SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2008. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug
Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes
FDA to collect user fees for certain applications for approval of drug
and biological products, on establishments where the products are made,
and on such products. Base revenue amounts to be generated from PDUFA
fees were established by PDUFA IV, with provisions for certain
adjustments. Fee revenue amounts for applications, establishments, and
products are to be established each year by FDA so that one-third of
the PDUFA fee revenues FDA collects each year will be generated from
each of these categories. This notice establishes fee rates for FY 2008
for application fees for an application requiring clinical data
($1,178,000), for an application not requiring clinical data or a
supplement requiring clinical data ($589,000), for establishment fees
($392,700), and for product fees ($65,030). These fees are effective on
October 1, 2007, and will remain in effect through September 30, 2008.
For applications and supplements that are submitted on or after October
1, 2007, the new fee schedule must be used. Invoices for establishment
and product fees for FY 2008 will be issued in October 2007, using the
new fee schedule.
FOR FURTHER INFORMATION CONTACT: Yanming Chae, Office of Financial
Management (HFA-120), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-5042
"Illegitimacy is something we should talk about in terms of not having it."
- Dan Quayle
