National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 99888-99889 [2024-29022]
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99888
Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Anti–KK–LC–1 T Cell
Receptors for the Treatment of Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), an institute of the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an Exclusive
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the
Supplementary Information section of
this notice to StraightLine Bio, Inc.
located in Princeton, New Jersey.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before December 26, 2024 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Suna Gulay French, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center at
Telephone; (240)–276–5530, Email:
suna.gulay@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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 ‘‘Anti–
KK–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.
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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:
Development, manufacture and
commercialization of autologous T cell
therapy products that are genetically
engineered via retroviral-mediated gene
transfer or CRISPR-based gene transfer
or transposon-mediated gene transfer to
express a T cell receptor (TCR) targeting
human Kita-Kyushu Lung Cancer
Antigen 1 (KK–LC–1) restricted to HLA–
A*01, as claimed in the Licensed Patent
Rights, for the treatment of KK–LC–1
positive cancers and premalignant
conditions in humans.
For the avoidance of doubt,
specifically excluded from the Field of
Use are:
1. Development, manufacture, and
commercialization of Natural Killer cell
therapy products engineered via viral
vectors (including lentivirus or
retrovirus) to express the TCR(s)
claimed in the Licensed Patent Rights;
and
2. Development, manufacture and
commercialization of a combination
therapy for the treatment of KK–LC–1
positive human cancers that do not have
the HLA–A*01 genotype, wherein the
treatment comprises as a step:
Modification of the patient’s tumor to
express the HLA–A*01 restriction
element.
This technology discloses isolated T
cell receptors (TCR) reactive to the 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–1—
expressing 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.
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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.
Date: December 6, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–29076 Filed 12–10–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource Related
Research Projects (R24 Clinical Trial Not
Allowed).
Date: January 30, 2025.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted).
Contact Person: Maryam Rohani, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G56, Rockville, MD
20892, (301) 761–6656, maryam.rohani@
nih.gov.
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Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 4, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–29022 Filed 12–10–24; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket Number USCG–2021–0183]
Final Programmatic Environmental
Impact Statement for the Expansion
and Modernization of Base Seattle
Coast Guard, DHS.
Notice of Availability; extension
of waiting period for the Final
Programmatic Environmental Impact
Statement Expansion and
Modernization of Base Seattle.
AGENCY:
ACTION:
The Coast Guard is extending
the waiting period for the Final
Programmatic Environmental Impact
Statement (PEIS) for the proposed
Expansion and Modernization of Base
Seattle. We published a Notice of
Availability of the Final PEIS on
November 15, 2024. That notice marked
the start of a 30-day waiting period. We
are extending the wait period. January
10, 2025, is the earliest date that the
Coast Guard would issue a final
decision.
DATES: The Coast Guard will not issue
a final decision on the proposed action
until at least January 10, 2025.
ADDRESSES: The complete text of the
Final PEIS is available in the docket,
which can be found by searching the
docket number USCG–2021–0183 using
the Federal eRulemaking Portal at
https://www.regulations.gov or at
https://www.dcms.uscg.mil/NEPA.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be sent to U.S. Coast Guard,
Shore Infrastructure Logistics Center,
Environmental Management Division,
ATTN: Dean Amundson, 1301 Clay
Street, Suite 700N, Oakland, CA 94612–
5203; phone 510–637–5541; email
BaseSeattlePEIS@uscg.mil.
SUPPLEMENTARY INFORMATION: The Final
PEIS was prepared in accordance with
the requirements of the National
Environmental Policy Act (NEPA), the
Council on Environmental Quality
regulations implementing NEPA (40
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CFR 1500–1508), DHS procedures for
implementing NEPA (DHS Instruction
Manual 023–01–001–01 (series)), Coast
Guard Environmental Planning Policy
(Commandant Instruction
[COMDTINST] 5090.1), and other
applicable DHS and Coast Guard
policies and guidance. A Notice of
Intent (NOI) to prepare the PEIS was
published in the Federal Register on
May 7, 2021 (86 FR 24637). On October
11, 2022, the Coast Guard published a
Notice of Availability (NOA) and a
request for comments on the Draft PEIS
(87 FR 61344). In response to a
comment in the Docket the Coast Guard
extended the Public Comment Period
until December 16, 2022, which was
announced in the Federal Register (87
FR 73011) and in local newspapers on
November 28, 2022.
The NOA for the Final PEIS was
published on November 15, 2024, and
the original wait period would have
concluded on December 16, 2024. The
Coast Guard will extend the wait period
for the Final PEIS to allow for additional
time for public review due to the
complexity of the proposed action and
the presence of multiple federal
holidays during the review period. The
Coast Guard will not issue a Record of
Decision until after January 10, 2025.
For more detailed information, please
see the original notice titled ‘‘Final
Programmatic Environmental Impact
Statement for the Expansion and
Modernization of Base Seattle’’
published on November 15, 2024 (89 FR
90302). A copy of that notice is also
available in the docket.
Following the wait period concluding
on January 10, 2025, the Coast Guard
will announce its Record of Decision,
which will be published in the Federal
Register.
Dated: December 5, 2024.
A. Grable,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Engineering and Logistics.
[FR Doc. 2024–29048 Filed 12–10–24; 8:45 am]
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99889
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA 2024–0034; OMB No.
1660–0068]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Federal Hotel and
Motel Fire Safety Declaration Form
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: 60-Day notice of Extension
extension and request for comments.
AGENCY:
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on an
extension, without change, of a
currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning a list
of hotels, motels, and similar places of
public accommodations meeting
minimum fire-safety requirements. The
information collected is voluntary and if
approved for listing, the lodging
establishment may be used by Federal
employees on government related travel
and for Federal agency conferences. As
the list is open to use by the public,
non-government travelers may use the
list to identify lodging meeting
minimum life-safety criteria from fire.
DATES: Comments must be submitted on
or before February 10, 2025.
ADDRESSES: To avoid duplicate
submissions to the docket, please
submit comments at
www.regulations.gov under Docket ID
FEMA–2024–0034. Follow the
instructions for submitting comments.
All submissions received must
include the agency name and Docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy and Security Notice that is
available via a link on the homepage of
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Teressa Kaas, Fire Program Specialist,
FEMA/U.S. Fire Administration, 301–
447–1263, and teressa.kaas@
SUMMARY:
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Agencies
[Federal Register Volume 89, Number 238 (Wednesday, December 11, 2024)]
[Notices]
[Pages 99888-99889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Resource Related Research
Projects (R24 Clinical Trial Not Allowed).
Date: January 30, 2025.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted).
Contact Person: Maryam Rohani, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities,
National Institute of Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, Room 3G56, Rockville, MD
20892, (301) 761-6656, [email protected].
[[Page 99889]]
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: December 4, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-29022 Filed 12-10-24; 8:45 am]
BILLING CODE 4140-01-P