Meeting of the Tick-Borne Disease Working Group, 54224-54225 [2022-18972]
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Federal Register / Vol. 87, No. 170 / Friday, September 2, 2022 / Notices
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On October
28, 2022, the committee will discuss
biologics license application 761176, for
131 I-omburtamab solution for injection,
submitted by Y-mAbs Therapeutics, Inc.
The proposed indication (use) for this
product is for the treatment of
neuroblastoma with central nervous
system/leptomeningeal metastases.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
October 14, 2022, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 1 p.m. to 2 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 5, 2022. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
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speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 6, 2022.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Philip Bautista
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19047 Filed 9–1–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act
(FACA), HHS is hereby giving notice
that the Advisory Committee on Organ
Transplantation (ACOT or Committee)
has been renewed. The effective date of
the charter renewal is August 31, 2022.
FOR FURTHER INFORMATION CONTACT:
Shelley Tims Grant (Designated Federal
Officer); HRSA Division of
Transplantation, HRSA, 5600 Fishers
Lane, 08W67, Rockville, Maryland
20857; 301–443–8036; or sgrant@
hrsa.gov.
SUMMARY:
ACOT
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities pursuant to 42 U.S.C. 217a;
SUPPLEMENTARY INFORMATION:
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section 222 of the Public Health Service
Act. ACOT may provide advice to the
Secretary on proposed Organ
Procurement and Transplantation
Network policies and such other matters
as the Secretary determines.
The renewed charter for ACOT was
approved on August 25, 2022. The filing
date of the renewed charter is August
31, 2022. The renewal of the ACOT
charter gives authorization for the
committee to operate until August 31,
2024.
A copy of the ACOT charter is
available on the ACOT website at
https://www.hrsa.gov/advisorycommittees/organ-transplantation. A
copy of the charter can also be obtained
by accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
website address for the FACA database
is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–18963 Filed 9–1–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As required by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a meeting.
The meeting will be open to the public
via webcast. For this meeting, the
TBDWG will (1) review the final draft of
chapters for the report and (2) further
discuss plans for developing the next
report to the HHS Secretary and
Congress on federal tick-borne activities
and research, taking into consideration
the 2018 and 2020 report. The 2022
report will address a wide range of
topics related to tick-borne diseases,
such as, surveillance, prevention,
diagnosis, diagnostics, and treatment;
identify advances made in research, as
well as overlap and gaps in tick-borne
disease research; and provide
recommendations regarding any
appropriate changes or improvements to
such activities and research.
DATES: The public can view the meeting
online via webcast on October 4–5, 2022
SUMMARY:
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Federal Register / Vol. 87, No. 170 / Friday, September 2, 2022 / Notices
from approximately 9 a.m. to 5 p.m. ET
(times are tentative and subject to
change) each day. 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/
2022-10-04/ when this
information becomes available.
FOR FURTHER INFORMATION CONTACT:
lotter on DSK11XQN23PROD with NOTICES1
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, Mary E. Switzer Building, 330
C Street SW, Suite L600, Washington,
DC 20024. Email: tickbornedisease@
hhs.gov. Phone: 202–795–7608.
Dated: August 23, 2022.
James J. Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2022–18972 Filed 9–1–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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
SUPPLEMENTARY INFORMATION: A link to
following meeting.
view the webcast can be found on the
The meeting will be closed to the
meeting website at https://www.hhs.gov/
public in accordance with the
ash/advisory-committees/
provisions set forth in sections
tickbornedisease/meetings/2022-10-04/
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
index.html when it becomes available.
as amended. The grant applications and
The public will have an opportunity to
present their views to the TBDWG orally the discussions could disclose
confidential trade secrets or commercial
during the meeting’s public comment
property such as patentable material,
session or by submitting a written
and personal information concerning
public comment. Comments should be
individuals associated with the grant
pertinent to the meeting discussion.
applications, the disclosure of which
Persons who wish to provide verbal or
would constitute a clearly unwarranted
written public comment should review
invasion of personal privacy.
instructions at https://www.hhs.gov/
ash/advisory-committees/
Name of Committee: Microbiology,
tickbornedisease/meetings/2022-10-04/
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
index.html and respond by midnight
B Research Study Section Microbiology and
September 26, 2022 ET. Verbal
Infectious Diseases B Research Study
comments will be limited to three
Section.
minutes each to accommodate as many
Date: October 26–27, 2022.
speakers as possible during the 30Time: 11:00 a.m. to 5:30 p.m.
minute session. Written public
Agenda: To review and evaluate grant
comments will be accessible to the
public on the TBDWG web page prior to applications.
