[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]


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

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.

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                                     number of    Average burden   total annual
             Estimated annual number of respondents                responses per     hours per     burden hours
                                                                    respondent       response        requested
----------------------------------------------------------------------------------------------------------------
100.............................................................               1            0.40              40
----------------------------------------------------------------------------------------------------------------

    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