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FY 2001 PDUFA Financial Report: Total Costs of the Process for the Review of Human Drug Applications

Table of Contents

Previous Section: Carryover Balances

The following table presents the costs for the review of human drug applications for FY's 2000 and 2001 by organizational component. This presents 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 obligations recorded as of 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.

FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS -- TOTAL COST

as of September 30, 2000 and 2001
FDA Component FY 2000 FY 2001
Center for Drug Evaluation and Research (CDER) $187,426,061 $194,878,267
Center for Biologics Evaluation and Research (CBER) $80,038,621 $80,505,442
Field Inspection and Investigational Costs (ORA) $21,922,502 $22,247,719
Agency General and Administrative Costs (OC) $25,534,938 $25,773,229
     
Total Process Costs $314,922,122 $323,404,657
Amount from Appropriations $167,646,122 $162,691,657
Amount from Fees $147,276,000 $160,713,000

The costs for all components rose slightly in FY 2001. This increase primarily reflects mandatory increases in pay rates for federal employees.

The Agency General and Administrative Costs, though up slightly, have continued to decline as a percent to total spending on the drug review process. As reflected in Appendix D, the percent of process costs devoted to this area since 1998 has been reduced by 23%.

Next Section: Management Challenges for FY 2002