National Institute on Drug Abuse; Notice of Closed Meeting, 69935-69936 [2023-22361]
Download as PDF
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
69935
May24,2023
Melissa Barhoover, Ph.D., RAC
Sen:ior Regulatory Affairs Manager
BectQn, Dickinson and Company
7 Loveton Circle,
Sparks, MD 21152-0999
Re: Revocation ofEUA220453
Dear Dr. Barhoover:
This letter is ill response to the request from Becton, Dickinson and Company ("BD')~ ill a ktter
received May 22, 2023, that the U.S. Food and Drug Admillistration (FDA) withdraw the EUA
for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System issued on
December 23, 2022. BD has decided not to manufacture or sell these kits moving forward and
requested that the EUA be withdrawn. FDA understands that, as of the date of this letter, no
VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System reagents were
distributed ill the United States.
The authorization of a device for. emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuantto section 564(gX2) oftlie Act,
be revoked. when circumstam:es make such revocation appropriate to pr-0tect ihe public health Qr
safety (section 564(g)(2)(C) of the Act). Because BD has requested that FDA withdraw the EUA
for the VIASURE Monkeypox vnus Real Time PCR Reagents for BD MA,X System, FDA has
determined that itis appropriate, to protect the public health or safety, to revoke this
authorization. Accordingly, FDA hereby revokes EUA220453 for the VIASURE MonkeYPox
virus Real Time PCR Reagents for BD MA,XSystem, pursuant to.section 564(g)(2XC) of the
Act. As of the date ofthis letter, the VIASURE Monkeypox virus Real Time PCR Reagents for
BD MA,X System is no longer authorized for emergency use by FDA.
Notice ofthis tevoc.ation wiil be published in the Federal Regzs.tet, p0rsu:ant to section 564(hXl)
oftheAct.
•
Sincerely~
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Admillistration •
[FR Doc. 2023–22390 Filed 10–6–23; 8:45 am]
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
BILLING CODE 4164–01–C
ddrumheller on DSK120RN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 1009 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.,
VerDate Sep<11>2014
18:39 Oct 06, 2023
Jkt 262001
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 on
Drug Abuse Special Emphasis Panel;
Implementing Comprehensive HIV Services
in Syringe Service Program Settings.
Date: November 17, 2023.
Time: 12:00 to 2:00 p.m.
E:\FR\FM\10OCN1.SGM
10OCN1
EN10OC23.021
Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
69936
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Trinh T. Tran, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Office of Extramural Policy, National
Institute on Drug Abuse, NIH, 301 North
Stonestreet Avenue, MSC 6021, Bethesda,
MD 20892 (301) 827–5843, trinh.tran@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS).
Dated: October 3, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–22361 Filed 10–6–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2023–0292]
National Chemical Transportation
Safety Advisory Committee; November
2023 Meetings
U.S. Coast Guard, Department
of Homeland Security.
ACTION: Notice of Federal advisory
committee meeting.
AGENCY:
The National Chemical
Transportation Safety Advisory
Committee (Committee) will conduct a
series of meetings over three days in
League City, TX, to discuss matters
relating to the safe and secure marine
transportation of hazardous materials.
The subcommittee meetings will also be
available by videoconference for those
unable to attend in person, however the
full committee meeting will be held in
person only. All meetings will be open
to the public.
DATES:
Meetings: National Chemical
Transportation Safety Advisory
Committee subcommittees will meet on
Tuesday, November 28 and Wednesday,
November 29, 2023, from 9 a.m. to 5
p.m. Central Standard Time (CST) each
day. The full Committee will meet on
Thursday, November 30, 2023, from 9
a.m. until 5 p.m. CST. Please note these
meetings may close early if the
Committee has completed its business.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:39 Oct 06, 2023
Jkt 262001
Comments and supporting
documents: To ensure your comments
are reviewed by Committee members
before the meeting, submit your written
comments no later than November 15,
2023.
The meeting will be held at
INEOS Oligomers USA, 2600 South
Shore Boulevard, Suite 400, League
City, TX 77573.
Pre-Registration Information: Preregistration is required for in-person
access to the meeting or to attend the
subcommittee meetings by
videoconference. Public attendees will
be required to pre-register no later than
noon, Eastern Standard Time, on
November 15, 2023, to be admitted to
the meeting. In-person attendance may
be capped due to limited space in the
meeting venue, and registration will be
on a first-come-first-served basis. To
pre-register, contact Lieutenant Ethan
Beard at Ethan.T.Beard@uscg.mil. You
will be asked to provide your name,
telephone number, email, company, or
group with which you are affiliated, and
whether you wish to attend virtually or
in person; if a foreign national, also
provide your country of citizenship,
passport country, country of residence,
place of birth, passport number, and
passport expiration date.
