[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.

----------------------------------------------------------------------------------------------------------------
                                                                  Estimated No.
                                                                  of responses       Average     Estimated total
                  Estimated No. of respondents                         per        burden hours    annual burden
                                                                   respondent     per response   hours requested
----------------------------------------------------------------------------------------------------------------
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
                                                                ------------------------------------------------
        Total..................................................            3920            0.33           1293.5
----------------------------------------------------------------------------------------------------------------

    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