National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 2103 [2023-00512]
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Federal Register / Vol. 88, No. 8 / Thursday, January 12, 2023 / Notices
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Photobiomodulation (PBM)
Devices—Premarket Notification
[510(k)] Submissions.’’ 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.
II. 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of the draft guidance may do so by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/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download
an electronic copy of
‘‘Photobiomodulation (PBM) Devices—
Premarket Notification [510(k)]
Submissions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 16030 and complete title to
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR part; guidance
Topic
807, subpart E ............................................................................
812 ..............................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, and 809 .......................................................................
50, 56 ..........................................................................................
Premarket notification ................................................................
Investigational Device Exemption ..............................................
Q-submissions ...........................................................................
0910–0120
0910–0078
0910–0756
Medical Device Labeling Regulations ........................................
Protection of Human Subjects: Informed Consent; Institutional
Review Boards.
Quality Systems Regulations .....................................................
0910–0485
0910–0130
820 ..............................................................................................
Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00422 Filed 1–11–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
identify the guidance you are
requesting.
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.
Special Emphasis Panel; HiLo Limited
Competition (UH3-Clinical Trial Required).
Date: March 27, 2023.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jason D. Hoffert, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard,
Bethesda, MD 20892, 301–496–9010,
hoffertj@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS).
Dated: January 9, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–00512 Filed 1–11–23; 8:45 am]
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Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Auditory System
Study Section.
Date: February 7–8, 2023.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
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[Federal Register Volume 88, Number 8 (Thursday, January 12, 2023)]
[Notices]
[Page 2103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
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 Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; HiLo Limited Competition
(UH3-Clinical Trial Required).
Date: March 27, 2023.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute of
Diabetes and Digestive and Kidney Diseases, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jason D. Hoffert, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892, 301-496-
9010, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS).
Dated: January 9, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-00512 Filed 1-11-23; 8:45 am]
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