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

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,

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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