[Federal Register Volume 70, Number 14 (Monday, January 24, 2005)]
[Notices]
[Page 3376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1176]



[[Page 3376]]

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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 July 31, 2005.
    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 263,000 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 t is 154,938. 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: 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: 145,852;
    Estimated Number of Responses Per Respondent: 1.14;
    Average Burden Hours Per Response: 0.14; and
    Estimated Total Annual Burden Hours Requested: 23,278.
    The annualized cost to respondents is estimated at: $232,780. There 
are no Capital Costs to report. There are no Operating or Maintenance 
Costs to report.

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                                                                  Estimated                      Estimated total
                                                 Estimated        number of     Average  burden   annual burden
             Type of respondents               annual number    responses per      hours per          hours
                                               of respondents     respondent        response        requested
----------------------------------------------------------------------------------------------------------------
Adults......................................         145,852             1.14             0.14           23,278
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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: January 10, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-1176 Filed 1-21-05; 8:45 am]
BILLING CODE 4140-01-P