FY 1998 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 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.
FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS -- TOTAL COST
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.
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