81_FR_12156 81 FR 12111 - Proposed Collection; 60-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI)

81 FR 12111 - Proposed Collection; 60-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 45 (March 8, 2016)

Page Range12111-12111
FR Document2016-05021

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Federal Register, Volume 81 Issue 45 (Tuesday, March 8, 2016)
[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Notices]
[Page 12111]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Survey To Assess the 
Feasibility of Establishing a Gynecologic Specimen Bank (NCI)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute, 
the National Institutes of Health (NIH) will publish periodic summaries 
of proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address one or more of the following points: 
(1) Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) The quality, utility, and clarity of the information to be 
collected; and (4) Minimize the burden of the collection of information 
on those who are to respond, including the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.

TO SUBMIT COMMENTS AND FOR FURTHER INFORMATION:  To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
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.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    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
                               ---------------------------------------------------------------------------------
    Totals....................  ................             250  ..............  ..............              42
----------------------------------------------------------------------------------------------------------------


    Dated: March 2, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-05021 Filed 3-7-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                             Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Notices                                                                                    12111

                                                      Dated: March 2, 2016.                                                  practical utility; (2) The accuracy of the                        gynecologic specimen bank (NCI), 0925–
                                                    Natasha M. Copeland,                                                     agency’s estimate of the burden of the                            NEW, National Cancer Institute (NCI),
                                                    Program Analyst, Office of Federal Advisory                              proposed collection of information,                               National Institutes of Health (NIH).
                                                    Committee Policy.                                                        including the validity of the                                        Need and Use of Information
                                                    [FR Doc. 2016–05020 Filed 3–7–16; 8:45 am]                               methodology and assumptions used; (3)
                                                                                                                                                                                               Collection: The National Cancer
                                                    BILLING CODE 4140–01–P                                                   The quality, utility, and clarity of the
                                                                                                                                                                                               Institute is assessing the feasibility of
                                                                                                                             information to be collected; and (4)
                                                                                                                             Minimize the burden of the collection of                          developing a tissue bank that would
                                                                                                                             information on those who are to                                   include tube and ovary tissues from
                                                    DEPARTMENT OF HEALTH AND
                                                    HUMAN SERVICES                                                           respond, including the use of                                     women undergoing surgery for benign
                                                                                                                             appropriate automated, electronic,                                conditions, risk reduction and early
                                                    National Institutes of Health                                            mechanical, or other technological                                stage cancer. Collecting tissues from
                                                                                                                             collection techniques or other forms of                           tubes and ovaries containing clinically
                                                    Proposed Collection; 60-Day Comment                                      information technology.                                           unsuspected precursors or early stage
                                                    Request; Survey To Assess the                                            TO SUBMIT COMMENTS AND FOR FURTHER                                cancer is challenging, especially among
                                                    Feasibility of Establishing a                                            INFORMATION: To obtain a copy of the                              women that are not at increased genetic
                                                    Gynecologic Specimen Bank (NCI)                                          data collection plans and instruments,                            risk. However, given that many
                                                                                                                             submit comments in writing, or request                            pathology laboratories have enhanced
                                                    SUMMARY:   In compliance with the                                                                                                          their processing protocols for
                                                                                                                             more information on the proposed
                                                    requirement of Section 3506(c)(2)(A) of                                                                                                    gynecologic surgical specimens
                                                                                                                             project, contact: Goli Samimi, Program
                                                    the Paperwork Reduction Act of 1995,
                                                                                                                             Director, Breast and Gynecologic Cancer                           removed for benign indications, it may
                                                    for opportunity for public comment on
                                                                                                                             Research Group, Division of Cancer                                be possible to develop a tissue resource.
                                                    proposed data collection projects, the
                                                                                                                             Prevention, 9609 Medical Center Drive,                            Accordingly, we are requesting
                                                    National Cancer Institute, the National
                                                                                                                             MSC 9783, Bethesda, MD 20892, or call                             information via a survey about the
                                                    Institutes of Health (NIH) will publish                                  non-toll-free number (240) 276–6582, or
                                                    periodic summaries of proposed                                                                                                             volume of samples that are accessioned
                                                                                                                             Email your request, including your                                at different pathology laboratories, and
                                                    projects to be submitted to the Office of                                address to: goli.samimi@nih.gov. Formal
                                                    Management and Budget (OMB) for                                                                                                            the methods used to process these
                                                                                                                             requests for additional plans and                                 samples. These data would provide
                                                    review and approval.                                                     instruments must be requested in                                  information necessary to assess the
                                                       Written comments and/or suggestions                                   writing.                                                          feasibility of establishing a tissue bank
                                                    from the public and affected agencies                                      Comment Due Date: Comments
                                                    are invited to address one or more of the                                                                                                  for research and provide insights into
                                                                                                                             regarding this information collection are
                                                    following points: (1) Whether the                                                                                                          the best design of a pilot study.
                                                                                                                             best assured of having their full effect if
                                                    proposed collection of information is                                    received within 60 days of the date of                               OMB approval is requested for 1 year.
                                                    necessary for the proper performance of                                  this publication.                                                 There are no costs to respondents other
                                                    the function of the agency, including                                      Proposed Collection: Survey to assess                           than their time. The total estimated
                                                    whether the information will have                                        the feasibility of establishing a                                 annualized burden hours are 42 hours.

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

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

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



                                                      Dated: March 2, 2016.                                                  Health, 31 Center Drive, Building 31,                             DEPARTMENT OF HEALTH AND
                                                    Karla Bailey,                                                            Conference Room 10, Bethesda, MD,                                 HUMAN SERVICES
                                                    Project Clearance Liaison, National Cancer                               20892 which was published in the
                                                    Institute, NIH.                                                          Federal Register on February 26, 2016,                            National Institutes of Health
                                                    [FR Doc. 2016–05021 Filed 3–7–16; 8:45 am]                               81 FR 9867.
                                                                                                                                                                                               National Cancer Institute; Notice of
                                                    BILLING CODE 4140–01–P                                                     The meeting notice is amended to                                Closed Meetings
                                                                                                                             change the meeting date to March 29,
                                                                                                                             2016. The meeting is open to the public.
                                                    DEPARTMENT OF HEALTH AND                                                                                                                     Pursuant to section 10(d) of the
                                                    HUMAN SERVICES                                                             Dated: March 2, 2016.
                                                                                                                                                                                               Federal Advisory Committee Act, as
                                                                                                                             David Clary,                                                      amended (5 U.S.C. App.), notice is
                                                    National Institutes of Health
                                                                                                                             Program Analyst, Office of Federal Advisory                       hereby given of the following meetings.
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    National Cancer Institute; Amended                                       Committee Policy.                                                   The meetings will be closed to the
                                                    Notice of Meeting                                                        [FR Doc. 2016–05018 Filed 3–7–16; 8:45 am]                        public in accordance with the
                                                                                                                             BILLING CODE 4140–01–P                                            provisions set forth in sections
                                                      Notice is hereby given of a change in                                                                                                    552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                    the meeting of the National Cancer                                                                                                         as amended. The grant applications and
                                                    Institute Board of Scientific Advisors,                                                                                                    the discussions could disclose
                                                    March 29, 2016, 08:30 a.m. to March 30,                                                                                                    confidential trade secrets or commercial
                                                    2016, 12:00 p.m., National Institutes of                                                                                                   property such as patentable material,


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Document Created: 2018-02-02 15:10:27
Document Modified: 2018-02-02 15:10:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
FR Citation81 FR 12111 

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