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FY2010 User Fee Collections

Back to Table of Contents: FY2010 AGDUFA Financial Report

AGDUFA specifies that the user fees shall be collected for certain abbreviated applications for generic new animal drugs upon their submission, and annual fees shall be collected for certain products and sponsors. The statute also specifies the amount FDA is allowed to collect for each of these categories, and how the fee rates should be adjusted in each fiscal year for increases in workload.

Under AGDUFA, fees collected and appropriated, but not spent by the end of a fiscal year, continue to remain available for FDA to spend in future fiscal years.  The balances carried forward from year to year are described on page 7.

Table 1 provides a breakout of user fees collected by fee category during the past two fiscal years, and also reflects the amount of open receivables.

Statement of Generic new Animal Drug User Fee Collections
and Receivables by Fee Sources
As of September 30, 2010
FY 2009
FY 2010
Application Fees
Product Fees
Sponsor Fees
Fees Receivable
Product Fees
Sponsor Fees
User fee collections are reported in the year the fee was originally due—referred to as cohort years.  For example, a fee originally due in FY 2009, even if it is received in FY 2010, is attributed to FY 2009 collections. 
In FY 2010, FDA received a total of $511,089 that was attributed to FY 2009 collections. Therefore, FDA increased its FY 2009 fee collections of $4,587,996 reported last year to $5,099,085 as of September 30, 2010.
The receivables for FY 2010 are from uncollected product and sponsor fees. After 90 days of attempting to collect the delinquent debt, FDA turns these receivables over to the Program Support Center (PSC) of the Office of the Secretary for collection.
Totals reported for each fiscal year are net of any refunds for that year.  In order to ensure the quality of the information provided in financial reports, FDA will update prior year collections and receivables each year.

Next Section: User Fee Obligations