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required by the
as amended by the
and by the
Food and Drug Administration
Department of Health and Human Services
March 2005
This Report is available in printer-friendly PDF format (102 KB)
Meeting the Legal Conditions for User Fees in FY 2004
Obligation of User Fee Revenues
Total Costs of the Process for the Review of Human Drug Applications
Management Challenges for FY 2005
Appendix A: Conditions for Assessment and Use of Fees
Appendix B: Exemptions and Waivers
Appendix C: Allowable and Excluded Costs for the Process for the Review of Human Drug Applications
Appendix D: Development of Costs for the Process for the Review of Human Drug Applications