[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41791-41792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 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), 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.
    Proposed Collection: Title: Prostate, Lung, Colorectal, and Ovarian 
Cancer Screening Trial (PLCO) (NCI). Type of Information Collection 
Request: Revision (OMB : 0925-0407, current expiration date 9/
30/2014). Need and Use of Information Collection: This trial was 
designed to determine if cancer screening for prostate, lung, 
colorectal, and ovarian cancer can reduce mortality from these cancers 
which currently cause an estimated 255,700 deaths annually in the U.S. 
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. The main change to this submission is that the 
Supplemental Questionnaire is being replaced with the Medication Use 
Questionnaire. As PLCO participants now range from 74-94 years of age, 
the focus is now on collecting additional information regarding 
medications that are particularly common among older adults. 
Additionally, the contracts for 8 of the 10 Screening Centers (SCs) 
ended in 2011 and the remaining two sites will close in 2012 and 2014. 
NCI has awarded a contract for continuation of participant follow-up 
activities to one data collection site named the PLCO Central Data 
Collection Center (CDCC). In 2011, participants were re-consented for 
at least an additional five years of follow-up. The current number of 
respondents is limited to the approximately 94,000 participants being 
actively followed up. The reports on cancer screening and prostate, 
lung, colorectal, and ovarian cancer mortality based on this trial have 
been published in peer review medical journals. 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. Frequency of Response: Annually. Affected 
Public: Individuals. Type of Respondents: Adult men and women. The 
annual reporting burden is provided for each study component as shown 
in Table 1 below. There are no Capital Costs, Operating Costs, and/or 
Maintenance Costs to report.

                                                        Table 1--Estimates of Annual Burden Hours
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                                                                                                                      Average time per
           Type of respondents                 Survey instrument          Number of respondents       Frequency of        response        Annual burden
                                                                                                        response       (minutes/hour)         hours
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Male and female participants............  ASU........................  94,000.....................              1.00              5/60             7,833

[[Page 41792]]

 
                                          Script for ASU Non-response  3,760......................              1.00              5/60               313
                                          HSQ........................  2,000......................              1.00              5/60               167
                                          MUQ........................  94,000.....................              1.00             15/60            23,500
                                                                                                                                       -----------------
    Total...............................  ...........................  ...........................  ................  ................            31,813
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    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Evaluate 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) Evaluate 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) Enhance 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. Christine D. Berg, Chief, Early Detection 
Research Group, National Cancer Institute, NIH, EPN Building, Room 
3100, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-
free number 301-496-8544 or email your request, including your address 
to: [email protected].
    Comments 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.

    Dated: July 10, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-17237 Filed 7-13-12; 8:45 am]
BILLING CODE 4140-01-P