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 2010 fee rates for all categories in August 2009
. In FY 2010, the highest fee was for an animal drug application – $290,400. Under ADUFA, as amended, the fee for a supplemental animal drug application (for which safety or effectiveness data are required) or an animal drug application subject to the criteria set forth in section 512(d)(4) of the FD&C Act must be one-half of the full animal drug application fee, which was $145,200 for FY 2010.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 $6,185, $73,850, and $57,100, respectively.
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 the agency established ADUFA fees for FY 2010 in August 2009.
Numbers of Animal Drug User Fees Collected and Anticipated in FY 2010
As of September 30, 2010
User Fee Category
# of Fees Actually Collected in FY 2010
# of Fees Anticipated in September 2009 when FY 2010 Fees were set
Animal Drug Applications
Full Application Fees
Half Application Fees²