[Federal Register Volume 59, Number 88 (Monday, May 9, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-11098] [[Page Unknown]] [Federal Register: May 9, 1994] ----------------------------------------------------------------------- FEDERAL TRADE COMMISSION Food and Drug Administration [GN# 2240] Statement of Organization, Functions, and Delegations of Authority Part H, Chapter HF (Food and Drug Administration) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970 and 56 FR 29484, June 27, 1991, as amended most recently in pertinent parts at 51 FR 39424, October 28, 1986) is amended to reflect the following reorganization in the Food and Drug Administration (FDA). FDA proposes to revise the substructure of the Office of Legislative Affairs within the Office of External Affairs. The purpose of the revisions to the substructure is to organize around program areas rather than the current oversight and legislative functional areas to increase the efficiency of FDA's legislative and oversight support on issues that pertain to specific programs including biologics, drugs, and devices; and provide the appropriate specialization that is required to more effectively perform these functions. Under section HF-B, Organization: 1. Delete subparagraphs (d-1) Oversight and Investigations Staff (HFADA) and (d-2) Legislation and Special Projects Staff (HFADB) in their entirety and insert the new subparagraphs (d-1) Congressional Affairs Staff I (HFADA), (d-2) Congressional Affairs Staff II (HFADC), and (d-3) Special Projects Staff (HFADD) under paragraph Office of Legislative Affairs (HFAD) under Office of External Affairs (HFAQ) reading as follows: Congressional Affairs Staff I (HFADA). Serves as the Agency focal point with Congress, the Department, PHS, and other agencies on all congressional and legislative issues and activities as they pertain to the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the National Center for Toxicological Research, and cross-cutting Agency organizational components and issues. Coordinates and prepares Agency responses to congressional and legislative inquiries and other sensitive correspondence on various issues that affect the Agency including proposed legislation, oversight, investigative, and constituent matters. Initiates, coordinates, and provides in-depth analyses of Agency legislative needs and proposed and pending legislation by preparing supporting documents, legislative proposals, and position papers for the Commissioner, Deputy Commissioners, other Agency officials, Congress, and OMB. Develops and coordinates testimony for the Agency and the Department for presentation to congressional committees; monitors hearings; and edits transcripts of Agency testimony. Provides information on the Agency's legislative programs and proposals to consumers and regulated industry. In collaboration with other FDA and Department offices, initiates and conducts appraisals of regulatory and scientific policies to resolve problems pertaining to FDA programs and policies under existing statutes. Congressional Affairs Staff II (HFADC). Serves as the Agency focal point with Congress, the Department, PHS, and other agencies on all congressional and legislative issues and activities as they pertain to the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. Coordinates and prepares Agency responses to congressional and legislative inquiries and other sensitive correspondence on various issues that affect the Agency including proposed legislation, oversight, investigative, and constituent matters. Initiates, coordinates, and provides in-depth analyses of Agency legislative needs and proposed and pending legislation by preparing supporting documents, legislative proposals, and position papers for the Commissioner, Deputy Commissioners, other Agency officials, Congress, and OMB. Develops and coordinates testimony for the Agency and the Department for presentation to congressional committees; monitors hearings; and edits transcripts of Agency testimony. Provides information on the Agency's legislative programs and proposals to consumers and regulated industry. In collaboration with other FDA and Department offices, initiates and conducts appraisals of regulatory and scientific policies to resolve problems pertaining to FDA programs and policies under existing statutes. Special Projects Staff (HFADD). Coordinates studies and investigations of Agency components that are conducted by outside organizations including the Office of Technology Assessment (OTA), Congressional Research Service (CRS), and the General Accounting Office (GAO). Monitors all GAO/OTA activities regarding FDA. Under Section HF-D, Delegation of Authority. Pending further delegations, directives, or orders by the Commissioner of Food and Drugs, all delegations of authority to officers or employees of the Office of Legislative Affairs in effect prior to this date shall continue in effect in them or their successors. Dated: April 12, 1994. David A. Kessler, Commissioner of Food and Drugs. [FR Doc. 94-11098 Filed 5-6-94; 8:45 am] BILLING CODE 4160-01-M