The National Chemical
Transportation Safety Advisory
Committee is committed to ensuring all
participants have equal access
regardless of disability status. If you
require reasonable accommodation due
to a disability to fully participate, please
email Lieutenant Ethan Beard at
Ethan.T.Beard@uscg.mil or call at 202–
372–1419 as soon as possible.
Instructions: You are free to submit
comments at any time, including orally
at the meeting as time permits, but if
you want Committee members to review
your comment before the meeting,
please submit your comments no later
than November 15, 2023. We are
particularly interested in comments on
the topics in the ‘‘Agenda’’ section
below. We encourage you to submit
comments through the Federal Decision
Making Portal at https://
www.regulations.gov/docket/USCG2023-0292. If your material cannot be
submitted using https://
www.regulations.gov, contact the
individual in the FOR FURTHER
INFORMATION CONTACT section of this
document for alternate instructions. You
must include the docket number USCG–
2023–0292. We do not redact personal
information from comments which are
posted at https://www.regulations.gov,
so any personal information provided in
a comment posted will be viewable by
ADDRESSES:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
the public. You may wish to review the
Privacy and Security Notice found via a
link on the homepage of https://
www.regulations.gov, and DHS’s
eRulemaking System of Records notice
(85 FR 14226, March 11, 2020). If you
encounter technical difficulties with
comment submission, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
Docket Search: Documents mentioned
in this notice as being available in the
docket, and all public comments, will
be in our online docket at https://
www.regulations.gov and can be viewed
by following that website’s instructions.
Additionally, if you go to the online
docket and sign-up for email alerts, you
will be notified when comments are
posted.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Ethan T. Beard, Alternate
Designated Federal Officer of the
National Chemical Transportation
Safety Advisory Committee, telephone
202–372–1419, or email Ethan.T.Beard@
uscg.mil.
SUPPLEMENTARY INFORMATION: Notice of
the meeting of the National Chemical
Transportation Safety Advisory
Committee is in compliance with the
Federal Advisory Committee Act, (Pub.
L. 117–286, 5. U.S.C., ch. 10). The
Committee is authorized by section 601
of the Frank LoBiondo Coast Guard
Authorization Act of 2018 (Pub. L. 115–
282, 132 Stat. 4192) and is codified in
46 U.S.C. 15101. The Committee
operates under the provisions of the
Federal Advisory Committee Act and 46
U.S.C. 15109. The Committee provides
advice and recommendations to the
Secretary of Homeland Security through
the Commandant of the U.S. Coast
Guard on matters related to the safe and
secure marine transportation of
hazardous materials.
Agenda
Tuesday, November 28, 2023
Two subcommittees will meet to
discuss the following task statements:
9:00 a.m.–12:00 p.m. CST
(1) Task Statement 21–01:
Recommendations on Loading Limits of
Gas Carriers and USCG Supplement to
International Hazardous Zone
Requirements.
1:30 p.m.–5:00 p.m. CST
(2) Task Statement 22–01:
Recommendations to Support
Reductions to Emissions and
Environmental Impacts Associated with
Marine Transport of Chemicals,
E:\FR\FM\10OCN1.SGM
10OCN1
Agencies
[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Notices]
[Pages 69935-69936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Pursuant to section 1009 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 on Drug Abuse Special
Emphasis Panel; Implementing Comprehensive HIV Services in Syringe
Service Program Settings.
Date: November 17, 2023.
Time: 12:00 to 2:00 p.m.
[[Page 69936]]
Agenda: To review and evaluate grant applications.
Place: National Institute of Health, National Institute on Drug
Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Trinh T. Tran, Ph.D., Scientific Review Officer,
Scientific Review Branch, Office of Extramural Policy, National
Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892 (301) 827-5843, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug
Abuse Scientist Development Award for Clinicians, Scientist
Development Awards, and Research Scientist Awards; 93.278, Drug
Abuse National Research Service Awards for Research Training;
93.279, Drug Abuse and Addiction Research Programs, National
Institutes of Health, HHS).
Dated: October 3, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-22361 Filed 10-6-23; 8:45 am]
BILLING CODE 4140-01-P