81 FR 31247 - Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 96 (May 18, 2016)

Page Range		31247-31248
FR Document		2016-11658

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, [email protected] 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.

Federal Register, Volume 81 Issue 96 (Wednesday, May 18, 2016)

[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31247-31248]
From the Federal Register Online [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31247

DATES: Only written comments and/or within fifteen (15) days from the date of Regulatory Affairs, OIRA_submission@
applications for a license which are this published notice. omb.eop.gov or by fax to 202–395–6974,
received by the NCI Technology Complete applications for a license in Attention: NIH Desk Officer.
Transfer Center on or before June 2, the field of use filed in response to this Comment Due Date: Comments
2016 will be considered. notice will be treated as objections to regarding this information collection are
ADDRESSES: Requests for copies of the the grant of the contemplated exclusive best assured of having their full effect if
patent application, inquiries, comments, start-up option license. Comments and received within 30 days of the date of
and other materials relating to the objections submitted to this notice will this publication.
contemplated exclusive license should not be made available for public
inspection and, to the extent permitted FOR FURTHER INFORMATION CONTACT: To
be directed to: David A. Lambertson,
by law, will not be released under the obtain a copy of the data collection
Ph.D., Senior Licensing and Patenting
Freedom of Information Act, 5 U.S.C. plans and instruments, or request more
Manager, National Cancer Institute,
552. information on the proposed project,
9609 Medical Center Drive, Rm 1–E530
contact: Goli Samimi, Program Director,
MSC9702, Rockville, MD 20850–9702, Dated: May 12, 2016.
Breast and Gynecologic Cancer Research
Email: david.lambertson@nih.gov. Richard U. Rodriguez, Group, Division of Cancer Prevention.
SUPPLEMENTARY INFORMATION: This Associate Director, Technology Transfer 9609 Medical Center Drive, MSC 9783,
invention concerns an anti-GPC3 Center, National Cancer Institute.
Bethesda, MD 20892, or call non-toll-
(Glypican-3) chimeric antigen receptor [FR Doc. 2016–11659 Filed 5–17–16; 8:45 am] free number (240) 276–6582, or Email
(CAR) and methods of using the CAR for BILLING CODE 4140–01–P your request, including your address to:
the treatment of GPC3-expressing goli.samimi@nih.gov. Formal requests
cancers. GPC3 is a cell surface antigen for additional plans and instruments
that is preferentially expressed on DEPARTMENT OF HEALTH AND must be requested in writing.
certain types of cancer cells, particularly HUMAN SERVICES
liver cancers such as hepatocellular Proposed Collection: Survey to assess
carcinoma (HCC). The anti-GPC3 CARs National Institutes of Health the feasibility of establishing a
of this technology contain (1) antigen gynecologic specimen bank (NCI), 0925–
Submission for OMB Review; 30-Day NEW, National Cancer Institute (NCI),
recognition sequences that bind
Comment Request; Survey To Assess National Institutes of Health (NIH).
specifically to GPC3 and (2) signaling
the Feasibility of Establishing a Need and Use of Information
domains that can activate the cytotoxic
Gynecologic Specimen Bank (NCI) Collection: The National Cancer
functions of a T cell. The anti-GPC3
CAR can be transduced into T cells that SUMMARY: Under the provisions of Institute is assessing the feasibility of
are harvested from a donor, followed by Section 3507(a)(1)(D) of the Paperwork developing a tissue bank that would
(a) selection and expansion of the T Reduction Act of 1995, the National include tube and ovary tissues from
cells expressing the anti-GPC3 CAR, and Cancer Institute, the National Institutes women undergoing surgery for benign
(b) reintroduction of the T cells into the of Health, has submitted to the Office of conditions, risk reduction and early
patient. Once the anti-GPC3 CAR- Management and Budget (OMB) a stage cancer. Collecting tissues from
expressing T cells are reintroduced into request for review and approval of the tubes and ovaries containing clinically
the patient, the T cells can selectively information collection listed below. unsuspected precursors or early stage
bind to GPC3-expressing cancer cells This proposed information collection cancer is challenging, especially among
through its antigen recognition was previously published in the Federal women that are not at increased genetic
sequences, thereby activating the T cell Register on March 8, 2016 page 12111 risk. However, given that many
through its signaling domains to and allowed 60 days for public pathology laboratories have enhanced
selectively kill the cancer cells. Through comment. No comments were received. their processing protocols for
this mechanism of action, the selectivity The purpose of this notice is to allow an gynecologic surgical specimens
of the a CAR allows the T cells to kill additional 30 days for public comment. removed for benign indications, it may
cancer cells while leaving healthy, The National Cancer Institute (NCI), be possible to develop a tissue resource.
essential cells unharmed. This can National Institutes of Health, may not Accordingly, we are requesting
result in an effective therapeutic conduct or sponsor, and the respondent information via a survey about the
strategy with fewer side effects due to is not required to respond to, an volume of samples that are accessioned
less non-specific killing of cells. information collection that has been at different pathology laboratories, and
The prospective exclusive license will extended, revised, or implemented on or the methods used to process these
be royalty bearing and will comply with after October 1, 1995, unless it displays samples. These data would provide
the terms and conditions of 35 U.S.C. a currently valid OMB control number. information necessary to assess the
209 and 37 CFR part 404.7. The Direct Comments to OMB: Written feasibility of establishing a tissue bank
prospective exclusive license may be comments and/or suggestions regarding for research and provide insights into
granted unless the NIH receives written the item(s) contained in this notice, the best design of a pilot study.
evidence and argument that establishes especially regarding the estimated OMB approval is requested for 1 year.
that the grant of the license would not public burden and associated response There are no costs to respondents other
be consistent with the requirements of time, should be directed to the: Office than their time. The total estimated
35 U.S.C. 209 and 37 CFR part 404.7 of Management and Budget, Office of annualized burden hours are 42 hours.
sradovich on DSK3TPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Frequency of Time per
Number of
Category of respondent Form name response per response Burden hours
respondents respondent (in hours)

