[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33764-33765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; HIV Study in Blood 
Donors From Five Chinese Regions

    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.
    Written comments and/or suggestions from the public and affected 
agencies are invited on 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, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be 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.
    To Submit Comments And For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Simone 
Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 
9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, 
or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Comment 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.
    Proposed Collection: HIV Study in Blood Donors from Five Chinese 
Regions, 0925-0596 reinstatement with change, National Heart, Lung and 
Blood Institute (NHLBI).
    Need and Use of Information Collection: This Study is a 
reinstatement of OMB Number: 0925-0596 expiration date, January 31, 
2012. To better understand the diversifying and changing Human 
Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk 
factors, especially those associated with recent HIV infections, this 
HIV risk factor study in China is proposed as part of the Recipient 
Epidemiology and Donor Evaluation Study-III (REDS-III). The major 
objectives of the study will be to evaluate the proportion of blood 
donors in China who test positive for HIV and have acquired their 
infection recently or more remotely; the risk of releasing a blood 
product that contains HIV (HIV residual risk); and the risk factors 
associated with HIV infection in China. The study will also assess the 
frequency of distinct HIV-1 viral lineages and drug resistant mutations 
among HIV-positive blood donors. In 2011, there were 780,000 people 
infected with HIV in China and it is estimated that over 300,000 HIV 
infected people in China are not aware of their infection status. The 
large migrating population and the complexity of HIV transmission 
routes in China make it difficult to implement a comprehensive and 
effective national HIV control strategy. Risk factors for infections 
can change over time; thus, identifying factors that contribute to the 
recent spread of HIV in a broad cross-section of an otherwise 
unselected general population, such as blood donors, is highly 
important for obtaining a complete picture of the epidemiology of HIV 
infection in China. Because the pace of globalization means infections 
can cross borders easily, the study objectives have direct relevance 
for HIV control in the U.S. and globally. Recent years have seen an 
increase in blood donations from repeat donors in most Chinese regions. 
This increase permits longer-term follow-up and testing of repeat 
donors which allow for calculation of new HIV infection rates and 
residual risks. The HIV data, for both recently and remotely acquired 
infections, from the proposed study will complement existing data on 
HIV risks obtained from general and high risk populations to provide 
comprehensive HIV surveillance data for China. This study will also 
monitor genetic characteristics of recently acquired infections through 
genotyping and drug resistance testing, thus serving a U.S. and global 
public health imperative to monitor the genotypes of HIV that have 
recently been transmitted. For HIV, the additional monitoring of drug 
resistance patterns in newly acquired infection is critical to 
determine if currently available antiretroviral medicines are capable 
of combating infection. Genotyping and host response information are 
scientifically important not only to China, but to the U.S. and other 
nations since they provide a broader global understanding of how to 
most effectively manage and potentially prevent HIV, for example 
through vaccine development. Efforts to develop vaccines funded by the 
National Institutes of Health and other U.S.-based organizations may 
directly benefit from the findings of this study.
    Blood donors are tested for transfusion-transmissible infections 
including HIV when they present to donate, and test result information 
as well as demographic data will be routinely collected in a database 
at the five blood centers participating in REDS-III studies (located in 
the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These 
data will allow for calculation of HIV incidence, prevalence, and 
residual risk. Additionally, a case-control study will be conducted 
over a 2 and 1/2 year period to evaluate the risk factors associated 
with HIV infection among blood donors. Cases will be defined as 
potential donors who deny risks on the donor screening questionnaire 
but are found to be positive on HIV testing (their donation is 
discarded). HIV-positive donors who gave blood at one of the five blood 
centers as stated above (primary sites) or at blood centers located in 
the Guangxi Autonomous Region (peripheral sites, recruited through the 
Guangxi CDC for this study only but not other REDS-III studies) will be 
eligible to participate and complete a Risk Factor Questionnaire that 
will assess general demographic and risk factor information pertinent 
to HIV infection. Controls will be negative for HIV on confirmatory 
testing. Assuming 50% response rate, it is anticipated that 390 HIV-
positive donors and 960 controls will participate in the case control 
study. The results of this study will contribute to global HIV 
surveillance and prevention, provide a broader global understanding of 
HIV epidemiology, and support public health efforts to most effectively 
manage and potentially prevent HIV transmission both worldwide and in 
the U.S.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total

[[Page 33765]]

estimated annualized burden hours are 450.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
                   Form name                               Type of  respondents              Number of     responses per   per  response   Total annual
                                                                                            respondents     respondent      (in hours)     burden hours
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HIV Risk factor Q..............................  Blood donors--Case Primary Sites.......             210               1           20/60              70
                                                 Blood donors--Case peripheral sites....             180               1           20/60              60
                                                 Blood donors--Control primary sites....             540               1           20/60             180
                                                 Blood donors--Control--peripheral sites             420               1           20/60             140
                                                 Blood donors--total....................           1,350               1           20/60             450
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    Dated: May 29, 2014.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute, NIH.
    Dated: May 29, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-13724 Filed 6-11-14; 8:45 am]
BILLING CODE 4140-01-P