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U.S. Department of Health and Human Services

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FY 2012 AGDUFA Performance Report

Commissioner’s Report

I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2012 Performance Report to Congress for the Animal Generic Drug User Fee Act (AGDUFA). On August 14, 2008, AGDUFA was signed into law. AGDUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first generic animal drug user fee program for FY 2009 through FY 2013. AGDUFA follows the Animal Drug User Fee Act (ADUFA) model and also is similar to the Prescription Drug User Fee Act (PDUFA) program.

This report marks the fourth year of FDA performance review under AGDUFA and finalizes performance results for FY 2010 and FY 2011, the second and third years of AGDUFA. This report also presents FDA’s preliminary accomplishments for FY 2012. It is my pleasure to report that FDA exceeded all performance goals for FY 2010 and FY 2011. FDA also met review-time goals for all FY 2012 cohort submissions reviewed or due for review by September 30, 2012. With reviews pending within the goal deadlines, FDA is on track to exceed all performance goals for FY 2012.

Each year under AGDUFA, the number of days to meet the review-time goals is decreased while the overall performance goal level of 90 percent of reviews is maintained. FDA agreed to these increasingly challenging goals as part of our commitment to improve the efficiency, quality, and predictability of the generic new animal drug review process. We look forward to the improvements in the generic new animal drug review process that AGDUFA will make possible in the coming years.

The report that follows presents FDA’s accomplishments for FY 2012, the fourth year operating under AGDUFA.

 

 

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs