FY 1998 PDUFA Financial Report: User Fee Revenues

Table of Contents

Previous Section: Meeting the Legal Conditions for User Fees in FY 1998

The PDUFA specified the user fee revenues to be collected from product, establishment, and application fees. Only half of the application fee was due upon submission of an application for FY 1993 through FY 1997. The remainder of the application fee is due 30 days from the date FDA issues an invoice after issuance of an action letter related to the application. Thus, fee revenue related to submissions received in those fiscal years may come due and be collected in succeeding years. Under FDAMA the full application fee is due upon submission of an application for applications submitted on or after October 1, 1997, eliminating the need to invoice when an action letter is issued.

Under PDUFA and FDAMA, any fees collected and not spent by the end of a fiscal year continue to remain available to the agency to spend in future fiscal years. The status and claims on balances carried over from year to year will be dealt with in the section of carryover balances on page 7. The following table provides a breakout of user fees by fee source during the past two fiscal years, and also reflects estimates of receivables.

The Fees Receivable for FY 1997 of $3,482,650 includes $2,508,900 of deferred collections, pending final resolution of waiver requests. Whether these actually result in collections depends on the outcome of these pending waiver requests. The remainder is primarily the second half of FY 1997 application fees that were billed late in FY 1998. The Fees Receivable for FY 1998 of $6,794,108 includes $1,029,258 of deferred collections, pending final resolution of waiver requests. Most of the balance from FY 1998 is product and establishment fees billed near the end of the fiscal year.

Additional Unbilled Fees of $2,613,750 for FY 1997 submissions were not billed or billable as of September 30, 1998, and have not been included in total receivables for FY 1997. These represent second-half application fees to be billed and collected upon completion of the first review action on applications filed in FY 1997. Therefore, the total projected revenues, before estimated waivers and reductions, related to FY 1997 submissions are $96,873,126 (94,259,376 + $2,613,750), and total estimated revenues related to FY 1998 submissions are $119,851,965.

A summary of exemption and waiver actions for FY's 1993 through 1996, FY 1997, and FY 1998 is included in Appendix B.

Next Section: Obligation of User Fee Revenues