Appendix B: Number of Fees Paid in FY 2011 - FY 2011 ADUFA Financial Report
ADUFA II established four 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 20101. The fee categories under ADUFA II (with FY 2011 fee rates for each) are:
1) Animal Drug Application ($316,200) and Supplemental Animal Drug Application Fees ($158,100) (animal drug applications subject to criteria set forth in section 512(d)(4) of the FD&C Act will be one-half of the full animal drug application fee);
2) Animal Drug Product Fees ($7,235);
3) Animal Drug Establishment Fees ($83,100); and
4) Animal Drug Sponsor Fees ($64,000).
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 the agency established FY 2011 ADUFA fees in August 2010.
Animal Drug User Fees Collected And Anticipated In
As Of September 30, 2011
# OF FEES ACTUALLY Full Application Fees Half Application Fees²
USER FEE CATEGORY
COLLECTED IN FY 2011
# OF FEES ANTICIPATED IN
WHEN FY 2011 FEES WERE SET
Animal Drug Applications 9 8.5 4 13.75 Products 721 672 Establishments 57 58.5 Sponsors 60 76
# OF FEES ACTUALLY
Full Application Fees
Half Application Fees²
1 FDA published FY 2011 animal drug user fee rates in the federal register notice – August 3, 2010 (75 FR 45632) http://edocket.access.gpo.gov/2010/pdf/2010-19037.pdf )
² Half application fees include supplemental animal drug applications (for which safety or effectiveness data are required) and an animal drug application subject to the criteria set forth in section 512(d)(4) of the FD&C Act.