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Executive Summary

EDWARDS COMMITTEE WILL HEAR HHS ASSISTANT SECRETARY JAMES MASON at its Dec. 17-18 meeting evaluate the role of FDA within the framework of HHS. In addition, James MacRae, acting administrator and deputy for the Office of Management and Budget's Office of Information and Regulatory Affairs, will discuss OMB's role in reviewing FDA regulations. Formally named the Advisory Committee on the Food and Drug Administration, the panel will convene at the Holiday Inn Capitol Hill in Washington, D.C. beginning at 8:30 a.m. on each day. The meeting is open to the public. The committee also will hear presentations on the results of recent meetings by its three subcommittees on drugs; medical devices; and food, cosmetics and veterinary medicine. FDA resource issues will be discussed by FDA Associate Commissioners for Management and Operations Sharon Smith Holston and Planning and Evaluation Gerald Barkdoll, PhD, and by Booz-Allen & Hamilton's Mary Jo Veverka. Booz Allen is conducting a pro bono review of FDA resource and management systems needs ("The Pink Sheet" Oct. 1, p. 17). In the afternoon, the committee agenda includes panels on FDA enforcement activities and field operations. The enforcement panel will include: Associate Commissioner for Regulatory Affairs Ron Chesemore; Office of Regulatory Affairs Enforcement Office Director Alan Hoeting; FDA Chief Counsel Margaret Jane Porter; Justice Department Office of Consumer Litigation, Civil Division, Director John Fleder; and House Energy & Commerce/Oversight Subcommittee staff investigator David Nelson. Field operations will be discussed by FDA Midwest Regional Food and Drug Director Burton Love and Mid-Atlantic District Director Thomas Hooker. The meeting will conclude with a discussion by the full committee of the "cross-cutting" issues revealed by the subcommittee reports and other presentations as the panel considers its future activities. That discussion will include presentations from subcommittee chairs Frank Samuel, Sherwin Gardner and Lawrence Horowitz, MD.

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