Lab Managers ................................... Survey .............................................. 250 1 10/60 42

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31248 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Frequency of Time per
Number of
Category of respondent Form name response per response Burden hours
respondents respondent (in hours)

Totals ......................................... ........................................................... 250 ........................ ........................ 42

Dated: May 7, 2016. MSC 7812, Bethesda, MD 20892, (301) 435– MSC 7846, Bethesda, MD 20892, (301) 435–
Karla Bailey, 2778, wangjia@csr.nih.gov. 1021, rovescaa@mail.nih.gov.
Project Clearance Liaison, National Cancer Name of Committee: Healthcare Delivery Name of Committee: Vascular and
Institute, NIH. and Methodologies, Integrated Review Hematology Integrated Review Group;
Group; Biomedical Computing and Health Hemostasis and Thrombosis Study Section.
[FR Doc. 2016–11658 Filed 5–17–16; 8:45 am]
Informatics Study Section. Date: June 14, 2016.
BILLING CODE 4140–01–P Date: June 9–10, 2016. Time: 8:00 a.m. to 6:00 p.m.
Time: 11:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant
Agenda: To review and evaluate grant applications.
DEPARTMENT OF HEALTH AND applications. Place: Residence Inn Bethesda, 7335
HUMAN SERVICES Place: National Institutes of Health, 6701 Wisconsin Avenue, Bethesda, MD 20814.
Rockledge Drive, Bethesda, MD 20892 Contact Person: Bukhtiar H Shah, Ph.D.,
National Institutes of Health (Virtual Meeting). DVM, Scientific Review Officer, Vascular and
Contact Person: Peter J Kozel, Ph.D., Hematology IRG, Center for Scientific
Center for Scientific Review; Notice of Scientific Review Officer, Center for Review, National Institutes of Health, 6701
Closed Meetings Scientific Review, National Institutes of Rockledge Drive, Room 4120, MSC 7802,
Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, (301) 806–7314,
Pursuant to section 10(d) of the Bethesda, MD 20892, 301–435–1116, shahb@csr.nih.gov.
kozelp@mail.nih.gov.
Federal Advisory Committee Act, as Name of Committee: Center for Scientific
amended (5 U.S.C. App.), notice is Name of Committee: Musculoskeletal, Oral Review Special Emphasis Panel;
and Skin Sciences Integrated Review Group; Collaborative Applications: Child
hereby given of the following meetings. Arthritis, Connective Tissue and Skin Study Psychopathology.
The meetings will be closed to the Section.
Date: June 14, 2016.
public in accordance with the Date: June 14–15, 2016.
Time: 3:00 p.m. to 5:00 p.m.
provisions set forth in sections Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant
applications.
applications.
as amended. The grant applications and Place: Bethesda Marriott, 5151 Pooks Hill Place: Best Western Tuscan Inn, 425 North
the discussions could disclose Road, Bethesda, MD 20814. Point Street, San Francisco, CA 94133.
confidential trade secrets or commercial Contact Person: Alexey Belkin, Scientific Contact Person: Jane A Doussard-
property such as patentable material, Review Officer, Center for Scientific Review, Roosevelt, Ph.D., Scientific Review Officer,
and personal information concerning National Institutes of Health, 6701 Rockledge Center for Scientific Review, National
DR Rm 4102, Bethesda, MD 20817, 301–435– Institutes of Health, 6701 Rockledge Drive,
individuals associated with the grant
3578, alexey.belkin@nih.gov. Room 3184, MSC 7848, Bethesda, MD 20892,
applications, the disclosure of which (301) 435–4445, doussarj@csr.nih.gov.
