Delegations of Authority and Organization; Office of the Commissioner and the Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is amending the delegations of authority statement that covers general redelegations of authority from the Commissioner of Food and Drugs to other officers of FDA. The amendment delegates authority to perform all functions relating to waivers or reductions of prescription drug user fees under the Prescription Drug User Fee Act of 1992 (PDUFA), as originally enacted and as reauthorized by the FDA Modernization Act of 1997 (the Modernization Act), to the Director, Center for Drug Evaluation and Research (CDER) and to the Associate Director for Policy, CDER, except for the functions that pertain to situations where ``the fees will exceed the anticipated present and future costs.'' The authority to waive or reduce user fees, previously redelegated to the Chief Mediator and Ombudsman/User Fee Waiver Officer, the Deputy Chief Mediator and Ombudsman, and the Deputy User Fee Waiver Officer is hereby revoked, except the authority to act upon requests for reconsideration of any user fee decision made by such officers prior to July 1, 1999. Also, as a result of the June 20, 1999, FDA reorganization, the Office of Operations component and the Deputy Commissioner for Operations position were abolished; therefore, the Deputy Commissioner will assume the role of the User Fee Appeals Officer and perform the associated functions.