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FY 2002 PDUFA Financial Report: User Fee Revenues

Table of Contents

Previous Section: Meeting the Legal Conditions for User Fees in FY 2002

PDUFA II 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 II, 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.

FOOD AND DRUG ADMINISTRATION
STATEMENT OF USER FEE REVENUES BY FEE SOURCE

as of September 30, 2002
  FY 2001 FY 2002
Fees Collected:    
Product Fees $51,666,580 $49,802,492
Establishment Fees $53,596,320 $51,872,176
Application Fees $33,204,819 $41,656,543
TOTAL FEES COLLECTED: $138,467,719 $143,331,211
     
Fees Receivable:    
Product Fees $131,352 $1,059,825
Establishment Fees $0 $714,200
Application Fees $158,496 $0
TOTAL FEES RECEIVABLE: $289,848 $1,744,025
     
Total User Fee Revenues: $138,757,567 $145,105,236
     

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 2001, even if it is received in FY 2002, is attributed to FY 2001 revenues. Totals reported for each year are net of any refunds for that year.

The Fees Receivable for FY 2001 of $289,848 include deferred collections of $116,779, pending final resolution of waiver requests. Most of the FY 2002 accounts receivable are product and establishment fees billed near the end of the fiscal year. Fees receivable for FY 2002 also include deferred collections of $253,424 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