[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
