[Federal Register Volume 73, Number 110 (Friday, June 6, 2008)]
[Notices]
[Pages 32338-32339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12641]


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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). Type of Information Collection Request: 
REVISION (OMB : 0925-0407, current expiry date 10/31/2008). 
Need and Use of Information Collection: This trial is designed to 
determine if screening for prostate, lung, colorectal and ovarian 
cancer can reduce mortality from these cancers which currently cause an 
estimated 254,900 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 
then through 2008. During the first approval period a pilot study was 
conducted to

[[Page 32339]]

evaluate recruitment methods and data collection procedures. 
Recruitment was completed in 2001 and data collection continues through 
2008. When participants enrolled in the trial they agreed to be 
followed for at least 13 years from the time of enrollment. The current 
number of respondents in the study is 136, 341; this is down from the 
total initially due to deaths. The primary endpoint of the trial is 
cancer-specific mortality for each of the four cancer sites (prostate, 
lung, colorectum, and ovary). In addition, cancer incidence, stage 
shift, and case survival are to be monitored to help understand and 
explain results. Biologic prognostic characteristics of the cancers 
will be measured and correlated with mortality to determine the 
mortality predictive value of these intermediate endpoints. Basic 
demographic data, risk factor data for the four cancer sites and 
screening history data, as collected from all subjects at baseline, 
will be used to assure comparability between the screening and control 
groups and make appropriate adjustments in analysis. Further, 
demographic and risk factor information may be used to analyze the 
differential effectiveness of screening in high versus low risk 
individuals. Frequency of Response: Annually. Affected Public: 
Individuals. Type of Respondents: Adult men and women. The estimated 
total annual burden hours requested is 11,401. The annualized cost to 
respondents is estimated at $219,919 per year, for a total of $659,756 
over the proposed three year renewal. There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.

                                                     Table A.12-1.--Estimates of Annual Burden Hours
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                                                                                                                      Average time per
            Type of respondents                       Survey instrument               Number of       Frequency of        response        Total annual
                                                                                     respondents        response       (minutes/hour)     burden hours
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Male and Female Participants...............  ASU................................           133,341              1.00              5/60         11,111.75
                                             HSQ................................             1,333              1.00              5/60            111.08
Male Participants..........................  Prostate...........................             1,067              1.00             10/60            177.83
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    Total..................................  ...................................  ................  ................  ................         11,400.66
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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) 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.

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 
3070, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-
free number 301-496-8544 or e-mail 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: May 29, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-12641 Filed 6-5-08; 8:45 am]
BILLING CODE 4140-01-P