National Institute of Mental Health; Notice of Closed Meeting, 54388 [2017-24899]
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54388
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
I. Background
Section 801.45 (21 CFR 801.45)
requires a device to be directly marked
with a UDI when the device is intended
to be used more than once and intended
to be reprocessed before each use.
However, ‘‘intended to be used more
than once’’ and ‘‘intended to be
reprocessed’’ are not defined in the UDI
regulations. This guidance provides
FDA’s interpretation of these terms,
clarifies when direct marking of devices
with a UDI is required, provides
recommendations for how labelers
should comply with the UDI direct
marking requirements, and clarifies the
criteria for exceptions to the direct
marking requirement.
In the Federal Register of June 26,
2015, FDA published the notice of
availability of ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Unique Device
Identification: Direct Marking of
Devices’’ (80 FR 36821) (the ‘‘Draft
Guidance’’). In the notice of availability,
FDA also solicited feedback on two
questions related to interpretation of
‘‘intended to be reprocessed’’: (1)
Should the definition of ‘‘reprocessing’’
for purposes of UDI direct marking
requirements include cleaning alone
without subsequent disinfection and/or
sterilization of the device? and (2) what
public health benefits would be served
by requiring a UDI direct marking to be
affixed to devices intended to be reused
for which reprocessing instructions
include cleaning only and not
disinfection and/or sterilization?
Interested persons were invited to
comment by September 24, 2015. FDA
considered the comments received on
the draft guidance, including comments
responding to the specific questions in
the notice of availability, and revised
the guidance as appropriate in response
to these comments.
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II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Unique Device
Identification: Direct Marking of
Devices.’’ It does not establish any rights
for any person and 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. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
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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.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Unique Device Identification: Direct
Marking of Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1400031 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
described 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 801 have been approved
under OMB control number 0910–0485;
the collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; and the collections
of information in 21 CFR part 830
pertaining to GUDID labeler accounts
and data submissions addressed in this
draft guidance document have been
approved under OMB control number
0910–0720.
Dated: November 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–24992 Filed 11–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Member Conflicts: Mental Health Services
Research.
Date: December 7, 2017.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: November 13, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–24899 Filed 11–16–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the NHLBI Institutional
Training Mechanism Review
Committee.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Institutional Training Mechanism Review
Committee.
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Page 54388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24899]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; Member Conflicts: Mental Health Services Research.
Date: December 7, 2017.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard,
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: November 13, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-24899 Filed 11-16-17; 8:45 am]
BILLING CODE 4140-01-P
