Submission for OMB Review; 30-Day Comment Request; Characterization of Risk of HIV and HIV Outcomes in the Brazilian Sickle Cell Disease (SCD) Population and Comparison of SCD Outcomes Between HIV Sero-Positive and Negative SCD (NHLBI), 55142-55143 [2015-22975]
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55142
Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices
Markers for Early Cancer Detection’’)
and would also be directly addressing
four of the key recommendations that
emerged in an NCI sponsored workshop
titled ‘‘Trends in 21st Century
Epidemiology: From Scientific
Discoveries to Population Health’’
(CEBP, 2013, issue 22, page 508). In
response to this, NCI DCCPS is
developing a biospecimen inventory
and online searchable catalog (or
‘‘Population Sciences Biospecimen
Catalog (PSBC)’’). The PSBC allows
scientists in the research community
and the NCI to locate specimens
appropriate for their population based
research projects. It is not NCI’s intent
to collect biospecimens; rather the
collections are descriptions of the
available data that can act as a resource
and be shared with researchers and
scientists who are interested. This
submission is via data upload to the
secure Web site in order to collect
information to manage and improve a
program and its resources for the use by
all scientists.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
80.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
time per
response
( in hours)
Total annual
burden hour
Form name
Type of respondent
Population Sciences Biospecimen Catalog Initial
Request.
Private Sector ...............
30
1
1
30
State Government ........
Private Sector ...............
30
30
1
1
1
20/60
30
10
State Government ........
30
1
20/60
10
Population Sciences Biospecimen Catalog Annual Update.
Dated: September 1, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National
Cancer Institute, NIH.
[FR Doc. 2015–23027 Filed 9–11–15; 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; Characterization of
Risk of HIV and HIV Outcomes in the
Brazilian Sickle Cell Disease (SCD)
Population and Comparison of SCD
Outcomes Between HIV Sero-Positive
and Negative SCD (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 Federal
Register on June 8, 2015 (80 FR 32388)
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,
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:15 Sep 11, 2015
Jkt 235001
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.
DATES: 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
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: Characterization
of risk of HIV and HIV outcomes in the
Brazilian Sickle Cell Disease (SCD)
population and comparison of SCD
outcomes between HIV sero-positive
and negative SCD patients 0925–NEW,
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH).
Need and Use of Information
Collection: The National Heart, Lung,
and Blood Institute (NHLBI) Recipient
Epidemiology and Donor Evaluation
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Study-III (REDS–III) program conducts
research focused on the safety of the
blood supply, the patients who are in
need of transfusions, and the
epidemiology of transfusiontransmissible infections such as human
immunodeficiency virus (HIV). Sickle
cell disease (SCD) is a blood disorder
that affects thousands of people in the
United States and Brazil. Many patients
with SCD need to be chronically
transfused with red blood cells and the
REDS–III research program has
established in Brazil a cohort of patients
with SCD to study transfusion outcomes
and infectious diseases such as HIV in
the SCD population.
Sickle cell disease predominantly
affects persons with sub-Saharan Africa
and other malaria-endemic regions
ancestry because people who carry one
sickle cell disease gene (you need 2 to
have sickle cell disease) have a survival
advantage for malaria. Sub-Saharan
Africa, where most people with SCD in
the world live, remains one of the
regions most severely affected by HIV,
with nearly 1 in every 20 adults living
with the virus. In the United States, HIV
also disproportionately affects persons
with African ancestry. Despite the
diseases’ occurrence in similar
populations and the fact that both HIV
and SCD are independent predictors of
outcomes such as stroke, there is a lack
of data to evaluate if patients with SCD
and HIV have different illnesses than
patients who have SCD- or HIV-only.
The proposed study will seek to
understand the risk of HIV in the SCD
population, describe HIV outcomes in
patients with SCD and compare SCD
complications between HIV-positive
E:\FR\FM\14SEN1.SGM
14SEN1
55143
Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices
and HIV-negative patients with SCD
using the infrastructure established by
the REDS–III SCD Cohort study.
