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FY 2002 PDUFA Financial Report: Meeting the Legal Conditions for User Fees in FY 2002

Table of Contents

Previous Section: Background

PDUFA II contains three legal conditions or “triggers” that must be satisfied each year before FDA can collect and spend user fees. FDA’s calculations showing how those conditions were met for FY 2002 are summarized below and presented in more detail in Appendix A.

The first condition is that FDA's overall Salaries and Expenses Appropriation (excluding user fees) must meet or exceed FDA's overall FY 1997 Salaries and Expenses Appropriation (excluding user fees and adjusted for inflation). In FY 2002, FDA’s overall Salaries and Expenses Appropriation (excluding user fees and excluding rent to GSA, which was also not included in the FY 1997 Appropriation amount) totaled $1,083,854,000. FDA’s FY 1997 total Salaries and Expenses appropriation, excluding user fees, and adjusted as required by the statute, was $905,411,978. Therefore, since the FY 2002 amount is greater, the first condition was met.

The second condition is that the amount of user fees collected each year must be specifically included in Appropriation Acts. For FY 2002, FDA’s Appropriation Act specified that $161,716,000 would come from PDUFA fees, in addition to sums provided in regular appropriations. The Appropriation Act specified that the fees collected could remain available until expended. Thus, the second condition was met.

The third condition is that user fees may be collected and used only in years when FDA also uses a specified minimum amount of appropriated funds for the review of human drug applications. The specified minimum is the amount FDA spent on the review of human drug applications from appropriations (exclusive of user fees) in FY 1997, adjusted for inflation. That amount, adjusted for inflation, is $163,377,089. In FY 2002, FDA obligated $185,815,399 from appropriated funds for the review of human drug applications. Since this amount exceeds the specified minimum amount, the third condition has been met.

Appendix A provides more detail on the calculations that show that these three statutory conditions were met.

Next Section: User Fee Revenues