Meeting of the Tick-Borne Disease Working Group, 66714-66715 [2022-23989]
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66714
Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Notices
October 19, 2022
SusanH/lftington, -Pt(D.
Medical Director
The Cleveland Clinic F'oundatio11
9:500 Euclid Avenue
Cleveland, OH 44195
Re: Revoi:ation of EUA210363.
Deat Dt Hattiftgton:
'llri.s letter is in: ri$ponse to th.e request from Cleveland Clmk RobertJ. TotnSich Path.ology and
Laboratory Medicine Irtstttute («Cleveland Clinic:), received via emai1 on October 7, 2022, that
the D.S. Food and DrugA:dministra:tion (FDA) revoke the EUAfor the SelfCheck COVJD-l.9
TaqPath Muitiptex PCll assay issued on August~~ 202L Ckweland Clinic indi:eated thatit is no
Jo~er osing the SeIICh~k COVIP~19 TaqPath Multiplet PCR.a$say and does not plan to -use it
in the future,
The authorizatio11 ot a device tor emetgertcy use under section 564 otilie.ltedetal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb;:3) may, pursuant tQ s.ectiQn .564(g)(:2) Qf the Act,
be revoked ·when cii:cµmst@ces nrakli} such revocation appropriate to protect the pt1.blic beal:th or
sat.ety (section S:64(g)(2)(C) otthe Ac{). Because Cleveland Clinic has notified FDA thatit is.no
longerusingtbe Selroheck COVID-19 t'aqPath Multiplex PCR.assa.y and does not plan. to use. it
itt the :futute and :requ:ested FDAtevoke the BUA for the SelfCheck COVID•li;> taqPath
Mui.tjplex PCR.assay;. FDA has ti'etermined that itis appropriate iQ ptot®I lhe publichealtl:tor
safe:ty to rin"Q:ke this authorization. Accordingly, FDA here!:)y revoke~ EUA2103'63 for the
Selfeheck COVID-1? TaqPath Multiplex PCR assay, pursuant to section 564($)(2)(C) of the
Act. As of the date of this letter, the SelfCheck COVIO- l9TaqPath Multiplex PCR assay is no
longer authorized for 6111etgency use by FDA
Notice of this revocation will be pqhfished in the FederatRegister; pursuanttQ sectfon 564(h)(1)
oftheAct.
Isl
Nami,tndje N, B!llll.Plli!, Ph.D.
Chief Scientist
:Food and Drug Administration
Secretary, Department of Health and
Human Services.
ACTION:
Notice; revision to meeting date.
[FR Doc. 2022–24072 Filed 11–3–22; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
VerDate Sep<11>2014
18:12 Nov 03, 2022
The Office of the Assistant
Secretary for Health published a notice
in the Federal Register on September
16, 2022, concerning a meeting of the
Tick-Borne Disease Working Group
(TBDWG) that was scheduled to occur
on December 7, 2022. This notice is
being amended to announce that the
meeting has been rescheduled to
November 21, 2022. This will be the
final TBDWG meeting.
SUMMARY:
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The meeting date announced in
the Federal Register at 87 FR 5693 on
September 16, 2022 is amended. The
public can view the meeting online via
webcast on November 21, 2022 from
approximately 10 a.m. to 12 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be
posted on the TBDWG web page at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
index.html when this information
becomes available.
DATES:
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EN04NO22.075
Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Notices
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Tower Building, 1101 Wootton
Parkway, Rockville, MD 20852. Email:
tickbornedisease@hhs.gov. Phone: 202–
795–7608.
A link to
view the webcast can be found on the
meeting website at https://www.hhs.gov/
ash/advisory-committees/
tickbornedisease/meetings/
when it becomes available. The public
will have an opportunity to present
their views to the TBDWG orally during
the meeting’s public comment session
or by submitting a written public
comment. Comments should be
pertinent to the meeting discussion.
Persons who wish to provide verbal or
written public comment should review
instructions at https://www.hhs.gov/
ash/advisory-committees/
tickbornedisease/meetings/
and respond by midnight November 13,
2022 ET. Verbal comments will be
limited to three minutes each to
accommodate as many speakers as
possible during the 30-minute session.
