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Appendix B: Number of Fees Paid in FY2010

Back to Table of Contents: FY2010 AGDUFA Financial Report

Number of Fees Paid in FY 2010

AGDUFA establishes three fee categories and sets 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 2010 fee rates for all categories in August 2009[1]. The fee categories under AGDUFA are 1) Abbreviated Applications for Generic New Animal Drugs ($75,000); 2) Generic New Animal Drug Product Fees ($3,255); and 3) Generic New Animal Drug Sponsor Fees which range from $27,025 to $54,050 depending on the level of sponsor fee. 
Table 8 summarizes the number and type of fees actually received in FY 2010 for cohort year 2010 in comparison to what the FDA estimated it would receive in FY 2010 when AGDUFA fees for FY 2010 were established in August 2010.
Numbers of Generic New Animal Drug User Fees Collected and Anticipated in FY 2010
As of September 30, 2010
 User Fee Category# of Fees Actually Collected in FY2010 # of Fees Anticipated in September 2009 when FY2010 Fees were set
Abbrev. New Animal Drug Applications 1320.4
Products 370549
Sponsors 34.533.075

[1] FDA published FY 2010 generic new animal drug user fee rates in the Federal Register notice – August 3, 2009 (74 FR 38434, http://edocket.access.gpo.gov/2009/pdf/E9-18458.pdf).


Next Section: Appendix C - Waivers and Reductions Granted