Center for Scientific Review; Notice of Closed Meetings, 81090-81091 [2024-23037]
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81090
Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Technology Transfer Center, 9609
Medical Center Drive, RM 3W–204,
MSC 9702, Bethesda, MD 20892–9702
(for business mail), Rockville, MD
20850–9702; Telephone: (240)–276–
5530; Email: suna.gulay@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent
Application No. 62/327,529, filed April
26, 2016 and entitled ‘‘Anti-KK–LC–1 T
Cell Receptors’’ [HHS Reference No. E–
153–2016–0–US–01];
2. PCT Patent Application No. PCT/
US2017/027865, filed April 17, 2017
and entitled ‘‘Anti-KK–LC–1 T Cell
Receptors’’ [HHS Reference No. E–153–
2016–0–PCT–02];
3. Australian Patent No. 2017258745,
issued July 14, 2022 and entitled ‘‘AntiKK–LC–1 T Cell Receptors’’ [HHS
Reference No. E–153–2016–0–AU–03];
4. Canadian Patent Application No.
3021898, filed April 17, 2017 and
entitled ‘‘Anti-KK–LC–1 T Cell
Receptors’’ [HHS Reference No. E–153–
2016–0–CA–04];
5. European Patent No. 3448882,
issued November 24, 2021 and entitled
‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS
Reference No. E–153–2016–0–EP–05];
a. Validated in the following
jurisdictions: CH, DE, BE, DK, ES, FI,
FR, GB, IE, IT, NL, NO and SE.
6. U.S. Patent No. 11,352,410, issued
June 7, 2022 and entitled ‘‘Anti-KK–LC–
1 T Cell Receptors’’ [HHS Reference No.
E–153–2016–0–US–06].
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the
following:
‘‘1. Development, manufacture, and
commercialization of autologous T cell
therapy products, including T cells with
stem-like properties, engineered via
retrovirus-mediated gene transfer to
express T cell receptors reactive to KitaKyushu Lung Cancer Antigen 1 (KK–
LC–1), as claimed in the Licensed Patent
Rights; such products to be developed
for treatment of patients carrying HLA–
A*01:01 histocompatibility haplotype,
and diagnosed with a cancer expressing
KK–LC–1 protein (‘‘KK–LC–1 Targeting
TCR–T Products’’).
2. Development, manufacture, and
commercialization of a combination
therapy for the treatment of KK–LC–1
expressing human cancers, independent
of their HLA phenotype, wherein the
treatment comprises:
a. Modification of the patient’s tumor
using Licensee’s proprietary technology
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to express the HLA–A*01:01 restriction
element, and
b. Treatment with the KK–LC–1
Targeting TCR–T Products.
For the avoidance of doubt,
specifically excluded from these Fields
of Use are Natural Killer cell therapy
products engineered via viral vectors
(including lentivirus or retrovirus) to
express the TCR(s) claimed in the
Licensed Patent Rights.’’
This technology discloses isolated T
cell receptors (TCR) reactive to the KitaKyushu lung cancer antigen 1 (KK–LC–
1) within the context of human
leukocyte antigen (HLA) A*01:01. KK–
LC–1 is expressed by various epithelial
cancers including carcinomas of the
bladder, cervix, stomach, breast, lung,
and pancreas. Due to its minimal
expression in normal tissues, this
antigen may be targeted on KK–LC–1expressing tumors with minimal normal
tissue toxicity.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: October 1, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–23029 Filed 10–4–24; 8:45 am]
BILLING CODE 4140–01–P
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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: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Drug Discovery and
Molecular Pharmacology B Study Section.
Date: October 31-November 1, 2024.
Time: 8:00 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: Razvan Cornea, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 904L,
Bethesda, MD 20892, (301) 480–1955,
cornearl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Imaging and
Bioengineering Technology for Visual
Systems (IBV).
Date: November 4–5, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Watergate, 2650 Virginia
Avenue NW, Washington, DC 20037.
Contact Person: Susan Gillmor, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (240) 762–3076, susan.gillmor@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Learning, Memory, Language,
Communication and Related Neuroscience.
Date: November 4–5, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785 kondratyevad@csr.nih.gov.
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices
Name of Committee: Applied Therapeutics
for Cancer Integrated Review Group; Drug
Discovery and Molecular Pharmacology C
Study Section.
Date: November 4–5, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Georgetown, 2350 M
Street NW, Washington, DC 20037.
Contact Person: Jeffrey Smiley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6194,
MSC 7804, Bethesda, MD 20892, (301) 272–
4596, smileyja@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Radiation Therapeutics and Biology.
Date: November 4, 2024.
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: Lambratu Rahman Sesay,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–905–
8294, rahman-sesay@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
conflict: Topics on Biobehavioral Processes
Date: November 4–5, 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 (Virtual Meeting).
