[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22211-22212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Prostate, Lung, 
Colorectal and Ovarian Cancer Screening Trial (PLCO) (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 
(NCI), 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 on 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) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to 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: Kelly Yu, 
Ph.D., Division of Cancer Prevention, 9609 Medical Center Drive, Room 
5E230, Rockville, MD 20850 or call non-toll-free number 240-276-7041 or 
Email your request, including your address to: <a href="/cdn-cgi/l/email-protection#29505c424c694448404507474041074e465f"><span class="__cf_email__" data-cfemail="b6cfc3ddd3f6dbd7dfda98d8dfde98d1d9c0">[email protected]</span></a>. 
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: Prostate, Lung, Colorectal, and Ovarian Cancer 
Screening Trial (PLCO), 0925-0407, Extension, National Cancer Institute 
(NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This is a request for a 
revision of the Prostate, Lung, Colorectal and Ovarian Cancer Screening 
Trial (PLCO). This trial was designed to determine if cancer screening 
for prostate, lung, colorectal, and ovarian cancer can reduce mortality 
from these cancers which caused an estimated 253,320 deaths in the U.S. 
in 2014. The design is a two-armed randomized trial of men and women 
aged 55 to 74 at entry. OMB first approved this study in 1993 and has 
approved it every 3 years since then. Recruitment was completed in 
2001, baseline cancer screening was completed in 2006, and data 
collection continues on the current cohort of 77,281 participants who 
are actively being followed. The additional follow-up will provide data 
that will clarify further the long term effects of the screening on 
cancer incidence and mortality for the four targeted cancers. Further, 
demographic and risk factor information may be used to analyze the 
differential effectiveness of cancer screening in high versus low risk 
individuals.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 26,320.

[[Page 22212]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
           Form name                 Type of         Number of     responses per   per response    Annual burden
                                   respondents      respondents     respondent    (minutes/hour)       hours
----------------------------------------------------------------------------------------------------------------
Annual Study Update(ASU) Form.  Participants who          77,281               1            5/60           6,440
                                 complete the
                                 ASU.
ASU Telephone Script..........  Non Responders             3,091               1            5/60             258
                                 to the ASU.
Authorization to Release        Participants who           2,700               1            3/60             135
 Medical Records.                report new
                                 cancers.
Health Status Questionnaire     Female                       960               1            5/60              87
 (Female) (HSQ).                 participants
                                 who complete
                                 the HSQ.
Health Status Questionnaire     Male                       1,040               1            5/60              80
 (Male) (HSQ).                   participants
                                 who complete
                                 the HSQ.
Medication Use Questionnaire    Participants who          77,281               1           15/60          19,320
 (MUQ).                          complete the
                                 MUQ.
----------------------------------------------------------------------------------------------------------------


    Dated: April 7, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-09090 Filed 4-20-15; 8:45 am]
 BILLING CODE 4140-01-P


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