Prospective Grant of an Exclusive Patent License: Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy, 11548-11549 [2021-03873]
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11548
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
Federal SUID/SIDS Workgroup
members, SUID/SIDS stakeholders,
clinical and maternal and child health
professionals. These audiences may use
the information collections to: (1)
Develop new campaign messages,
materials, and/or training curricula; (2)
monitor and improve campaign
activities; (3) make decisions about
campaign activities; (4) inform current
campaign activities; and (5) inform and/
or change practices and behaviors of
program participants.
Examples of the types of information
collections that could be included under
this generic clearance include: Focus
groups and key informant interviews
with parents/caregivers and/or health
professionals to get feedback on
distribution and outreach activities,
and/or campaign messages; and Surveys
with parents/caregivers and/or health
professionals to: (1) Assess the
usefulness of the new STS campaign
materials, including print and on-line
multi-media materials, (2) track
outreach experiences of program
participants, (3) assess training
participants’ changes in knowledge
related to safe infant sleep behavior and
implementation of learned outreach and
education methods, and (4) assess
program participants’ resource needs.
The sub-studies for this generic
clearance will be small in scale,
designed to obtain results frequently
and quickly to guide campaign
development and implementation,
inform campaign direction, and be used
internally for campaign management
purposes. NICHD’s current scope and
capacity for STS generic sub-studies is
non-existent and this request would fill
this gap.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
13,305.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Focus Groups ...................................
Interviews ..........................................
Pre-/Post-Tests .................................
Pre-/Post-Tests .................................
Surveys .............................................
Tracking/Feedback Form ..................
General Public ..................................
General Public ..................................
General Public ..................................
Health Professionals ........................
Health Professionals ........................
Health Educators ..............................
Total ...........................................
...........................................................
Dated: February 12, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
[FR Doc. 2021–03870 Filed 2–24–21; 8:45 am]
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Engineered Tumor
Infiltrating Lymphocytes for Cancer
Therapy
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
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Iovance
Biotherapeutics, Inc. (‘‘Iovance’’),
headquartered in San Carlos, CA.
Jkt 253001
215
50
1,500
10,000
1,500
40
26,285
49,305
........................
13,305
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before March 12, 2021 will be
considered.
DATES:
E–068–2018: Tethered Interleukin-15
and Interleukin-21
Notice.
17:04 Feb 24, 2021
1
1
15/60
15/60
30/60
1
Intellectual Property
National Institutes of Health,
VerDate Sep<11>2014
1
1
2
2
1
2
SUPPLEMENTARY INFORMATION:
HHS.
SUMMARY:
215
50
3,000
20,000
3,000
20
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,
Telephone: (240)–276–5484; Email:
andy.burke@nih.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Average
burden
per response,
in hours
ADDRESSES:
BILLING CODE 4140–01–P
AGENCY:
Number of
responses per
respondent
Number of
respondents
Form name
1. US Provisional Patent Application
62/628,454, filed February 9, 2018 (E–
068–2018–0–US–01);
2. International Patent Application
PCT/US2019/016975, filed February 7,
2019 (E–068–2018–0–PCT–02);
3. Australian Patent Application
2019218785, filed August 7, 2020 (E–
068–2018–0–AU–03);
4. Chinese Patent Application
201980012443.3, filed August 7, 2020
(E–068–2018–0–CN–04);
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Total annual
burden hours
5. European Patent Application
19709154.9, filed August 18, 2020 (E–
068–2018–0–EP–05);
6. United States Patent Application
16/964,796, filed July 24, 2020 (E–068–
2018–0–US–06); and
7. Canadian Patent Application
3,090,512, filed August 5, 2020 (E–068–
2018–0–CA–07).
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:
‘‘The use of the Licensed Patent
Rights to develop, manufacture,
distribute, sell, and use unselected
whole autologous tumor infiltrating
lymphocyte (TIL) adoptive cell therapy
products for the treatment of metastatic
melanoma, lung, breast, bladder, and
HPV-positive cancers. Specifically
excluded from this Agreement are
methods of generating or using selected
subpopulations of TIL and the use of T
cell receptors isolated from TIL.’’
E–068–2018 is primarily directed to
recombinant constructs for the coexpression of Interleukins-15 and 21
(IL–15 and 21). IL–15 and IL–21 have
been reported to support the function of
anti-tumor T cells; however, their
E:\FR\FM\25FEN1.SGM
25FEN1
11549
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
clinical utility has been constrained, in
part, by dose-limiting toxicity following
systemic administration and the need
for repeated dosing. The subject
invention addresses these limitations
through synthetic IL–15/21 sequences
which incorporate flexible linker
regions and cell membrane anchors. T
cells engineered to express these
constructs experience autocrine IL–15/
21 signaling leading to enhanced antitumor function in vivo.
