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Appendix C: Waivers and Reductions Granted

Back to Table of Contents:  FY 2009 AGDUFA Financial Report


AGDUFA directs FDA to waive or reduce fees for Minor Use or Minor Species (MUMS) applications.  The waiver for MUMS is applied when the abbreviated application for a generic new animal drug is intended solely to provide for a minor use or minor species indication.

The tables below summarize the waivers and the reductions actions taken by FDA for fees payable in FY 2009, as well as the value of each granted.  Please note that the waivers and the reductions granted in the tables below are for cohort year 2009 only.


WAIVERS AND REDUCTIONS GRANTED AND USED BY FEE CATEGORY IN FY 2009
AS OF SEPTEMBER 30, 2009

 

ReasonApplication & SupplementProductSponsorTotal
Minor Use/Minor Species011
Total012


VALUE OF WAIVERS AND REDUCTIONS GRANTED AND USED IN FY 2009
AS OF SEPTEMBER 30, 2009

Fee CategoryFee RateNumberValue
Applications$41,4000$0
Products$3,0051$3,005
Sponsors (100%)$56,3500$0
Sponsors (75%)$56,3500$0
Sponsors (50%)$28,1751$28,175
Totaln/a2$31,180


The waivers and the reductions presented in the table above were fees that were otherwise due and payable in FY 2009, and reflect revenue that would otherwise have been collected by FDA. 

In FY 2009, FDA did not deny any requests for waivers or reductions. 

Next Section:  Appendix D - Allowable and Excluded Costs for the Process for the Review of Abbreviated Applications for Generic New Drugs