[Federal Register Volume 73, Number 155 (Monday, August 11, 2008)]
[Notices]
[Pages 46628-46629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


 Submission for OMB Review; Comment Request; The Prevalence and 
Incidence of HIV Molecular Variants and Their Correlation With Risk 
Behaviors and HIV Treatment in Brazilian Blood Donors

    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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on May 29, 2008, pages 30951-30952 and allowed 60 days for 
public comment. 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 current 
valid OMB control number.
    Proposed Collection: Title: The Prevalence and Incidence of HIV 
Molecular Variants and Their Correlation With Risk Behaviors and HIV 
Treatment in Brazilian Blood Donors. Type of Information Collection 
Request: New. Need and Use of Information Collection: Establishing and 
monitoring viral prevalence and incidence rates, and identifying risk 
behaviors for HIV incidence among blood donors, are critical to 
assessing and reducing risk of HIV transmission through blood 
transfusion. Identifying donation samples from donors with recent HIV 
infection is particularly critical as it enables characterization of 
the viral subtypes currently transmitted within the screened population 
and hence most likely to ``break-through'' routine screening measures 
(i.e., peri-seroconversion window period donations). Molecular 
surveillance of incident HIV infections in blood donors not only 
characterizes genotypes of recently infected donors for purposes of 
blood safety, but also enables documentation of the rates of primary 
transmission of anti-viral drug resistant strains in the community, 
serving a public health role in identifying new HIV infections for 
anti-retroviral treatment. Both a prospective surveillance and a case-
control design are proposed to enroll all eligible HIV seropositives 
detected at three blood centers in Brazil (Sao Paulo, Belo Horizante, 
and Rec[iacute]fe) plus a satellite center in Rio de Janeiro. A 
comparison of epidemiological risk profiles will be made between the 
seropositive donors and a group of randomly selected seronegative 
donors.
    There are three study aims. Laboratory studies (LS-EIA testing and 
sequencing of pol region) on linked specimens from all enrolled HIV 
cases, will allow for estimation of HIV prevalence and incidence 
relative to genotype and putative route of infection. Data derived from 
molecular genotyping, including drug resistant genotypes, will be 
provided, along with counseling, to all enrolled HIV positive donors to 
facilitate their clinical care via referral to the Brazilian national 
HIV treatment system. Our findings 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 broad monitoring of the HIV epidemic in Brazil and assessment of 
the impact of donor selection criteria on these parameters. Finally, 
HIV cases and a group of controls, through responses to a 
questionnaire, will provide data on HIV risk behaviors among 
prospective blood donors. This HIV risk behavior data will be used as 
covariates in the molecular surveillance analyses described above, as 
well as aid in assessing whether modifications may be needed to 
Brazil's routine blood center operational donor screening 
questionnaire.
    The study participants will return to their local blood center for 
the administration of an informed consent form, explaining the 
confidential nature of the research study as well as the risks and 
benefits to their participation. Once enrolled, they will be asked to 
complete the self-administered risk factor questionnaire. In addition, 
a small blood sample will be collected from each HIV seropositive 
participant to be used for the genotyping and drug resistance testing. 
The results of the drug resistance testing will be communicated back to 
the seropositive participants during an in-person counseling session at 
the blood center.
    Defining prevalence and incidence in blood donors and residual risk 
of HIV transmission by transfusions may lead to new regulations and 
blood safety initiatives in Brazil. The data can be used to project the 
yield, safety impact and cost effectiveness of implementing enhanced 
testing strategies such as combination antigen-antibody assays and/or 
NAT. Determination of HIV risk factors in donors (first time versus 
repeat donor status; volunteer versus replacement status; demographics 
and risk behaviors) will support policy discussions over strategies to 
recruit the safest possible donors in Brazil. The findings from this 
project will also complement similar monitoring of HIV prevalence, 
incidence, transfusion risk and molecular variants in the U.S. and 
other funded international REDS-II sites, 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: 2,000; 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: 800. The annualized cost to respondents is 
estimated at: $5,200 (based on $6.50 per hour). There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

[[Page 46629]]



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                                                                  Estimated
                                                                  number of      Average burden  Estimated total
                Etimated number of respondents                  responses per      hours per      annual burden
                                                                  respondent        response     hours requested
----------------------------------------------------------------------------------------------------------------
 2,000.......................................................               1             0.40              800
----------------------------------------------------------------------------------------------------------------

    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, New Executive Office Building, Room 10235, Washington, DC 
20503, 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 Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Room 9144, 6701 Rockledge Drive, MSC 7950, Bethesda, 
MD 20892-7950, or call 301-435-0065, or E-mail your request to 
[email protected].
    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: August 1, 2008.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
 [FR Doc. E8-18491 Filed 8-8-08; 8:45 am]
BILLING CODE 4140-01-P