Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005

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The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2005. The Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Prescription Drug User Fee Amendments of 2002 (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. Base revenue amounts for application fees, establishment fees, and product fees for FY 2005 were established by PDUFA III. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the levels established in the statute, after those amounts have been first adjusted for inflation and workload. This notice establishes fee rates for FY 2005 for application fees ($672,000 for an application requiring clinical data, and $336,000 for an application not requiring clinical data or a supplement requiring clinical data), establishment fees ($262,200), and product fees ($41,710). These fees are effective on October 1, 2004, and will remain in effect through September 30, 2005. For applicati