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Appendix C: Waivers and Reductions Granted - FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 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.

Tables 9 and 10 summarize the waivers and the reductions actions taken by FDA for fees payable in FY 2011, 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 2011 only.

Table 9
Waivers and Reductions Granted and Used by Fee Category
in FY 2011
As of September 30, 2011

 Minor Use/Minor Species 0 2 2 4

Table 10
Value of Waivers and Reductions Granted and Used in FY 2011
as of September 30, 2011 

 Applications $92,600 0 $0
 Products $5,440 2 $10,880
 Sponsors (100%) $55,950 0 $0
 Sponsors (75%) $41,963 0 $0
 Sponsors (50%) $27,975 2 $55,950
 TOTAL  4 $66,830

The value of waivers and reductions presented in Table 10 were fees that were due and payable in FY 2011, and reflect revenue that would otherwise have been collected by FDA. 

In FY 2011, FDA denied no waiver requests.

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