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Executive Summary

FDA USER FEES WOULD BE REQUIRED FOR EACH DOSAGE FORM NDA filing under the agency's proposed rule, FDA Financial Management Div. Director Frank Claunts told the Regulatory Affairs Professionals Society at its annual meeting Sept. 19 in Washington, D.C. Asked if two fees would be required for NDAs submitted for separate dosage forms of the same drug, such as tablets and capsules, Claunts responded affirmatively. The FDAer noted, however, that if an NDA is withdrawn and later resubmitted, the agency will not request a second payment. Concern regarding FDA's proposal to charge a fee for NDA/ANDA reviews was indicated in several questions addressed to Claunts. For instance, the FDAer was asked if such a charge would "help large firms monopolize the industry at the expense of small start-up companies." Claunts responded: "If you believe it will, and you have information or fact to support that point of view, please put them down and submit them to us." He also suggested that individuals submit comments on the inflationary potential of user charges. The comment period on the proposal runs through November. Asked if government appropriations to FDA will be reduced by a comparable amount if user fees are implemented, Claunts said that "under the President's budget, as submitted to Congress in January, FDA appropriations were reduced by $5 mil. and FDA would have been allowed to keep the first $5 mil. it collected" from user fees. He said that under the provisions of the current proposal, user charges will go to the Treasury Department. Brandname companies have said they would be more receptive to the concept of user fees if the money was kept within the agency to assist in the overall drug review process. Claunts noted that FDA is interested in receiving comments regarding FDA retention of user fee payments.

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