[Federal Register Volume 64, Number 73 (Friday, April 16, 1999)]
[Notices]
[Pages 18918-18919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Data 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 September 30, 1999.
    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 55 to 74 at entry. The anticipated 
total sample size, after 6\1/2\ 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,

[[Page 18919]]

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: 141,250;
    Estimated Number of Responses Per Respondent: 1.5;
    Average Burden Hours Per Response: .42; and
    Estimated Total Annual Burden Hours Requested: 91,288.
    The annualized cost to respondents is estimated at: $912,884. 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 (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 
June 15, 1999.

    Dated: April 8, 1999.
Reesa Nichols,
OMB Clearance Liaison.
[FR Doc. 99-9487 Filed 4-15-99; 8:45 am]
BILLING CODE 4140-10-M