96-14431. Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial; Proposed Collection; Comment Request;

[Federal Register Volume 61, Number 111 (Friday, June 7, 1996)]
[Notices]
[Page 29106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14431]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial; 
Proposed Collection; Comment Request;

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 September 30, 
1996. 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 
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: 75,333; Estimated Number of Responses per Respondent: 1.7; 
Average Burden Hours Per Response: .573; and Estimated Total Annual 
Burden Hours Requested: 73,400. The annualized cost to respondents is 
estimated at: $734,290. 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.

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 330, 6130 Executive Boulevard, Bethesda, MD 20892-
7346, or call non-toll-free number [phone] or E-mail your 
request, including your address to: [e-mail]

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: May 30, 1996.
Philip D. Amoruso,
Executive Officer, NCI.
[FR Doc. 96-14431 Filed 6-6-96; 8:45 am]
BILLING CODE 4140-01-M