[Federal Register Volume 60, Number 243 (Tuesday, December 19, 1995)]
[Notices]
[Pages 65350-65351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30813]



-----------------------------------------------------------------------

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 59 FR 17106, April 11, 1994) is amended to reflect the 
following reorganization within the Center for Devices and Radiological 
Health (CDRH), Office of Operations, Food and Drug Administration 
(FDA).
    The Center for Devices and Radiological Health is abolishing the 
Office of Health Physics (OHP), the Office of Health Affairs (OHA), and 
the Office of Standards and Regulations (OSR) and realigning their 
functions into existing line and staff offices within the Center. The 
goal of this realignment is to more effectively manage the resources 
invested in these functional areas, consolidate similar functions, 
realign medical expertise closer to program needs, and streamline the 
current organizational structure.
    Under section HF-B, Organization:
    1. Delete subparagraphs Office of Health Physics (HFW12), the 
Office of Health Affairs (HFW13), and the Office of Standards and 
Regulations (HFW14) under paragraph Center for Devices and Radiological 
Health (HFW), in their entirety.
    2. Insert the following new subparagraphs under paragraph Office of 
Operations (HFA9), Center for Devices and Radiological Health (HFW) 
reading as follows:
    Office of Systems and Management (HFW11). Advises the Center 
Director regarding all administrative management matters.
    Plans, develops, and implements Center management policies and 
programs concerning financial and human resource management, contracts 
and grants management, conference management, occupational safety, 
organizational, and general office services support.
    Develops and implements the Center's long-range, strategic, and 
operational plans.
    Develops and applies evaluation techniques to measure the 
effectiveness of Center programs.
    Provides general information and technical publication services to 
the Center.
    Plans, conducts, and coordinates Center committee management 
activities.
    Determines and implements Center strategy and utilization of 
information management resources.
    Designs administrative, scientific, and technical information 
systems in support of Center programs.
    Provides assistance to Center staff in accessing information 
necessary to carry out the Center's mission.
    Coordinates requests and Center activities pertaining to the 
Freedom of Information and Privacy Acts.
    Office of Health and Industry Programs (HFWG). Analyzes medical 
device and radiation-emitting product user-related problems and 
conducts 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 
nonfinancial 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.
    Provides leadership and technical expertise to the Center and other 
Departmental components in applying health physics procedures and 
radiation protection principles.
    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 
General 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.
    Coordinates international relations activities as required by the 
Safe Medical Devices Act of 1990.
    Office of Science and Technology (HFWE). Provides scientific 
support and laboratory analyses in response to the program needs of 
other Center and Agency components.
    Plans, develops, and implements an intramural science program 
covering key areas of engineering, physics, and biology; develops, 
modifies, and validates test methods and measurement techniques, risk 
assessments and hazard analyses, and generic techniques to enhance 
product safety and usefulness.
    Provides scientific and engineering support in the review of 
regulatory documents, the development of regulatory decisions, and the 
analysis of postmarket surveillance issues.
    Plans, conducts, or stimulates research on the human health effects 
of radiation and medical devices.
    Participates in the development of national and international 
consensus standards and voluntary guidelines through interaction with 
appropriate standards committees; coordinates with other standards-
setting groups representing national and international standards-
setting organizations; conducts the review and analysis of performance 
standards, guides and documents related to the Center's mission.
    Establishes official liaisons with Standards Development 
Organizations. Coordinates the liaison within the Center. Establishes 
and maintains 

[[Page 65351]]
records on committee participation and status of medical device 
standards used by the Center.
    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: November 28, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-30813 Filed 12-18-95; 8:45 am]
BILLING CODE 4160-01-F ----