Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers, 31246-31247 [2016-11659]
Download as PDF
<![CDATA[
31246
Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Network Allied Health Training
Program Performance Improvement
Measurement System (PIMS)
OMB No.: 0906–xxxx—NEW.
Abstract: The Rural Network Allied
Health Training Program will support
the development of formal, mature rural
health networks that focus on activities
that achieve efficiencies, expand access
to, coordinate and improve the quality
of essential health care services, and
strengthen the rural health care system
as a whole. This purpose will be
achieved through the recruitment,
clinical training, and retention of allied
health professionals.
This program will further support
integrated rural health networks that
can partner with local community
colleges and other accredited
educational institutions (such as
vocational and technical colleges) to
develop formal clinical training
programs.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy (FORHP), including: (a)
Access to care; (b) population
demographics; (c) staffing; (d)
consortium/network; (e) sustainability;
and (f) project specific domains. Several
measures will be used for this program.
All measures will speak to FORHP’s
progress toward meeting the goals.
Number of
respondents
Form name
Number of
responses per
respondent
Likely Respondents: The respondents
are recipients of the Rural Network
Allied Health Training Program grant
funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Rural Network Allied Health Training Program Performance Measures .................................................................
10
1
10
6.55
65.5
Total ..............................................................................
10
........................
10
........................
65.5
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–11672 Filed 5–17–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: The Development of an AntiGPC3 Chimeric Antigen Receptor
(CAR) Based on HN3 for the Treatment
of Human Cancers
National Institutes of Health,
Public Health Service, Department of
Health and Human Services.
AGENCY:
sradovich on DSK3TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
license to practice the inventions
embodied in:
SUMMARY:
VerDate Sep<11>2014
17:10 May 17, 2016
Jkt 238001
Intellectual Property: U.S. Provisional
Patent Application 61/654,232 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–US–01]; PCT Patent
Application PCT/US2013/043633
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–
PCT–02]; Chinese Patent Application
201380039993.7 entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–CN–03]; Japanese Patent
Application 2015–515243 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–JP–04]; South Korea
Patent Application 10–2014–7037046
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–KR–
05]; Singapore Patent Application
11201407972R entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–SG–06]; United States Patent
Application 14/403,896 entitled ‘‘Highaffinity Monoclonal Antibodies To
Glypican-3 And Use Thereof’’ [HHS Ref.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
E–136–2012/0–US–07]; and all
continuing U.S. and foreign patents/
patent applications for the technology
family, to Lentigen Technology, Inc.
The patent rights to these inventions
have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive licensed
territory may be the United States,
Australia, Canada, the European Union,
Russia, China, Hong Kong, Japan,
Taiwan, South Korea and Singapore,
and the field of use may be limited to:
‘‘The development of a glypican-3
(GPC3) chimeric antigen receptor (CAR)based immunotherapy using autologous
(meaning one individual is both the
donor and the recipient) primary human
lymphocytes (T cells or NK cells)
transfected with a lentiviral or retroviral
vector, wherein the vector expresses a
CAR having (1) a single antigen
specificity and (2) comprising at least:
(a) the complementary determining
region (CDR) sequences of the anti-GPC3
antibody known as HN3; and (b) a T cell
signaling domain; for the prophylaxis
and treatment of GPC3-expressing
cancers.’’
E:\FR\FM\18MYN1.SGM
18MYN1
31247
Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before June 2,
2016 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, National Cancer Institute,
9609 Medical Center Drive, Rm 1–E530
MSC9702, Rockville, MD 20850–9702,
Email: david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns an anti-GPC3
(Glypican-3) chimeric antigen receptor
(CAR) and methods of using the CAR for
the treatment of GPC3-expressing
cancers. GPC3 is a cell surface antigen
that is preferentially expressed on
certain types of cancer cells, particularly
liver cancers such as hepatocellular
carcinoma (HCC). The anti-GPC3 CARs
of this technology contain (1) antigen
recognition sequences that bind
specifically to GPC3 and (2) signaling
domains that can activate the cytotoxic
functions of a T cell. The anti-GPC3
CAR can be transduced into T cells that
are harvested from a donor, followed by
(a) selection and expansion of the T
cells expressing the anti-GPC3 CAR, and
(b) reintroduction of the T cells into the
patient. Once the anti-GPC3 CARexpressing T cells are reintroduced into
the patient, the T cells can selectively
bind to GPC3-expressing cancer cells
through its antigen recognition
sequences, thereby activating the T cell
through its signaling domains to
selectively kill the cancer cells. Through
this mechanism of action, the selectivity
of the a CAR allows the T cells to kill
cancer cells while leaving healthy,
essential cells unharmed. This can
result in an effective therapeutic
strategy with fewer side effects due to
less non-specific killing of cells.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless the NIH 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 404.7
sradovich on DSK3TPTVN1PROD with NOTICES
DATES:
within fifteen (15) days from the date of
this published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
start-up option license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Goli Samimi, Program Director,
Breast and Gynecologic Cancer Research
Group, Division of Cancer Prevention.
