Submission for OMB Review; Comment Request (30-Day FRN); Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI), 62518 [2012-25184]

Download as PDF 62518 Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices Dated: October 9, 2012. Ron A. Otten, Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–25248 Filed 10–12–12; 8:45 am] BILLING CODE 4163–18–P 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) 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 SUMMARY: 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-tollfree 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 Number of respondents Number of responses per respondent Average time per response (in hrs) Total burden hours Type of respondents Form name Male and Female Participants .......... ASU .................................................. Script for ASU Non-response .......... HSQ ................................................. MUQ ................................................. 94,000 3,760 2,000 94,000 1 1 1 1 5/60 5/60 5/60 15/60 7,833 313 167 23,500 Total ........................................... .......................................................... ........................ ........................ ........................ 31,813 Dated: October 5, 2012. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, NCI, NIH. [FR Doc. 2012–25184 Filed 10–12–12; 8:45 am] erowe on DSK2VPTVN1PROD with BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request: Recipient Epidemiology and Donor Evaluation Study-III (REDS–III) Request for Generic Clearance 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 SUMMARY: VerDate Mar<15>2010 15:21 Oct 12, 2012 Jkt 229001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS–III). Type of Information Collection Request: New. Need and Use of Information Collection: The objective of the Recipient Epidemiology and Donor Evaluation E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[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]

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

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