Submission for OMB Review; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI), 41805 [2011-17750]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Notices]
[Page 41805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17750]



[[Page 41805]]

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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 April 
20, 2011 (76 FR 22108) and allowed 60 days for public comment. One 
public comment was received on April 20, 2011 which commented on the 
government spending money to support NIH. An email response was sent on 
May 18, 2011 stating, ``Thank you for your comments and we will take it 
under advisement.'' 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) (NCI). Type of Information Collection 
Request: Revision (OMB : 0925-0407, current expiry date 10/31/
2011). 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 254,570 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 2011. 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 2014. 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 122,655; 
this is down from the initial total due to deaths. 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 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 annual 
reporting burden is provided for each study component as shown in the 
Table 1 below. There are no Capital Costs, Operating Costs, and/or 
Maintenance Costs to report.

                                                        Table 1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Average time per
             Type of respondents                    Survey  instrument            Number of         Frequency of         response        Annual burden
                                                                                 respondents          response        (minutes/hour)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Male and Female Participants................  ASU...........................             92,941               1.00        5/60 (0.08)              7,745
                                              HSQ...........................              2,000               1.00        5/60 (0.08)                167
                                              SQX...........................             92,941               1.00       30/60 (0.50)             46,471
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............................  .................  .................  .................             54,383
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 Attention: NIH Desk Officer, Office of Management and 
Budget, at OIRA_submission@omb.eop.gov 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 3100, 6130 Executive Boulevard, Bethesda, MD 
20892, or call non-toll-free number 301-496-8544 or e-mail your 
request, including your address to: bergc@mail.nih.gov.
    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: July 7, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-17750 Filed 7-14-11; 8:45 am]
BILLING CODE 4140-01-P