Appendix B: Number of Fees Paid in FY 2009
ADUFA II established four fee categories and sets fee revenue 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 . In FY 2009, the highest fee was for an animal drug application – $246,300. A supplemental animal drug application (for which safety or effectiveness data are required) or an animal drug application subject to the criteria set forth is section 512(d)(4) must be 50 percent of an animal drug application fee according to ADUFA, which was $123,150. The other fee categories under ADUFA are animal drug products, animal drug establishments, and animal drug sponsor fees, each of which must be paid annually. They are $4,925, $59,450, and $52,700, respectively.
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 ADUFA fees for FY 2009 were established in September 2008.
FOOD AND DRUG ADMINISTRATION
NUMBERS OF 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 in September 2008 when FY 2009 Fees were set|
|Animal Drug Applications|
|Full Application Fees||5||7.5|
|Half Application Fees²||8||13.25|