Appendix B: Number of Applications Paid By Fees in FY 2009
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 2009 fee rates for all categories in September 2008 . The fee categories under AGDUFA are 1) Abbreviated Applications for Generic New Animal Drugs ($41,400); 2) Generic New Animal Drug Product Fees ($3,005); and 3) Generic New Animal Drug Sponsor Fees which range from $28,175 to $56,350 depending on the level of sponsor fee.
The table below summarizes the number and type of fees actually received in FY 2009 for cohort year 2009 in comparison to what the FDA estimated it would receive in FY 2009 when AGDUFA fees for FY 2009 were established in September 2008.
FOOD AND DRUG ADMINISTRATION
NUMBERS OF GENERIC NEW ANIMAL DRUG USER FEES COLLECTED AND
ANTICIPATED IN FY 2009
AS OF SEPTEMBER 30, 2009
User Fee Category # of Fees Actually Collected in FY 2009 # of Fees Anticipated Abbrev. New Animal Drug Applications 22 35 Products 609 563 Sponsers 33.25 30