The Animal Generic Drug User Fee Act of 2008 (AGDUFA) requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Act. Required under AGDUFA, this report covers activities for fiscal year (FY) 2010.
AGDUFA specifies that the following three legal conditions must be satisfied each fiscal year in order for FDA to collect and spend AGDUFA user fees:
- FDA’s overall Salaries and Expenses Appropriation, excluding fees, must exceed FDA’s overall FY 2003 Salaries and Expenses Appropriation, excluding fees and adjusted for inflation.
- Fee collections must be specified in Appropriation Acts.
- FDA must spend at least as much from appropriated funds for the review of abbreviated applications for generic new animal drug applications as it spent in FY 2008, adjusted for inflation.
This report explains how FDA met the three legal conditions in FY 2010. The statements and tables in the report provide data on generic new animal drug user fee collections and expenditures for FY 2010. In FY 2010, FDA collected $4.5 million in generic new animal drug user fees, spent $4.7 million in user fees for the review process, and carried a cash balance of $2.2 million forward for future fiscal years.
AGDUFA implementation strategies facilitated the recruitment of new review staff in FY 2010. The generic new animal drug user fees and appropriations spent in FY 2010 supported 49 staff years, including salary and operational expenses to support the staff responsible for the process for the review of animal generic drug applications. In FY 2008, before the enactment of AGDUFA, FDA dedicated 26 full-time equivalents (FTEs) to this process. In FY 2011, FDA will spend user fees and appropriations to continue enhancing the review program and improve communications to meet the challenging performance goals associated with this program in FY 2011.