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User Fee Obligations: FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 AGDUFA Financial Report

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 2011, FDA obligated $4,685,800 from generic animal drug user fees. Table 2 provides a breakout of user fee obligations by expense categories during the past two fiscal years.

Table 2
Generic New Animal Drug User Fee Obligations by Expense Categories
as of September 30, 2011

 EXPENSE CATEGORY FY 2010 FY 2011
 Personnel Compensation and Benefits $3,196,041 $3,042,223
 Travel and Transportation $140,037 $108,677
 Rent $105,100 $17,900
 Communications $20,868 $23,232
 Contract Services $910,233 $1,272,376
 Equipment and Supplies $341,734 $203,568
 Other[1] $22,787 $17,824
 TOTAL OBLIGATIONS $4,736,800 $4,685,800
[1] Other includes expenses from categories such as rent payments to others, printing & reproduction, and other miscellaneous expenses.

FDA dedicated 26 Full-Time Equivalents (FTE) to the process for the review of generic animal drug applications in FY 2008, before AGDUFA was enacted.  In FY 2011, AGDUFA fees and appropriations paid for a total of 53 FTE, 27 more FTEs than were used in FY 2008 for the review process.  Employee salary and benefits paid from user fees in FY 2011 totaled approximately 65 percent of the obligations from user fees.  FDA is working to strengthen and expand its capacities to conduct efficient and timely reviews, and to ensure the safety and effectiveness of generic new animal drugs. 

See the section Total Cost Of The Process For The Review Of Abbreviated Applications For Generic New Animal Drugs, on page 10, for more discussion on the total process costs for the review of abbreviated applications for generic new animal drugs.

Next Section: Carryover Balances – FY 2011 AGDUFA Financial Report