Meeting the Legal Conditions for User Fees in FY 2011: FY 2011 AGDUFA Financial Report
AGDUFA imposes three legal conditions that must be satisfied in each fiscal year before FDA can collect and spend generic animal drug user fees. A summary of how each of these legal conditions was satisfied in FY 2011 is shown below. Detailed explanations and calculations are described in Appendix A.
The first legal condition: FDA’s overall Salaries and Expenses appropriation (excluding user fees) must meet or exceed FDA’s FY 2003 Salaries and Expenses appropriation (excluding user fees), including an adjustment for inflation. In FY 2011, FDA’s appropriation for salaries and expenses was $2,447,021,000 excluding user fees. FDA’s FY 2003 Salaries and Expenses appropriation, excluding user fees and then adjusted for inflation, was $1,637,978,110. Therefore, the first legal condition was satisfied.
The second legal condition: The amount of user fees collected for each fiscal year must be specified in that year’s Appropriation Acts. The President signed the FY 2011 Agriculture, Rural Development, Food And Drug Administration And Related Agencies Appropriations Act (Public Law 112-10) on April 15, 2011. It specified that $5,397,000 shall be derived from generic animal drug user fees. Therefore, the second legal condition was satisfied.
The third legal condition: User fees may be collected and used only in years when FDA spends a specified minimum amount of appropriated funds for the review of generic animal drug applications. This specified minimum is the amount FDA spent on the review of generic new animal drug applications from appropriations (exclusive of user fees) in FY 2008, adjusted for inflation. The specified minimum level for FY 2011 is $5,701,432. In FY 2011, FDA obligated $6,819,284 from appropriations (exclusive of user fees) for the review of abbreviated applications for generic new animal drugs. Under AGDUFA, the condition is considered met if the total review expense funded by appropriations in any year is more than the amount that is three percent below the specified minimum. Because FDA spent more than the specified minimum amount from appropriations in FY 2011, the third legal condition was satisfied.