Prescription Drug User Fee Rates for Fiscal Year 2012

Samenvatting

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C 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 document establishes fee rates for FY 2012 for application fees for an application requiring clinical data ($1,841,500), for an application not requiring clinical data or a supplement requiring clinical data ($920,750), for establishment fees ($520,100), and for product fees ($98,970). These fees are effective on October 1, 2011, and will