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