[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67176-67177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26761]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; HIV Study in
Blood Donors From Five Chinese Regions (NHLBI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register in Volume 79, June 12, 2014 on page 33764 and allowed 60-days
for public comment. One public comment was received that was a personal
opinion regarding conducting research about the Chinese blood donation
system. The purpose of this notice is to allow an additional 30 days
for public comment. The National Institutes of Health (NIH) 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 currently
valid OMB control number.
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, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments 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.
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 with change 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 US 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 US 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 US 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 US-based
[[Page 67177]]
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 US.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated burden hours are
450.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
HIV Risk factor Q............. Blood donors-- 210 1 20/60 70
Case Primary
Sites.
Blood donors-- 180 1 20/60 60
Case peripheral
sites.
Blood donors-- 540 1 20/60 180
Control primary
sites.
Blood donors-- 420 1 20/60 140
Control
peripheral
sites.
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Dated: October 28, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-26761 Filed 11-10-14; 8:45 am]
BILLING CODE 4140-01-P