Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors, 20544-20545 [2023-07117]
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20544
Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W624, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Tushar Deb, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W624, Rockville, Maryland 20850,
240–276–6132, tushar.deb@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: April 3, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–07213 Filed 4–5–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 31, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–07160 Filed 4–5–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Manufacture,
Distribution, Sale and Use of T-CellBased Immunotherapies for Solid
Tumors
National Institutes of Health,
Notice.
The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Cancer Institute, both institutes of the
National Institutes of Health,
Department of Health and Human
Services, are 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 EnZeta Inc. of the State of
Delaware.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before April 21, 2023 will be
considered.
DATES:
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Richard T. Girards, Jr., Esq.,
MBA, Senior Technology Transfer
Manager, National Institutes of Health,
NCI Technology Transfer Center by
email (richard.girards@nih.gov) or
phone (240–276–6825).
ADDRESSES:
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4140–01–P
ACTION:
Notice is hereby given of the
cancellation of the National Library of
Medicine Board of Scientific
Counselors, April 27, 2023, 11 a.m. to 5
p.m., Virtual Meeting, which was
published in the Federal Register on
October 6, 2022, 87 FR 193, Page
Number 60696.
This notice is being amended to
announce that the meeting is cancelled
and will not be rescheduled.
National Institute on Aging; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Aging, May 16, 2023, 02:00
p.m. to May 17, 2023, 02:30 p.m.,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue,
Jkt 259001
[FR Doc. 2023–07161 Filed 4–5–23; 8:45 am]
HHS.
National Library of Medicine;
Cancellation of Meeting
21:13 Apr 05, 2023
Dated: March 31, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
AGENCY:
National Institutes of Health
VerDate Sep<11>2014
Bethesda, MD 20892 which was
published in the Federal Register on
December 28, 2022, 321142.
The meeting notice is amended to
change the start time of the meeting
from 10:00 a.m., to 9:00 a.m. on the
second day May 17, 2023. The end time
will also change from 2:30 p.m. to 1:30
p.m. on May 17, 2023. The meeting is
Partially Closed to the public.
SUPPLEMENTARY INFORMATION:
PO 00000
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Intellectual Property
E–010–2021: Enhanced Antigen
Reactivity of Immune Cells Expressing a
Mutant Non–Signaling CD3 Zeta Chain
1. United States Provisional Patent
Application No. 63/113,428, filed 13
November 2020 (HHS Reference No. E–
010–2021–0–US–01);
2. International Patent Application
No. PCT/US2021/059109, filed 12
November 2021 (HHS Reference No. E–
010–2021–0–PCT–02); and
3. any and all other U.S. and ex-U.S.
patents and patent applications
claiming priority to any one of the
foregoing, now or in the future.
The patent and patent application
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
fields of use may be limited to the
following: manufacture, distribution,
sale and use of T-cell-based
immunotherapies for solid tumors.
These technologies disclose, e.g., cells
expressing a modified CD3 subunit
chain comprising at least one ITAM
deletion. The inventive cells and
populations thereof can be formulated
into a composition, such as a
pharmaceutical composition. Such cells
and compositions thereof can be
utilized to treat a wide variety of
conditions, including but not limited to
the indications within the scope of the
contemplated exclusive license.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 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 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 from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
E:\FR\FM\06APN1.SGM
06APN1
Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
Dated: March 30, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
17–005, as they are currently providing
nationally- and regionally-focused
treatment and recovery training
activities, which will continue to be
funded through this supplement.
This is not a formal request for
application. Assistance will only be
provided to the 10 ATTC Regional
Centers and ATTC National
Coordinating Office recipients based on
the receipt of a satisfactory application
and associated budget that is approved
by a review group.
[FR Doc. 2023–07117 Filed 4–5–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Dated: March 31, 2023.
Carlos Castillo,
ECSB Acting Branch Chief, SAMHSA.
Fiscal Year (FY) 2023 Notice of
Supplemental Funding Opportunity
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of intent to award
supplemental funding.
[FR Doc. 2023–07131 Filed 4–5–23; 8:45 am]
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) is supporting administrative
supplements in scope of the parent
award for the 11 eligible grant recipients
funded in FY 2017, under the Addiction
Technology Transfer Centers (ATTC)
Cooperative Agreements, Notice of
Funding Opportunity (NOFO) TI–17–
005. Recipients may receive up to
$743,757 each, for a total of $8,181,327.
These recipients have a current project
end date of September 29, 2023. The
supplemental funding will extend the
project period by one-year and will
continue training and technical
assistance for providers who are serving
patients with substance use disorder by
improving their capacity and
understanding of evidence-based
practices, especially practices that are
effective in combating substance
misuse, including the opioid crisis.
FOR FURTHER INFORMATION CONTACT:
Twyla Adams, Senior Public Health
Advisor, Substance Abuse and Mental
Health Services Administration, 5600
Fishers Lane, Rockville, MD 20857,
telephone: 240–2761576; email:
Twyla.Adams@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
Funding Opportunity Title: FY 2017
Addiction Technology Transfer Centers
Cooperative Agreements NOFO TI–17–
005.
