FY 2000 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 1999 and 2000 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.
|FDA Component||FY 1999||FY 2000|
|Center for Drug Evaluation and Research (CDER)||$166,562,594||$187,426,061|
|Center for Biologics Evaluation and Research (CBER)||$73,316,714||$80,038,621|
|Field Inspection and Investigational Costs (ORA)||$17,753,152||$21,922,502|
|Agency General and Administrative Costs (OC)||$24,552,117||$25,534,938|
|Total Process Costs||$282,184,575||$314,922,122|
|Amount from Appropriations||$159,669,575||$167,646,122|
|Amount from Fees||$122,515,000||$147,276,000|
The costs for CDER, CBER and ORA rose in FY 2000. This reflects: (1) mandatory increases in pay rates for federal employees; (2) increased staffing levels as a result of more aggressive and successful recruiting, especially in CDER; and (3) increased information technology expenditures as FDA gears up for the new information technology challenges imposed by PDUFA II goals.
The very slight increase in Agency General and Administrative Costs, compared with all other components, results directly from the Commissioner's recent downsizing and streamlining of the Office of the Commissioner. As reflected in Appendix D, the percent of process costs devoted to this area since 1998 has been reduced by 22%.
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