[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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