[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: [email protected].
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