[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]


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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