Obligation of User Fee Obligations
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 2009, FDA obligated $13,379,200 from animal drug user fees. The following table provides a breakout of user fee obligations by expense categories during the past 2 fiscal years.
FOOD AND DRUG ADMINISTRATION
STATEMENT OF ANIMAL DRUG USER FEE OBLIGATIONS BY EXPENSE CATEGORIES
AS OF SEPTEMBER 30, 2009
|Expense Category||FY 2008||FY 2009|
|Personnel Compensation and Benefits||$8,008,826||$8,977,105|
|Travel and Transportation||$319,494||$188,126|
|Equipment and Supplies||$1,128,899||$832,567|
Other includes expenses from categories such as rent payments to others, printing & reproduction, and other miscellaneous expenses.
The overall ADUFA process spending from user fees decreased 1 percent in FY 2009. The reason for the slight decrease was the implementation of a conservative spending plan in FY 2009. With the economy struggling and the declining number of applications coming in, FDA believed that a conservative spending plan would help ensure the stability of the program over the next four years. The largest increases in spending were associated with personnel compensation and rent, reflecting the increase in full time equivalents (FTEs) supported and the increased cost of an FTE in FY 2009. See the section TOTAL COST OF THE PROCESS FOR THE REVIEW OF ANIMAL DRUG APPLICATIONS, on page 9, 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 2009, FDA dedicated a total of 281 FTE positions to the process for the review of animal drug applications, of which 70 were funded by animal drug user fees. In addition to funding 70 FTEs in FY 2009, animal 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 as necessary to meet the challenging performance goals associated with this program in FY 2010.