Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI), 31247-31248 [2016-11658]

Download as PDF 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
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