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Executive Summary

FDA OFFICE OF DEPUTY COMMISSIONER FOR POLICY BEING ORGANIZED into three separate staffs that will work together to develop agency policy. Under the plan, the policy development staff will be headed by former Executive Assistant to the Deputy Commissioner Robert Eccleston. The regulations policy staff -- previously the Division of Regulations Policy at the Office of Regulatory Affairs -- will continue under the direction of Robert Spencer. A third group, the policy research staff, has not yet been established. New staff members include William Schwemer, who had a brief stint as executive director of the Regulatory Affairs Professionals Society from December 1990 to mid-year, and is a former FDA assistant associate commissioner for regulatory affairs. He rejoins FDA as a special assistant to Deputy Commissioner for Policy Michael Taylor. In his new position, Schwemer will focus on policy issues concerning other government agencies, and state and local governments. Also joining Taylor's staff is former FDA Office of the Commissioner Program Management Staff Director William Hubbard, who has been named Associate Commissioner for Policy Coordination. In addition, Center for Food Safety and Applied Nutrition Product Policy Staff Director Richard Ronk will serve as the Center's liaison to Taylor's office. Taylor was approved by the White House in April as deputy commissioner for policy. His office's responsibilities are the oversight of all FDA regulations in development. The organization of Taylor's staff into three units appears to be part of the plan to expedite the review of hundreds of proposed regs languishing at the agency and the establishment of procedures to expedite the regulations issuance process.

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