[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