[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79006-79008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
[[Page 79007]]
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
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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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Average time
Type of respondents Number of Frequency of per Hourly wage Respondent
respondents response respondents 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated
[[Page 79008]]
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]
BILLING CODE 4140-01-P