FY 2016 GDUFA Financial Report
Required by the
Generic Drug User Fee Amendments
As amended
Food and Drug Administration
Department of Health and Human Services
April 2017
Printable Version of the FY2016 GDUFA Financial Report
Table of Contents
- Executive Summary-FY2016 GDUFA Financial Report
- Background-FY2016 GDUFA Financial Report
- Legal Conditions-FY2016 GDUFA Financial Report
- User Fee Collections-FY2016 GDUFA Financial Report
- User Fee Obligations-FY2016 GDUFA Financial Report
- Carryover Balances-FY2016 GDUFA Financial Report
- Collections Realized-FY2016 GDUFA Financial Report
- Reserves and Balances Available for Allocation-FY2016 GDUFA Financial Report
- Total GDUFA Program Costs-FY2016 GDUFA Financial Report
- Full-Time Equivalent-FY2016 GDUFA Financial Reports
Appendices
- Appendix A-Conditions for Assessment and Uses of Fees
- Appendix B-Fees, Rates, and Fee Paying Submission Trends
- Appendix C-Included and Excluded Costs for the GDUFA Program
- Appendix D-Development of Costs for the GDUFA Program