Submission for OMB Review; Comment Request: Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil, 21785-21787 [2012-8684]
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[FR Doc. 2012–8701 Filed 4–10–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21785
Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–8695 Filed 4–10–12; 8:45 am]
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Medical Countermeasures Initiative
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countermeasure development, highlight
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to the development and advancement of
medical countermeasures, facilitate
innovative directions, and inform
stakeholders on medical
countermeasure-related scientific
progress and accomplishments.
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PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Frm 00065
Fmt 4703
Sfmt 4703
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 antiretroviral treatment, and enabling
documentation of the rates of primary
E:\FR\FM\11APN1.SGM
11APN1
21786
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices
transmission of anti-viral drug resistant
strains in the community. This study is
a continuation of a previous research
project which enrolled eligible HIVpositive 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 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) 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 selfadministered risk factor questionnaire
by computer. In addition, a small blood
sample will be collected from each HIVpositive participant to be used for the
genotyping and drug resistance testing.
The results of the drug resistance testing
will be communicated back to the HIVpositive 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 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 number of responses
per respondent
Average burden hours per
response
Estimated total annual burden
hours requested
100
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Estimated annual number of
respondents
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;
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(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
PO 00000
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time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov 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: glynnsa@nhlbi.nih.gov.
E:\FR\FM\11APN1.SGM
11APN1
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute: Notice of Closed Meeting
wreier-aviles on DSK5TPTVN1PROD with NOTICES
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 meeting.
The meeting 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Loan Repayment Grant Review.
Date: May 4, 2012.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7179, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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21787
Dated: April 4, 2012.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Dated: April 5, 2012.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–8719 Filed 4–10–12; 8:45 am]
[FR Doc. 2012–8721 Filed 4–10–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
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 meeting.
The meeting 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Companion
Diagnostics
Date: May 22, 2012
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals
Place: National Institutes of Health, 6116
Executive Boulevard, Room 707, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Jeannette F Korczak, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd., Room
8115, Bethesda, MD 20892, 301–496–9767,
korczakj@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
PO 00000
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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.
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: Center for Scientific
Review Special Emphasis Panel; Retinal
Biology and TBI in Developing Brain.
Date: April 27, 2012.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
IRG Chief, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@csr.nih.gov.
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Review Special Emphasis Panel; Member
Conflict: Radiation Therapeutics.
Date: May 3, 2012.
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Careen K Tang-Toth,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
3504, tothct@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Nursing and
Related Clinical Sciences Overflow.
Date: May 8, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\11APN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21785-21787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8684]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
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, OIRA_submission@omb.eop.gov 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:
glynnsa@nhlbi.nih.gov.
[[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
