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Color additive fees

This article was originally published in The Rose Sheet

Executive Summary

Administration draft bill would charge $4.5 mil. in color and food additive registration fees in FY 2000, rising to $14.9 mil. in fiscal 2004. In addition, the FDA Review Fee Act would set color and food additive petition fees at up to $260,000 per filing; by 2004, fees would increase to as much as $400,000 per petition. Fee amounts would depend on the petition category; a "Tier I" filing would be for approval of an additional use of an existing additive, while a "Tier III" filing would be necessary for a first-time approval resulting in "significant dietary exposure" or "raise novel safety issues," according to the draft document. Small businesses would be required to pay one-half the fee. The Administration is seeking a congressional sponsor. In the past, Congress has not favored additional user fees
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