• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

FY 2000 PDUFA Financial Report: User Fee Revenues

Table of Contents

Previous Section: Meeting the Legal Conditions for User Fees in FY 2000

The PDUFA specifies that fee revenues are to be collected from establishment, product, and application fees. Under FDAMA, annual application fee amounts are specified in statute, but adjusted 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 and FDAMA, any fees collected and 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, 2000
  FY 1999 FY 2000
Fees Collected:
Product Fees $41,833,192 $43,829,964
Establishment Fees $41,541,794 $45,802,542
Application Fees $38,636,530 $48,066,442
TOTAL FEES COLLECTED: $122,011,516 $137,698,948
Fees Receivable:
Product Fees $293,824 $3,033,768
Establishment Fees $647,955 $5,245,781
Application Fees $0 $0
TOTAL FEES RECEIVABLE: $941,779 $8,279,549
Total User Fee Revenues: $122,953,295 $145,978,497

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 1999, even if it is received in FY 2000, is attributed to FY 1999 revenues. Totals reported for each year are net of any refunds for that year. Application fees collected for FY 2000 include a few fees for applications that will not be filed until FY 2001.

The Fees Receivable for FY 1999 of $941,779 includes deferred collections of $684,796, pending final resolution of waiver requests. Most of the FY 2000 accounts receivable are product and establishment fees billed near the end of the fiscal year.

A summary of exemption and waiver actions is included in Appendix B.

Next Section: Obligation of User Fee Revenues