[Federal Register Volume 59, Number 190 (Monday, October 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24216]


[[Page Unknown]]

[Federal Register: October 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary
Office of the General Counsel and Public Health Service
Food and Drug Administration

 

Statement of Organization, Functions, and Delegations of 
Authority

    Part A, Chapter AG (Office of the General Counsel) (38 FR 17032, 
June 28, 1973, as amended most recently at 57 FR 10765, March 30, 1992) 
and Part H, Chapter HF (Food and Drug Administration) 35 FR 3685, 
February 25, 1970, as amended most recently at 59 FR 38482, July 28, 
1994) of the Statement of Organization, Functions, and Delegations of 
Authority for the Department of Health and Human Services is amended to 
reflect an organizational change in the Office of the General Counsel 
(OGC) and in the Food and Drug Administration (FDA).
    The OGC in the Office of the Secretary, HHS, and FDA find it in 
their common interest and interest of the Department to test the 
efficacy of decentralizing the provision of legal services to FDA by 
establishing an organizational component within FDA comprised of 
lawyers and support staff who will provide certain legal services 
exclusively to that Agency and be funded by that Agency, but be subject 
to the supervision of the General Counsel with respect to legal policy 
and direction. OGC will continue to provide legal services to FDA in 
the areas of ethics, business and administrative law, legislation, 
personnel, and procurement on the same basis as OGC provides such 
services to other HHS operating divisions generally. A new Office of 
the Chief Counsel will be established in FDAs Office of the 
Commissioner and simultaneously the Food and Drug Division will be 
removed from OGC.
    The following changes are made to reflect the organizational 
change:
Under Chapter AG, Section AG-B, Organization
    1. Under Section AG.22 Divisions in the Office of the General 
Counsel delete subparagraph 4 Food and Drug Division in its entirety.
Under Chapter HF, Section HF-B, Organization
    2. Insert a new subparagraph under the Office of the Commissioner 
(HF), the Office of Chief Counsel (HFA-J) reading as follows:
    (a-6) Office of Chief Counsel (HFA-J). Subject to the professional 
supervision and control of the General Counsel, represents the FDA in 
court proceedings and administrative hearings with respect to programs 
administered by the FDA.
    Provides legal advice and policy guidance for programs administered 
by the FDA.
    Acts as liaison to the Department of Justice and other Federal 
Departments for programs administered by FDA.
    Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by FDA.
    Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.
    Reviews proposed legislation affecting FDA that originates in the 
Department or on which Congress requests the views of the Department.
    Provides legal advice and assistance to the Office of the Secretary 
on matters within the expertise of the Chief Counsel.

    Dated: September 17, 1994.

    Effective Date: October 1, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-24216 Filed 9-30-94; 8:45 am]
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