The limited studies focused on HIV in
SCD have suggested that HIV may not
occur as frequently in patients with SCD
as in people who do not have SCD.
While it has been hypothesized that
perhaps SCD pathophysiology has a
unique effect on HIV infection or
replication, none of the studies have
adequately measured risk factors for
HIV in patients with SCD. The first
objective of the proposed study is to
compare HIV risk factors between 150
patients with SCD (cases) randomly
selected from the REDS–III SCD Cohort
study and 150 individuals without SCD
(controls) from a demographically
similar population. An assessment that
has been well validated in previous
studies has been modified for the SCD
population and will be used to collect
data regarding HIV risk behaviors. The
second objective of the proposed study
will seek to enroll approximately 25
patients with SCD and HIV who consent
to have detailed information regarding
their diseases retrieved from their
medical records. This will allow for an
in-depth evaluation of how patients
with both diseases fare. Additionally,
patients who have SCD but not HIV will
be compared to patients who have both
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Type of
respondents
Objective 1, Risk Factor Informed Consents.
Objective 2, Risk Factor Informed Consent.
Objectives 1 and 2, Risk Factor Assessment.
Adult SCD cases and controls ....................
300
1
15/60
75
Adult previously enrolled REDS–II and III
HIV SCD patients.
Adult SCD cases and controls, and Adult
previously enrolled REDS–II and III HIV
SCD patients.
25
1
15/60
6
325
1
45/60
244
Dated: September 8, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–22975 Filed 9–11–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
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: Population Sciences
and Epidemiology Integrated Review Group,
Behavioral Genetics and Epidemiology Study
Section.
Date: October 5, 2015.
Time: 8:00 a.m. to 6:00 p.m.
VerDate Sep<11>2014
18:15 Sep 11, 2015
Jkt 235001
Number of
respondents
diseases to better understand how one
disease affects the other disease.
Information on the HIV-negative
patients with SCD has already been
collected because they participated in
the REDS–III SCD Cohort study. This
study will provide critical information
to guide the management and future
research for patients with HIV and SCD
in Brazil, the United States, and
worldwide.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
325.
Agenda: To review and evaluate grant
applications.
Place: Marriott Wardman Park Washington
DC Hotel, 2600 Woodley Road NW.,
Washington, DC 20008.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR14–165:
Clinical Studies of Mental Illness Not
Involving Treatment, Development, Efficacy,
or Effectiveness Trials (Collaborative R01).
Date: October 5, 2015.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Wardman Park Washington
DC Hotel, 2600 Woodley Road NW.,
Washington, DC 20008.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group, Basic Mechanisms of Cancer
Therapeutics Study Section.
Date: October 8–9, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance New Orleans Pere
Marquette Hotel, 817 Common Street, New
Orleans, LA.
Contact Person: Lambratu Rahman Sesay,
Ph.D., Scientific Review Officer, Center for
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Total annual
burden hours
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahman-sesayl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR Panel:
Mouse Models for Translational Research.
Date: October 9, 2015.
Time: 12:00 p.m. to 5:30 p.m..
Agenda: To review and evaluate grant
applications.
Place: Renaissance Pere Marquette Hotel,
New Orleans, 817 Common Street, New
Orleans, LA 70112.
Contact Person: Lambratu Rahman Sesay,
Ph.D., 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: Cell Biology
Integrated Review Group, Intercellular
Interactions Study Section.
Date: October 13–14, 2015.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.nih.gov.
Name of Committee: Immunology
Integrated Review Group, Cellular and
Molecular Immunology—B Study Section.
Date: October 15–16, 2015.
Time: 8:00 a.m. to 5:00 p.m.
