[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Page 41508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day 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 Institutes of Health (NIH), has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on April 21, 2015 (80 FR 22211), 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 Cancer Institute (NCI), 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.
    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, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: Kelly Yu, Ph.D., Division of Cancer 
Prevention, 9609 Medical Center Drive, Room 5E230, Rockville, MD 20850 
call non-toll-free number 240-276-7041 or Email your request, including 
your address to: [email protected]. Formal requests for additional 
plans and instruments must be requested in writing.
    Proposed Collection: Prostate, Lung, Colorectal and Ovarian Cancer 
Screening Trial (PLCO) 0925-0407, Revision, National Cancer Institute 
(NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This is a request for a 
revision of the Prostate, Lung, Colorectal and Ovarian Cancer Screening 
Trial (PLCO). This trial was designed to determine if cancer screening 
for prostate, lung, colorectal, and ovarian cancer can reduce mortality 
from these cancers which caused an estimated 253,320 deaths in the U.S 
in 2014. 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. Recruitment was completed in 
2001, baseline cancer screening was completed in 2006, and data 
collection continues on the current cohort of 77,281 participants who 
are actively being followed. 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 cancer 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 26,320.

                                        Estimated Annualized Burden Hours
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                                                                                   Average time
                                     Type of         Number of       Number of     per response    Annual burden
           Form name               respondents      respondents    responses per     (minutes/         hours
                                                                    respondent         hour)
----------------------------------------------------------------------------------------------------------------
Annual Study Update (ASU) Form  Participants who          77,281               1            5/60           6,440
                                 complete the
                                 ASU.
ASU Telephone Script..........  Non Responders             3,091               1            5/60             258
                                 to the ASU.
Authorization to Release        Participants who           2,700               1            3/60             135
 Medical Records.                report new
                                 cancers.
Health Status Questionnaire     Female                       960               1            5/60              80
 (Female) (HSQ).                 participants
                                 who complete
                                 the HSQ.
Health Status Questionnaire     Male                       1,040               1            5/60              87
 (Male) (HSQ).                   participants
                                 who complete
                                 the HSQ.
Medication Use Questionnaire    Participants who          77,281               1           15/60          19,320
 (MUQ).                          complete the
                                 MUQ.
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    Dated: June 23, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-17340 Filed 7-14-15; 8:45 am]
 BILLING CODE 4140-01-P