Assistance Listing Number: 93.243.
Authority: Section 509 of the Public
Health Service Act, as amended.
Justification: Eligibility for this
supplemental funding is limited to the
10 ATTC Regional Centers and ATTC
National Coordinating Office funded in
FY 2017, under the ATTC Cooperative
Agreements funding announcement TI–
Substance Abuse and Mental Health
Services Administration
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
21:13 Apr 05, 2023
Jkt 259001
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fiscal Year (FY) 2023 Notice of
Supplemental Funding Opportunity
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of intent to award
supplemental funding.
AGENCY:
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) is supporting administrative
supplements in scope of the parent
award for the 11 eligible grant recipients
funded in FY 2019 under the Prevention
Technology Transfer Centers (PTTCs)
Cooperative Agreements, Notice of
Funding Opportunity (NOFO) SP–19–
001. The PTTC National Coordinating
Center may receive up to $493,966 and
the 10 PTTC Regional Centers may
receive up to $600,000 each for a total
of $6,492,160. These recipients have a
project end date of September 29, 2023.
The supplemental funding will extend
the project period by one-year and will
continue providing training and
technical assistance services and quality
improvement activities to the substance
abuse prevention workforce including
professionals and pre-professionals,
organizations, and others in the
prevention community.
FOR FURTHER INFORMATION CONTACT: Thia
Walker, DrPH., Public Health Advisor,
Substance Abuse and Mental Health
Services Administration, 5600 Fishers
Lane, Rockville, MD 20857, telephone
240–276–1835; email: Thia.Walker@
samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
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20545
Funding Opportunity Title: FY 2019
Prevention Technology Transfer Centers
Cooperative Agreements SP–19–001.
Assistance Listing Number: 93.243.
Authority: Section 509 of the Public
Health Service Act, as amended.
Justification: Eligibility for this
supplemental funding is limited to the
ten PTTC Regional Centers and PTTC
National Coordinating Office funded
under the PTTC Cooperative
Agreements funding announcement SP–
19–001, as they are currently providing
nationally- and regionally-focused
training and technical assistance
services and quality improvement
activities to the substance abuse
prevention workforce including
professionals and pre-professionals,
organizations, and others in the
prevention community, which will
continue to be funded through this
supplement.
This is not a formal request for
application. Assistance will only be
provided to the 10 PTTC Regional
Centers and PTTC National
Coordinating Center recipients based on
the receipt of a satisfactory application
and associated budget that is approved
by a review group.
Dated: March 31, 2023.
Carlos Castillo,
ECSB Acting Branch Chief, SAMHSA.
[FR Doc. 2023–07130 Filed 4–5–23; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 2023 Notice of
Supplemental Funding Opportunity
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of intent to award
supplemental funding.
AGENCY:
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) is supporting administrative
supplements in scope of the parent
award for the 11 eligible grant recipients
funded in FY 2018 under the Mental
Health Technology Transfer Centers
(MHTTCs) Cooperative Agreements,
Notice of Funding Opportunity (NOFO)
SM–18–005. The MHTTC National
Coordinating Center may receive up to
$900,000 and the 10 MHTTC Regional
Centers may receive up to $1,045,454
each. These recipients have a project
SUMMARY:
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20544-20545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07117]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Manufacture,
Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid
Tumors
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health
and Human Development and the National Cancer Institute, both
institutes of the National Institutes of Health, Department of Health
and Human Services, are 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 EnZeta Inc. of the State of Delaware.
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 April 21, 2023 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior
Technology Transfer Manager, National Institutes of Health, NCI
Technology Transfer Center by email ([email protected]) or phone
(240-276-6825).
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-010-2021: Enhanced Antigen Reactivity of Immune Cells Expressing a
Mutant Non-Signaling CD3 Zeta Chain
1. United States Provisional Patent Application No. 63/113,428,
filed 13 November 2020 (HHS Reference No. E-010-2021-0-US-01);
2. International Patent Application No. PCT/US2021/059109, filed 12
November 2021 (HHS Reference No. E-010-2021-0-PCT-02); and
3. any and all other U.S. and ex-U.S. patents and patent
applications claiming priority to any one of the foregoing, now or in
the future.
The patent and patent application 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 fields of use may be limited to the following: manufacture,
distribution, sale and use of T-cell-based immunotherapies for solid
tumors.
These technologies disclose, e.g., cells expressing a modified CD3
subunit chain comprising at least one ITAM deletion. The inventive
cells and populations thereof can be formulated into a composition,
such as a pharmaceutical composition. Such cells and compositions
thereof can be utilized to treat a wide variety of conditions,
including but not limited to the indications within the scope of the
contemplated exclusive license.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
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 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 from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
[[Page 20545]]
Dated: March 30, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2023-07117 Filed 4-5-23; 8:45 am]
BILLING CODE 4140-01-P