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 establishing 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 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: February 12, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–03873 Filed 2–24–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; CareerTrac
AGENCY:
National Institutes of Health,
HHS.
ACTION:
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: CareerTrac0925–0568—expiration date April 30,
2021, REVISION, Fogarty International
Center (FIC), National Institute of
Environmental Health Sciences
(NIEHS), National Cancer Institute
(NCI), National Institute of Diabetes and
Digestive Kidney Diseases, (NIDDK),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of this data
collection system is to track, evaluate
and report short and long-term outputs,
outcomes and impacts of trainees
involved in health research training
programs-specifically tracking this for at
least ten years following training by
having Principal Investigators enter data
after trainees have completed the
program. The data collection system
provides a streamlined, web-based
application permitting principal
investigators to record career
achievement progress by trainee on a
voluntary basis. FIC, NCI, NIDDK, and
NIEHS management will use this data to
monitor, evaluate and adjust grants to
ensure desired outcomes are achieved,
comply with OMB Part requirements,
respond to congressional inquiries, and
as a guide to inform future strategic and
management decisions regarding the
grant program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
12,705.
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Kristi
Pettibone, Health Scientist
Administrator, Program Analysis
Branch, Division of Extramural Research
and Training, NIEHS, NIH, 560 Davis
Dr., Morrisville, NC 27560, or call nontoll-free number (984) 287–3303 or
Email your request, including your
address to: pettibonekg@niehs.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on December 12, 2020, page
79493–79494 (64 FR 15367) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Fogarty International Center (FIC),
National Cancer Institute (NCI),
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
and National Institute of Environmental
Health Sciences (NIEHS), may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
FIC Grantee .....................................................................................................
NIEHS Grantee ................................................................................................
NCI CRCHD Grantee ......................................................................................
NCI D43 Grantee .............................................................................................
Superfund Grantee ..........................................................................................
VerDate Sep<11>2014
17:04 Feb 24, 2021
Jkt 253001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
90
60
244
20
30
E:\FR\FM\25FEN1.SGM
20
45
22
22
105
25FEN1
Average
burden per
response
(in hours)
40/60
40/60
40/60
40/60
40/60
Total annual
burden hour
1,200
1,800
3,579
293
2,100
]]>Agencies
[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11548-11549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03873]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Engineered
Tumor Infiltrating Lymphocytes for Cancer Therapy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 Patents and Patent Applications listed in
the Supplementary Information section of this Notice to Iovance
Biotherapeutics, Inc. (``Iovance''), headquartered in San Carlos, CA.
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 March 12, 2021 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, Telephone: (240)-276-5484;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-068-2018: Tethered Interleukin-15 and Interleukin-21
1. US Provisional Patent Application 62/628,454, filed February 9,
2018 (E-068-2018-0-US-01);
2. International Patent Application PCT/US2019/016975, filed
February 7, 2019 (E-068-2018-0-PCT-02);
3. Australian Patent Application 2019218785, filed August 7, 2020
(E-068-2018-0-AU-03);
4. Chinese Patent Application 201980012443.3, filed August 7, 2020
(E-068-2018-0-CN-04);
5. European Patent Application 19709154.9, filed August 18, 2020
(E-068-2018-0-EP-05);
6. United States Patent Application 16/964,796, filed July 24, 2020
(E-068-2018-0-US-06); and
7. Canadian Patent Application 3,090,512, filed August 5, 2020 (E-
068-2018-0-CA-07).
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:
``The use of the Licensed Patent Rights to develop, manufacture,
distribute, sell, and use unselected whole autologous tumor
infiltrating lymphocyte (TIL) adoptive cell therapy products for the
treatment of metastatic melanoma, lung, breast, bladder, and HPV-
positive cancers. Specifically excluded from this Agreement are methods
of generating or using selected subpopulations of TIL and the use of T
cell receptors isolated from TIL.''
E-068-2018 is primarily directed to recombinant constructs for the
co-expression of Interleukins-15 and 21 (IL-15 and 21). IL-15 and IL-21
have been reported to support the function of anti-tumor T cells;
however, their
[[Page 11549]]
clinical utility has been constrained, in part, by dose-limiting
toxicity following systemic administration and the need for repeated
dosing. The subject invention addresses these limitations through
synthetic IL-15/21 sequences which incorporate flexible linker regions
and cell membrane anchors. T cells engineered to express these
constructs experience autocrine IL-15/21 signaling leading to enhanced
anti-tumor function in vivo.
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 establishing
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 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: February 12, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-03873 Filed 2-24-21; 8:45 am]
BILLING CODE 4140-01-P
