Center for Scientific Review; Notice of Closed Meetings, 46024-46025 [2019-18894]
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Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices
Dated: August 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 2,
2019, FDA published a notice of
availability with a 60-day comment
period to request comments on the draft
guidance for industry and FDA staff
entitled ‘‘Testing and Labeling Medical
Devices for Safety in the Magnetic
Resonance (MR) Environment.’’
The Agency has received a request for
a 30-day extension of the comment
period. The request conveyed concern
that the current 60-day comment period
does not allow sufficient time to
develop a meaningful or thoughtful
response.
FDA has considered the request and
is extending the comment period for the
notice of availability for 30 days, until
October 31, 2019. The Agency believes
that a 30-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying guidance on these important
issues.
II. Significance of Guidance
FDA is issuing this draft guidance
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The draft guidance, when finalized, will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 this topic. 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.
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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of the draft guidance may do so by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/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Testing and Labeling Medical
Devices for Safety in the Magnetic
Resonance (MR) Environment’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500059 to
identify the guidance you are
requesting.
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Dated: August 27, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Mental Health
Services Research Committee,
November 7, 2019, 8:00 a.m. to
November 7, 2019 p.m., 05:00 p.m., The
Dupont Hotel, 1500 New Hampshire
Avenue NW, Washington, DC 20036
which was published in the Federal
Register on August 201, 2019, 84 FR
43150.
This notice is to amend the date of the
Mental Health Service Research
Committee (SERV) meeting from
November 7, 2019 to November 8, 2019.
The meeting times and location remain
the same. The meeting is closed to the
public.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Cures Acceleration
Network Review Board, September 19,
2019, 11:00 a.m. to 4:30 p.m., PORTER
NEUROSCIENCE RESEARCH CENTER,
Building 35A, 35 Convent Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
June 27, 2019, 84 FR 30744 Pg. 30744.
This meeting notice is amended to
change the start time from 11:00 a.m. to
10:00 a.m. The meeting is open to the
public.
Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18901 Filed 8–30–19; 8:45 am]
[FR Doc. 2019–18895 Filed 8–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Office of the Director, National
Institutes of Health; Amended Notice
of Meeting
Center for Scientific Review; Notice of
Closed Meetings
Notice is hereby given of a change in
the meeting of the Council of Councils,
September 6, 2019, 08:15 a.m. to 04:00
p.m., National Institutes of Health, The
Natcher Building, Building 45, Room E,
45 Center Drive, Bethesda, MD 20892
which was published in the Federal
Register on February 08, 2019, 84 FR
2890.
The meeting notice is amended to
change the open and closed session
meeting times as follows: The morning
open session will change from 8:15
a.m.–12:00 p.m. to 8:00 a.m.–12:00 p.m.;
the closed session will change from
12:00 p.m.–1:30 p.m. to 12:00 p.m.–
12:45 p.m.; and the afternoon open
session will change from 1:30 p.m.–4:00
p.m. to 12:45 p.m.–4:15 p.m. The
meeting is partially closed to the public.
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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: Biological Chemistry
and Macromolecular Biophysics Integrated
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Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices
Review Group; Biochemistry and Biophysics
of Membranes Study Section.
Date: September 25, 2019.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Nuria E. Assa-Munt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Cellular Signaling
and Regulatory Systems Study Section.
Date: September 26–27, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, 301–435–
1022, balasundaramd@csr.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Hepatobiliary Pathophysiology Study
Section.
Date: September 30–October 1, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Jianxin Hu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2156,
Bethesda, MD 20892, 301–827–4417,
jianxinh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18894 Filed 8–30–19; 8:45 am]
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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
VerDate Sep<11>2014
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Jkt 247001
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Biorepository of Human Induced Pluripotent
Stem Cells.
Date: September 23, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Office of Scientific Review/DERA,
National Heart, Lung and Blood Institute,
6701 Rockledge Drive, Bethesda, MD 20879
(Telephone Conference Call).
Contact Person: Melissa E. Nagelin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7202, Bethesda, MD 20892, 301–435–0297,
nagelinmh2@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: August 27, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18898 Filed 8–30–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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,
PO 00000
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46025
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;
NIMH Clinical Trials to Test the
Effectiveness of Treatment, Preventive, and
Services Interventions (R01).
Date: September 20, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852,
(Virtual Meeting).
Contact Person: Marcy Ellen Burstein,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6143, MSC 9606,
Bethesda, MD 20892–9606, 301–443–9699,
bursteinme@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
NRSA Institutional Research Grant Training
Review.
Date: September 27, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Hotel, 1500 New
Hampshire Avenue NW, Washington, DC
20036.
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
Activities, National Institute of Mental
Health, NIH, Neuroscience Center/Room
6150/MSC 9606, 6001 Executive Boulevard,
Bethesda, MD 20892–9606, 301–443–2742,
nick.gaiano@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Psychosocial Treatment Development.
Date: September 27, 2019.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852,
(Virtual Meeting).
Contact Person: David I. Sommers, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892, 301–443–7861,
dsommers@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18900 Filed 8–30–19; 8:45 am]
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Agencies
[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46024-46025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18894]
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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: Biological Chemistry and Macromolecular
Biophysics Integrated
[[Page 46025]]
Review Group; Biochemistry and Biophysics of Membranes Study
Section.
Date: September 25, 2019.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Nuria E. Assa-Munt, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164, MSC 7806, Bethesda, MD
20892, (301) 451-1323, [email protected].
Name of Committee: Cell Biology Integrated Review Group;
Cellular Signaling and Regulatory Systems Study Section.
Date: September 26-27, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: David Balasundaram, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD
20892, 301-435-1022, [email protected].
Name of Committee: Digestive, Kidney and Urological Systems
Integrated Review Group; Hepatobiliary Pathophysiology Study
Section.
Date: September 30-October 1, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Jianxin Hu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 2156, Bethesda, MD 20892, 301-827-4417,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-18894 Filed 8-30-19; 8:45 am]
BILLING CODE 4140-01-P