FY2010 User Fee Obligations
User fees are expended only for costs necessary to support the process for the review of abbreviated applications for generic new animal drugs, as defined in AGDUFA. Allowable and excludable costs for the process for the review of abbreviated applications for generic new animal drugs are described in Appendix D.
In FY 2010, FDA obligated $4,736,800 from generic animal drug user fees. Table 2 provides a breakout of user fee obligations by expense categories during the past fiscal year.
Statement of Generic NEW Animal Drug User Fee Obligations by Expense Categories
As of September 30, 2010
Personnel Compensation and Benefits
Travel and Transportation
Equipment and Supplies
 Other includes expenses from categories such as rent payments to others, printing & reproduction, and other miscellaneous expenses.
See the section Total Cost of the Process for the Review of ABBREVIATED APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS, on page 9, for more discussion on the total process costs for AGDUFA.
FDA is working to strengthen and expand its capacities to conduct efficient and timely reviews, and to ensure the safety and effectiveness of the generic new animal drugs. FDA dedicated 26 staff-years to the process for the review of animal generic drug applications in FY 2008, before AGDUFA was enacted.
In FY 2010, FDA dedicated a total of 49 full time equivalents (FTE) to the process for the review of animal generic drug applications. Animal generic drug user fees supported other operational expenses such as computers, furniture, supplies, rent, and other infrastructure needs to fully support these FTEs. During FY 2011, FDA expects to continue to enhance the review program necessary to meet the challenging performance goals associated with this program.