[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Page 5834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2904]


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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

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. Type of Information Collection Request: 
EXTENSION, OMB control number 0925-0407, expiration date October 31, 
2002. 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 251,000 deaths annually in the U.S. The design is a two-armed 
randomized trial of men and women aged 55 to 74 at entry. The total 
sample size after more than 8 years of recruitment is 154,956. 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 will be used 
to analyze the differential effectiveness of screening in high versus 
low risk individuals. Frequency of Response: On occasion. Affected 
Public: Individuals or households. Type of Respondents: Adult men and 
women. The annual reporting burden is as follows: Estimated Number of 
Respondents: 150,598; Estimated Number of Responses Per Respondent: 
1.38; Average Burden Hours Per Response: 0.19; and Estimated Total 
Annual Burden Hours Requested: 39,597. The annualized cost to 
respondents is estimated at: $395,970. There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.
    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. John Gohagan, Chief, Early Detection Branch, 
EDCOP, National Cancer institute, NIH, EPN Building, Room 3100, 6130 
Executive Boulevard, Bethesda, MD 20892-7346, or call non-toll-free 
number (301) 496-3982 or e-mail your request, including your address 
to: [email protected].
    Comments Due Date: Comments regarding this information collections 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: January 28, 2002.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 02-2904 Filed 2-6-02; 8:45 am]
BILLING CODE 4140-01-M