[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