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55142-55143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22975]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request;
Characterization of Risk of HIV and HIV Outcomes in the Brazilian
Sickle Cell Disease (SCD) Population and Comparison of SCD Outcomes
Between HIV Sero-Positive and Negative SCD (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 Federal Register on June 8,
2015 (80 FR 32388) 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.
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.
DATES: 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 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: Characterization of risk of HIV and HIV
outcomes in the Brazilian Sickle Cell Disease (SCD) population and
comparison of SCD outcomes between HIV sero-positive and negative SCD
patients 0925-NEW, National Heart, Lung, and Blood Institute (NHLBI),
the National Institutes of Health (NIH).
Need and Use of Information Collection: The National Heart, Lung,
and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation
Study-III (REDS-III) program conducts research focused on the safety of
the blood supply, the patients who are in need of transfusions, and the
epidemiology of transfusion-transmissible infections such as human
immunodeficiency virus (HIV). Sickle cell disease (SCD) is a blood
disorder that affects thousands of people in the United States and
Brazil. Many patients with SCD need to be chronically transfused with
red blood cells and the REDS-III research program has established in
Brazil a cohort of patients with SCD to study transfusion outcomes and
infectious diseases such as HIV in the SCD population.
Sickle cell disease predominantly affects persons with sub-Saharan
Africa and other malaria-endemic regions ancestry because people who
carry one sickle cell disease gene (you need 2 to have sickle cell
disease) have a survival advantage for malaria. Sub-Saharan Africa,
where most people with SCD in the world live, remains one of the
regions most severely affected by HIV, with nearly 1 in every 20 adults
living with the virus. In the United States, HIV also
disproportionately affects persons with African ancestry. Despite the
diseases' occurrence in similar populations and the fact that both HIV
and SCD are independent predictors of outcomes such as stroke, there is
a lack of data to evaluate if patients with SCD and HIV have different
illnesses than patients who have SCD- or HIV-only. The proposed study
will seek to understand the risk of HIV in the SCD population, describe
HIV outcomes in patients with SCD and compare SCD complications between
HIV-positive
[[Page 55143]]
and HIV-negative patients with SCD using the infrastructure established
by the REDS-III SCD Cohort study.
The limited studies focused on HIV in SCD have suggested that HIV
may not occur as frequently in patients with SCD as in people who do
not have SCD. While it has been hypothesized that perhaps SCD
pathophysiology has a unique effect on HIV infection or replication,
none of the studies have adequately measured risk factors for HIV in
patients with SCD. The first objective of the proposed study is to
compare HIV risk factors between 150 patients with SCD (cases) randomly
selected from the REDS-III SCD Cohort study and 150 individuals without
SCD (controls) from a demographically similar population. An assessment
that has been well validated in previous studies has been modified for
the SCD population and will be used to collect data regarding HIV risk
behaviors. The second objective of the proposed study will seek to
enroll approximately 25 patients with SCD and HIV who consent to have
detailed information regarding their diseases retrieved from their
medical records. This will allow for an in-depth evaluation of how
patients with both diseases fare. Additionally, patients who have SCD
but not HIV will be compared to patients who have both diseases to
better understand how one disease affects the other disease.
Information on the HIV-negative patients with SCD has already been
collected because they participated in the REDS-III SCD Cohort study.
This study will provide critical information to guide the management
and future research for patients with HIV and SCD in Brazil, the United
States, and worldwide.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 325.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondents respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Objective 1, Risk Factor Adult SCD cases 300 1 15/60 75
Informed Consents. and controls.
Objective 2, Risk Factor Adult previously 25 1 15/60 6
Informed Consent. enrolled REDS-
II and III HIV
SCD patients.
Objectives 1 and 2, Risk Adult SCD cases 325 1 45/60 244
Factor Assessment. and controls,
and Adult
previously
enrolled REDS-
II and III HIV
SCD patients.
----------------------------------------------------------------------------------------------------------------
Dated: September 8, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-22975 Filed 9-11-15; 8:45 am]
BILLING CODE 4140-01-P