Written public comments will be
accessible to the public on the TBDWG
web page prior to the meeting.
SUPPLEMENTARY INFORMATION:
Dated: October 25, 2022.
James J. Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2022–23989 Filed 11–3–22; 8:45 am]
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (Parent
R13 Clinical Trial Not Allowed) Re-Issue PA–
20–207.
Date: December 5–7, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G13B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Yong Gao, Ph.D., Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, Room 3G13B, Rockville, MD 20852,
(240) 669–5048, yong.gao@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS).
Dated: November 1, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24064 Filed 11–3–22; 8:45 am]
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
National Institute of Allergy and
Infectious 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
VerDate Sep<11>2014
18:12 Nov 03, 2022
Jkt 259001
Dated: November 1, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24063 Filed 11–3–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
National Institutes of Health,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kristina S. Wickham,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20852, 301–761–5390,
kristina.wickham@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
AGENCY:
BILLING CODE 4140–01–P
66715
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
Allergy and Infectious Diseases Special
Emphasis Panel; Enhancing HIV Reservoir
Susceptibility to Elimination (R01 Clinical
Trial Not Allowed).
Date: November 30–December 1, 2022.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
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ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. This meeting is a virtual
meeting and is open to the public.
Written comments will be accepted, and
registration is required to present oral
comments.
DATES: Meeting: Scheduled for
December 15, 2022, 1:30 p.m.–5:00 p.m.
Eastern Standard Time (EST). Ending
times are approximate; meeting may end
earlier or run later. Written Public
Comment Submissions: Deadline is
December 08, 2022. Registration for Oral
Comments: Deadline is December 08,
2022.
ADDRESSES: Meeting web page: The
preliminary agenda, registration, and
other meeting materials will be available
at https://ntp.niehs.nih.gov/go/165 by
November 10, 2022. Virtual Meeting:
The URL for viewing the virtual meeting
will be provided on the meeting web
page the day before the meeting.
FOR FURTHER INFORMATION CONTACT: Dr.
Milene Brownlow, Designated Federal
SUMMARY:
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04NON1
Agencies
[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Pages 66714-66715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23989]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Tick-Borne Disease Working Group
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice; revision to meeting date.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Health published a
notice in the Federal Register on September 16, 2022, concerning a
meeting of the Tick-Borne Disease Working Group (TBDWG) that was
scheduled to occur on December 7, 2022. This notice is being amended to
announce that the meeting has been rescheduled to November 21, 2022.
This will be the final TBDWG meeting.
DATES: The meeting date announced in the Federal Register at 87 FR 5693
on September 16, 2022 is amended. The public can view the meeting
online via webcast on November 21, 2022 from approximately 10 a.m. to
12 p.m. ET (times are tentative and subject to change). The confirmed
times and agenda items for the meeting will be posted on the TBDWG web
page at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/ when this information becomes available.
[[Page 66715]]
FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal
Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS
Policy, Office of the Assistant Secretary for Health, Department of
Health and Human Services, Tower Building, 1101 Wootton Parkway,
Rockville, MD 20852. Email: [email protected]. Phone: 202-795-
7608.
SUPPLEMENTARY INFORMATION: A link to view the webcast can be found on
the meeting website at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/ when it becomes available. The
public will have an opportunity to present their views to the TBDWG
orally during the meeting's public comment session or by submitting a
written public comment. Comments should be pertinent to the meeting
discussion. Persons who wish to provide verbal or written public
comment should review instructions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/ and respond by midnight
November 13, 2022 ET. Verbal comments will be limited to three minutes
each to accommodate as many speakers as possible during the 30-minute
session. Written public comments will be accessible to the public on
the TBDWG web page prior to the meeting.
Dated: October 25, 2022.
James J. Berger,
Designated Federal Officer, Tick-Borne Disease Working Group, Office of
Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2022-23989 Filed 11-3-22; 8:45 am]
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