National Institute of Mental Health; Notice of Meeting, 54628 [2023-17255]
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54628
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
§ 314.161 that ANJESO (meloxicam)
solution, 30 mg/mL, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
ANJESO (meloxicam) solution, 30 mg/
mL, was withdrawn for reasons of safety
or effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ANJESO
(meloxicam) solution, 30 mg/mL, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list ANJESO (meloxicam)
solution, 30 mg/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ANJESO (meloxicam) solution, 30
mg/mL, may be approved by the Agency
as long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17263 Filed 8–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Mental Health Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
Podcasting website (https://
videocast.nih.gov/).
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 Advisory
Mental Health Council.
Date: September 7–8, 2023.
Closed: September 7, 2023, 12:00 p.m. to
4:30 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health, NSC
Building, Rooms 1255 & 1265, 6001
Executive Blvd., Rockville, MD 20852.
Open: September 8, 2023, 12:00 p.m. to
4:00 p.m.
Agenda: Presentation of the NIMH
Director’s Report and discussion of NIMH
programs.
Place: National Institutes of Health,
Neuroscience Center, Rooms 1145 & 1155,
6001 Executive Boulevard, Rockville, MD
20852,
Contact Person: Tracy L. Waldeck, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
DHHS Neuroscience Center, 6001 Executive
Boulevard, Bethesda, MD 20892, (301) 480–
6833, tracy.waldeck@nih.gov
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Dated: August 8, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–17255 Filed 8–10–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Deafness and
Other Communication Disorders
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting
website (https://videocast.nih.gov/).
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 Deafness and
Other Communication Disorders Advisory
Council.
Date: September 14–15, 2023.
Closed: September 14, 2023, 9:00 a.m. to
11:00 a.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: Porter Neuroscience Research
Center, Building 35A, Room 620/630, 35
Convent Drive, Bethesda, MD 20892.
Open: September 14, 2023, 1:00 p.m. to
4:35 p.m.
Agenda: Staff reports on divisional,
programmatical, and special activities.
Place: Porter Neuroscience Research
Center, Building 35A, Room 620/630, 35
Convent Drive, Bethesda, MD 20892.
Closed: September 15, 2023, 9:00 a.m. to
9:40 a.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Page 54628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17255]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Mental Health Council.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting. The open session will be
videocast and can be accessed from the NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
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 Advisory Mental Health Council.
Date: September 7-8, 2023.
Closed: September 7, 2023, 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications and/or
proposals.
Place: National Institutes of Health, NSC Building, Rooms 1255 &
1265, 6001 Executive Blvd., Rockville, MD 20852.
Open: September 8, 2023, 12:00 p.m. to 4:00 p.m.
Agenda: Presentation of the NIMH Director's Report and
discussion of NIMH programs.
Place: National Institutes of Health, Neuroscience Center, Rooms
1145 & 1155, 6001 Executive Boulevard, Rockville, MD 20852,
Contact Person: Tracy L. Waldeck, Ph.D., Director, Division of
Extramural Activities, National Institute of Mental Health, NIH,
DHHS Neuroscience Center, 6001 Executive Boulevard, Bethesda, MD
20892, (301) 480-6833, [email protected]
Any member of the public interested in presenting oral comments
to the committee may notify the Contact Person listed on this notice
at least 10 days in advance of the meeting. Interested individuals
and representatives of organizations may submit a letter of intent,
a brief description of the organization represented, and a short
description of the oral presentation. Only one representative of an
organization may be allowed to present oral comments and if accepted
by the committee, presentations may be limited to five minutes. Both
printed and electronic copies are requested for the record. In
addition, any interested person may file written comments with the
committee by forwarding their statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's home
page: www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/index.shtml, where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: August 8, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-17255 Filed 8-10-23; 8:45 am]
BILLING CODE 4140-01-P