[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35685-35686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Prostate, Lung, 
Colorectal and Ovarian Cancer Screening Trial

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request to review and approve the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on January 
24, 2005, page 3376 and allowed 60-days for public comment. Three 
requests for more information were received. Additional information on 
the proposed collection was sent to each requestor. The purpose of this 
notice is to allow an additional 30 days for public comment.
    5 CFR 1320.5 (General requirements) Reporting and Recordkeeping 
Requirements: Final Rule requires that the agency inform the potential 
persons who are to respond to the collection of information that such 
persons are not required to respond to the collection of information 
unless it displays a currently valid OMB control number. This 
information is required to be stated in the 30-day Federal Register 
Notice.
    Proposed Collection: Title: Prostate, Lung, Colorectal and Ovarian 
Cancer Screening Trial. Type of Information Collection Request: 
Revision, 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        number of      Average burden  Estimated total
             Type of respondents               annual number    responses per      hours per      annual burden
                                               of respondents     respondent        response     hours requested
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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 should address 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235,

[[Page 35686]]

Washington, DC 20503, Attention: Desk Officer for NIH. 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 30-days 
of the date of this publication.

    Dated: June 10, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-12128 Filed 6-20-05; 8:45 am]
BILLING CODE 4140-01-P