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FY 1998 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 1997 and 1998 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. 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.


as of September 30, 1998


FDA Component FY 1997 FY 1998
Center for Drug Evaluation and Research (CDER) $127,686,288 $144,227,003
Center for Biologics Evaluation and Research (CBER) $66,102,113 $66,275,840
Field Inspection and Investigational Costs (ORA) $14,849,704 $16,904,301
Agency General and Administrative Costs $23,610,630 $26,044,491
Total Process Costs $232,248,735 $253,451,635
Amount from Appropriations $147,959,689 $151,836,635
Amount from Fees $84,289,046 $101,615,000

The costs for CDER rose significantly in FY 1998. This reflects increased staffing levels and information technology expenditures as CDER gears up for the new challenges imposed by PDUFA goals for FY's 1998-2002. CBER expenditures remained relatively flat, in spite of substantial increases in pay costs in FY 1998, because research resources that had been allocated to CBER from PDUFA revenues are being phased out. Much of the additional review staff that CBER will need to meet new goals will be provided by reassignment of research staff to review work.

The slight increases in ORA and General and Administrative costs is roughly proportional to the increase in overall process costs.

Next Section: Management Challenges for FY 1999