[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8153-8154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02480]
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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: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood
Institute (NHLBI), the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval the information collection listed below. This
proposed information collection was previously published in the Federal
Register in Volume 77, No. 199/Monday, October 15, 2012, pages 62518-
62519, and allowed 60-days for public comment. No comments have been
received. 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.
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 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.
[[Page 8154]]
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: Focus Groups: 1 per
respondent; Cognitive Interviews: 2 per respondent; Respondent Surveys:
3 per respondent. Average Burden of Hours per Response: Focus Groups:
1.5 hours per respondent; Cognitive Interviews: 1 hour per respondent;
Respondent Surveys: 20 minutes per respondent Estimated Total Annual
Burden Hours Requested: 7,532. The annualized total costs to all
respondents are $66,288. There are no Capital Costs to report. There
are no Operating or Maintenance Costs to report.
Estimated Burden Hours for Proposed Example Studies To Be Conducted Under This Clearance
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Annual
Type of collection Number of frequency per Hours per Total hours
respondents response response
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Focus Groups.................................... 300 1 1.5 450
Cognitive Interviews............................ 500 2 1.0 1,000
Respondent Surveys.............................. 6,082 3 .33 6,082
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Total....................................... 6,882 .............. .............. 7,532
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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.
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: Desk Officer for NIH. 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:
[email protected].
Comments 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.
Dated: January 13, 2013.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: January 13, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-02480 Filed 2-4-13; 8:45 am]
BILLING CODE 4141-01-P