would constitute a clearly unwarranted Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small Name of Committee: Oncology 1-Basic
invasion of personal privacy. Translational Integrated Review Group;
Business: Cancer Drug Development and
Name of Committee: Healthcare Delivery Therapeutics. Tumor Progression and Metastasis Study
and Methodologies Integrated Review Group; Date: June 14–15, 2016. Section.
Community Influences on Health Behavior Time: 8:00 a.m. to 5:00 p.m. Date: June 15–16, 2016.
Study Section. Agenda: To review and evaluate grant Time: 8:00 a.m. to 5:00 p.m.
Date: June 9–10, 2016. applications. Agenda: To review and evaluate grant
Time: 8:00 a.m. to 5:30 p.m. Place: National Institutes of Health, 6701 applications.
Agenda: To review and evaluate grant Rockledge Drive, Bethesda, MD 20892, Place: Hotel Solamar, 435 6th Avenue, San
applications. (Virtual Meeting). Diego, CA 92101.
Place: Westin Grand, 2350 M Street NW., Contact Person: Lilia Topol, Ph.D., Contact Person: Rolf Jakobi, Ph.D.,
Washington, DC 20037. Scientific Review Officer, Center for Scientific Review Officer, Center for
Contact Person: Wenchi Liang, Ph.D., Scientific Review, National Institutes of Scientific Review, National Institutes of
Scientific Review Officer, Center for Health, 6701 Rockledge Drive, Room 6192, Health, 6701 Rockledge Drive, Room 6187,
Scientific Review, National Institutes of MSC 7804, Bethesda, MD 20892, 301–451– MSC 7806, Bethesda, MD 20892, 301–495–
Health, 6701 Rockledge Drive, Room 3150, 0131, ltopol@mail.nih.gov. 1718, jakobir@mail.nih.gov.
MSC 7770, Bethesda, MD 20892, 301–435– Name of Committee: Brain Disorders and Name of Committee: Center for Scientific
0681, liangw3@csr.nih.gov. Clinical Neuroscience, Integrated Review Review Special Emphasis Panel; Small
Name of Committee: Immunology Group; Clinical Neuroscience and Business: Cancer Diagnostics and Treatments
Integrated Review Group; Vaccines Against Neurodegeneration Study Section. (CDT).
Microbial Diseases Study Section. Date: June 14–15, 2016. Date: June 15–16, 2016.
Date: June 9–10, 2016. Time: 8:00 a.m. to 5:00 p.m. Time: 8:00 a.m. to 6:00 p.m.
Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant Agenda: To review and evaluate grant
sradovich on DSK3TPTVN1PROD with NOTICES

Agenda: To review and evaluate grant applications. applications.
applications. Place: Doubletree Hotel Washington, 1515 Place: National Institutes of Health, 6701
Place: Hilton Washington/Rockville, 1750 Rhode Island Ave NW., Washington, DC Rockledge Drive, Bethesda, MD 20892
Rockville Pike, Rockville, MD 20852. 20005. (Virtual Meeting).
Contact Person: Jian Wang, MD, Ph.D., Contact Person: Alessandra C Rovescalli, Contact Person: Zhang-Zhi Hu, MD,
Scientific Review Officer, Center for Ph.D., Scientific Review Officer, National Scientific Review Officer, Center for
Scientific Review, National Institutes of Institutes of Health, Center for Scientific Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4218, Review, 6701 Rockledge Drive, Rm 5205 Health, 6701 Rockledge Drive, Room 6186,

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Document Created: 2016-05-18 00:07:04
Document Modified: 2016-05-18 00:07:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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.
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
FR Citation		81 FR 31247

81 FR 31247 - Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 96 (May 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health