Establishment of Prescription Drug User Fee Rates for Fiscal Year 2003

Résumé

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2003. The Federal Food, Drug, and Cosmetic Act (the act), as amended most recently by the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA or PDUFA III)), 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. This notice establishes fee rates by PDUFA for FY 2003 for application fees ($533,400 for an application requiring clinical data, and $266,700 for an application not requiring clinical data or a supplement requiring clinical data), establishment fees ($209,900), and product fees ($32,400). These fees are effective on October 1, 2002, and will remain in effect through September 30, 2003. For applications and supplements that are submitted on or after October 1, 2002, the new fee schedule must be used. Invoices for establishment and product fees for FY 2003 will be issued in August 2002 using the new fee schedule.