[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Pages 22108-22109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9509]
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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 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
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 the 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 Number of Frequency of response Annual burden
instrument respondents response (minutes/hour) hours
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Male and Female Participants.................................. ASU 92,941 1.00 5/60 7,745
(0.08)
HSQ 2,000 1.00 5/60 167
(0.08)
SQX 92,941 1.00 30/60 46,471
(0.50)
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Total..................................................... ................ ................ ................ ................ 54,383
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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 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]
BILLING CODE 4140-01-P