[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
