[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
----------------------------------------------------------------------------------------------------------------
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