[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]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Hourly Respondent
Type of respondents respondents response per response wage 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.
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