The Animal Drug User Fee Act of 2003 (ADUFA), as amended in 2008, requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Act. Required under ADUFA, this is the sixth financial report that covers activities for fiscal year (FY) 2009.
ADUFA, as amended, specifies that the following three legal conditions must be satisfied each fiscal year in order for FDA to collect and spend ADUFA 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 animal drug applications as it spent in FY 2003, adjusted for inflation.
This report explains how FDA met the three legal conditions in FY 2009. The statements and tables in the report provide data on animal drug user fee collections and expenditures for FY 2009. In FY 2009, FDA collected $13.4 million in animal drug user fees, spent $13.4 million in user fees for the review process, and carried a cash balance of roughly $4 million forward for future fiscal years—about the same amount as carried forward at the end of FY 2008.
ADUFA implementation strategies facilitated the recruitment of new review staff in FY 2009. The animal drug user fees and appropriations spent in FY 2009 supported 281 full-time equivalent staff years, including salary and operational expenses to support the staff responsible for the process for the review of animal drug applications. In FY 2010, FDA will spend user fees to continue enhancing the review program, continue development of the electronic submission tool, and improve communications to meet the challenging performance goals associated with this program in FY 2010.