Center for Scientific Review; Notice of Closed Meetings, 5010-5011 [2023-01542]
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Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / Notices
treatment of adult patients with
relapsed or refractory DLBCL, not
otherwise specified, after at least two
prior therapies. Confirmatory studies are
post-marketing studies to verify and
describe the clinical benefit of a product
after it receives accelerated approval.
The new proposed indication is based
on the confirmatory study, POLARIX
(Study GO39942), conducted to fulfill
post-marketing requirement 3630–1
detailed in the June 10, 2019, approval
letter, available at https://
www.accessdata.fda.gov/drugsatfda_
docs/appletter/2019/
761121Orig1s000ltr.pdf. Based on the
results of the POLARIX study, the
committee will discuss the benefit-risk
profile of POLIVY in patients with
previously untreated DLBCL.
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
February 24, 2023, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 3:15 p.m. to 4:15 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
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 February
14, 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
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notify interested persons regarding their
request to speak by February 15, 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 Yvette Waples
(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: January 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01553 Filed 1–25–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA DK22–003
Promoting Organ and Tissue Donation
Among Health Disparity Populations (R01—
Clinical Trial Optional).
Date: March 9, 2023.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
PO 00000
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and Kidney Diseases, Democracy II, 6707
Democracy Blvd. Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, National Institute
of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health,
Bethesda, MD 20892, 301–594–2242,
jerkinsa@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: January 20, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–01541 Filed 1–25–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Population Sciences
and Epidemiology Integrated Review Group;
Analytics and Statistics for Population
Research Panel B Study Section.
Date: February 22–23, 2023.
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 (Virtual Meeting).
Contact Person: Maria De Jesus Diaz Perez,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000G,
Bethesda, MD 20892, (301) 496–4227,
diazperezm2@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Cell Structure and
Function 1 Study Section.
Date: February 23–24, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\26JAN1.SGM
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Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / Notices
Place: Hotel Monaco, 700 F Street NW,
Washington, DC 20001.
Contact Person: Jessica Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–402–3717, jessica.smith6@
nih.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
Hypersensitivity, Autoimmune, and Immunemediated Diseases Study Section.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Xinrui Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–2084,
xinrui.li@nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Adult Psychopathology and Disorders
of Aging Study Section.
Date: February 23–24, 2023.
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 (Virtual Meeting).
Contact Person: Benjamin G. Shapero,
Ph.D. Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7848 Bethesda, MD 20892, (301) 402–
4786, shaperobg@mail.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Hepatobiliary Pathophysiology Study
Section.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Jianxin Hu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2156
Bethesda, MD 20892, 301–827–4417,
jianxinh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Fellowships;
Biophysical, Physiological, Pharmacological
and Bioengineering Neuroscience.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Jennifer Kielczewski,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1042, jennifer.kielczewski@
nih.gov.
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Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Interventions to Prevent and Treat
Addictions Study Section.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Sarah Vidal, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 710Q,
Bethesda, MD 20892, (301) 480–5359,
sarah.vidal@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Mechanisms
of Cancer Therapeutics C.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Gloria Huei-Ting Su,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–496–0465, gloria.su@nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Imaging Guided
Interventions and Surgery Study Section.
Date: February 23–24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Ella Fung Jones, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–0777, ella.jones@nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Addiction Risks and Mechanisms Study
Section.
Date: February 23–24, 2023.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Darcy Hotel, 1515 Rhode Island
Avenue, Washington, DC 20005.
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: Vascular and
Hematology Integrated Review Group; Basic
Biology of Blood, Heart and Vasculature
Study Section.
Date: February 23–24, 2023.
Time: 9:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
PO 00000
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Contact Person: Aisha Lanette Walker,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–3527, aisha.walker@
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)
Dated: January 20, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–01542 Filed 1–25–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; High Impact,
Interdisciplinary Science in NIDDK Research
Areas (RC2).
Date: February 23, 2023.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Cheryl Nordstrom, Ph.D.,
Scientific Review Officer, NIDDK/Scientific
Review Branch, National Institutes of Health,
6707 Democracy Blvd., Room 7013,
Bethesda, MD 20892, 301–402–6711,
cheryl.nordstrom@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
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5010-5011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01542]
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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 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: Population Sciences and Epidemiology
Integrated Review Group; Analytics and Statistics for Population
Research Panel B Study Section.
Date: February 22-23, 2023.
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 (Virtual Meeting).
Contact Person: Maria De Jesus Diaz Perez, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000G, Bethesda, MD 20892, (301)
496-4227, [email protected].
Name of Committee: Cell Biology Integrated Review Group; Cell
Structure and Function 1 Study Section.
Date: February 23-24, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 5011]]
Place: Hotel Monaco, 700 F Street NW, Washington, DC 20001.
Contact Person: Jessica Smith, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, 301-402-3717,
[email protected].
Name of Committee: Infectious Diseases and Immunology B
Integrated Review Group; Hypersensitivity, Autoimmune, and Immune-
mediated Diseases Study Section.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Xinrui Li, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 594-2084,
[email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Adult Psychopathology and Disorders of
Aging Study Section.
Date: February 23-24, 2023.
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 (Virtual Meeting).
Contact Person: Benjamin G. Shapero, Ph.D. Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182, MSC 7848 Bethesda, MD
20892, (301) 402-4786, [email protected].
Name of Committee: Digestive, Kidney and Urological Systems
Integrated Review Group; Hepatobiliary Pathophysiology Study
Section.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Jianxin Hu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 2156 Bethesda, MD 20892, 301-827-4417,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel Fellowships; Biophysical, Physiological, Pharmacological and
Bioengineering Neuroscience.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Jennifer Kielczewski, 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: Risk, Prevention and Health Behavior
Integrated Review Group; Interventions to Prevent and Treat
Addictions Study Section.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Sarah Vidal, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 710Q, Bethesda, MD 20892, (301) 480-5359,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Mechanisms of Cancer Therapeutics C.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Gloria Huei-Ting Su, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-496-0465,
[email protected].
Name of Committee: Surgical Sciences, Biomedical Imaging and
Bioengineering Integrated Review Group; Imaging Guided Interventions
and Surgery Study Section.
Date: February 23-24, 2023.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Ella Fung Jones, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496-0777,
[email protected].
Name of Committee: Risk, Prevention and Health Behavior
Integrated Review Group; Addiction Risks and Mechanisms Study
Section.
Date: February 23-24, 2023.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Darcy Hotel, 1515 Rhode Island Avenue, Washington, DC
20005.
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: Vascular and Hematology Integrated Review
Group; Basic Biology of Blood, Heart and Vasculature Study Section.
Date: February 23-24, 2023.
Time: 9:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Aisha Lanette Walker, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-3527,
[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: January 20, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-01542 Filed 1-25-23; 8:45 am]
BILLING CODE 4140-01-P
