• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Appendix C: Waivers and Reductions Granted (FY 2010)

Back to Table of Contents: FY2010 ADUFA Financial Report
 
 
ADUFA II directs FDA to waive or reduce fees in five different circumstances when: 
  • the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;
  • the fees to be paid by such person will exceed the anticipated present and future costs incurred by FDA in conducting the process for the review of animal drug applications for such person;
  • the animal drug application or the supplemental animal drug application is intended solely to provide for use of the animal drug in a free-choice medicated feed;
  • the animal drug application or the supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or
  • the sponsor involved is a small business submitting its first animal drug application to FDA for review.
 
Tables 9 and 10 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
Establishment
Sponsor
Total
Significant Barrier to Innovation
0
0
0
33
33
Free Choice Feeds
0
0
0
2
2
Minor Use or Minor Species
0
10
3
47
60
Small Business
2
0
0
0
2
Total
2
10
3
82
97

TABLE 10
Value of Waivers and Reductions Granted and Used in FY 2010
As of September 30, 2010
 
Fee Category
Fee Rate
Number
Value
Full Application Fee
$290,400
2
$580,800
Half Application Fee
$145,200
0
$0
Products
$6,185
10
$61,850
Establishments
$73,850
3
$221,550
Sponsors
$57,100
82
$4,682,200
Total
 
97
$5,546,400
         
 
The waivers and the reductions presented in table 10 were fees that were due and payable in FY 2010, and reflect revenue that would otherwise have been collected by FDA. 
 
In addition to the waivers and reductions shown in table 10, on September 30, 2010, there were three waiver requests pending relating to fees payable in FY 2010 that were requested on the basis that fees assessed exceed FDA’s costs.
 
In FY 2010, FDA denied one application for sponsor fee waiver and reduction.