[Federal Register Volume 62, Number 7 (Friday, January 10, 1997)]
[Notices]
[Page 1462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-578]



[[Page 1462]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 
part at 60 FR 65350, December 19, 1995) is amended to reflect the 
realignment of the Office of Health and Industry Programs, Center for 
Devices and Radiological Health (CDRH), Office of Operations, in the 
Food and Drug Administration (FDA).
     The Immediate Office of the Director, Office of Health and 
Industry Programs will consist of two new staffs; the Regulations Staff 
and the Staff College. CDRH believes that the establishment of these 
two new staffs within the Immediate Office of the Director, Office of 
Health and Industry Programs, will increase visibility to important 
program areas of the Center.
     Under section HF-B, Organization:
     1. Insert the following new subparagraphs under paragraph Office 
of Health and Industry Programs (HFWG), Center for Devices and 
Radiological Health (HFW), reading as follows:
     Program Operations Staff (HFWG-1). Provides all necessary 
administrative support to the Office.
    Provides services to track the status of on-going Office programs 
as well as all incoming and outgoing congressional and FDA or Center-
tracked correspondence.
    Provides personnel computer support to Office staff including the 
evaluation of hardware and software, installation of hardware and 
software and assistance in resolving hardware and software problems.
    Responds to public and government requests for information about 
medical device and radiation-emitting products. Serves as the Center 
Consumer Affairs Representative.
    Regulations Staff (HFWG-2). Advises the Center Director and 
appropriate Agency officials on FDA regulation development 
responsibilities relating to medical devices and radiological health 
activities. Serves as the Center focal point for liaison on regulations 
development activities with the Office of Chief Counsel.
    Coordinates the development, review and submission of Federal 
Register publications for the Center. Prepares position statements for 
the Center on standards promulgated by other organizations.
    Staff College (HFWG-3). Develops necessary training courses for 
Center employees by providing continuing education credits for selected 
programs; providing live satellite teleconferences and distance 
learning telecasts; and coordinating and sponsoring a variety of 
seminars and lectures.
    Performs needs assessments and develops training objectives. 
Designs courses and course evaluations.
     2. Prior Delegations of Authority. Pending further delegations, 
directives, or orders by the Commissioner of Food and Drugs, all 
delegations of authority to positions of the affected organizations in 
effect prior to this date shall continue in effect in them or their 
successors.

    Dated: December 13, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-578 Filed 1-9-97; 8:45 am]
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