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FY 2001 PDUFA Financial Report: User Fee Revenues

Table of Contents

Previous Section: Meeting the Legal Conditions for User Fees in FY 2001

The PDUFA specifies that fee revenues are to be collected from establishment, product, and application fees. The statute specifies annual application fee amounts and how they are adjusted each year for inflation. Fees for establishments and products are set each year so that the total amount of revenue collected from each category (establishment fees and product fees) equals the revenue FDA expects to collect from application fees that year.

Under PDUFA, any fees collected and appropriated but not spent by the end of a fiscal year continue to remain available to FDA to spend in future fiscal years. The balances carried over from year to year are covered in the section on carryover balances beginning on page 6. The following table provides a breakout of user fees by fee source during the past two fiscal years, and also reflects estimates of receivables.


as of September 30, 2001
  FY 2000 FY 2001
Fees Collected:
Product Fees $47,023,404 $49,235,108
Establishment Fees $50,416,886 $50,676,540
Application Fees $43,841,732 $33,326,676
TOTAL FEES COLLECTED: $141,282,022 $133,238,324
Fees Receivable:
Product Fees $139,713 $2,692,716
Establishment Fees $70,986 $3,290,008
Application Fees $0 $0
TOTAL FEES RECEIVABLE: $210,699 $5,982,724
Total User Fee Revenues: $141,492,721 $139,221,048

Note that user fee revenues are reported in the year the fee was originally due-referred to as cohort years. For example, a fee due in FY 2000, even if it is received in FY 2001, is attributed to FY 2000 revenues. Totals reported for each year are net of any refunds for that year. Application fees collected for FY 2001 may include a few fees for applications that will not be filed until FY 2002

The Fees Receivable for FY 2000 of $210,699 includes deferred collections of $110,904, pending final resolution of waiver requests. Most of the FY 2001 accounts receivable are product and establishment fees billed near the end of the fiscal year. Fees receivable for FY 2001 also include deferred collections of $333,699 pending final resolution of waiver requests. A summary of exemption and waiver actions is included in Appendix B.

Next Section: Obligation of User Fee Revenues