National Institute on Aging; Notice of Closed Meeting, 28064-28065 [2019-12712]
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28064
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before July 2, 2019 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: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)-276–5484;
Facsimile: (240)-276–5504; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Intellectual Property
Group A
HLA–A3-Restricted T Cell Receptors
Against Mutated RAS
1. U.S. Provisional Patent Application
62/749,750, filed October 24, 2018 (E–
166–2018–0–US–01).
HLA Class II-Restricted T Cell Receptors
Against RAS With G12R Mutation
1. U.S. Provisional Patent Application
62/795,203, filed January 22, 2019 (E–
029–2019–0–US–01).
Group B
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Methods of Producing T Cell
Populations Using Hydroxycitric Acid
and/or a Salt Thereof
1. U.S. Provisional Patent Application
62/661,941, filed April 24, 2018 (E–094–
2018–0–US–01); and
2. International Patent Application
PCT/US2019/028513, filed April 22,
2019 (E–094–2018–0–PCT–02).
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
fields of use may be limited to the
following:
Fields of Use Applying to Intellectual
Property Groups A and B
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by CRISPR to express T cell
receptors reactive to mutated KRAS, as
claimed in the Licensed Patent Rights,
for the treatment of human cancers.
Specifically excluded from this field of
use are retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers.
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Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Fields of Use Applying to Intellectual
Property Group B
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by CRISPR to express T cell
receptors reactive to mutated p53, as
claimed in the Licensed Patent Rights,
for the treatment of cancer in humans.
‘‘Development, manufacture and
commercialization of autologous, tumor
infiltrating lymphocyte (TIL)-based
adoptive T cell therapy products
reactive to mutated p53, isolated as
claimed in the Licensed Patent Rights,
for the treatment of human cancers.
Specifically excluded from this field of
use are genetically engineered TIL cell
therapy products for the treatment of
human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Intellectual Property Group A is
primarily directed to isolated T cell
receptors (TCRs) reactive to mutated
Kirsten rat sarcoma viral oncogene
homolog (KRAS), within the context of
several human leukocyte antigens
(HLAs). Mutated KRAS, which plays a
well-defined driver role in oncogenesis,
is expressed by a variety of human
cancers, including: pancreatic, lung,
endometrial, ovarian and prostate. Due
to its restricted expression in
precancerous and cancerous cells, this
antigen may be targeted on mutant
KRAS-expressing tumors with minimal
normal tissue toxicity.
Intellectual Property Group B is
primarily directed to methods of
preparing isolated populations of T cells
by culturing them in the presence of
hydroxycitric acid and/or a salt thereof,
and methods of treating cancer using
populations of T cells cultured in such
a manner.
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 which
establishes that the grant of the license
would not be consistent with the
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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 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.
Dated: June 3, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–12707 Filed 6–14–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel; High Priority
Research Networks.
Date: June 26, 2019.
Time: 12:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Ave,
Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Kimberly Firth, Ph.D.,
National Institutes of Health, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7702, firthkm@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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28065
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: June 12, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–12712 Filed 6–14–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Assurance (Interinstitutional,
Foreign, and Domestic) and Annual
Report. Office of the Director (OD)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
OMB#0925–NEW, Office of the Director
(OD), National Institutes of Health
(NIH).
FOR FURTHER INFORMATION CONTACT: To
Need and Use of Information
submit comments in writing or request
Collection: The Office of Laboratory
more information on the proposed
Welfare (OLAW) is responsible for the
collection, contact: Eileen M. Morgan,
implementation, general administration,
Director, Division of Assurances, Office
of Laboratory Animal Welfare, NIH, call and interpretation of the Public Health
(301) 594–2289 or email your request to Service (PHS) Policy on Humane Care
olawdocs@mail.nih.gov. Formal requests and Use of Laboratory Animals (Policy)
for information collection forms must be as codified in 42 CFR 52.8. The PHS
Policy implements the Health Research
requested via email to olawdocs@
Extension Act (HREA) of 1985 (Pub. L.
mail.nih.gov.
99–158 as codified in 42 U.S.C. 289d).
SUPPLEMENTARY INFORMATION: Section
The PHS Policy requires entities that
3506(c)(2)(A) of the Paperwork
conduct research involving vertebrate
Reduction Act of 1995 requires written
animals using PHS funds to have an
comments and/or suggestions from the
public and affected agencies are invited Institutional Animal Care and Use
Committee (IACUC), provide assurance
to address one or more of the following
that requirements of the Policy are met,
points: (1) Whether the proposed
and submit an annual report. An
collection of information is necessary
institution’s animal care and use
for the proper performance of the
program is described in the Animal
function of the agency, including
Welfare Assurance (Assurance)
whether the information will have
document and sets forth institutional
practical utility; (2) The accuracy of the
compliance with PHS Policy. The
agency’s estimate of the burden of the
purpose of the Assurance
proposed collection of information,
(Interinstitutional, Foreign, and
including the validity of the
methodology and assumptions used; (3) Domestic) and Annual Report is to
Ways to enhance the quality, utility, and provide OLAW with documentation to
satisfy the requirements of the HREA,
clarity of the information to be
collected; and (4) Ways to minimize the illustrate institutional adherence to PHS
Policy, and enable OLAW to carry out
burden of the collection of information
its mission to ensure the humane care
on those who are to respond, including
and use of animals in PHS-supported
the use of appropriate automated,
research, testing, and training, thereby
electronic, mechanical, or other
contributing to the quality of PHStechnological collection techniques or
supported activities.
other forms of information technology.
OMB approval is requested for 3
Proposed Collection Title: Assurance
years. The total estimated annualized
(Interinstitutional, Foreign, and
burden hours are 8,140.
Domestic) and Annual Report,
within 60 days of the date of this
publication.
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of
Laboratory Animal Welfare (OLAW) in
the Office of Extramural Research has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. The purpose of
this notice is to allow 60 days for public
comment.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
DATES:
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ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Annual
burden
hours
Type of
respondents
Interinstitutional Assurance ..................................
Interinstitutional Assurance ..................................
Foreign Assurance ...............................................
Domestic Assurance .............................................
Domestic Assurance .............................................
Annual Report .......................................................
Foreign ..........................
Domestic .......................
Renewal and New ........
Renewal ........................
New ...............................
All Domestic ..................
40
660
60
220
20
940
1
1
1
1
1
1
30/60
30/60
1
26
30
90/60
20
330
60
5,720
600
1,410
Total ...............................................................
.......................................
........................
1,940
........................
8,140
Dated: June 11, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–12734 Filed 6–14–19; 8:45 am]
BILLING CODE 4140–01–P
Number of
respondents
Number of
responses per
respondent
Document
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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16:34 Jun 14, 2019
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amended, notice is hereby given of the
following meetings.
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,
E:\FR\FM\17JNN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28064-28065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12712]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on Aging Special Emphasis
Panel; High Priority Research Networks.
Date: June 26, 2019.
Time: 12:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Ave, Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Kimberly Firth, Ph.D., National Institutes of
Health, National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702,
[email protected].
This notice is being published less than 15 days prior to the
meeting due to the timing
[[Page 28065]]
limitations imposed by the review and funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: June 12, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-12712 Filed 6-14-19; 8:45 am]
BILLING CODE 4140-01-P
