National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 5010 [2023-01541]
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lotter on DSK11XQN23PROD with NOTICES1
5010
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
VerDate Sep<11>2014
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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]
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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
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
Frm 00049
Fmt 4703
Sfmt 4703
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.
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[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Page 5010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01541]
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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
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 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, [email protected].
(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]
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