Submission for OMB Review; 30-Day Comment Request Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil (NHLBI), 15218-15220 [2015-06565]
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
letter, which finds Licensee’s kit to be a
medical device substantially equivalent to
one or more similar legally marketed devices,
and states that the Licensee’s device can be
marketed in the U.S. (i.e., 510(k) cleared),
such test kit to be distributed in commerce
for the purpose of predicting survival,
response to therapy, or cancer recurrence in
breast cancer patients.’’
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of
Theranostic Kits for mTOR Analogbased Chemotherapy
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant to
ProVivoX, Inc., of an exclusive
evaluation option license to practice the
inventions embodied in the following
US Patent, US Patent Application, and
International Patent Application (and all
foreign counterparts): US Provisional
Patent Application Serial No. 61/
144,501, filed 14 January 2009, entitled:
‘‘Ratio-based Biomarker of Survival
Utilizing PTEN and Phospho-AKT’’
[HHS Reference No. E–025–2009/0–US–
01]; International Application No. PCT/
US2010/020944, filed on 13 January
2010, entitled: ‘‘Ratio-based Biomarkers
and Methods of Use Thereof’’ [HHS
Reference No. E–025–2009/0–PCT–02];
US Patent Application Serial No. 13/
144,474, filed 13 July 2011 [HHS
Reference No. E–025–2009/0–US–02];
and Canadian Patent Application No.
2,749,601, filed on 13 January 2010
[HHS Reference No. E–025–2009/0–CA–
05]. The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive evaluation
option license territory may be United
States and Canada, and the field of use
may be limited to:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
a. ‘‘Exclusive use of the Licensed Patent
Rights to develop an immunohistochemistry
(IHC)- or tissue microarray-based test kit for
use with human tissue samples and approved
in the United States and Canada as a Class
III medical device, such test kit to be
distributed in commerce for the for the
purpose of predicting survival, response to
therapy, or cancer recurrence in breast cancer
patients.’’
b. ‘‘Non-exclusive use of the Licensed
Patent Rights to develop an
immunohistochemistry (IHC)- or tissue
microarray-based test kit for use with human
tissue samples and for which the United
States FDA issues an order, in the form of a
VerDate Sep<11>2014
16:51 Mar 20, 2015
Jkt 235001
Upon the expiration or termination of
the exclusive evaluation option license,
ProVivoX, Inc., will have the exclusive
right to execute an exclusive
commercialization license which will
supersede and replace the exclusive
evaluation option license with no
greater field of use and territory than
granted in the exclusive evaluation
option license.
DATES: Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before April
7, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Patrick McCue, Ph.D., Licensing and
Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5560; Facsimile:
(301) 402–0220; Email: mccuepat@
mail.nih.gov.
The
technology describes a method of
identifying cancer patients that may
benefit from mTOR analog-based
chemotherapy or agents directed against
the AKT pathway.
The prospective exclusive evaluation
license is being considered under the
small business initiative launched on 1
October 2011, and will comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR part 404. The prospective
exclusive evaluation option license, and
a subsequent exclusive
commercialization license, may be
granted unless the NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404
within fifteen (15) days from the date of
this published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
evaluation option license. Comments
and objections submitted to this notice
will not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Freedom of Information Act, 5 U.S.C.
552.
Dated: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–06487 Filed 3–20–15; 8:45 am]
BILLING CODE 4140–01–P
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)
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, OIRA_submission@
omb.eop.gov 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
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
15219
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Center, Suite 9142, 6701 Rockledge
Drive, Bethesda, MD 20892, or call 301–
435–0065, or Email your request,
including your address to: glynnsa@
nhlbi.nih.gov. 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 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 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 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.
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 selfadministered risk factor questionnaire
by computer. In addition, a small blood
sample is collected from each HIVpositive participant to be used for the
Type of
respondent
Form name
Risk Factor Informed Consent .................................................
VerDate Sep<11>2014
16:51 Mar 20, 2015
Jkt 235001
PO 00000
Frm 00034
Number of
respondents
Adult Donors
Fmt 4703
Sfmt 4703
genotyping and drug resistance testing.
The results of the drug resistance testing
are 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. 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
responses per
respondent
100
E:\FR\FM\23MRN1.SGM
1
23MRN1
Average
burden per
response
(in hours)
5/60
Total
annual
burden
hour
8
15220
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Type of
respondent
Form name
Risk Factor Assessment ..........................................................
Dated: March 11, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
BILLING CODE 4141–01–P
Background
Agency for Healthcare Research and
Quality
Patient Safety Organizations: Expired
Listing From Premerus PSO, LLC
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b–21 to b–26, (Patient Safety
Act) and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, (73 FR 70732–
70814), provide for the formation of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of healthcare
delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
The listing from the Premerus PSO, LLC
has expired and AHRQ has delisted the
PSO accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on January 10, 2015.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
mstockstill on DSK4VPTVN1PROD with NOTICES
16:51 Mar 20, 2015
Jkt 235001
Dated: March 17, 2015.
Sharon B. Arnold,
Deputy Director, AHRQ.
[FR Doc. 2015–06454 Filed 3–20–15; 8:45 am]
BILLING CODE 4160–90–P
Frm 00035
1
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
Total
annual
burden
hour
19/60
40
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Commercial License Agreement:
Development of 5T4 Antibody-Drug
Conjugates for the Treatment of
Human Cancers
AGENCY:
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
the PSO’s listing expires. Section
3.108(d) of the Patient Safety Rule
requires AHRQ to provide public notice
when it removes an organization from
the list of federally approved PSOs.
Premerus PSO, LLC, PSO number
P0120, a component entity of Premerus,
Inc., chose to let its listing expire by not
seeking continued listing. Accordingly,
Premerus PSO, LLC was delisted
effective at 12:00 Midnight ET (2400) on
January 10, 2015.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
PO 00000
Number of
responses per
respondent
100
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Adult Donors
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email: PSO@
AHRQ.hhs.gov.
[FR Doc. 2015–06565 Filed 3–20–15; 8:45 am]
SUMMARY:
Number of
respondents
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an start-up exclusive commercial
license to practice the inventions
embodied in U.S. Patent Application
No. 62/034,995 entitled ‘‘Human
Monoclonal Antibodies Specific for 5T4
and Methods of Their Use’’ filed August
8, 20014 [HHS Ref. E–158–2014/0–US–
01] and all related continuing and
foreign patents/patent applications for
the technology family to Concortis, Inc.
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
prospective start-up exclusive
commercial license territory may be
worldwide and the field of use may be
limited to the development of 5T4
antibody drug conjugate therapeutics for
the treatment of human cancers using
Concortis’ proprietary conjugation
technologies.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
7, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive
evaluation option license should be
directed to: Whitney Hastings, Ph.D.,
Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 451–7337; Facsimile: (301) 402–
0220; Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: 5T4 is an
antigen expressed in a number of
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15218-15220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06565]
-----------------------------------------------------------------------
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, OIRA_submission@omb.eop.gov 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:
glynnsa@nhlbi.nih.gov. 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
----------------------------------------------------------------------------------------------------------------
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
