Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products

摘要

The Food and Drug Administration (FDA) is issuing this notice, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), to establish the fiscal year (FY) 2008 fees that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. The Federal Food, Drug, and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to collect user fees for certain direct-to-consumer (DTC) television advertisements submitted to FDA for advisory review.