9609 Medical Center Drive, MSC 9783,
Bethesda, MD 20892, or call non-tollfree number (240) 276–6582, or Email
your request, including your address to:
goli.samimi@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Survey to assess
the feasibility of establishing a
gynecologic specimen bank (NCI), 0925–
NEW, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute is assessing the feasibility of
developing a tissue bank that would
include tube and ovary tissues from
women undergoing surgery for benign
conditions, risk reduction and early
stage cancer. Collecting tissues from
tubes and ovaries containing clinically
unsuspected precursors or early stage
cancer is challenging, especially among
women that are not at increased genetic
risk. However, given that many
pathology laboratories have enhanced
their processing protocols for
gynecologic surgical specimens
removed for benign indications, it may
be possible to develop a tissue resource.
Accordingly, we are requesting
information via a survey about the
volume of samples that are accessioned
at different pathology laboratories, and
the methods used to process these
samples. These data would provide
information necessary to assess the
feasibility of establishing a tissue bank
for research and provide insights into
the best design of a pilot study.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 42 hours.
FOR FURTHER INFORMATION CONTACT:
Dated: May 12, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2016–11659 Filed 5–17–16; 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; Survey To Assess
the Feasibility of Establishing a
Gynecologic Specimen Bank (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health, has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on March 8, 2016 page 12111
and allowed 60 days for public
comment. No comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Cancer Institute (NCI),
National Institutes of Health, 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
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
SUMMARY:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Category of respondent
Form name
Lab Managers ...................................
Survey ..............................................
VerDate Sep<11>2014
17:10 May 17, 2016
Jkt 238001
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Frequency of
response per
respondent
250
E:\FR\FM\18MYN1.SGM
1
18MYN1
Time per
response
(in hours)
10/60
Burden hours
42
]]>Agencies
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31246-31247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: The Development of an
Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the
Treatment of Human Cancers
AGENCY: National Institutes of Health, Public Health Service,
Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive license to practice the inventions embodied in:
Intellectual Property: U.S. Provisional Patent Application 61/
654,232 entitled ``High-affinity Monoclonal Antibodies To Glypican-3
And Use Thereof'' [HHS Ref. E-136-2012/0-US-01]; PCT Patent Application
PCT/US2013/043633 entitled ``High-affinity Monoclonal Antibodies To
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-PCT-02]; Chinese
Patent Application 201380039993.7 entitled ``High-affinity Monoclonal
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-
03]; Japanese Patent Application 2015-515243 entitled ``High-affinity
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-JP-04]; South Korea Patent Application 10-2014-7037046 entitled
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof''
[HHS Ref. E-136-2012/0-KR-05]; Singapore Patent Application
11201407972R entitled ``High-affinity Monoclonal Antibodies To
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-SG-06]; United
States Patent Application 14/403,896 entitled ``High-affinity
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-07]; and all continuing U.S. and foreign patents/patent
applications for the technology family, to Lentigen Technology, Inc.
The patent rights to these inventions have been assigned to and/or
exclusively licensed to the Government of the United States of America.
The prospective exclusive licensed territory may be the United
States, Australia, Canada, the European Union, Russia, China, Hong
Kong, Japan, Taiwan, South Korea and Singapore, and the field of use
may be limited to: ``The development of a glypican-3 (GPC3) chimeric
antigen receptor (CAR)-based immunotherapy using autologous (meaning
one individual is both the donor and the recipient) primary human
lymphocytes (T cells or NK cells) transfected with a lentiviral or
retroviral vector, wherein the vector expresses a CAR having (1) a
single antigen specificity and (2) comprising at least: (a) the
complementary determining region (CDR) sequences of the anti-GPC3
antibody known as HN3; and (b) a T cell signaling domain; for the
prophylaxis and treatment of GPC3-expressing cancers.''
[[Page 31247]]
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center on or before June 2,
2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: David A. Lambertson, Ph.D., Senior
Licensing and Patenting Manager, National Cancer Institute, 9609
Medical Center Drive, Rm 1-E530 MSC9702, Rockville, MD 20850-9702,
Email: david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns an anti-GPC3
(Glypican-3) chimeric antigen receptor (CAR) and methods of using the
CAR for the treatment of GPC3-expressing cancers. GPC3 is a cell
surface antigen that is preferentially expressed on certain types of
cancer cells, particularly liver cancers such as hepatocellular
carcinoma (HCC). The anti-GPC3 CARs of this technology contain (1)
antigen recognition sequences that bind specifically to GPC3 and (2)
signaling domains that can activate the cytotoxic functions of a T
cell. The anti-GPC3 CAR can be transduced into T cells that are
harvested from a donor, followed by (a) selection and expansion of the
T cells expressing the anti-GPC3 CAR, and (b) reintroduction of the T
cells into the patient. Once the anti-GPC3 CAR-expressing T cells are
reintroduced into the patient, the T cells can selectively bind to
GPC3-expressing cancer cells through its antigen recognition sequences,
thereby activating the T cell through its signaling domains to
selectively kill the cancer cells. Through this mechanism of action,
the selectivity of the a CAR allows the T cells to kill cancer cells
while leaving healthy, essential cells unharmed. This can result in an
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404.7. The prospective exclusive license may be granted unless the NIH
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 404.7 within fifteen (15) days from the date
of this published notice.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive start-up option license. Comments and
objections submitted to this notice will not be made available for
public inspection and, to the extent permitted by law, will not be
released under the Freedom of Information Act, 5 U.S.C. 552.
Dated: May 12, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2016-11659 Filed 5-17-16; 8:45 am]
BILLING CODE 4140-01-P
