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User Fee Collections: FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 AGDUFA Financial Report

AGDUFA specifies that user fees shall be collected for certain abbreviated applications for generic new animal drugs, 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.

Table 1
Generic New Animal Drug User Fee Collections
and Receivables by Fee Source
as of September 30, 2011 

 Application Fees $1,016,350 $1,018,568
 Product Fees $1,308,485 $1,882,240
 Sponsor Fees $2,067,374 $2,042,068
 TOTAL COLLECTIONS $4,392,209 $4,942,876
 Product Fees $3,255 $5,440
 Sponsor Fees $27,025 $84,005
 TOTAL RECEIVABLES $30,280 $89,445


Numbers may not total precisely due to rounding to the nearest dollar.

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 2010, even if it is received in FY 2011, is attributed to FY 2010 collections.  Totals reported are net of any refunds for the cohort year. In order to ensure the quality of the information provided in this financial report, FDA updates prior year numbers annually.  In FY 2011, FDA received a total of $381,822 that was attributed to FY 2010 collections. Therefore, FDA increased its

FY 2010 fee collections of $4,010,387 reported last year to $4,392,209 as of September 30, 2011.


The receivables for FY 2011 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.  After 180 days of the outstanding debt PSC will turn the debt over to the United States Treasury for collection.


Next Section: User Fee Obligations - FY 2011 AGDUFA Financial Report