Meeting of the National Advisory Committee on Rural Health and Human Services, 55706-55707 [2023-17526]
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Notices
796–7973, email: ODAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
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 the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform. The Committee
will discuss new drug application
(NDA) 215500, for eflornithine tablets,
submitted by USWM, LLC (doing
business as U.S. WorldMeds). The
proposed indication (use) for this
product is to reduce the risk of relapse
in pediatric patients with high-risk
neuroblastoma who have completed
multiagent, multimodality therapy.
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 and/or video conference
meeting 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 and
video 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 to the Docket (see
ADDRESSES) on or before September 20,
2023, will be provided to the
Committee. Oral presentations from the
public will be scheduled between
approximately 1:15 p.m. and 2:15 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
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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
September 12, 2023. 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
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 13, 2023.
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 Joyce
Frimpong (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/
AboutAdvisoryCommittees/
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. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and that the ends of justice
will be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
Dated: August 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17510 Filed 8–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Committee on Rural Health and Human
Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) scheduled a public
meeting. Information about NACRHHS
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisorycommittees/rural-health/.
DATES:
• Wednesday, September 6, 2023, 9
a.m.–5 p.m. Mountain Daylight Time
(MDT);
• Thursday, September 7, 2023, 9
a.m.–5 p.m. MDT; and
• Friday, September 8, 2023, 9 a.m.–
12 p.m. MDT.
ADDRESSES: This meeting will be held in
the Hilton Garden Inn—Downtown, 125
N Cascade Avenue, Colorado Springs,
Colorado. The meeting will also be
accessible to the public via Zoom.
Meeting details are included below.
Please use the following information to
join the meeting: https://
us02web.zoom.us/j/83751255130?pwd=
eU5RMzhCMm5WNmh
4SXlHNUloS3ViUT09 Passcode:
884256.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Sahira Rafiullah, Executive Secretary of
NACRHHS, 5600 Fishers Lane,
Rockville, Maryland 20857; 240–316–
5874; or srafiullah@hrsa.gov.
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning both
rural health and rural human services.
At the September meeting, NACRHHS
will discuss the availability of disability
services in rural areas. Members of the
public will have the opportunity to
provide comments. Public participants
wishing to provide oral comments must
submit a written version of their
statement at least 3 business days in
advance of the scheduled meeting. Oral
comments will be honored in the order
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Notices
they are requested and may be limited
as time permits. Public participants
wishing to offer a written statement
should send it to Sahira Rafiullah, using
the contact information above, at least 3
business days prior to the meeting.
Individuals who plan to attend and
need special assistance or other
reasonable accommodation should
notify Sahira Rafiullah at the address
and phone number listed above at least
10 business days prior to the meeting.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
Dated: August 11, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–17600 Filed 8–15–23; 8:45 am]
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
[FR Doc. 2023–17526 Filed 8–15–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
lotter on DSK11XQN23PROD with NOTICES1
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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Factors Determining Blood Group Immunity.
Date: September 14, 2023.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Michael P. Reilly, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 208–Z,
Bethesda, MD 20892, (301) 827–7975,
reillymp@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)
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55707
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 of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Digestive Diseases
Research Core Centers (P30).
Date: November 16–17, 2023.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
NIDDK, Democracy II, Suite 7000A, 6707
Democracy Boulevard, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, NIDDK/Scientific Review
Branch, National Institutes of Health, 6707
Democracy Boulevard, Room: 7011,
Bethesda, MD 20892–2542, (301) 594–7799
yangj@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: August 10, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–17520 Filed 8–15–23; 8:45 am]
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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 of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Defining the Social
Epigenome in Type 2 Diabetes Development
in a High-Risk Diverse Population.
Date: November 2, 2023.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NIDDK
Democracy II, Suite 7000A, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7345, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: August 10, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–17561 Filed 8–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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National Institutes of Health
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]]>Agencies
[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55706-55707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17526]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the National Advisory Committee on Rural Health and
Human Services
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Secretary's National Advisory Committee on
Rural Health and Human Services (NACRHHS) scheduled a public meeting.
Information about NACRHHS and the agenda for this meeting can be found
on the NACRHHS website at https://www.hrsa.gov/advisory-committees/rural-health/.
DATES:
Wednesday, September 6, 2023, 9 a.m.-5 p.m. Mountain
Daylight Time (MDT);
Thursday, September 7, 2023, 9 a.m.-5 p.m. MDT; and
Friday, September 8, 2023, 9 a.m.-12 p.m. MDT.
ADDRESSES: This meeting will be held in the Hilton Garden Inn--
Downtown, 125 N Cascade Avenue, Colorado Springs, Colorado. The meeting
will also be accessible to the public via Zoom. Meeting details are
included below. Please use the following information to join the
meeting: https://us02web.zoom.us/j/83751255130?pwd=eU5RMzhCMm5WNmh4SXlHNUloS3ViUT09 Passcode: 884256.
FOR FURTHER INFORMATION CONTACT: Sahira Rafiullah, Executive Secretary
of NACRHHS, 5600 Fishers Lane, Rockville, Maryland 20857; 240-316-5874;
or [email protected].
SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations
to the Secretary of Health and Human Services on policy, program
development, and other matters of significance concerning both rural
health and rural human services. At the September meeting, NACRHHS will
discuss the availability of disability services in rural areas. Members
of the public will have the opportunity to provide comments. Public
participants wishing to provide oral comments must submit a written
version of their statement at least 3 business days in advance of the
scheduled meeting. Oral comments will be honored in the order
[[Page 55707]]
they are requested and may be limited as time permits. Public
participants wishing to offer a written statement should send it to
Sahira Rafiullah, using the contact information above, at least 3
business days prior to the meeting. Individuals who plan to attend and
need special assistance or other reasonable accommodation should notify
Sahira Rafiullah at the address and phone number listed above at least
10 business days prior to the meeting.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2023-17526 Filed 8-15-23; 8:45 am]
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