AGDUFA imposes three legal conditions that must be satisfied in each fiscal year before FDA can collect and spend animal generic drug user fees. A summary of how each of these legal conditions was satisfied in FY 2010 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 2010, FDA’s budget authority appropriation for salaries and expenses was $2,344,656,000 excluding user fees. FDA’s FY 2003 Salaries and Expenses appropriation, excluding user fees and then adjusted for inflation, was $1,640,978,301. Because $2,344,656,000 is greater than $1,640,978,301, 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. For FY 2010, The Agriculture, Rural Development, Food And Drug Administration And Related Agencies Appropriations Act
(Public Law 111-80) specified that $5,106,000 shall be derived from generic new animal drug user fees. The Appropriation Act also specified that the fees collected by FDA remain available to FDA until expended. Therefore, the second legal condition for FY 2010 was satisfied.
The third legal condition. User fees may be collected and used only in years when FDA spends at least as much from appropriated funds (excluding user fees) on the process for the review of abbreviated applications for generic new animal drug applications as it did in FY 2008 adjusted for inflation. This is referred to as the specified minimum in this report. Under AGDUFA, the condition is considered met if the total review expense funded by appropriations in any year is no more than 3 percent below the specified minimum. The specified minimum level for FY 2010 after the adjustment for inflation is $5,711,874. In FY 2010, FDA obligated $6,408,309 from appropriations, exclusive of user fees, for the review of abbreviated applications for generic new animal drugs. Because FDA spent more than the specified minimum amount from appropriations in FY 2010, the third legal condition was satisfied.
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