[Federal Register Volume 61, Number 2 (Wednesday, January 3, 1996)]
[Notices]
[Pages 170-171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-00032]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
Food and Drug Administration


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 58 FR 14214, March 16, 1993 and 57 FR 54243, November 17, 1992) 
is amended to reflect an organization change in the Food and Drug 
Administration (FDA).
    The Office of Communication, Training, and Manufacturers 
Assistance, Center for Biologics Evaluation and Research (CBER) is 
being established to increase the visibility and accessibility of 
training and consumer and 

[[Page 171]]
professional affairs activities. All training and communications 
functions have been centralized in the new Office. The Office will also 
serve as the focal point for overall industry liaison and communication 
activities within the Center. Training and staff development functions 
will be deleted from the Office of Management.
    Under section HF-B, Organization:-
    1. Delete the subparagraph Office of Management (HFB12), under the 
Office of the Center Director (HFB1), Center for Biologics Evaluation 
and Research (HFB), under the Office of Operations (HFA9), in its 
entirety and insert a new subparagraph (p-2) reading as follows:
     Office of Management (HFB12). Monitors the development and 
operation of planning systems for Center activities and resource 
allocations and advises the Center Director on Center administrative 
policies, guidelines, and information systems and services.
     Directs and counsels Center managers through program evaluation 
and technological forecasting.
    Plans and directs Center operations for financial, personnel, and 
administrative management services.
     Directs Center organization, management, and information systems.
     Manages studies designed to improve processes and resource 
allocations in the Center.
     Advises the Center on contract and grant proposals.
     2. Insert a new subparagraph, Office of Communication, Training, 
and Manufacturers Assistance (HFBN), under the Office of the Center 
Director (HFB1), reading as follows:
     Office of Communication, Training, and Manufacturers Assistance 
(HFBN). Manages the Center's overall professional and management 
training program, career and staff development program, an employee 
orientation program, and related employee development policies.
     Develops and maintains effective channels of both internal and 
external communication.
     Serves as a liaison with Center components to provide advice and 
assistance to manufacturers and scientific associations to promote 
their understanding and compliance with FDA regulations.
    Responsible for all activities relating to the administration of 
the Center's central document room.
    Directs the Center's consumer and professional informational 
activities in coordination with the other Agency components.
     3. 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 12, 1995.
 David A. Kessler,
 Commissioner of Food and Drugs.
[FR Doc. 96-00032 Filed 1-2-96; 8:45 am]
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