August 2, 2013
The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2014 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 additional 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 intended for food. 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 and give consumers a lower cost alternative to pioneer drugs. AGDUFA II reauthorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, generic new animal drug products, and certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs through FY 2018. The user fees for sponsors are pro-rated based on the number of approved abbreviated applications the sponsor currently holds.
ADUFA III FY 2014 fees Animal Drug Application $396,600 Supplemental Animal Drug Application (requiring safety or effectiveness data) $198,300 Product $9,075 Establishment $105,800 Sponsor $101,150
|AGDUFA II FY 2014 fees|
|Abbreviated Generic New Animal Drug Application (requiring safety or effectiveness data)||$177,900|
|Abbreviated Generic New Animal Drug Application (as described in 21 CFR 360b(d)(4)) – 50% of application fee||$88,950|
100% (holds > 6 approved abbreviated applications)
75% (holds 2-6 approved abbreviated applications)
50% (holds 0-1 approved abbreviated applications)
The Federal Register notices also provide details on how to submit payment for the FY 2014 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2013, until September 30, 2014. FDA will issue invoices for FY 2014 product, establishment, and sponsor fees by December 31, 2013, and payment will be due by January 31, 2014. FDA will not accept an application for filing unless the sponsor has paid all the fees it owes.
For more information, contact Lisa Kable, Center for Veterinary Medicine (HFV-10), FDA, 7529 Standish Place, Rockville, MD 20855, 240-276-9718. Please send general questions concerning ADUFA to firstname.lastname@example.org and questions concerning AGDUFA to email@example.com.