Establishment of Prescription Drug User Fee Revenues and Rates for Fiscal Year 1995

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The Food and Drug Administration (FDA) is announcing that it is establishing user fee revenues and rates for Fiscal Year (FY) 1995. The Prescription Drug User Fee Act of 1992 (the PDUFA) 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 marketed products. Fees for applications, establishments, and products for FY 1993 were established by the PDUFA. Fees for FY 1994 and later years are to be determined by FDA using criteria delineated in the statute.