[Federal Register Volume 67, Number 102 (Tuesday, May 28, 2002)]
[Notices]
[Pages 36900-36901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13276]


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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 for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on February 
7, 2002, page 5834 and allowed 60 days for public comment. No public 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Institutes of 
Health may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.

Proposed Collection

    Title: Prostate, Lung, Colorectal and Ovarian Cancer Screening 
Trial. Type of Information Collection Request: Revision, 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 should address 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.

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, Washington, DC 20503, Attention: Desk

[[Page 36901]]

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. John Gohagan, Chief, Early Detection Research Group, National 
Cancer Institute, NIH, EPN Building, Suite 3100, 6130 Executive 
Boulevard, MSC7346, 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 collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: May 21, 2002.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 02-13276 Filed 5-24-02; 8:45 am]
BILLING CODE 4140-01-M