Contact Person: Natalie S Dailey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 827–4451, daileyns@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–24–
129: Specific Pathogen Free Macaque
Colonies.
Date: November 4, 2024.
Time: 1:00 p.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 (Virtual Meeting).
Contact Person: Latha Malaiyandi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812Q,
Bethesda, MD 20892, (301) 435–1999,
malaiyandilm@csr.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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Dated: October 1, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–23037 Filed 10–4–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2024–0002; Internal
Agency Docket No. FEMA–B–2463]
Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice.
Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment
regarding the preliminary FIRM, and
where applicable, the FIS report that the
Federal Emergency Management Agency
(FEMA) has provided to the affected
communities. The FIRM and FIS report
are the basis of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
in order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP).
DATES: Comments are to be submitted
on or before January 6, 2025.
ADDRESSES: The Preliminary FIRM, and
where applicable, the FIS report for
each community are available for
inspection at both the online location
https://hazards.fema.gov/femaportal/
prelimdownload and the respective
Community Map Repository address
listed in the tables below. Additionally,
the current effective FIRM and FIS
report for each community are
accessible online through the FEMA
Map Service Center at https://
msc.fema.gov for comparison.
You may submit comments, identified
by Docket No. FEMA–B–2463, to Rick
Sacbibit, Chief, Engineering Services
SUMMARY:
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Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov.
FOR FURTHER INFORMATION CONTACT: Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov; or visit
the FEMA Mapping and Insurance
eXchange (FMIX) online at https://
www.floodmaps.fema.gov/fhm/fmx_
main.html.
FEMA
proposes to make flood hazard
determinations for each community
listed below, in accordance with section
110 of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
These proposed flood hazard
determinations, together with the
floodplain management criteria required
by 44 CFR 60.3, are the minimum that
are required. They should not be
construed to mean that the community
must change any existing ordinances
that are more stringent in their
floodplain management requirements.
The community may at any time enact
stricter requirements of its own or
pursuant to policies established by other
Federal, State, or regional entities.
These flood hazard determinations are
used to meet the floodplain
management requirements of the NFIP.
The communities affected by the
flood hazard determinations are
provided in the tables below. Any
request for reconsideration of the
revised flood hazard information shown
on the Preliminary FIRM and FIS report
that satisfies the data requirements
outlined in 44 CFR 67.6(b) is considered
an appeal. Comments unrelated to the
flood hazard determinations also will be
considered before the FIRM and FIS
report become effective.
Use of a Scientific Resolution Panel
(SRP) is available to communities in
support of the appeal resolution
process. SRPs are independent panels of
experts in hydrology, hydraulics, and
other pertinent sciences established to
review conflicting scientific and
technical data and provide
recommendations for resolution. Use of
the SRP only may be exercised after
FEMA and local communities have been
engaged in a collaborative consultation
process for at least 60 days without a
mutually acceptable resolution of an
appeal. Additional information
regarding the SRP process can be found
SUPPLEMENTARY INFORMATION:
AGENCY:
81091
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]]>Agencies
[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81090-81091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23037]
-----------------------------------------------------------------------
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: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group; Drug Discovery and Molecular
Pharmacology B Study Section.
Date: October 31-November 1, 2024.
Time: 8:00 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: Razvan Cornea, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 904L, Bethesda, MD 20892, (301) 480-1955,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Imaging and Bioengineering Technology for Visual Systems
(IBV).
Date: November 4-5, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Watergate, 2650 Virginia Avenue NW, Washington, DC
20037.
Contact Person: Susan Gillmor, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (240) 762-3076,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Learning, Memory, Language, Communication and
Related Neuroscience.
Date: November 4-5, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Canopy by Hilton, 940 Rose Avenue, North Bethesda, MD
20852.
Contact Person: Alexei Kondratyev, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD
20892, 301-435-1785 [email protected].
[[Page 81091]]
Name of Committee: Applied Therapeutics for Cancer Integrated
Review Group; Drug Discovery and Molecular Pharmacology C Study
Section.
Date: November 4-5, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Westin Georgetown, 2350 M Street NW, Washington, DC
20037.
Contact Person: Jeffrey Smiley, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD
20892, (301) 272-4596, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Radiation Therapeutics and Biology.
Date: November 4, 2024.
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: Lambratu Rahman Sesay, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD
20892, 301-905-8294, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member conflict: Topics on Biobehavioral Processes
Date: November 4-5, 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 (Virtual Meeting).
Contact Person: Natalie S Dailey, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 827-4451,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-24-129: Specific Pathogen Free Macaque Colonies.
Date: November 4, 2024.
Time: 1:00 p.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 (Virtual Meeting).
Contact Person: Latha Malaiyandi, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812Q, Bethesda, MD 20892, (301)
435-1999, [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: October 1, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-23037 Filed 10-4-24; 8:45 am]
BILLING CODE 4140-01-P
