Proposed Collection; Comment Request; Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil, 2072-2073 [2012-571]
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2072
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2011, THROUGH SEPTEMBER 30, 2011
PMA No.
Docket No.
Applicant
Trade name
P100031, FDA–2011–M–
0502.
P100032, FDA–2011–M–
0503.
Roche Diagnostics Corp. .....
P100001, FDA–2011–M–
0563.
Ortho-Clinical Diagnostics,
Inc..
P110001,
0564.
P100044,
0600.
P110020,
0601.
P110012,
0630.
FDA–2011–M–
Abbott Vascular ...................
ELECSYS ANTI–HBC IMMUNOASSAY & ELECSYS
PRECICONTROL ANTI–HBC.
ELECSYS ANTI–HBC IMMUNOASSAY, ELECSYS
PRECICONTROL ANTI–HBC FOR USE ON THE
ELECSYS 2010 IMMUNOASSAY ANALYZER.
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI–
HBE
REAGENT
PACK,
VITROS
IMMUNODIAGNOSTIC PRODUCTS ANTI–HBE CALIBRATOR, AND VITROS IMMUNODIAGNOSTIC
PRODUCTS ANTI–HBE CONTROLS.
RX HERCULINK ELITE RENAL STENT SYSTEM ...........
July 20, 2011.
FDA–2011–M–
Intersect ENT .......................
PROPEL .............................................................................
August 11, 2011.
FDA–2011–M–
Roche Molecular Systems,
Inc..
Abbott Molecular, Inc. ..........
COBAS 4800 BRAF V600 MUTATION TEST ...................
August 17, 2011.
VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS
PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK
POSITIVE CONTROL SLIDES.
NEURX DPS DIAPHRAGM PACING SYSTEM ................
August 26, 2011.
FDA–2011–M–
H100006, FDA–2011–M–
0707.
Roche Diagnostics Corp. .....
Synapse Biomedical, Inc. ....
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: January 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–537 Filed 1–12–12; 8:45 am]
BILLING CODE 4160–01–P
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
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
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 antiretroviral 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Approval date
June 22, 2011.
June 27, 2011.
July 20, 2011.
September 28, 2011.
the cities of Sao Paulo, Recife, Rio de
Janeiro and Belo Horizonte, but this
time restricted to the study of HIVpositive 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 longstanding 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
E:\FR\FM\13JAN1.SGM
13JAN1
2073
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
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 selfadministered 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 inperson 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
number of
responses per
respondent
Estimated annual number of respondents
100 ...............................................................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
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,
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
or call (301) 435–0065, or Email your
request to: glynnsa@nhlbi.nih.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
1
Average
burden hours
per response
0.40
Estimated
total annual
burden hours
requested
40
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Medical Imaging
Study Section.
Date: February 1–2, 2012.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Serrano Hotel, 405 Taylor Street,
San Francisco, CA 94102.
Contact Person: Xiang-Ning Li, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5112,
MSC 7854, Bethesda, MD 20892, (301) 435–
1744, lixiang@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Mechanisms of
Sensory, Perceptual, and Cognitive Processes
Study Section.
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2072-2073]
From the Federal Register Online via the Government Printing 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:
glynnsa@nhlbi.nih.gov.
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
