National Institute of Environmental Health Sciences; Notice of Closed Meeting, 55625 [2021-21793]
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
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number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21687 Filed 10–5–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Personalized Tumor
Vaccine and Use Thereof for Cancer
Immunotherapy
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
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
(U.S.) Patents and Patent Applications
listed in the Supplementary Information
section of this notice to NE1 Inc, located
at 515 Madison Avenue, 8th Fl. Suite
8096, New York, NY 10022.
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 October 21, 2021 will be
considered.
SUMMARY:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Dr. Berna Uygur,
Technology Transfer Manager, NCI
Technology Transfer Center, Telephone:
(240)-276–5530; Email: berna.uygur@
nih.gov.
jspears on DSK121TN23PROD with NOTICES1
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
(United States Provisional) Patent
Application No. 62/946,934, filed on
December 11, 2019 and entitled
‘‘Personalized Tumor Vaccine and Use
Thereof for Cancer Immunotherapy’’
VerDate Sep<11>2014
20:38 Oct 05, 2021
Jkt 256001
55625
[HHS Reference No. E–003–2020/0–US–
01]. (PCT) Patent Application No. PCT/
US2020/064412, filed on December 11,
2020 and entitled ‘‘Personalized Tumor
Vaccine and Use Thereof for Cancer
Immunotherapy’’ [HHS Reference No.
E–003–2020/0–PCT–02].
The patent rights in this invention are
co-owned by (a) the United States of
America, as represented by the
Secretary, Department of Health and
Human Services, (b) University of South
Bohemia, and (c) NE1 Inc. The
prospective exclusive license territory
may be worldwide, and the field of use
may be limited to: Development,
manufacture, and commercialization of
the MBTA Therapy Products, as claimed
in the Licensed Patent Rights, for the
treatment of cancer in humans.
This technology discloses ‘‘MBTA
Therapy Product(s)’’ which are vaccine
products comprising irradiated tumor
cells pulsed with phagocytic agonists
(Mannan-BAM, a polysaccharide
derivative of mannan), TLR (Toll-like
receptor) ligands, and Anti-CD40monoclonal antibody. The MBTA
Therapy Products may be used as
personalized tumor vaccines to treat
cancer.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 1, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Dated: September 30, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–21845 Filed 10–5–21; 8:45 am]
[FR Doc. 2021–21793 Filed 10–5–21; 8:45 am]
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National Institutes of Health
National Institute of Environmental
Health Sciences; 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
Environmental Health Sciences Special
Emphasis Panel; Mechanism for TimeSensitive Research Opportunities in
Environmental Health Sciences.
Date: October 12, 2021.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Research Triangle Park, NC
27713 (Virtual Meeting).
Contact Person: Quentin Li, M.D., Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute Environmental Health
Sciences, P.O. Box 12233, MSC K3–05,
Research Triangle Park, NC 27709, 240–858–
3914, quentin.li@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
E:\FR\FM\06OCN1.SGM
06OCN1
Agencies
[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Page 55625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; 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 Environmental Health
Sciences Special Emphasis Panel; Mechanism for Time-Sensitive
Research Opportunities in Environmental Health Sciences.
Date: October 12, 2021.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Environmental Health Sciences,
Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27713
(Virtual Meeting).
Contact Person: Quentin Li, M.D., Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research
and Training, Nat. Institute Environmental Health Sciences, P.O. Box
12233, MSC K3-05, Research Triangle Park, NC 27709, 240-858-3914,
[email protected].
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.115,
Biometry and Risk Estimation--Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic
Research and Education; 93.894, Resources and Manpower Development
in the Environmental Health Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114, Applied Toxicological Research
and Testing, National Institutes of Health, HHS)
Dated: September 30, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-21793 Filed 10-5-21; 8:45 am]
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