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ADUFA II
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ADUFA II Federal Register Notices
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ADUFA I

The Law

• Public Law 110—316 (Animal Drug User Fee Amendments of 2008), 110th Congress, August 14, 2008

On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA). ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extend ADUFA until 2013. ADUFA amends the Food, Drug and Cosmetic Act to authorize FDA to collect fees to enhance the performance of the new animal drug review process and 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 consumption.

The ADUFA reauthorization maintains the FY 08 review timeframes for key submissions, in addition to enhancements to the program. The most significant of these is the “end review amendment” process. This amendment will enable the FDA to work with a drug manufacturer to make corrections to address deficiencies at the end of the review process, rather than restarting the review clock. This will improve efficiency by significantly reducing the number of submission review cycles.

In addition, this reauthorization encourages increased communications between FDA and industry, and also provides for improvements to the information technology infrastructure of animal drug review, providing a tool which enables industry to submit drug applications electronically and gives reviewers the ability to evaluate those applications online.

The reauthorization of ADUFA will generate $98 million in user fees over five years (FY 2009 – FY 2013).

For general questions regarding ADUFA, please send your inquiries to cvmadufa@fda.hhs.gov.

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