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Appendix C: Waivers and Reductions Granted

Back to Table of Contents: FY2010 AGDUFA Financial Reports

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 2010, 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 2010 only.
 
TABLE 9
Waivers and Reductions Granted and Used by Fee Category in FY 2010
As of September 30, 2010
 
Reason
Application & Supplement
Product
Sponsor
Total
Minor Use/Minor Species
0
1
2
3
Total
0
1
2
3
 
 
TABLE 10
Value of Waivers and Reductions Granted and Used in FY 2010
As of September 30, 2010
 
Fee Category
Fee Rate
Number
Value
Applications
$75,000
0
$0
Products
$3,255
1
$3,255
Sponsors (100%)
$54,050
0
$0
Sponsors (75%)
$40,538
0
$0
Sponsors (50%)
$27,025
2
$54,050
Total
 
3
$57,305
         
 
The waivers and the reductions presented in the table above were fees that were due and payable in FY 2010, and reflect revenue that would otherwise have been collected by FDA. 
 

In FY 2010, FDA denied one sponsor fee waiver request.  

Next Section: Appendix D - Allowable and Excluded costs for the process for the review of Animal Drug Applications