Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI)
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 via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-11658
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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
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Frequency of Time per
Category of respondent Form name Number of response per response (in Burden hours
respondents respondent hours)
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Lab Managers.................. Survey.......... 250 1 10/60 42
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Page 31248
Totals.................... ................ 250 .............. .............. 42
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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
