[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)
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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