[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15218-15220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Prevalence, 
Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors 
in Brazil (NHLBI)

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 FR in Volume 79 on December 
31, 2014 on page 78876 and allowed 60-days for public comment. One 
public comment was received that was a personal opinion regarding 
conducting research about the Brazil blood donation system. 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.
    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, <a href="/cdn-cgi/l/email-protection#f1beb8a3b0ae8284939c988282989e9fb19e9c93df949e81df969e87"><span class="__cf_email__" data-cfemail="7936302b38260a0c1b14100a0a1016173916141b571c1609571e160f">[email protected]</span></a> or by fax to 202-395-6974, 
Attention: Desk Officer for NIH.
    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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: Simone Glynn, MD, Project Officer/ICD 
Contact, Two Rockledge

[[Page 15219]]

Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 
301-435-0065, or Email your request, including your address to: 
<a href="/cdn-cgi/l/email-protection#43242f3a2d2d3022032d2b2f212a6d2d2a2b6d242c35"><span class="__cf_email__" data-cfemail="10777c697e7e6371507e787c72793e7e79783e777f66">[email protected]</span></a>. Formal requests for additional plans and 
instruments must be requested in writing.

Proposed Collection: Prevalence, Incidence, Epidemiology and Molecular 
Variants of HIV, in Blood Donors in Brazil 0925-0597, Expiration Date, 
July 31, 2015, Extension, the 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 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 the current protocol that is approved by OMB, which 
expires on July 31, 2015, includes both a prospective surveillance and 
a case study designed to enroll eligible HIV seropositives detected at 
four participating blood centers in Brazil. This project is being 
conducted 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.
    Given the initiation of NAT testing for HIV (and HCV) 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 continue to be used at 
the four REDS-III blood centers in Brazil during the 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 
continue to 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 continue to be 
performed by the Blood Systems Research Institute, San Francisco, 
California, USA, which is the REDS-III Central Laboratory.
    Since Dec 2012, the study has enrolled 223 HIV-positive donors (51 
at Hemorio-Rio de Janeiro, 38 at Hemominas-Minas Gerais, 67 at Hemope-
Pernambuco and 67 at Fundacao Pro-Sangue-Sao Paulo) with a target 
enrollment of 500 by 2017. It is important to continue the study and 
enroll more HIV infected donors to inform trend analyses. Preliminary 
evaluation of data has shown that respondent donors are completing the 
entire questionnaire including information about their risk behaviors. 
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 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. It is worth noting that Brazil 
is the first developing country to implement early treatment initiation 
for all individuals living with HIV/AIDS irrespective of CD4 count; 
this new universal treatment policy went into effect in 2014.
    Findings from this study will be compared to trends in prevalence, 
incidence, and molecular variants from studies of the general 
population and high risk populations in Brazil, thus allowing for 
broader and more effective monitoring of the HIV epidemic in Brazil, as 
well as assessment of the impact of donor selection criteria on these 
parameters. We also propose to continue to examine trends in risk 
behaviors by comparing the data previously collected to the data we 
plan to collect for the next three year period. This will allow for 
extended trend analyses over a 10-year period that complements 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.

----------------------------------------------------------------------------------------------------------------
                                                                        Number of    Average burden     Total
             Form name                   Type of        Number of     responses per   per response      annual
                                       respondent      respondents     respondent      (in hours)    burden hour
----------------------------------------------------------------------------------------------------------------
Risk Factor Informed Consent.......    Adult Donors             100               1            5/60            8

[[Page 15220]]

 
Risk Factor Assessment.............    Adult Donors             100               1           19/60           40
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    Dated: March 11, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-06565 Filed 3-20-15; 8:45 am]
 BILLING CODE 4141-01-P


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