Proposed Collection; Comment Request: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) Request for Generic Clearance, 62518-62519 [2012-25247]
Download as PDF
<![CDATA[
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
Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices
Study-III (REDS–III) program is to
ensure safe and effective blood banking
and transfusion medicine practices
through a comprehensive, multifaceted
strategy involving basic, translational,
and clinical research to improve the
benefits of transfusion while reducing
its risks. The conduct of epidemiologic,
survey, and laboratory studies is the
cornerstone of REDS–III and its
predecessors, the REDS and REDS–II
programs. Over the past 20 years, the
National Heart, Lung, and Blood
Institute (NHLBI) REDS programs have
proven to be the premier research
programs in blood collection and
transfusion safety in the United States.
Successive renditions of the REDS
programs have built upon the many
successes that this research network has
realized over the years while being
responsive to changing research and
clinical needs, and adapting to emerging
priorities. Research findings have served
to improve the screening of donors and
collected blood products, blood banking
practices, diagnoses, and the basic
science principles of transfusion
medicine.
While significant progress has been
made, transfusion therapy—a very
commonly used therapy affecting about
six million recipients annually in the
U.S.—remains one of the least
understood medical procedures. REDS–
II conducted studies of blood donor
health but much more needs to be
learned, including how donor genetic or
environmental factors may affect the
quality of collected blood components
and influence non-infectious
transfusion complications in recipients.
Additionally, there is always the
potential that a new, emerging or reemerging infection may pose a threat to
the safety of the U.S. blood supply.
Much of the success of the REDS
programs was due to their ability to
respond in a timely fashion to potential
blood safety threats such as West Nile
Virus (WNV) in 2002 or Xenotropic
Murine Leukemia Virus Related Virus
(XMRV) in 2009. Globally, the threat of
HIV and other blood-borne infections to
blood safety remains real and has to be
closely monitored. Therefore,
continuing collection of new scientific
evidence through REDS–III is both
critical to public health in the U.S. and
to countries struggling with the HIV
epidemic where blood safety and
availability are major concerns.
Additionally, the research areas
encompassed in REDS–III have been
and continue to be hypothesis
generating, leading to the development
of new basic and translational research
projects with implications well beyond
the fields of blood banking and
transfusion medicine. REDS–III has also
been charged with the tasks of
education and training and integration
of these components in a transfusion
medicine research network.
With this submission, the REDS–III
Study seeks approval from OMB to
62519
develop research studies with data
collection activities using focus groups,
cognitive interviews, questionnaires
and/or qualitative interviews following
all required informed consent
procedures for respondents and parents/
caregivers as appropriate. With this
generic clearance, study investigators
will be able to use the OMB-approved
data collection methods where
appropriate to plan and implement time
sensitive studies. Such studies that fall
within the overall scope of this
submission will be subjected to
expedited review and approval by OMB
before their implementation.
Additionally, studies are reviewed by an
NHLBI Observational Study Monitoring
Board (OSMB) and by all relevant IRBs.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Males and females 16
years old or older. The annual reporting
burden is as follows: Estimated Number
of Respondents: 6,882; Estimated
Number of Responses per Respondent:
1; Average Burden of Hours per
Response: 1 hour; Estimated Total
Annual Burden Hours Requested: 6,826.
The annualized total costs to all
respondents except for the Brazil and
South Africa studies are estimated at
$53,964 (based on $9.00 per hour). The
annualized total cost to all respondents
for the Brazil and South African studies
is $2,940. There are no capital,
operating, or maintenance costs to the
respondents.
ESTIMATED BURDEN HOURS FOR PROPOSED EXAMPLE STUDIES TO BE CONDUCTED UNDER THIS CLEARANCE
Number of
respondents
Forms
erowe on DSK2VPTVN1PROD with
Summary of Burdens .......................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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 the assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information 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,
VerDate Mar<15>2010
15:21 Oct 12, 2012
Jkt 229001
6,882
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Simone Glynn,
MD, Project Officer/ICD Contact, Two
Rockledge Center, Suite 9142, 6701
Rockledge Drive, Bethesda, MD 20892,
or call 301–435–0065, or Email your
request to: glynnsa@nhlbi.nih.gov.
