Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI), 31247-31248 [2016-11658]
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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
31248
Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Category of respondent
Totals .........................................
...........................................................
Dated: May 7, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
[FR Doc. 2016–11658 Filed 5–17–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
sradovich on DSK3TPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: Healthcare Delivery
and Methodologies Integrated Review Group;
Community Influences on Health Behavior
Study Section.
Date: June 9–10, 2016.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Grand, 2350 M Street NW.,
Washington, DC 20037.
Contact Person: Wenchi Liang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3150,
MSC 7770, Bethesda, MD 20892, 301–435–
0681, liangw3@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group; Vaccines Against
Microbial Diseases Study Section.
Date: June 9–10, 2016.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Jian Wang, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4218,
VerDate Sep<11>2014
17:10 May 17, 2016
Number of
respondents
Form name
Jkt 238001
250
MSC 7812, Bethesda, MD 20892, (301) 435–
2778, wangjia@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies, Integrated Review
Group; Biomedical Computing and Health
Informatics Study Section.
Date: June 9–10, 2016.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Peter J Kozel, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
Bethesda, MD 20892, 301–435–1116,
kozelp@mail.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Arthritis, Connective Tissue and Skin Study
Section.
Date: June 14–15, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Alexey Belkin, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
DR Rm 4102, Bethesda, MD 20817, 301–435–
3578, alexey.belkin@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cancer Drug Development and
Therapeutics.
Date: June 14–15, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lilia Topol, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, 301–451–
0131, ltopol@mail.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience, Integrated Review
Group; Clinical Neuroscience and
Neurodegeneration Study Section.
Date: June 14–15, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Washington, 1515
Rhode Island Ave NW., Washington, DC
20005.
Contact Person: Alessandra C Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
Frequency of
response per
respondent
Time per
response
(in hours)
........................
........................
Burden hours
42
MSC 7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hemostasis and Thrombosis Study Section.
Date: June 14, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Bukhtiar H Shah, Ph.D.,
DVM, Scientific Review Officer, Vascular and
Hematology IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4120, MSC 7802,
Bethesda, MD 20892, (301) 806–7314,
shahb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Collaborative Applications: Child
Psychopathology.
Date: June 14, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Best Western Tuscan Inn, 425 North
Point Street, San Francisco, CA 94133.
Contact Person: Jane A DoussardRoosevelt, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3184, MSC 7848, Bethesda, MD 20892,
(301) 435–4445, doussarj@csr.nih.gov.
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Tumor Progression and Metastasis Study
Section.
Date: June 15–16, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Solamar, 435 6th Avenue, San
Diego, CA 92101.
Contact Person: Rolf Jakobi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7806, Bethesda, MD 20892, 301–495–
1718, jakobir@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cancer Diagnostics and Treatments
(CDT).
Date: June 15–16, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Zhang-Zhi Hu, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31247-31248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11658]
-----------------------------------------------------------------------
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)
SUMMARY: 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 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.
FOR FURTHER INFORMATION CONTACT: 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-toll-
free 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.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Frequency of Time per
Category of respondent Form name Number of response per response (in Burden hours
respondents respondent hours)
----------------------------------------------------------------------------------------------------------------
Lab Managers.................. Survey.......... 250 1 10/60 42
---------------------------------------------------------------
[[Page 31248]]
Totals.................... ................ 250 .............. .............. 42
----------------------------------------------------------------------------------------------------------------
Dated: May 7, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-11658 Filed 5-17-16; 8:45 am]
BILLING CODE 4140-01-P
