FY 2001 user fee rates

Executive Summary

Drug applications requiring clinical data will cost $309,647, an 8.4% increase from $285,740 in FY 2000. Applications not requiring clinical data, and applications for supplements requiring clinical data, will cost half that amount: $154,823, up from $142,870 in FY 2000. FDA projects the receipt of 163.6 fee-paying full-application-equivalent submissions in FY 2001, 10.1 more than FY 2000's 153.5 estimated receipts. The agency incorporates an FY 2000 inflation adjustment of 3.81% into its FY 2001 user fee rate