User Fee Obligations in FY 2011
User fees are expended only for costs necessary to support the process for the review of medical device applications, as defined in MDUFMA. Allowable and excludable costs for the process for the review of medical device applications are described in Appendix D.
In FY 2011 FDA obligated $59,256,500 from medical device user fees. Table 2 provides a breakout of user fee obligations by expense category during the past two fiscal years.
Medical Device User Fee Obligations By Expense Category
As Of September 30, 2011
EXPENSE CATEGORY FY 2010 FY 2011 Personnel Compensation and Benefits $40,825,395 $45,184,270 Travel and Transportation $418,913 $508,956 GSA Rent $2,446,935 $3,237,103 Communications $256,820 $442,278 Contract Services $12,145,166 $8,817,457 Equipment and Supplies $982,624 $1,003,088 Other1 $111,247 $63,348 TOTAL OBLIGATIONS $57,187,100 $59,256,500
1Other includes expenses from categories such as rent payments to others, printing & reproduction and other miscellaneous expenses.
FDA saw a decrease in the amount of user fees contributing to contract services. This decrease is directly related to the decrease in the costs for operation and maintenance of equipment used for the review of medical device applications. Those funds were applied towards the costs associated with compensation and benefits for FTEs that support the process for the review of medical device applications.
FDA dedicated 829 FTEs to the process for the review of medical device applications in FY 2002 before MDUFMA was enacted. In FY 2011 MDUFMA fees and appropriations paid for a total of 1,275 FTEs, 446 more FTEs than were used in FY 2002 for the review process. Also, in FY 2011 84 additional contractor staff years were dedicated to the medical device review process than in FY 2002. Employee salary and benefits paid from user fees in FY 2011 totaled over 76 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 medical devices.