[Federal Register Volume 61, Number 162 (Tuesday, August 20, 1996)]
[Notices]
[Pages 43063-43064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

SUMMARY: Under the provisions of Section 3506(c)(2)(A) 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 June 7, 
1996, page 29106 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

[[Page 43064]]

Collection: EXTENSION, OMB control number 0925-0407, expiration date 
September 30, 1996. Need and Use of Information Collection Request: 
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 anticipated total sample size, after four and one half 
years of recruitment, is projected to be 148,000. 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: 100,522; Estimated Number of Responses per Respondent: 
1.98; Average Burden Hours Per Response: 0.59; and Estimated Total 
Annual Burden Hours Requested: 114,537. The annualized cost to 
respondents is estimated at: $1,145,367. 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) 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, Washington, D.C. 
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. John Gohagan , Chief, Early Detection 
Branch, EDCOP, National Cancer Institute, NIH, EPN Building, Room 330, 
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 on or before 
September 19, 1996.

    Dated: August 9, 1996.
Philip D. Amoruso,
Executive Officer, NCI.
[FR Doc. 96-21127 Filed 8-19-96; 8:45 am]
BILLING CODE 4140-01-M