Proposed Collection; 60-Day Comment Request; Specimen Resource Locator (National Cancer Institute), 36871-36872 [2020-13139]
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Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Notices
Dated: June 12, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13095 Filed 6–17–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
Neurological Disorders and Stroke Special
Emphasis Panel; NSD–B Conflict SEP.
Date: July 1, 2020.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Neuroscience Center, 6001
Executive Blvd., North Bethesda, MD 20852
(Video Assisted Meeting).
Contact Person: Joel A. Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH NSC, 6001 Executive Blvd.,
Room 3205, MSC 9529, Bethesda, MD 20892,
(301)–496–9223, joel.saydoff@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; R13 Review.
Date: July 6, 2020.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Neuroscience Center, 6001
Executive Blvd., North Bethesda, MD 20852
(Video Assisted Meeting).
Contact Person: Li Jia, Ph.D., Scientific
Review Officer, Scientific Review Branch,
Division of Extramural Research, NINDS/
NIH, 6001 Executive Boulevard, Room
3208D, Rockville, MD 20852, 301–451–2854,
li.jia@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NSD–K: Clinical Trials in
Neurological Disorders.
Date: July 7, 2020.
Time: 9:00 a.m. to 3:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Neuroscience Center, 6001
Executive Blvd., North Bethesda, MD 20852
(Video Assisted Meeting).
Contact Person: Shanta Rajaram, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH NSC, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Bethesda, Md 20892,
(301) 435–6033, rajarams@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: June 12, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13097 Filed 6–17–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Specimen Resource Locator
(National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Cancer Institute (NCI) will publish
periodic summaries of propose projects
to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Joanne Demchok, Program
Director, Cancer Diagnosis Program,
Division of Cancer Treatment and
Diagnosis, 9609 Medical Center Drive,
Rockville, Md 20892 or call non-toll-free
number 240–276–5959 or Email your
request, including your address to:
peterjo@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
FOR FURTHER INFORMATION CONTACT:
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36871
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Specimen
Resource Locator (NCI), 0925–0703:
Expiration Date 11/30/2020, REVISION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The availability of
specimens and associated data is critical
to increase our knowledge of cancer
biology, and to translate important
research discoveries to clinical
application. The development of
molecular technologies in cancer
patients, with defined molecular
abnormalities, advances identification
and development of clinically useful
biomarkers and diagnostic assays that
guide treatment.
The discovery and validation of
cancer prevention markers require
access, by researchers, to quality clinical
biospecimens. In response, to this need,
NCI’s Cancer Diagnosis Program
developed, and is expanding, a
searchable database: Specimen Resource
Locator (SRL) https://
specimens.cancer.gov/tissue/
default.htm. The SRL allows scientist in
the research community and the NCI to
locate specimens needed for their
research. The SRL lists all NCI
supported and non-NCI supported
biospecimens repositories and their
links. It is not NCI’s intent to collect the
biospecimens; rather the collections are
descriptions of the available data that
can act as a resource and be shared with
researchers and scientists who are
interested. This submission does not
involve any analysis.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
SUPPLEMENTARY INFORMATION:
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36872
Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Notices
estimated annualized burden hours are
68.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Form name
Type of respondent
Initial Request ...................................
State Government ............................
Federal Government ........................
State Government ............................
Federal Government ........................
70
60
20
10
1
1
1
1
30/60
30/60
5/60
5/60
35
30
2
1
...........................................................
........................
160
........................
68
Annual Update ..................................
Totals .........................................
Dated: June 15, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
Intellectual Property
[FR Doc. 2020–13139 Filed 6–17–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cell Therapies
for Cancer
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
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Ziopharm
Oncology, Inc. (‘‘Ziopharm’’),
headquartered in Boston, MA.
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 July 6, 2020 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: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)–276–5484 or Email:
andy.burke@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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Group A
E–031–2020: HLA Class I-Restricted T
Cell Receptors Against RAS with
G12D Mutation
1. U.S. Provisional Patent Application
62/975,544, filed February 12, 2020
(E–031–2020–0–US–01).
E–074–2020: HLA Class I-Restricted T
Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application
62/976,655, filed February 14, 2020
(E–074–2020–0–US–01).
E–088–2020: HLA Class II-Restricted T
Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application
62/981,856, filed February 26, 2020
(E–088–2020–0–US–01).
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 Group A
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer 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, a) retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers, and
b) CRISPR-engineered peripheral blood
T 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.’’
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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.
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 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 10, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–13137 Filed 6–17–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Notices]
[Pages 36871-36872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Specimen Resource
Locator (National Cancer Institute)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health, National Cancer
Institute (NCI) will publish periodic summaries of propose projects to
be submitted to the Office of Management and Budget (OMB) for review
and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Joanne
Demchok, Program Director, Cancer Diagnosis Program, Division of Cancer
Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, Md 20892
or call non-toll-free number 240-276-5959 or Email your request,
including your address to: [email protected]. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Specimen Resource Locator (NCI), 0925-
0703: Expiration Date 11/30/2020, REVISION, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The availability of
specimens and associated data is critical to increase our knowledge of
cancer biology, and to translate important research discoveries to
clinical application. The development of molecular technologies in
cancer patients, with defined molecular abnormalities, advances
identification and development of clinically useful biomarkers and
diagnostic assays that guide treatment.
The discovery and validation of cancer prevention markers require
access, by researchers, to quality clinical biospecimens. In response,
to this need, NCI's Cancer Diagnosis Program developed, and is
expanding, a searchable database: Specimen Resource Locator (SRL)
https://specimens.cancer.gov/tissue/default.htm. The SRL allows
scientist in the research community and the NCI to locate specimens
needed for their research. The SRL lists all NCI supported and non-NCI
supported biospecimens repositories and their links. It is not NCI's
intent to collect the biospecimens; rather the collections are
descriptions of the available data that can act as a resource and be
shared with researchers and scientists who are interested. This
submission does not involve any analysis.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total
[[Page 36872]]
estimated annualized burden hours are 68.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total burden
respondent respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Initial Request............... State Government 70 1 30/60 35
Federal 60 1 30/60 30
Government.
Annual Update................. State Government 20 1 5/60 2
Federal 10 1 5/60 1
Government.
---------------------------------------------------------------
Totals.................... ................ .............. 160 .............. 68
----------------------------------------------------------------------------------------------------------------
Dated: June 15, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2020-13139 Filed 6-17-20; 8:45 am]
BILLING CODE 4140-01-P
