[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, [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.

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: [email protected]. 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