[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Pages 22108-22109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9509]



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 expiry date 10/31/
2011). 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 254,570 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 2011. During the first approval period a pilot study was 
conducted to evaluate recruitment methods and data collection 
procedures. Recruitment was completed in 2001 and data collection 
continues through 2014. 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 122,655; 
this is down from the initial total due to deaths. The primary endpoint 
of the trial is cancer specific mortality for each of the four cancer 
sites (prostate, lung, colorectal, 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 
    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 the Table 1 
below. There are no Capital Costs, Operating Costs, and/or Maintenance 
Costs to report.

                                                        Table 1--Estimates of Annual Burden Hours
                                                                                                                      Average time per
                      Type of respondents                            Survey           Number of       Frequency of        response        Annual burden
                                                                   instrument        respondents        response       (minutes/hour)         hours
Male and Female Participants..................................               ASU            92,941              1.00              5/60             7,745
                                                                             HSQ             2,000              1.00              5/60               167
                                                                             SQX            92,941              1.00             30/60            46,471
    Total.....................................................  ................  ................  ................  ................            54,383

    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 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.

[[Page 22109]]

    Dated: April 13, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-9509 Filed 4-19-11; 8:45 am]