[Federal Register Volume 59, Number 39 (Monday, February 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4459]


[Federal Register: February 28, 1994]


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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 58 FR 35960, July 2, 1993) is amended to reflect a reorganization 
within the Center for Devices and Radiological Health (CDRH), Office of 
Operations, Food and Drug Administration (FDA). FDA proposes to 
reorganize its Office of Training and Assistance (which will be 
retitled as the Office of Health and Industry Programs) within CDRH. 
The Office functions will be revised and now include implementation of 
the Mammography Quality Standards Act of 1992.
    Under section HF-B, Organization:

    1. Under the Office of Operations (HFA9), Center for the Devices 
and Radiological Health (HFW), delete subparagraph Office of 
Training and Assistance (HFWG) in its entirety and insert a new 
subparagraph Office of Health and Industry Programs (HFWG) reading 
as follows:
    Analyzes medical device and radiation-emitting product user-
related problems and conduct research applying systems analysis and 
human factors to problem identification and solution strategies. 
Implements and evaluates user-related solution strategies.
    Conducts and evaluates programs to provide technical and other 
non-financial assistance to small manufacturers of medical devices 
to promote their understanding of compliance with the medical device 
amendments and regulations.
    Provides, maintains, and applies expertise in communications 
technology in support of Center and FDA programs.
    Develops and implements strategies for obtaining, analyzing, and 
incorporating the views and needs of health professionals, lay 
device users, and industry into the Center policy and decision-
making processes as well as in problem analysis, resolution strategy 
development, implementation, and evaluation processes.
    Establishes and operates a program to implement the Mammography 
Quality Standards Act of 1992.

    Under Chapter HF, Section HF-D, 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: February 16, 1994.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 94-4459 Filed 2-25-94; 8:45 am]
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