 2013, was designed to enhance the performance of the generic new animal drug review process and enable FDA to better ensure that generic new animal drug products are safe and effective, thus giving consumers a lower cost alternative to pioneer drugs. AGDUFA II reauthorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of such 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 II reauthorizes FDA to collect user fees through FY 2018.
ADUFA III FY 2015 Fees: Animal Drug Application $400,600; Supplemental Animal Drug Application requiring safety or effectiveness data and Animal Drug Application subject to criteria in 21 U.S.C. 360b(d)(4)) $200,300; Product $8,075; Establishment $104,150; Sponsor $94,450.
AGDUFA II FY 2015 fees: Abbreviated Generic New Animal Drug Application (except those subject to criteria in 21 U.S.C. 360b(d)(4)) $189,200; Abbreviated Generic New Animal Drug Application subject to criteria in 21 U.S.C. 360b(d)(4) (50% of application fee) $94,600; Product $8,500.
Sponsor: 100% (holds > 6 approved abbreviated applications) $80,900; 75% (holds 2-6 approved abbreviated applications) $60,675; 50% (holds 0-1 approved abbreviated applications) $40,450.
The Federal Register notices provide details on how to submit payment for the FY 2015 user fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2014, until September 30, 2015. FDA will issue invoices for FY 2015 product, establishment, and sponsor fees by December 31, 2014, and payment will be due by January 31, 2015. FDA will not accept an application for filing unless the sponsor has paid all fees due.