Center for Scientific Review; Notice of Closed Meetings, 80260-80261 [2024-22607]
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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
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FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: EMDAC@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 Committee will discuss
new drug application 210934, for
sotagliflozin oral tablet, submitted by
Lexicon Pharmaceuticals, Inc., for the
proposed indication, as an adjunct to
insulin therapy, to improve glycemic
control in adults with type 1 diabetes
mellitus and chronic kidney disease.
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 the location
of the advisory committee meeting and
at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The online presentation of
materials 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 October 17,
2024, 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
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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, whether they would like to
present online or in-person, and an
indication of the approximate time
requested to make their presentation on
or before October 8, 2024. 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. Similarly, room for
interested persons to participate inperson may be limited. If the number of
registrants requesting to speak in-person
during the open public hearing is
greater than can be reasonably
accommodated in the venue for the inperson portion of the advisory
committee meeting, FDA may conduct a
lottery to determine the speakers who
will be invited to participate in-person.
The contact person will notify
interested persons regarding their
request to speak by October 9, 2024.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
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 in conjunction with
the physical meeting room (see
location). This waiver is in the interest
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of allowing greater transparency and
opportunities for public participation,
in addition to convenience for advisory
committee members, speakers, and
guest speakers. The conditions for
issuance of a waiver under 21 CFR 10.19
are met.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22570 Filed 10–1–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 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: Center for Scientific
Review Special Emphasis Panel; Social
Psychology and Interpersonal Processes:
Social Isolation and Loneliness.
Date: October 28, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: David E. Pollio, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1006F,
Bethesda, MD 20892, (301) 594–4002,
polliode@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Health Services Research: Big Data, Health
Information Technology, and Clinical
Informatics.
Date: October 29–30, 2024.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Debasmita Patra, Ph.D.,
Scientific Review Officer, Center for
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1006E,
Bethesda, MD 20892, (301) 827–5187,
debasmita.patra@nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neuronal Communications
Study Section.
Date: October 29–30, 2024.
Time: 9:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Prithi Rajan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1042, prithi.rajan@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Immune Defense Mechanism to
Infection.
Date: October 29, 2024.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Maria Chiara G. MonacoKushner, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Dr.,
Bethesda, MD 20892, (301) 555–1212,
monaco@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Services: Quality and Effectiveness
Study Section.
Date: October 30–31, 2024.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Meeting Format: In Person.
Contact Person: Angela D. Thrasher, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000J,
Bethesda, MD 20892, (301) 480–6894,
thrasherad@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Innate
Immunity A.
Date: October 30, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kenneth M. Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, MSC 7808,
Bethesda, MD 20892, 301–496–6980,
izumikm@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
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Group; Biomaterials and Biointerfaces Study
Section.
Date: October 30–31, 2024.
Time: 9:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Jennifer Fiori O’Connell,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (410) 454–8478, jennifer.oconnell@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Advancing Therapeutics.
Date: October 30, 2024.
Time: 9:30 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Michael James Knapp,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–0600, mike.knapp@nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Addiction Risks and Mechanisms
Study Section.
Date: October 30–31, 2024.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kristen Prentice, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3112,
MSC 7808, Bethesda, MD 20892, (301) 496–
0726, prenticekj@mail.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Tumor Evolution, Heterogeneity and
Metastasis Study Section.
Date: October 30–31, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Rolf Jakobi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
MSC 7806, Bethesda, MD 20892, 301–435–
1718, jakobir@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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80261
Dated: September 27, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–22607 Filed 10–1–24; 8:45 am]
BILLING CODE 4140–01–P
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
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 Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA High Impact
Specialized Innovation Program (RC2)
Review.
Date: January 23, 2025.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 9609 Medical Center Drive,
Rockville, MD 20892 (Virtual).
Contact Person: Jing Chen, Ph.D., Scientific
Review Officer, Office of Scientific Review,
National Center for Advancing Translational
Sciences, National Institutes of Health, 9609
Medical Center Drive, Suite 1E504, Bethesda,
MD 20892, (301) 827–3268, chenjing@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: September 27, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–22608 Filed 10–1–24; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80260-80261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22607]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 1009 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: Center for Scientific Review Special Emphasis
Panel; Social Psychology and Interpersonal Processes: Social
Isolation and Loneliness.
Date: October 28, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: David E. Pollio, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1006F, Bethesda, MD 20892, (301)
594-4002, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Topics in Health Services Research: Big Data, Health
Information Technology, and Clinical Informatics.
Date: October 29-30, 2024.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Debasmita Patra, Ph.D., Scientific Review
Officer, Center for
[[Page 80261]]
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 1006E, Bethesda, MD 20892, (301) 827-5187,
[email protected].
Name of Committee: Molecular, Cellular and Developmental
Neuroscience Integrated Review Group; Neuronal Communications Study
Section.
Date: October 29-30, 2024.
Time: 9:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Prithi Rajan, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 435-1042,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Immune Defense Mechanism to Infection.
Date: October 29, 2024.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Maria Chiara G. Monaco-Kushner, Ph.D.,
Scientific Review Officer, Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892, (301)
555-1212, [email protected].
Name of Committee: Healthcare Delivery and Methodologies
Integrated Review Group; Health Services: Quality and Effectiveness
Study Section.
Date: October 30-31, 2024.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Meeting Format: In Person.
Contact Person: Angela D. Thrasher, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000J, Bethesda, MD 20892, (301)
480-6894, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Innate Immunity A.
Date: October 30, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kenneth M. Izumi, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, MSC 7808, Bethesda, MD 20892, 301-496-
6980, [email protected].
Name of Committee: Bioengineering Sciences & Technologies
Integrated Review Group; Biomaterials and Biointerfaces Study
Section.
Date: October 30-31, 2024.
Time: 9:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Jennifer Fiori O'Connell, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (410) 454-8478,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Advancing Therapeutics.
Date: October 30, 2024.
Time: 9:30 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Michael James Knapp, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 402-0600,
[email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Addiction Risks and Mechanisms Study
Section.
Date: October 30-31, 2024.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kristen Prentice, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3112, MSC 7808, Bethesda, MD
20892, (301) 496-0726, [email protected].
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Tumor Evolution, Heterogeneity and Metastasis Study
Section.
Date: October 30-31, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6190, MSC 7806, Bethesda, MD 20892, 301-435-
1718, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: September 27, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2024-22607 Filed 10-1-24; 8:45 am]
BILLING CODE 4140-01-P