Place: National Institute of Allergy and
the meeting.
Infectious Diseases, National Institutes of
Background and Authority: The Tick- Health, 5601 Fishers Lane, Room 3F58,
Borne Disease Working Group was
Rockville, MD 20892 (Virtual Meeting).
established on August 10, 2017, in
Contact Person: Mario Cerritelli, Ph.D.,
Scientific Review Officer, National Institute
accordance with Section 2062 of the
21st Century Cures Act, and the Federal of Allergy and Infectious Diseases, National
Advisory Committee Act, 5 U.S.C. App., Institutes of Health, 5601 Fishers Lane, Room
3F58, Rockville, MD 20892, 240–669–5199,
as amended, to provide expertise and
cerritem@mail.nih.gov.
review federal efforts related to all tick(Catalogue of Federal Domestic Assistance
borne diseases, to help ensure
Program Nos. 93.855, Allergy, Immunology,
interagency coordination and minimize
and Transplantation Research; 93.856,
overlap, and to examine research
Microbiology and Infectious Diseases
priorities. The TBDWG is required to
Research, National Institutes of Health, HHS)
submit a report to the HHS Secretary
Dated: August 30, 2022.
and Congress on their findings and any
recommendations for the federal
Tyeshia M. Roberson-Curtis,
response to tick-borne disease every two Program Analyst, Office of Federal Advisory
years.
Committee Policy.
[FR Doc. 2022–19054 Filed 9–1–22; 8:45 am]
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54225
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Research Education
Program Advancing the Careers of a Diverse
Research Workforce (R25 Clinical Trial Not
Allowed).
Date: September 30, 2022.
Time: 10:00 a.m. to 6:00 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 3G21,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Dimitrios Nikolaos
Vatakis, Ph.D., Scientific Review Officer,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G21, Rockville, MD
20892, 301–761–7176, dimitrios.vatakis@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Biomarker Signatures of TB
Infection in Young Children With and
Without HIV (R01 Clinical Trial Not
Allowed).
Date: October 4, 2022.
Time: 10:00 a.m. to 6:00 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 3G21,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Dimitrios N. Vatakis,
Ph.D., Scientific Review Officer, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, Room 3G21, Rockville, MD 20892,
301–761–7176, dimitrios.vatakis@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)
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[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Pages 54224-54225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18972]
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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.
-----------------------------------------------------------------------
SUMMARY: As required by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting.
The meeting will be open to the public via webcast. For this meeting,
the TBDWG will (1) review the final draft of chapters for the report
and (2) further discuss plans for developing the next report to the HHS
Secretary and Congress on federal tick-borne activities and research,
taking into consideration the 2018 and 2020 report. The 2022 report
will address a wide range of topics related to tick-borne diseases,
such as, surveillance, prevention, diagnosis, diagnostics, and
treatment; identify advances made in research, as well as overlap and
gaps in tick-borne disease research; and provide recommendations
regarding any appropriate changes or improvements to such activities
and research.
DATES: The public can view the meeting online via webcast on October 4-
5, 2022
[[Page 54225]]
from approximately 9 a.m. to 5 p.m. ET (times are tentative and subject
to change) each day. 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/2022-10-04/
when this information becomes available.
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, Mary E. Switzer Building, 330 C Street SW,
Suite L600, Washington, DC 20024. 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/2022-10-04/ 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/2022-10-04/ and
respond by midnight September 26, 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.
Background and Authority: The Tick-Borne Disease Working Group was
established on August 10, 2017, in accordance with Section 2062 of the
21st Century Cures Act, and the Federal Advisory Committee Act, 5
U.S.C. App., as amended, to provide expertise and review federal
efforts related to all tick-borne diseases, to help ensure interagency
coordination and minimize overlap, and to examine research priorities.
The TBDWG is required to submit a report to the HHS Secretary and
Congress on their findings and any recommendations for the federal
response to tick-borne disease every two years.
Dated: August 23, 2022.
James J. Berger,
Designated Federal Officer, Tick-Borne Disease Working Group, Office of
Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2022-18972 Filed 9-1-22; 8:45 am]
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