[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
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2,000....................................................... 1 0.40 800
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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, 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