Meeting the Legal Conditions for User Fees in FY 2009
ADUFA imposes three legal conditions that must be satisfied in each fiscal year before FDA can collect and spend animal drug user fees. A summary of how each of these legal conditions was satisfied in FY 2009 is shown below. Detailed explanations and calculations are described in Appendix A.
The first legal condition. FDA’s budget authority appropriation for salaries and expenses (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 2009, FDA’s budget authority appropriation for salaries and expenses was $2,038,964,000, excluding user fees. FDA’s FY 2003 salaries and expenses appropriation, excluding user fees and then adjusted for inflation, was $1,583,111,972. Because $2,038,964,000 is greater than $1,583,111,972 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 2009 Omnibus Appropriations Act (Public Law 111-8) specifying amounts collectable from fees during FY 2009, on March 11, 2009. It specified that $15,260,000 shall be derived from 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 2009 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 animal drug applications as it did in FY 2003 adjusted for inflation. This is referred to as the specified minimum in this report. Under ADUFA, 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 2009 after the adjustment for inflation is $37,797,742. In FY 2009, FDA obligated $49,863,275 from appropriations for the reviews of animal drug applications. Because FDA spent more than the specified minimum amount from appropriations in FY 2009, the third legal condition was satisfied. The obligated appropriation total exceeded the minimum level by a higher margin than usual in FY 2009. This was a direct result of the large increase in appropriated funds animal drugs received in the budget at the beginning of the year.