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

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 (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 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