For Industry

Animal Generic Drug User Fee Act (AGDUFA)

AGDUFA I

On August 14, 2008, President Bush signed into law the Animal Generic Drug User Fee Act (AGDUFA) of 2008. This Act amends the Food, Drug and Cosmetic Act by authorizing the first ever generic animal drug user fee program (for either human or animal drugs). FDA’s responsibilities under the Federal Food, Drug, and Cosmetic Act include ensuring that generic animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. These fees support these responsibilities and enhance the performance of the generic new animal drug review process. The generic drug review program provided consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs.

Under AGDUFA I, FDA agreed to meet review performance goals to improve the timeliness and predictability of the animal generic drug review process. AGDUFA generated $28 million in user fees over five years (FY 2009 – FY 2013).

AGDUFA II

On June 13, 2013, President Obama signed the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, reauthorizing AGDUFA, also referred to as AGDUFA II. AGDUFA I was set to expire September 30, 2013, and the new reauthorization extends AGDUFA until 2018.

The AGDUFA II reauthorization provided several enhancements to the program, including developing Question Based Review Process for Bioequivalence Submissions; shortening review time for key submission types, and reducing proportion provided by application fees from 30% to 25%. Additionally, there were Chemistry, Manufacturing, and Controls (CMC) enhancements, including: permitting the manufacturing supplements to be resubmitted as “Supplement-Changes Being Effected in 30 Days” if deficiencies are not substantial for manufacturing supplements requiring prior approval according to 21 CFR 514.8(b); permitting comparability protocols as described in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without substantial data in a INAD file; and developing guidance for a two-phased CMC technical section submission and review process under the INAD file. The reauthorization of AGDUFA is targeted to generate $38 million in user fees over five years (FY 2014 – FY 2018).

For general questions regarding AGDUFA, please send your inquiries to cvmagdufa@fda.hhs.gov.

Page Last Updated: 04/19/2016
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