The Animal Drug User Fee Act of 2003 (ADUFA), amended the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorized FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. ADUFA I generated $43 million in user fees over five years (FY 2003 – FY 2008). FDA’s responsibilities under the FFDCA include ensuring that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. These additional resources support these responsibilities, and enhance the timeliness and predictability of application reviews for sustained performance.
On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA), also referred to as ADUFA II. ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extended ADUFA until 2013. The ADUFA II reauthorization maintained the FY 2008 review timeframes for key submissions and generated $89 million in user fees over five years (FY 2009 – FY 2013).
On June 13, 2013, President Obama signed the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, reauthorizing ADUFA, also referred to as ADUFA III. ADUFA II was set to expire September 30, 2013, and the new reauthorization extends ADUFA until 2018.
The ADUFA III reauthorization maintained the FY 2013 review timeframes for key submissions in addition to enhancements to the program. Enhancements include: replacing the End Review Amendment (ERA) with a short second round review; reducing time for microbial food safety hazard characterization submissions to 100 days; adding a variable inflation adjuster to account for changes in CVM’s costs using the Consumer Price Index as a guide; and reducing the proportion provided by application fees from 25% to 20%. 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 Agency agreed to explore the feasibility of pursuing an expanded conditional approval and of pursuing a use of multiple new animal drugs in the same medicated feed be subject to an approved application. The reauthorization of ADUFA is targeted to generate $114 million in user fees over five years (FY 2014 – FY 2018).
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