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

Back to Table of Contents: FY 2011 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 granted 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

 REASON APPLICATION & SUPPLEMENT PRODUCT ESTABLISHMENT SPONSOR TOTAL
 Significant Barrier to Innovation 0 0 0 35 35
 Free Choice Feeds 1 0 0 5 6
 Minor Use or Minor Species 1 10 2 49 62
 Small Business 1 0 0 0 1
 TOTAL 3 10 2 89 104

Table 10
Value Of Waivers And Reductions Granted And Used In FY 2011
As Of September 30, 2011

 FEE CATEGORY FEE RATE NUMBER VALUE
 Full Application Fee $316,200 3 $948,600
 Half Application Fee $158,100 0 $0
 Products $7,235 10 $72,350
 Establishments $83,100 2 $166,200
 Sponsors $64,000 89 $5,696,000
 TOTAL  104 $6,883,150

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 addition to the waivers and reductions shown in Table 10 there were 11 sponsor waivers issued for the FY 2010 Clean-up billing cycle.  For FY 2010 Fees Exceed Cost Waivers and Reductions there were three Sponsor and five Product waivers issued.   

In FY 2011, FDA denied four applications for sponsor fee waiver and reduction.

Next Section: Appendix D – Allowable and Excluded Costs for the Process for the Review of Animal Drug Applications