[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]


-----------------------------------------------------------------------

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.
----------------------------------------------------------------------------------------------------------------


    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