[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25184]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request (30-Day FRN); 
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 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 July 16, 2012 (FR 77, 41791) and allowed 60-days for public 
comment. One public comment was received and a response was sent. The 
comment referenced alternative research that is unrelated to cancer 
screening. 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.
    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 email your request, including 
your address to: bergc@mail.nih.gov.
    Comments regarding this information collection are best assured of 
having their full effect if received within 30 days of the date of this 
publication.
    Proposed Collection: Prostate, Lung, Colorectal, and Ovarian Cancer 
Screening Trial (PLCO), OMB No: 0925-0407, Expiration Date 9/30/2014, 
Revision, National Cancer Center (NCI), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: This trial was designed to 
determine if screening for prostate, lung, colorectal, and ovarian 
cancer can reduce mortality from these cancers which currently cause an 
estimated 255,700 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 2014. During the first approval period a pilot study was 
conducted to evaluate recruitment methods and data collection 
procedures. Recruitment was completed in 2001, screening was completed 
in 2006, and data collection continues through 2016. When participants 
enrolled in the trial they agreed to be followed for at least 13 years 
from the time of enrollment. In 2011, participants were re-consented 
for at least an additional five years of follow-up. The current number 
of respondents is limited to the approximately 94,000 participants 
being actively followed up. This is down from the initial total. The 
reports on screening and prostate, lung, colorectal and ovarian cancer 
mortality based on this trial have been published in peer review 
medical journals. The additional follow-up will provide data that will 
clarify further the long term effects of the screening on cancer 
incidence and mortality for the four targeted cancers. Further, 
demographic and risk factor information may be used to analyze the 
differential effectiveness of screening in high versus low risk 
individuals.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 31,813.

                                                          Estimates of Annualized Burden Hours
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                                                                                                             Number of     Average time
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent       (in hrs)          hours
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Male and Female Participants...................  ASU....................................          94,000               1            5/60           7,833
                                                 Script for ASU Non-response............           3,760               1            5/60             313
                                                 HSQ....................................           2,000               1            5/60             167
                                                 MUQ....................................          94,000               1           15/60          23,500
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          31,813
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    Dated: October 5, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2012-25184 Filed 10-12-12; 8:45 am]
BILLING CODE 4140-01-P