Meeting the Legal Conditions for User Fees in FY 2010
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PDUFA imposes three legal conditions that FDA must satisfy each year before the Agency may collect and spend user fees. The calculations on how these conditions were met in FY 2010 are summarized below and are explained in greater 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 2010, FDA’s overall Salaries and Expenses appropriation (excluding user fees and excluding rent to the U.S. General Services Administration (GSA), which was also not included in the FY 1997 appropriation amount) totaled $2,200,634,000. FDA’s FY 1997 total Salaries and Expenses appropriation (excluding user fees) multiplied by the FY 2010 adjustment factor as required by the statute, and rounded to the nearest thousand dollars, was $1,121,816,000. Therefore, since the FY 2010 appropriated amount is greater, the first condition was met.
The second condition is that the amount of user fees collected in each year must be specified in Appropriation Acts. The President signed the Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Appropriations Act, 2010 (Public Law 111-80) specifying amounts collectable from fees during FY 2010 on October 21, 2009. It provided for $578,162,000from prescription drug user fees. The Appropriation Act specified that the fees collected could remain available until expended. Thus, the second condition was met.
The third condition is that FDA may collect and spend user fees 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 for FY 2010 and rounded to the nearest thousand dollars, is $202,426,000. In FY 2010, FDA obligated $358,587,181 from appropriated funds for the process for the review of human drug applications. Since this amount exceeds the specified minimum amount, the third condition has been met.
provides more detailed calculations and explanations of how FDA met each of these three statutory conditions.
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