Comments 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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00030
Fmt 4703
Sfmt 9990
Number of
responses
per
respondent
Average
burden per
response
(in hours)
1
0.25–1 hour
Total annual
burden hours
6,826
Dated: August 24, 2012.
Keith Hoots,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, NIH.
Dated: October 1, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–25247 Filed 10–12–12; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Pages 62518-62519]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25247]
-----------------------------------------------------------------------
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
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 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
[[Page 62519]]
Study-III (REDS-III) program is to ensure safe and effective blood
banking and transfusion medicine practices through a comprehensive,
multifaceted strategy involving basic, translational, and clinical
research to improve the benefits of transfusion while reducing its
risks. The conduct of epidemiologic, survey, and laboratory studies is
the cornerstone of REDS-III and its predecessors, the REDS and REDS-II
programs. Over the past 20 years, the National Heart, Lung, and Blood
Institute (NHLBI) REDS programs have proven to be the premier research
programs in blood collection and transfusion safety in the United
States. Successive renditions of the REDS programs have built upon the
many successes that this research network has realized over the years
while being responsive to changing research and clinical needs, and
adapting to emerging priorities. Research findings have served to
improve the screening of donors and collected blood products, blood
banking practices, diagnoses, and the basic science principles of
transfusion medicine.
While significant progress has been made, transfusion therapy--a
very commonly used therapy affecting about six million recipients
annually in the U.S.--remains one of the least understood medical
procedures. REDS-II conducted studies of blood donor health but much
more needs to be learned, including how donor genetic or environmental
factors may affect the quality of collected blood components and
influence non-infectious transfusion complications in recipients.
Additionally, there is always the potential that a new, emerging or re-
emerging infection may pose a threat to the safety of the U.S. blood
supply. Much of the success of the REDS programs was due to their
ability to respond in a timely fashion to potential blood safety
threats such as West Nile Virus (WNV) in 2002 or Xenotropic Murine
Leukemia Virus Related Virus (XMRV) in 2009. Globally, the threat of
HIV and other blood-borne infections to blood safety remains real and
has to be closely monitored. Therefore, continuing collection of new
scientific evidence through REDS-III is both critical to public health
in the U.S. and to countries struggling with the HIV epidemic where
blood safety and availability are major concerns. Additionally, the
research areas encompassed in REDS-III have been and continue to be
hypothesis generating, leading to the development of new basic and
translational research projects with implications well beyond the
fields of blood banking and transfusion medicine. REDS-III has also
been charged with the tasks of education and training and integration
of these components in a transfusion medicine research network.
With this submission, the REDS-III Study seeks approval from OMB to
develop research studies with data collection activities using focus
groups, cognitive interviews, questionnaires and/or qualitative
interviews following all required informed consent procedures for
respondents and parents/caregivers as appropriate. With this generic
clearance, study investigators will be able to use the OMB-approved
data collection methods where appropriate to plan and implement time
sensitive studies. Such studies that fall within the overall scope of
this submission will be subjected to expedited review and approval by
OMB before their implementation. Additionally, studies are reviewed by
an NHLBI Observational Study Monitoring Board (OSMB) and by all
relevant IRBs.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Males and females 16 years old or older. The annual
reporting burden is as follows: Estimated Number of Respondents: 6,882;
Estimated Number of Responses per Respondent: 1; Average Burden of
Hours per Response: 1 hour; Estimated Total Annual Burden Hours
Requested: 6,826. The annualized total costs to all respondents except
for the Brazil and South Africa studies are estimated at $53,964 (based
on $9.00 per hour). The annualized total cost to all respondents for
the Brazil and South African studies is $2,940. There are no capital,
operating, or maintenance costs to the respondents.
Estimated Burden Hours for Proposed Example Studies To Be Conducted Under This Clearance
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Summary of Burdens.............................. 6,882 1 0.25-1 hour 6,826
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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 the assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information 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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Simone Glynn, MD, Project Officer/ICD Contact,
Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD
20892, or call 301-435-0065, or Email your request to:
glynnsa@nhlbi.nih.gov.
Comments 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.
Dated: August 24, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: October 1, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-25247 Filed 10-12-12; 8:45 am]
BILLING CODE 4140-01-P
