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, 46628-46629 [E8-18491]
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Federal Register / Vol. 73, No. 155 / Monday, August 11, 2008 / Notices
Moderator: Ashley Golden
Moderator E-mail: a_golden@teampsa.com.
For Further Information Contact: Anyone
requesting information regarding the
Committee should contact Louis D.
Coccodrilli, Designated Federal Official for
the ACICBL, Bureau of Health Professions,
Health Resources and Services
Administration, Parklawn Building, Rm. 9–
36, 5600 Fishers Lane, Rockville, Maryland
20857; (301) 443–6950 or
lcoccodrilli@hrsa.gov. Marie Ulysse, HRSA
Scholar, can also be contacted for inquiries
at (301) 443–6529 or mulysse@hrsa.gov.
Dated: August 4, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–18393 Filed 8–8–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rmajette on PRODPC74 with NOTICES
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
VerDate Aug<31>2005
15:22 Aug 08, 2008
Jkt 214001
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., periseroconversion 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 Recıfe) 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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\11AUN1.SGM
11AUN1
46629
Federal Register / Vol. 73, No. 155 / Monday, August 11, 2008 / Notices
Estimated number of responses per respondent
Etimated number of respondents
2,000 ......................................................................................................................................
rmajette on PRODPC74 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.
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
nemog@nih.gov.
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
VerDate Aug<31>2005
15:22 Aug 08, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Advisory Committee to the Director,
National Institutes of Health (NIH).
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 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 property.
Name of Committee: Advisory Committee
to the Director, NIH.
Date: August 15, 2008.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Penny Burgoon, Senior
Assistant to the Deputy Director, Office of the
Director, National Institutes of Health, 1
Center Drive, Building 1, Room 114,
Bethesda, MD 20892, (301) 451–5870,
burgoonp@od.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nih.gov/about/director/acd.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Average burden
hours per response
1
Estimated total
annual burden
hours requested
0.40
800
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: August 5, 2008.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–18494 Filed 8–8–08; 8:45 am]
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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. Appendix 2), 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, Oncology
Area.
Date: September 8, 2008.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Lambratu Rahman, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahmanl@csr.nih.gov.
Name of Committee: Oncological Sciences
Integrated Review Group, Cancer Molecular
Pathobiology Study Section.
Date: September 15–16, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 73, Number 155 (Monday, August 11, 2008)]
[Notices]
[Pages 46628-46629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18491]
-----------------------------------------------------------------------
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]]
----------------------------------------------------------------------------------------------------------------
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
nemog@nih.gov.
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
