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Executive Summary: FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 AGDUFA Financial Report

The Animal Generic Drug User Fee Act (AGDUFA) of 2008 requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Act.  Required under AGDUFA, this report covers activities for fiscal year (FY) 2011.

AGDUFA specifies that the following three legal conditions must be satisfied each fiscal year in order for FDA to collect and spend AGDUFA user fees:

1.            FDA’s overall Salaries and Expenses Appropriation, excluding fees, must be equal to or exceed

 FDA’s overall FY 2003 Salaries and Expenses Appropriation, excluding fees and adjusted for


2.             The fee amounts FDA can collect must be specified in appropriation acts.

3.             FDA must spend more than the amount that is three percent below the minimum spending level

 from appropriations for the review of abbreviated applications for generic new animal drug

 applications as it spent in FY 2008, adjusted for inflation.

This report explains how FDA met these three legal conditions in FY 2011.  The statements and tables in the report provide data on FY 2011 generic new animal drug user fee collections, expenditures, and carryover balance, as well as comparative data from earlier periods. 

In FY 2011, FDA collected nearly $5.2 million in generic new animal drug user fees, spent $4.7 million in user fees for the review process, and carried a cash balance of $2.7 million forward for future fiscal years. 

AGDUFA user fees and appropriations in FY 2011 supported 53 full-time equivalent (FTE) staff years, including salaries and operational expenses to support the staff responsible for the process of reviewing generic new animal drug applications.   

In FY 2012, FDA will spend user fees to continue enhancing the program, while focusing on improving the efficiency, quality, and predictability of the generic animal drug review process. 

Next Section: Background - FY 2011 AGDUFA Financial Report