[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59724-59725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

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: 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 
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

[[Page 59725]]

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 a 
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.

Tables 1-1 and 1-2: Estimate of Requested Burden Hours and Dollar Value 
of Burden Hours

                                       Table 1-1--Estimates of Hour Burden
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                                                     Number of     Frequency of    Average time     Annual hour
               Type of respondents                  respondents      response      per response       burden
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Cases...........................................            1650               1            0.58             957
Controls........................................            2500               1            0.58            1450
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    Total.......................................            4150  ..............  ..............            2407
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                                    Table 1-2--Annualized Cost to Respondents
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                                          Number of     Frequency of    Average time     Hourly     Respondent
         Type of respondents             respondents      response      per response   wage rate       cost
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Cases................................            1650               1            0.58        $18          17,226
Controls.............................            2500               1            0.58         18          26,100
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    Total............................            4150  ..............  ..............  .........          43,326
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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) 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.

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 Ms Elizabeth Wagner, Project Officer, NHLBI, Two 
Rockledge Center, Room 9030, 6701 Rockledge Drive, Bethesda, MD 20892-
7950, or call 301-451-9491, 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 60 days 
of the date of this publication.

    Dated: September 16, 2010.
Ms. Elizabeth Wagner,
NHLBI Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-24278 Filed 9-27-10; 8:45 am]
BILLING CODE 4140-01-P