[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22211-22212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09090]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Prostate, Lung,
Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), National Institutes of Health (NIH), will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
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) 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) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to 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.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
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 or 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.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Prostate, Lung, Colorectal, and Ovarian Cancer
Screening Trial (PLCO), 0925-0407, Extension, 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.
[[Page 22212]]
Estimated Annualized Burden Hours
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Number of Average time
Form name Type of Number of responses per per response Annual burden
respondents respondents respondent (minutes/hour) hours
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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 87
(Female) (HSQ). participants
who complete
the HSQ.
Health Status Questionnaire Male 1,040 1 5/60 80
(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: April 7, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-09090 Filed 4-20-15; 8:45 am]
BILLING CODE 4140-01-P