82 FR 54388 - National Institute of Mental Health; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 221 (November 17, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54388-54388 | |
| FR Document | 2017-24899 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Page 54388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24899] ----------------------------------------------------------------------- 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, [email protected]. (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
![54388 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
I. Background the internet. A search capability for all 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Section 801.45 (21 CFR 801.45) Center for Devices and Radiological as amended. The grant applications and
requires a device to be directly marked Health guidance documents is available the discussions could disclose
with a UDI when the device is intended at https://www.fda.gov/MedicalDevices/ confidential trade secrets or commercial
to be used more than once and intended DeviceRegulationandGuidance/ property such as patentable material,
to be reprocessed before each use. GuidanceDocuments/default.htm. and personal information concerning
However, ‘‘intended to be used more Guidance documents are also available individuals associated with the grant
than once’’ and ‘‘intended to be at https://www.fda.gov/BiologicsBlood applications, the disclosure of which
reprocessed’’ are not defined in the UDI Vaccines/GuidanceCompliance would constitute a clearly unwarranted
regulations. This guidance provides RegulatoryInformation/default.htm or invasion of personal privacy.
FDA’s interpretation of these terms, https://www.regulations.gov. Persons Name of Committee: National Institute of
clarifies when direct marking of devices unable to download an electronic copy Mental Health Special Emphasis Panel;
with a UDI is required, provides of ‘‘Unique Device Identification: Direct Member Conflicts: Mental Health Services
recommendations for how labelers Marking of Devices’’ may send an email Research.
request to CDRH-Guidance@fda.hhs.gov Date: December 7, 2017.
should comply with the UDI direct Time: 11:30 a.m. to 12:30 p.m.
marking requirements, and clarifies the to receive an electronic copy of the
Agenda: To review and evaluate grant
criteria for exceptions to the direct document. Please use the document
applications.
marking requirement. number 1400031 to identify the Place: National Institutes of Health,
In the Federal Register of June 26, guidance you are requesting. Neuroscience Center, 6001 Executive
2015, FDA published the notice of IV. Paperwork Reduction Act of 1995 Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
availability of ‘‘Draft Guidance for This guidance refers to previously Contact Person: Karen Gavin-Evans, Ph.D.,
Industry and Food and Drug approved collections of information Scientific Review Officer, Division of
Administration Staff: Unique Device described in FDA regulations. These Extramural Activities, National Institute of
Identification: Direct Marking of collections of information are subject to Mental Health, NIH, Neuroscience Center,
Devices’’ (80 FR 36821) (the ‘‘Draft review by the Office of Management and 6001 Executive Boulevard, Room 6153, MSC
Guidance’’). In the notice of availability, 9606, Bethesda, MD 20892, 301–451–2356,
Budget (OMB) under the Paperwork gavinevanskm@mail.nih.gov.
FDA also solicited feedback on two Reduction Act of 1995 (44 U.S.C. 3501–
questions related to interpretation of (Catalogue of Federal Domestic Assistance
3520). The collections of information in Program No. 93.242, Mental Health Research
‘‘intended to be reprocessed’’: (1) 21 CFR part 801 have been approved Grants, National Institutes of Health, HHS)
Should the definition of ‘‘reprocessing’’ under OMB control number 0910–0485;
for purposes of UDI direct marking Dated: November 13, 2017.
the collections of information in 21 CFR
requirements include cleaning alone Melanie J. Pantoja,
part 807, subpart E, have been approved
without subsequent disinfection and/or under OMB control number 0910–0120; Program Analyst, Office of Federal Advisory
sterilization of the device? and (2) what Committee Policy.
the collections of information in 21 CFR
public health benefits would be served part 814, subparts A through E, have [FR Doc. 2017–24899 Filed 11–16–17; 8:45 am]
by requiring a UDI direct marking to be been approved under OMB control BILLING CODE 4140–01–P
affixed to devices intended to be reused number 0910–0231; the collections of
for which reprocessing instructions information in 21 CFR part 820 have
include cleaning only and not DEPARTMENT OF HEALTH AND
been approved under OMB control
disinfection and/or sterilization? HUMAN SERVICES
number 0910–0073; and the collections
Interested persons were invited to of information in 21 CFR part 830
comment by September 24, 2015. FDA National Institutes of Health
pertaining to GUDID labeler accounts
considered the comments received on and data submissions addressed in this National Heart, Lung, and Blood
the draft guidance, including comments draft guidance document have been Institute; Notice of Closed Meeting
responding to the specific questions in approved under OMB control number
the notice of availability, and revised 0910–0720. Pursuant to section 10(d) of the
the guidance as appropriate in response Federal Advisory Committee Act, as
to these comments. Dated: November 14, 2017. amended, notice is hereby given of a
Leslie Kux, meeting of the NHLBI Institutional
II. Significance of Guidance Associate Commissioner for Policy. Training Mechanism Review
This guidance is being issued [FR Doc. 2017–24992 Filed 11–16–17; 8:45 am] Committee.
consistent with FDA’s good guidance BILLING CODE 4164–01–P The meeting will be closed to the
practices regulation (21 CFR 10.115). public in accordance with the
The guidance represents the current provisions set forth in sections
thinking of FDA on ‘‘Unique Device DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Identification: Direct Marking of HUMAN SERVICES as amended. The grant applications and
Devices.’’ It does not establish any rights the discussions could disclose
for any person and is not binding on National Institutes of Health confidential trade secrets or commercial
FDA or the public. You can use an property such as patentable material,
National Institute of Mental Health;
alternative approach if it satisfies the and personal information concerning
Notice of Closed Meeting
sradovich on DSK3GMQ082PROD with NOTICES
requirements of the applicable statutes individuals associated with the grant
and regulations. This guidance is not Pursuant to section 10(d) of the applications, the disclosure of which
subject to Executive Order 12866. Federal Advisory Committee Act, as would constitute a clearly unwarranted
amended, notice is hereby given of the invasion of personal privacy.
III. Electronic Access
following meeting. Name of Committee: Heart, Lung, and
Persons interested in obtaining a copy The meeting will be closed to the Blood Initial Review Group; NHLBI
of the guidance may do so by public in accordance with the Institutional Training Mechanism Review
downloading an electronic copy from provisions set forth in sections Committee.
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Document Created: 2017-11-17 05:15:15
Document Modified: 2017-11-17 05:15:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | December 7, 2017. | |
| FR Citation | 82 FR 54388 |
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