• 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

User Fee Revenues

Back to Table of Contents:  FY 2009 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.

As of September 30, 2009

Fiscal YearFY 2008FY 2009
Fees Collected:
Application Fees$154,164,400$182,835,800
Establishment Fees$168,357,952$174,483,232
Product Fees$157,763,524$155,917,120
Total Fees Collected:$480,285,876$513,236,152
Fees Receivable:
Application Fees$281,800$34,900
Establishment Fees$589,050$638,400
Product Fees$589,050$643,680
Total Fees Receivable:$1,065,940$1,316,980
Total User Fee Revenues:$481,351,816$514,553,132


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 2008, even if it is received in FY 2009, is attributed to FY 2008 revenues.  Totals reported for each year are net of any refunds for that year.

FDA bills the uncollected fees twice a year – August and November.  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 Fee Revenues