User Fee Obligations (FY 2010)
User fees are expended only for costs necessary to support the process for the review of animal drug applications, as defined in ADUFA. Allowable and excludable costs for the process for the review of animal drug applications are described in Appendix D.
In FY 2010, FDA obligated $16,600,700 from animal drug user fees. Table 2 provides a breakout of user fee obligations by expense categories during the past two fiscal years.
Statement of Animal Drug User Fee Obligations by Expense Categories
As of September 30, 2010
Personnel Compensation and Benefits
Travel and Transportation
Equipment and Supplies
The overall ADUFA process spending from user fees increased 24 percent in FY 2010. This increase in spending was primarily in the Contract Services expense category. These funds were utilized in developing the Electronic Submissions Tool scheduled to be deployed in FY 2011. See the section Total Cost of the Process for the Review of Animal Drug Applications, on page 10, for more discussion on the total process costs for ADUFA.
FDA is working to strengthen and expand its capacities to conduct efficient and timely reviews, and to ensure the safety and effectiveness of new animal drugs. FDA dedicated 197 staff-years to the process for the review of animal drug applications in FY 2003, before ADUFA was enacted.
In FY 2010, FDA dedicated a total of 285 full-time equivalents (FTE) to the process for the review of animal drug applications. Animal drug user fees supported other operational expenses such as computers, furniture, supplies, rent, and other infrastructure needs to support these FTEs. During FY 2011, FDA expects to continue to enhance the review program as necessary to meet the challenging performance goals associated with this program in FY 2011.
Other includes expenses from categories such as rent payments to others, printing & reproduction, and other miscellaneous expenses.