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User Fee Revenues (FY 2010 PDUFA)

Back to Table of Contents: FY 2010 PDUFA Financial Report

PDUFA IV specifies that FDA shall collect fee revenues from establishment, product, and application fees. The statute specifies revenue amounts for each of these categories and specifies that the statutory amounts are to be adjusted in each fiscal year for inflation, workload, and statutory drug safety increases. FDA then establishes fees at the beginning of each fiscal year so that the total revenue collected approximates the adjusted statutory total fee amount.

Under PDUFA, 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 over from year to year are described in the section on carryover balances beginning on page 7.
The following table provides a breakout of user fees collected by fee category during the past two fiscal years, and also reflects estimates of receivables.
Table 1
Statement of PDUFA User Fee Revenues by Fee Source
As of September 30, 2010          

Fiscal Year
FY 2009
FY 2010
Fees Collected:
Application Fees
Establishment Fees
Product Fees
Total Fees Collected:
Fee Receivables:
Application Fees
Establishment Fees
Product Fees
Total Fees Receivable:

Note that user fee revenues are reported in the year the fee was originally due—referred to as cohort years. Collections in a cohort year include all fees for applications filed in that 12 month period, from October 1 through September 30, regardless of when the cash was actually received.   For example, a fee due in FY 2009, even if it is received in FY 2010, is attributed to FY 2009 revenues. Totals reported are net of any refunds for that year.
FDA bills the uncollected fees twice a year – in August for fees due on October 1, and in November after the close of the fiscal year for product and establishments that were not billed and paid for in the earlier billing for the fiscal year. In order to ensure the quality of the information provided in this financial report, FDA updates prior year numbers each year. 

Next Section: Obligation of User Fees Revenues