Executive Summary: FY 2011 ADUFA Financial Report
The Animal Drug User Fee Act (ADUFA) of 2003, 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 report covers activities for fiscal year (FY) 2011.
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:
1. FDA’s overall Salaries and Expenses Appropriation, excluding fees, must meet or exceed FDA’s
overall FY 2003 Salaries and Expenses Appropriation, excluding fees and adjusted for inflation.
2. The fee amounts FDA can collect must be specified in appropriation acts.
3. FDA must spend more than the amount that is three percent below the minimum spending level
from appropriations 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 these three legal conditions in FY 2011. The statements and tables in the report provide data on FY 2011 animal drug user fee collections, expenditures, and carryover balance, as well as comparative data from earlier periods.
In FY 2011, FDA collected $18.1 million in animal drug user fees, spent $16.6 million in user fees for the review process, and carried a cash balance of $4.7 million forward for future fiscal years.
ADUFA user fees and appropriations in FY 2011 supported 289 Full-Time Equivalent (FTE) staff years, including salary and operational expenses to support the staff responsible for the process for the review of animal drug applications.
In FY 2012, FDA will spend user fees to continue enhancing the program, focusing on improving the efficiency, quality, and predictability of the new animal drug review process.