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Executive Summary

FDA ESTABLISHING ASSOCIATE COMMISSIONER SLOT TO HEAD SCIENCE OFFICE that will provide guidance to the agency on a broad range of policy issues. The new office was officially authorized by HHS Asst. Secty. Brandt in a March 8 Federal Register notice. The primary function of the new Office of Science will be to advise and assist the commissioner and FDA officials on scientific issues "which have an impact on policy, direction and long-range goals," Brandt explained. The office will coordinate and provide guidance for scientific policy "in program areas which cross major agency component lines and scientific aspects which are critical or controversial, including the agency risk assessment policy." The Federal Register notice states that the new unit will serve "as the focal point for overall management of scientific agency research, training, contracts and fellowship activities." In addition to representing FDA on scientific matters with other agencies, industry and academia, the Office of Science will evaluate "the adequacy of scientific resources available to the agency." The new associate commissioner will be chosen after a formal search. The unit initially will have a staff of nine; eight positions are expected to be filled by personnel from the commissioner's office. The new office is an outgrowth of the Office of Scientific Coordination, which was formed in January 1983, and reflects the efforts the agency has been making in recent years to highlight its scientific base. "By establishing the new office, FDA seeks to emphasize the high priority it gives to developing scientific expertise and improving research," the agency stated in a March 9 Talk Paper. Last year's reorganization of the Center for Drugs & Biologic included the creation of two new positions for a scientific director and deputy scientific director reporting directly to Drugs & Biologics Director Meyer.

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