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Appendix B: Number of Fees Paid in FY 2011 - FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 AGDUFA Financial Report

AGDUFA established three fee categories and set fee revenues for each category.  Based on the statutory revenues and estimated numbers of fees that would be paid in each category, FDA published the FY 2011 fee rates for all categories in August 2010[1].  The fee categories under AGDUFA (with FY 2011 fee rates) are:

1) Abbreviated Applications for Generic New Animal Drugs ($92,600);

2) Generic New Animal Drug Product Fees ($5,440); and

3) Generic New Animal Drug Sponsor Fees which range from $27,975 to $55,950 depending on the level of sponsor fee. 

Table 8 summarizes the number and type of fees actually received in FY 2011 for cohort year 2011 in comparison to what the FDA estimated it would receive in FY 2011 when AGDUFA fees for FY 2011 were established in August 2010.  

Table 8
Generic New Animal Drug User Fees Collected and Anticipated in
FY 2011
as of September 30, 2011

 USER FEE CATEGORY # OF FEES ACTUALLY COLLECTED IN FY 2011

 # OF FEES ANTICIPATED IN AUGUST 2010 WHEN

FY 2011 FEES WERE SET
Abbrev. New Animal Drug Applications 11 17.5
Products 346 347.4
Sponsors 36.50 33.75

Next Section: Appendix C – Waivers and Reductions Granted



[1] FDA published FY 2011 generic new animal drug user fee rates in the Federal Register notice – August 3, 2010 (75 FR 45636,http://edocket.access.gpo.gov/2010/pdf/2010-19040.pdf).