[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Notices]
[Page 46696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 April 
16, 1999, pages 18918-18919 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 Collection Request: Revision, OMB control 
number 0925-0407, expiration date October 31, 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 aged 55 to 74 at entry. The anticipated total sample 
size, after eight 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: 142,359; Estimated Number of Responses per Respondent: 
1.65; Average Burden Hours Per Response: 0.40; and Estimated Total 
Annual Burden Hours Requested: 94,809. The annualized cost to 
respondents is estimated at: $948,090. 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, DC 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 Research Group, 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 27, 1999.

    Dated: August 19, 1999.
Reesa L. Nichols,
NCI Project Clearance Liaison.
[FR Doc. 99-22242 Filed 8-25-99; 8:45 am]
BILLING CODE 4140-01-M