Notice of Publication of the Revised Guidebook for the National Practitioner Data Bank (NPDB), 36997 [2015-15802]
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Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Notices
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Wolfgang Kainz, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 1129, Silver Spring,
MD 20993–0002, 301–661–7595.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance to provide an
assessment paradigm for RF-induced
heating on or near multi-component or
multi-configuration passive medical
devices in the MR environment. During
MR scanning, applied RF excitation
pulses induce currents that can cause
heating of electrically conductive
materials. RF-induced heating of
medical devices made with conductive
materials may lead to patient burns. To
minimize the risk of patient burns
during MR scanning, sponsors should
comprehensively assess devices in all
configurations and combinations.
However, multi-component passive
devices, such as orthopedic fixation
devices, may permit a very large number
of possible device configurations and
combinations of individual components.
Testing all possibilities may be
impracticable and unnecessary. This
draft guidance provides an approach to
identify a manageable number of device
configurations or combinations for the
testing of RF-induced heating in the MR
environment. Additionally, this draft
guidance provides recommendations on
how to assess RF-induced device
heating for multi-configuration passive
medical devices.
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II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the assessment of RF-induced
heating of multi-component, or multiconfiguration, passive medical devices
in the MR environment. It does not
establish any rights for any person and
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is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Assessment of RadiofrequencyInduced Heating in the Magnetic
Resonance (MR) Environment for MultiConfiguration Passive Medical Devices’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500001 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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36997
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Publication of the Revised
Guidebook for the National Practitioner
Data Bank (NPDB)
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
ACTION:
Notice.
The National Practitioner
Data Bank (NPDB) announces the
release of the revised user Guidebook.
The NPDB is a confidential information
clearinghouse created by Congress and
intended to facilitate a comprehensive
review of the professional credentials of
health care practitioners, entities, and
suppliers. The Guidebook is the primary
policy document explaining the statutes
and regulations behind and operation of
the NPDB. It serves as an essential
reference for NPDB users, offering
reporting and querying examples,
explanations, definitions, and
frequently asked questions. The new
Guidebook incorporates legislative and
regulatory changes adopted since its last
edition, including the NPDB’s merger
with the Healthcare Integrity and
Protection Data Bank.
In November 2013, the Health
Resources and Services Administration
(HRSA) released a draft Guidebook to
the public for review and comment by
NPDB stakeholders and other interested
parties. It announced the draft
Guidebook’s availability in the Federal
Register. HRSA received more than 360
separate comments, consisting of
analyses of issues raised by the draft
Guidebook. The NPDB carefully studied
all comments received, and many led to
detailed analyses of how NPDB explains
its policies to its audiences. The final
Guidebook is now available at
www.npdb.hrsa.gov and replaces
previous Guidebooks.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ernia P. Hughes, MBA, Director of the
Division of Practitioner Data Bank,
Bureau of Health Workforce, Health
Resources and Services Administration
at: NPDBPolicy@hrsa.gov or 301–443–
2300.
Dated: June 18, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015–15802 Filed 6–26–15; 8:45 am]
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Agencies
[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Page 36997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Publication of the Revised Guidebook for the National
Practitioner Data Bank (NPDB)
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Practitioner Data Bank (NPDB) announces the
release of the revised user Guidebook. The NPDB is a confidential
information clearinghouse created by Congress and intended to
facilitate a comprehensive review of the professional credentials of
health care practitioners, entities, and suppliers. The Guidebook is
the primary policy document explaining the statutes and regulations
behind and operation of the NPDB. It serves as an essential reference
for NPDB users, offering reporting and querying examples, explanations,
definitions, and frequently asked questions. The new Guidebook
incorporates legislative and regulatory changes adopted since its last
edition, including the NPDB's merger with the Healthcare Integrity and
Protection Data Bank.
In November 2013, the Health Resources and Services Administration
(HRSA) released a draft Guidebook to the public for review and comment
by NPDB stakeholders and other interested parties. It announced the
draft Guidebook's availability in the Federal Register. HRSA received
more than 360 separate comments, consisting of analyses of issues
raised by the draft Guidebook. The NPDB carefully studied all comments
received, and many led to detailed analyses of how NPDB explains its
policies to its audiences. The final Guidebook is now available at
www.npdb.hrsa.gov and replaces previous Guidebooks.
FOR FURTHER INFORMATION CONTACT: Ernia P. Hughes, MBA, Director of the
Division of Practitioner Data Bank, Bureau of Health Workforce, Health
Resources and Services Administration at: NPDBPolicy@hrsa.gov or 301-
443-2300.
Dated: June 18, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-15802 Filed 6-26-15; 8:45 am]
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