[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Pages 79006-79008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31734]



National Institutes of Health

Submission for OMB Review; Comment Request; Transfusion-
Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors: 
Improving the Safety of the U.S. Blood Supply Through Hemovigilance

    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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on September 28, 2010, Volume 75, No. 187, pages 59724-59725 
and allowed 60 days for public comment. 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 current valid OMB control number.
    Proposed Collection: Title: Transfusion-transmitted retrovirus and 
hepatitis virus rates and risk factors: Improving the safety of the 
U.S. blood supply through hemovigilance. Type of Information Collection 
Request: NEW. Need and Use of Information Collection: Information on 
current risk factors in blood donors as assessed using analytical study 
designs is largely unavailable in the U.S. Studies of risk factor 
profiles among HIV-infected donors were funded by the CDC for 
approximately 10 years after implementation of serologic screening in 
the mid-1980s, whereas studies of HTLV- and HCV-seropositive (and 
indeterminate) donors, funded by NIH, were conducted in the early 
1990s, but unfortunately, none of these studies is ongoing. Infection 
trend analyses have been conducted by the American Red Cross (ARC). The 
findings show continued HIV risk with the prevalence of HIV in first 
time donors hovering around 10 per 100,000 donations in each of the 
last 10 years and the incidence in repeat donors increasing from 1.49 
per 100,000 person-years in 1999-2000 to 2.16 per 100,000 persons-years 
in 2007-2008. While the prevalence of HCV in first time donors 
decreased over this time interval from 345 to 163 per 100,000 
donations, the incidence in repeat donors did not decrease and evidence 
of incident infection in first time donors increased. Moreover specific 
age, gender and race/ethnicity groups were over-represented. 
Significantly increased incidence of both HIV and HCV were observed in 
2007/2008 compared to 2005/2006. Similar analyses for HBV have shown an 
incidence in all donors of 3.4 per 100,000 person-years which is lower

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than earlier estimates, but remains higher than for HIV and HCV.
    This project represents a collaborative pilot research study that 
will include a comprehensive interview study of viral infection 
positive blood donors at the American Red Cross (ARC), Blood Systems 
Inc. (BSI) and New York Blood Center (NYBC) in order to identify the 
current predominant risk factors for virus positive donations and will 
also establish a donor biovigilance capacity that currently does not 
exist in the U.S. At this time it is not easy to integrate risk factor 
data and disease marker surveillance information within or across 
different blood collection organizations because common interview 
procedures and laboratory confirmation procedures are not being used 
and so we cannot easily tabulate and analyze behavioral risks or viral 
infections in U.S. blood donors. This creates the potential for gaps in 
our understanding of absolute incidence and prevalence as well as risks 
that could lead to transfusion-transmitted disease. Combined data are 
critical for appropriate national surveillance efforts. For example, 
this information could be used to target educational interventions to 
reduce donations from persons with high risk behaviors. This is 
particularly important in the case of behaviors associated with 
incident (recently acquired) infections because these donations have 
the greatest potential transmission risk because they could be missed 
during routine testing. As part of the project a comprehensive 
research-quality biovigilance database will be created that integrates 
existing operational information on blood donors, disease marker 
testing and blood components collected by participating organizations 
into a research database. The combined database will capture infectious 
disease and risk factor information on nearly 60% of all blood donors 
and donations in the country. Following successful completion of the 
risk factor interviews and research database development, the 
biovigilance network pilot can be expanded to include additional blood 
centers and/or re-focused on other safety threats as warranted, such as 
XMRV. This pilot biovigilance network will thereby establish a 
standardized process for integration of information across blood 
collection organizations.
    The Specific Aims are to:
    (1) Define consensus infectious disease testing classification 
algorithms for HIV, HCV, HBV, and HTLV that can be used to consistently 
classify donation testing results across blood collection organizations 
in the U.S. This will allow for better estimates of infection disease 
marker prevalence and incidence in the U.S.
    (2) Determine current behavioral risk factors associated with 
prevalent and incident (when possible) HIV, HCV, HBV and HTLV 
infections in blood donors, including parenteral and sexual risks, 
across the participating blood collection organizations using a case-
control study design.
    (3) Determine nationally-representative infectious disease marker 
prevalence and incidence for HIV, HCV, HBV, and HTLV overall and by 
demographic characteristics of donors. This will be accomplished by 
forming research databases from operational data at BSI and NYBC into 
formats that can be combined with the ARC research database.
    (4) Analyze integrated risk factor and infectious marker testing 
data together because when taken together these may show that blood 
centers are not achieving the same degree of success in educational 
efforts to prevent donation by donors with risk behaviors across all 
demographic groups.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Adult blood donors. The annual reporting burden is as 
follows: Estimated Number of Respondents:4150; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.58 
and Estimated Total Annual Burden Hours Requested: 2407. The annualized 
cost to respondents is estimated at: $43,326 (based on $18 per hour). 
There are no Capital Costs to report. There are no Operating or 
Maintenance Costs to report.

                                       Table 1-1--Estimates of Hour Burden
                                                     Number of     Frequency of    Average time     Annual hour
               Type of respondents                  respondents      response      per response       burden
Cases...........................................            1650               1            0.58             957
Controls........................................            2500               1            0.58            1450
    Total.......................................            4150  ..............  ..............            2407

                                    Table 1-2--Annualized Cost to Respondents
                                                                   Average time
       Type of respondents           Number of     Frequency of         per         Hourly wage     Respondent
                                    respondents      response       respondents        rate            cost
Cases...........................            1650               1            0.58             $18          17,226
Controls........................            2500               1            0.58              18          26,100
    Total.......................            4150  ..............  ..............  ..............          43,326

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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

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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: 
Dr. Simone Glynn, Project Officer, NHLBI, Two Rockledge Center, Room 
9142, 6701 Rockledge Drive, Bethesda, MD 20892-7950, or call 301-435-
0065, or E-mail 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: December 16, 2010.
Simone Glynn,
Branch Chief, Transfusion Medicine and Cellular Therapeutics Branch, 
Division of Blood Diseases and Resources, National Heart, Lung, and 
Blood Institute, NIH.
[FR Doc. 2010-31734 Filed 12-16-10; 8:45 am]