About FDA
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FY 2011 AGDUFA Financial Report
Required by the
Animal Generic Drug User Fee Act of 2008
Food and Drug Administration
Department of Health and Human Services
September 2011
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Printable Version of FY 2011 AGDUFA Financial Report
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Table of Contents
- Executive Summary
- Background
- Meeting the Legal Conditions for User Fees in FY 2011
- User Fee Collections
- User Fee Obligations
- Carryover Balances
- Collections Ceilings, Collections Realized, and Offset
- Reserves and Balance Available for Allocation
- Total Cost of the Process for the Review of Abbreviated Applications for Generic New Animal Drugs
- Management Challenges for FY 2012
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Appendices
- Appendix A: Conditions for Assessment and Use of Fees
- Appendix B: Number of Fees Paid in FY 2011
- Appendix C: Waivers and Reductions Granted
- Appendix D: Allowable and Excluded Costs for the Process for the Review of Abbreviated Applications for Generic New Animal Drugs
- Appendix E: Development of Costs for the Process for the Review of Abbreviated Applications for Generic New Animal Drugs
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