[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2072-2073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-571]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Prevalence, Incidence,
Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil
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.
Proposed Collection: Title: Prevalence, Incidence, Epidemiology and
Molecular Variants of HIV in Blood Donors in Brazil. Type of
Information Collection Request: Extension (OMB No. 0925-0597). Need and
Use of Information Collection: Establishing and monitoring viral
prevalence and incidence rates, and identifying behavioral risk
behaviors for HIV infection among 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--(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
[[Page 2073]]
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 will be enrolled for a 5-year period from March 2012
through February 2017. According to the Brazilian guidelines, blood
donors are requested to return to the blood bank for HIV confirmatory
testing and HIV counseling. Donors will be 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 will be asked to complete a
confidential self-administered risk factor questionnaire by computer.
In addition, a small blood sample will be collected from each HIV
positive participant to be used for the genotyping and drug resistance
testing. The results of the drug resistance testing will be
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.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The annual reporting burden is as
follows: Estimated Number of Respondents: 100; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response: 0.40
(including administration of the informed consent form and
questionnaire completion instructions); and Estimated Total Annual
Burden Hours Requested: 40. The annualized cost to respondents is
estimated at: $260 (based on $6.50 per hour). There are no Capital
Costs to report. There are no Operating or Maintenance Costs to report.
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Estimated Estimated
number of Average burden total annual
Estimated annual number of respondents responses per hours per burden hours
respondent response requested
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100............................................................. 1 0.40 40
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Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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 the assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information 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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, 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 to:
[email protected].
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.
Dated: January 3, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: January 3, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-571 Filed 1-12-12; 8:45 am]
BILLING CODE 4140-01-P