[Federal Register Volume 62, Number 1 (Thursday, January 2, 1997)]
[Notices]
[Page 103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33383]


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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 Surveillance and Biometrics, Center for 
Devices and Radiological Health (CDRH), Office of Operations, in the 
Food and Drug Administration (FDA).
    The functional statements of the Office of Surveillance and 
Biometrics have been modified to include participation in research and 
consultation on health economics and cost effectiveness methodology 
issues. In addition, program management activities have been elevated 
to the immediate office which will tighten the span of control within 
the Office.
    Under section HF-B, Organization:
    1. Delete the subparagraph Program Management Staff (HFWH2), Center 
for Devices and Radiological Health (HFW), in its entirety.
    2. Delete the subparagraphs Office of Surveillance and Biometrics 
(HFWH) in their entirety and insert the following new subparagraphs 
under Office of Surveillance and Biometrics (HFWH), reading as follows:
    Office of Surveillance and Biometrics. Advises, coordinates, and 
provides consultation to the Center Director and other Agency officials 
including the Commissioner on Center programs and policies concerning 
premarket review activities, postmarket management activities, 
surveillance and biometrics programs and activities, and regulatory 
matters for medical devices and radiological products.
    Establishes policy for surveillance programs. Designs, develops, 
and implements a Center program to acquire device experience 
information; identifies and analyzes device problems; develops solution 
strategies to such problems; and tracks programs or solution 
implementations.
    Provides statistical, epidemiological, and biometric services, and 
conducts research in support of the operating and scientific programs 
of the Center.
    Represents the Center with other governmental agencies (Federal, 
State, and International), industry, and consumer organizations on 
issues related to the activities of the Office including postmarket 
management activities.
    Provides consultation to Center Offices on health economics and 
cost effectiveness methodology issues pertaining to claims for medical 
devices.
    Plans, develops, and implements office administrative support and 
services including program planning, financial management, extramural 
and collaborative efforts, procurement, travel, personnel 
administration, employee development and training, employee 
evaluations, recognition programs, property management, and facility 
space management.
    3. Delete the subparagraphs Issues Management Staff (HFWH1) in 
their entirety and insert the following new subparagraphs under 
paragraph Issues Management Staff (HFWH1), Center for Devices and 
Radiological Health (HFW), reading as follows:
    Issues Management Staff (HFWH1). Directs and monitors the analysis, 
resolution, development and solution implementation of postmarket 
issues; presents these issues to the CDRH, FDA, other agencies, and 
foreign governments as appropriate. Coordinates and disseminates 
information on developing issues and solution strategies within CDRH, 
FDA, and with other agencies and foreign governments as appropriate.
    Provides and coordinates input on postmarket concerns and 
perspectives in support of Center initiatives, including encouragement 
and facilitation of the use of postmarket data available within the 
Center.
    Develops and directs systems that track and monitor CDRH's 
postmarket surveillance issues; documents the recommendations, 
resolutions, and solution monitoring, and produces final reports for 
review by Center management.
    Directs the preparation of issue papers and other reports or 
studies to promote the resolution of public health issues; coordinates 
these analyses with subject matter experts throughout CDRH, FDA and 
other Department of Health and Human Services agencies as required.
    Represents CDRH's postmarketing surveillance concerns at industry, 
trade, professional, Agency, and international meetings. Develops and 
delivers speeches and papers, and acts as the Center's liaisons for 
postmarket issues.
    4. 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 27, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-33383 Filed 12-31-96; 8:45 am]
BILLING CODE 4160-01-F