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