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U.S. Department of Health and Human Services

For Industry

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AGDUFA Introduction

September 24, 2008

IMPORTANT INFORMATION FROM FDA CONCERNING THE PASSAGE OF THE ANIMAL GENERIC DRUG USER FEE ACT OF 2008:

On August 14, 2008, the President signed the Animal Generic Drug User Fee Act of 2008 (AGDUFA), Public Law 108-316.  The Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.

FDA is developing an initial list of applicants that may be subject to an application, product, and/or sponsor fee.  Before FDA can begin collecting fees, Congress must also pass an appropriation Act providing for the generic new animal drug fees.  FDA must also develop systems to collect, safeguard, process, and account for fees.  Until such time that we can publish detailed payment instructions, we ask that you do not send any fee payments to FDA.

Within 30 days after appropriation of generic new animal drug user fees by Congress, FDA will publish another notice in the Federal Register providing payment instructions for abbreviated applications for generic new animal drugs so that these fees may be paid in advance of the submission of such abbreviated applications from that time forward.  FDA will also issue invoices for fees for abbreviated applications for generic new animal drugs submitted on or after July 1, 2008, through the time of the publication of the Federal Register notice.  After that time, FDA will not consider an abbreviated application for a generic abbreviated new animal drug complete unless the application fee for that application has been paid in advance.

Within 30 days after appropriation of generic new animal drug user fees by Congress, FDA will also issue invoices for product and sponsor fees for FY 2009.

FDA is not canceling any submission and is not asking applicants to withdraw any submission due to lack of fee payment during this transition period.  Review activities will continue as usual for all abbreviated applications for generic new animal drugs submitted on or after July 1, 2008, and investigational submissions for generic new animal drugs submitted on or after September 1, 2008.

An applicant who wants to qualify for the minor use/minor species waiver provided for in AGDUFA should not submit any documentation or requests until FDA issues a detailed Guidance for Industry providing instructions on how and where to send your request for the waiver provided for in AGDUFA.