User Fee Collections in FY 2011
MDUFMA specifies that user fees shall be collected for medical device applications and annual fees shall be collected for establishment registration and periodic reporting through FY 2012. The statute also directs FDA to set the fee rate for each application type and for periodic reports as a percentage of the standard fee for a PMA.
Under MDUFMA, fees collected and appropriated, but not spent by the end of a fiscal year, continue to remain available for FDA to spend in future years. The balances carried forward from year to year are described on page 6.
Table 1 provides totals of user fees collected during the past two fiscal years, and also reflects the amount of open receivables.
Medical Device Fee User Fee Collections And Receivables
As Of September 30, 2011
|FY 2010||FY 2011|
Total Fees Collected
Numbers may not add due to rounding to the nearest dollar
1Unearned Fees are fees received for applications that had not been submitted to FDA as of September 30, 2011 or for FY 2011 establishment fees received without identification of the remitter. They are included above in the 'Total Fees Collected' amounts.
User fee collections are reported in the year the fee was originally due—referred to as the cohort year. For example, a fee originally due in FY 2010, even if it is received in FY 2011, is attributed to FY 2010 collections. Totals reported are net of any refunds for the cohort year. In order to ensure the quality of the information provided in these financial reports, FDA updates prior year numbers annually.
In FY 2011 the total fee collections reported in the FY 2010 financial report decreased by $1,327,927 to $65,621,660 as of September 30, 2011. Additionally, all but $2,834,902 of the unearned income reported last year has now been either refunded or credited to the cohort year in which the application was actually received.
The receivables for FY 2010 and FY 2011 are from uncollected establishment and periodic reporting fees. After 90 days of attempting to collect the delinquent debt, FDA turns these receivables over to the Program Support Center (PSC) of the Office of the Secretary for further attempts at collection. After 180 days of the outstanding debt, PSC turns the debt over to the United States Treasury for further collection efforts.
 FDA published FY 2011 medical device user fee rates in a Federal Register Notice on August 3, 2010. The specific fees for FY 2011 are found in Appendix B, on page B-1.