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Total Costs of the Process for the Review of Human Drug Applications (FY 2010 PDUFA)

Back of Table of Contents: FY 2010 PDUFA Financial Report

Table 6 presents the costs for the review of human drug applications for FY 2009 and FY 2010 by organizational components. It indicates the full cost of the process for the review of human drug applications, including costs paid both from appropriations and from user fee revenues. The amounts are based upon the obligations recorded at the end of each fiscal year. In the past, over 81 percent of amounts obligated are expended within one year, and 96 percent within two years. Thus, obligations represent an accurate measure of costs.

 
Table 6
Process for the Review of Human Drug Applications – Total Costs
As of September 30, 2009 and 2010

FDA Component
FY 2009
FY 2010
Center for Drug Evaluation and Research (CDER)
$585,414,578
$640,509,784
Center for Biologics Evaluation and Research (CBER)
$170,363,705
$176,353,112
Field Inspection and Investigation Costs (ORA)
$36,509,080
$34,968,204
Agency General and Administrative Costs (OC)
$63,138,931
$80,014,481
 
 
 
Total Process Costs
$855,426,294
$931,845,581
     Amount from Appropriations
$343,374,894
$358,587,181
     Amount from Fees
$512,051,400
$573,258,400

 
Of the total of $931,845,581 obligated in support of the process for the review of human drug applications as defined in PDUFA in FY 2010, about 62 percent came from PDUFA fees and about 38 percent came from appropriations. The costs for all components except ORA increased in FY 2010.  The increases in expenditures primarily reflects the fact that in FY 2010 FDA used a total of 3,760 FTE for the process for the review of human drug applications, 234 more FTE than the 3,526 FTE utilized by FDA in FY 2009.  Most of this increase reflected FDA’s success in hiring or reassigning employees to work in support of the process of the review of human drug applications. A portion of the cost increase is also due to mandatory pay and benefit increases for all Federal employees.
 
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