[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Pages 62518-62519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25247]
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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: 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
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Number of Average burden
Forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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Summary of Burdens.............................. 6,882 1 0.25-1 hour 6,826
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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.
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:
[email protected].
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