Appendix C: Waivers and Reductions Granted
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.
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
|Reason||Application & |
|Significant Barrier to Innovation||1||0||0||23||24|
|Free Choice Feeds||0||0||0||2||2|
|Minor Use or Minor Species||2||10||3||43||58|
VALUE OF WAIVERS AND REDUCTIONS GRANTED AND USED IN FY 2009
AS OF SEPTEMBER 30, 2009
|Fee Category||Fee Rate||Number||Value|
|Full Application Fee||$246,300||3||$738,900|
|Half Application Fee||$123,150||0||$0|
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 addition to the waivers and reductions shown above, on September 30, 2009, there were 11 waiver requests pending relating to fees payable in FY 2009 that were requested on the basis that fees assessed exceed FDA’s costs.
For FY 2008, FDA granted an additional 20 waivers after September 30, 2008, that therefore were not reported in the FY 2008 Financial Report. They included 5 sponsor fee waivers, 10 product fee waivers, and 5 establishment fee waivers. The aggregate value of these additional FY 2008 waivers granted in FY 2009 was $539,940.
In FY 2009, FDA denied two applications for waivers and reductions. They included one application fee waiver and one sponsor fee waiver.