[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78876-78878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60 Day Comment Request Prevalence, 
Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors 
in Brazil (NHLBI)

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 non-toll-free 
number (301)-435-0065, or Email your request to: <a href="/cdn-cgi/l/email-protection#e483889d8a8a9785a48a8c88868dca8a8d8cca838b92"><span class="__cf_email__" data-cfemail="d6b1baafb8b8a5b796b8bebab4bff8b8bfbef8b1b9a0">[email protected]</span></a>. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Comments 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: Prevalence, Incidence, Epidemiology and 
Molecular Variants of HIV in Blood Donors in Brazil 0925-0597 
expiration date, July 31, 2015, Extension, National Heart, Lung, and 
Blood Institute (NHLBI), the National Institutes of Health (NIH).
    Need and Use of Information Collection: Establishing and monitoring 
viral prevalence and incidence rates, and identifying behavioral risk 
behaviors for HIV infection among

[[Page 78877]]

donors are critical steps to assessing and reducing risk of HIV 
transmission through blood transfusion. Detecting donors with recently 
acquired HIV infection is particularly critical as it enables 
characterization of the viral subtypes currently transmitted within the 
screened population. In addition to characterizing genotypes of 
recently infected donors for purposes of blood safety, molecular 
surveillance of incident HIV infections in blood donors serves 
important public health roles by identifying new HIV infections for 
anti-retroviral treatment, and enabling documentation of the rates of 
primary transmission of anti-viral drug resistant strains in the 
community. This study is a continuation of a previous research project 
which enrolled eligible HIV positive blood donors and analyzed HIV 
molecular variants and their association with risk.
    This previous project was conducted by the NHLBI Retrovirus 
Epidemiology Donor Study--II (REDS-II) International Brazil program and 
included not only data collection on HIV seropositive donors but also 
collection of risk factor data on uninfected donors. The current 
Recipient Epidemiology and Donor Evaluation Study--III (REDS-III) 
research proposal is a continuation of the previous REDS-II project at 
the same four blood centers in Brazil, located in the cities of Sao 
Paulo, Recife, Rio de Janeiro and Belo Horizonte, but this time 
restricted to the study of HIV-positive subjects.
    The primary study aims are to continue monitoring HIV molecular 
variants and risk behaviors in blood donors in Brazil, and to evaluate 
HIV subtype and drug resistance profiles among HIV positive donors 
according to HIV infection status (recent versus long-standing 
infection), year of donation, and site of collection. Additional study 
objectives include determining trends in HIV molecular variants and 
risk factors associated with HIV infection by combining data collected 
in the previous REDS-II project with that which will be obtained in the 
planned research activities.
    Nucleic acid testing (NAT) testing for HIV is currently being 
implemented in Brazil. It will be important to continue to collect 
molecular surveillance and risk factor data on HIV infections, 
especially now that infections that might not have been identified by 
serology testing alone could be recognized through the use of NAT. NAT-
only infections represent very recently acquired infections. The NAT 
assay will be used at the four REDS-III blood centers in Brazil during 
the planned research activities. In addition, in order to distinguish 
between recent seroconversion and long-standing infection, samples from 
all HIV antibody--dual reactive donations and/or NAT positive donations 
will be tested by the Recent Infection Testing Algorithm (RITA) which 
is based on use of a sensitive/less-sensitive enzyme immunoassay 
(``detuned'' Enzyme Immunoassay). RITA testing will be performed by the 
Blood Systems Research Institute, San Francisco, California, USA, which 
is the REDS-III Central Laboratory.
    Subjects are being enrolled for a 5-year period from July 2012 
through 2017. According to the Brazilian guidelines, blood donors are 
requested to return to the blood bank for HIV confirmatory testing and 
HIV counseling. Donors are invited to participate in the study through 
administration of informed consent when they return for HIV counseling. 
Once informed consent has been administered and enrollment has 
occurred, participants are asked to complete a confidential self-
administered risk factor questionnaire by computer. In addition, a 
small blood sample is collected from each HIV positive participant to 
be used for the genotyping and drug resistance testing. The results of 
the drug resistance testing are communicated back to the HIV positive 
participants during an in-person counseling session at the blood 
center. For those individuals who do not return for confirmatory 
testing, the samples will be anonymized and sent to the REDS-III 
central laboratory to perform the recent infection testing algorithm 
(RITA).
    This research effort will allow for an evaluation of trends in the 
trafficking of non-B subtypes and rates of transmission of drug 
resistant viral strains in low risk blood donors. These data could also 
be compared with data from similar studies in higher risk populations. 
Monitoring drug resistance strains is extremely important in a country 
that provides free anti-retroviral therapy for HIV infected 
individuals, many of whom have low level education and modest 
resources, thus making compliance with drug regimens and hence the risk 
of drug resistant HIV a serious problem.
    The findings from this project will add to those obtained in the 
REDS-II study, allowing for extended trend analyses over a 10-year 
period and will complement similar monitoring of HIV prevalence, 
incidence, transfusion risk and molecular variants in the USA and other 
funded international REDS-III sites in South Africa and China, thus 
allowing direct comparisons of these parameters on a global level.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 40.

 
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                                                                                                          Number of      Average burden
                    Form name                             Type of respondent             Number of      responses per     per response     Total annual
                                                                                        respondents       respondent       (in hours)      burden hour
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Risk Factor Assessment..........................  Adult Donors......................             100                1            24/60               40
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[[Page 78878]]

    Dated: December 18, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-30657 Filed 12-30-14; 8:45 am]
BILLING CODE 4140-01-P


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