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, 59724-59725 [2010-24278]
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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
people, caregivers, and health
professionals (physicians and nonphysicians). The annual reporting
burden is as follows: Estimated Number
of Respondents: 630. Estimated Number
of Responses per Respondent: 1.
Average Burden Hours Per Response:
0.37. Estimated Total Annual Burden
Hours Requested: 234. The annualized
cost to respondents is estimated at:
Estimated
number of
respondents
Type of respondents
$5,680. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average burden
hours per
response
Estimated total
annual burden
hours
requested
Older adults ...................................................................................................
Non-physician health professionals and caregivers ......................................
Physicians ......................................................................................................
260
310
60
1
1
1
.37
.35
.5
97
107
30
Total ........................................................................................................
........................
........................
..........................
234
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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Megan Homer,
Writer/Editor, Office of
Communications and Public Liaison,
NIH, Building 31C Room 5C27, 9000
Rockville Pike, Bethesda, MD 20892, or
call non-toll-free number 301–496–1752
or E-mail your request, including your
address to: homerm@mail.nih.gov.
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.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Dated: September 22, 2010.
Lynn Hellinger,
Director of Management, National Institutes
of Health.
[FR Doc. 2010–24277 Filed 9–27–10; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
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
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
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
from 1.49 per 100,000 person-years in
1999–2000 to 2.16 per 100,000 personsyears 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
E:\FR\FM\28SEN1.SGM
28SEN1
59725
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
(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.
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 casecontrol study design.
(3) Determine nationallyrepresentative 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.
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.
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
respondents
Type of respondents
Frequency of
response
Average time
per response
Annual hour
burden
Cases ...............................................................................................................
Controls ............................................................................................................
1650
2500
1
1
0.58
0.58
957
1450
Total ..........................................................................................................
4150
........................
........................
2407
TABLE 1–2—ANNUALIZED COST TO RESPONDENTS
Number of
respondents
Type of respondents
Frequency of
response
Average time
per response
Hourly
wage rate
Respondent
cost
1650
2500
1
1
0.58
0.58
$18
18
17,226
26,100
Total ......................................................................................
srobinson on DSKHWCL6B1PROD with NOTICES
Cases ...........................................................................................
Controls ........................................................................................
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
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
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
elizabeth.wagner@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
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
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59724-59725]
From the Federal Register Online via the Government Printing 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
elizabeth.wagner@nih.gov.
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
