[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21785-21787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: Prevalence, 
Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors 
in Brazil

    Summary: Under the provisions of Section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood 
Institute (NHLBI), 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 on January 13, 2012, page 2072, and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The National 
Institutes of Health 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.
    Proposed Collection: Title: Prevalence, Incidence, Epidemiology and 
Molecular Variants of HIV in Blood Donors in Brazil. Type of 
Information Collection Request: Reinstatement (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

[[Page 21786]]

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 
S[atilde]o 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) 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 will be enrolled for a 5-year period from March 2012 (or 
when OMB approval is received) 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 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 HIV 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: Blood Donors 18 years old or older. 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 annual number of      Estimated number of       Average burden hours per     Estimated total annual
        respondents            responses per respondent            response             burden hours 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.
    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: Desk Officer for NIH. 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].

[[Page 21787]]

    Comments 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.

    Dated: March 27, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute, NIH.
    Dated: March 30, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-8684 Filed 4-10-12; 8:45 am]
BILLING CODE 4140-01-P