[Federal Register Volume 73, Number 204 (Tuesday, October 21, 2008)]
[Notices]
[Pages 62514-62516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24947]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Evaluation of Risk
Factors Associated With Viral Infections in Chinese Donors: a. Risk
Factors Associated With HIV; b. Risk Factors Associated With Hepatitis
B Virus (HBV) and Hepatitis C Virus (HCV).
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 July 31,
2008, pages 44751-44753 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
[[Page 62515]]
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: Evaluation of Risk Factors Associated
with Viral Infections in Chinese Donors: a. Risk factors associated
with Human Immunodeficiency Virus (HIV), b. Risk factors associated
with Hepatitis B virus (HBV) and Hepatitis C virus (HCV). This
collection will cover two protocols as stated in the title. The first
protocol will aim to study risk factors associated with HIV in Chinese
donors and the second protocol will study risk factors related to HBV
and HCV in Chinese donors. Type of Information Collection Request: NEW.
Need and Use of Information Collection: Understanding the risk factors
associated with HIV, HBV and HCV infections in donors is essential for
developing donor behavioral screening policies. Injection drug use,
sexual transmissions, transfusion history, and medical injections are
thought to be major routes of transmission in China but their relative
importance in blood donors is unknown.
In the U.S., risk factors have been better characterized, but
questions still remain. Risk factors cannot be identified in 33% and
40% of persons with acute hepatitis B and C respectively, and risk
factors may differ between the U.S. and China. This study will improve
our understanding of potential transfusion transmitted viral risk
factors that cannot be optimally studied in the U.S. because of their
low prevalence. For example, we may be able to assess whether
treatments commonly used in China, such as acupuncture and medical
injections, are important routes of HBV and HCV transmission.
The primary objectives of the proposed study are to assess:
The primary risk factors associated with HIV, HBV and HCV.
The relative importance of injection drug use,
heterosexual transmission, family history, transfusion history, history
of previous whole blood or plasma donation, male to male sex, medical
injections, acupuncture, and tattoos as routes of transmission for HIV,
HBV and HCV.
Other important routes of transmission for these viruses
such as sex with an injection drug user, snorting drugs, living with
someone who has HBV and HCV, living with someone who injects drugs,
sharing a toothbrush or a razor, having been in jail, occupational
history, having surgery, etc.
It is proposed to conduct a large, multi blood center case-control
study to meet the study objectives. Cases for the HIV protocol will be
donors with confirmed anti-HIV antibody reactivity. Blood centers will
select a random group of donors with negative infectious disease test
results as Controls for this study. Controls will be enrolled with a
2:1 ratio to Cases and will be matched to the Cases by blood center and
donation month. Blood centers will contact potential Controls by phone
and/or mail, inviting them to come back to participate in this study.
Cases and Controls will be consented and interviewed using the same
Risk Factor Questionnaire (RFQ) by Chinese-CDC (C-CDC) or blood center
staff, either at the local C-CDC or blood center.
The second protocol assessing risk factors related to HBV and HCV
will have three groups of donors: ``HBV Group'': HBV (HBsAg) positive
donors either from prescreening (rapid testing) or routine screening
testing. Confirmatory testing for HBV will be done for these donors.
``HCV Group'': HCV (anti-HCV) positive donors from routine screening
testing (blood centers do not do prescreening rapid testing for anti-
HCV). Confirmatory testing for HCV will be done for these donors. The
third group will be a ``Control Group'' including donors with negative
results for all prescreening and routine screening tests. No additional
testing is done for these donors. On a monthly basis, the blood centers
will use the confirmatory testing results for HBV and HCV respectively,
to generate a list of cases. For that same month, the blood center will
generate a list of controls (randomly selected and matched by blood
center and month of donation). The same control group will be used for
HBV and HCV cases. Donors in all three groups will be mailed a Risk
Factor Survey study packet. The packet will include a study information
sheet (discussing the purpose and nature of this study), an informed
consent document explaining the voluntary nature, the benefits and
risks of this study, a RFQ, a small monetary reward for taking the
survey and an envelope with paid postage for the donor to mail their
completed questionnaire back to the blood center.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The annual reporting burden is as
follows: Estimated Number of Respondents: 3,920; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response:
0.33; and Estimated Total Annual Burden Hours Requested: 1,293.5. The
annualized cost to respondents is estimated at: $1,940.25 (based on
$1.50 per hour). According to China's National Bureau of Statistics in
2006, the average annual wage in China is 21,001 Chinese Yuan (or
$2,958 U.S. dollars based on current exchange rate of 1 U.S. dollar =
7.1). There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
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Estimated No.
of responses Average Estimated total
Estimated No. of respondents per burden hours annual burden
respondent per response hours requested
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HIV Risk factor:
Case....................................................... 350 0.33 115.5
Control.................................................... 700 0.33 231
HBV and HCV Risk factor:
Case....................................................... 1700 0.33 561
Control.................................................... 1170 0.33 386
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Total.................................................. 3920 0.33 1293.5
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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) 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) The
accuracy of the agency's estimate of the burden of the proposed
collection of information,
[[Page 62516]]
including the validity of the methodology and the assumptions used; (3)
Ways to enhance the quality, utility, and clarity of the information
collected; and (4) Ways to 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 public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, 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. George Nemo, Project Officer, NHLBI, Two
Rockledge Center, Room 9144, 6701 Rockledge Drive, MSC 7950, 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: October 8, 2008.
Dr. George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. E8-24947 Filed 10-20-08; 8:45 am]
BILLING CODE 4140-01-P