Obligation of 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 2009, FDA obligated $2,125,300 from generic animal drug user fees. The following table provides a breakout of user fee obligations by expense categories during the past fiscal year.
FOOD AND DRUG ADMINISTRATION
STATEMENT OF GENERIC NEW ANIMAL DRUG USER FEE
OBLIGATIONS BY EXPENSE CATEGORIES
AS OF SEPTEMBER 30, 2009
Expense Category FY 2009 Personnel Compensation and Benefits $1,669,902 Travel and Transportation $55,653 Rent $103,720 Communications $23,229 Contract Services $233,939 Equipment and Supplies $35,569 Other (1) $3,288 Total Obligations $2,125,300
(1) 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 2009, FDA dedicated a total of 41 FTE positions to the process for the review of animal generic drug applications, of which 9 were funded by animal drug user fees. In addition to funding 9 FTEs in FY 2009, animal generic drug user fees supported other operational expenses such as computers, furniture, supplies, rent, and other infrastructure needs. During FY 2010, FDA expects to continue to enhance the review program necessary to meet the challenging performance goals associated with this program.