[Federal Register Volume 73, Number 160 (Monday, August 18, 2008)]
[Notices]
[Pages 48214-48215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18981]


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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 (PLCO) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) 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 June 6, 
2008, Volume 73, Number 110, Page 32338 and allowed 60 days for public 
comment. In response to the notice, there were no public comments 
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 (PLCO). Type of Information Collection Request: 
REVISION (OMB : 0925-0407, current expiry date 10/31/2008). 
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 254,900 deaths annually in the U.S. The design is a two-armed 
randomized trial of men and women aged 55 to 74 at entry. OMB first 
approved this study in 1993 and has approved it every 3 years since 
then through 2008. During the first approval period a pilot study was 
conducted to evaluate recruitment methods and data collection 
procedures. Recruitment was completed in 2001 and data collection 
continues through 2008. When participants enrolled in the trial they 
agreed to be followed for at least 13 years from the time of 
enrollment. The current number of respondents in the study is 136, 341; 
this is down from the total initially due to deaths. The primary 
endpoint of the trial is cancer-specific mortality for each of the four 
cancer sites (prostate, lung, colorectum, 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 may be used 
to analyze the differential effectiveness of screening in high versus 
low risk individuals. Frequency of Response: Annually. Affected Public: 
Individuals. Type of Respondents: Adult men and women. The estimated 
total annual burden hours requested is 11,401. The annualized cost to 
respondents is estimated at $219,919 per year, for a total of $659,756 
over the proposed three year renewal. There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.

                                 Table A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
       Type of respondents            Survey         Number of     Frequency of    per response    Total annual
                                    instrument      respondents      response         (hours)      burden hours
----------------------------------------------------------------------------------------------------------------
Male and Female Participants....             ASU      133,341.00            1.00            5/60       11,111.75
                                             HSQ        1,333.33            1.00            5/60          111.08
Male Participants...............        Prostate        1,066.67            1.00           10/60          177.83
                                                                                                 ---------------
    Total.......................  ..............  ..............  ..............  ..............       11,400.66
----------------------------------------------------------------------------------------------------------------

    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

[[Page 48215]]

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 Attention: NIH Desk Officer, Office of Management and 
Budget, at [email protected] or by fax to 202-395-6974. To 
request more information on the proposed project or to obtain a copy of 
the data collection plans and instruments, contact: Dr. Christine D. 
Berg, Chief, Early Detection Research Group, National Cancer Institute, 
NIH, EPN Building, Room 3070, 6130 Executive Boulevard, Bethesda, MD 
20892, or call non-toll-free number 301-496-8544 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 30 days 
of the date of this publication.

    Dated: August 5, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-18981 Filed 8-19-08; 8:45 am]
BILLING CODE 4140-01-P