Proposed Collection; 60 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 Patients (NHLBI), 32388-32389 [2015-13837]
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Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices
nhlbi.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
National Institutes of Health
DATES:
Comments Due Date: Comments
Proposed Collection; 60 Day Comment regarding this information collection are
Request Characterization of Risk of
best assured of having their full effect if
HIV and HIV Outcomes in the Brazilian received within 60 days of the date of
Sickle Cell Disease (SCD) Population
this publication.
and Comparison of SCD Outcomes
Proposed Collection: Characterization
Between HIV Sero-Positive and
of risk of HIV and HIV outcomes in the
Negative SCD Patients (NHLBI)
Brazilian Sickle Cell Disease (SCD)
population and comparison of SCD
SUMMARY: In compliance with the
outcomes between HIV sero-positive
requirement of Section 3506(c)(2)(A) of
and negative SCD patients 0925–NEW,
the Paperwork Reduction Act of 1995,
National Heart, Lung, and Blood
for opportunity for public comment on
Institute (NHLBI), the National
proposed data collection projects, the
Institutes of Health (NIH).
National Heart, Lung, and Blood
Need and Use of Information
Institute (NHLBI), the National
Collection: The National Heart, Lung,
Institutes of Health (NIH), will publish
and Blood Institute (NHLBI) Recipient
periodic summaries of proposed
Epidemiology and Donor Evaluation
projects to the Office of Management
Study-III (REDS–III) program conducts
and Budget (OMB) for review and
research focused on the safety of the
approval.
blood supply, the patients who are in
Written comments and/or suggestions need of transfusions, and the
from the public and affected agencies
epidemiology of transfusionare invited on one or more of the
transmissible infections such as human
following points: (1) Whether the
immunodeficiency virus (HIV). Sickle
proposed collection of information is
cell disease (SCD) is a blood disorder
necessary for the proper performance of that affects thousands of people in the
the function of the agency, including
United States and Brazil. Many patients
whether the information will have
with SCD need to be chronically
practical utility; (2) The accuracy of the
transfused with red blood cells and the
agency’s estimate of the burden of the
REDS–III research program has
proposed collection of information,
established in Brazil a cohort of patients
including the validity of the
with SCD to study transfusion outcomes
methodology and assumptions used; (3) and infectious diseases such as HIV in
Ways to enhance the quality, utility, and the SCD population.
clarity of the information to be
Sickle cell disease predominantly
collected; and (4) Ways to minimize the affects persons with sub-Saharan Africa
burden of the collection of information
and other malaria-endemic regions
on those who are to respond, including
ancestry because people who carry one
the use of appropriate automated,
sickle cell disease gene (you need 2 to
electronic, mechanical, or other
have sickle cell disease) have a survival
technological collection techniques or
advantage for malaria. Sub-Saharan
other forms of information technology.
Africa, where most people with SCD in
the world live, remains one of the
TO SUBMIT COMMENTS AND FOR FURTHER
regions most severely affected by HIV,
INFORMATION: To obtain a copy of the
with nearly 1 in every 20 adults living
data collection plans and instruments,
with the virus. In the United States, HIV
submit comments in writing, or request
also disproportionately affects persons
more information on the proposed
with African ancestry. Despite the
project, contact: Simone Glynn, MD,
diseases’ occurrence in similar
Project Officer/ICD Contact, Two
populations and the fact that both HIV
Rockledge Center, Suite 9142, 6701
and SCD are independent predictors of
Rockledge Drive, Bethesda, MD 20892,
outcomes such as stroke, there is a lack
or call non-toll-free number (301) 435–
0065, or Email your request to: glynnsa@ of data to evaluate if patients with SCD
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Number of
respondents
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
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
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Form name
Type of respondents
Objective 1 Risk Factor Informed
Consents.
Objective 2 Risk Factor Informed
Consent.
Adult SCD cases and controls .........
300
1
15/60
75
Adult previously enrolled REDS–II
and III HIV SCD patients.
25
1
15/60
6
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Fmt 4703
Sfmt 4703
E:\FR\FM\08JNN1.SGM
08JNN1
32389
Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices
Number of
respondents
Form name
Type of respondents
Objectives 1 and 2 Risk Factor Assessment.
Adult SCD cases and controls, and
Adult previously enrolled REDS–II
and III HIV SCD patients.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–13837 Filed 6–5–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
mstockstill on DSK4VPTVN1PROD 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 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: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–14–022:
Improving Diabetes Management in Young
Children with Type 1 Diabetes (DP3).
Date: June 24, 2015.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Ancillary Studies:
Kramer.
Date: July 10, 2015.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
VerDate Sep<11>2014
17:09 Jun 05, 2015
Jkt 235001
325
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; R13 Conference
Grant Applications.
Date: July 16, 2015.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
755, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799, yangj@
extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Psychosocial and
Behavioral Aspects of Bariatric Surgery
(R01).
Date: July 23, 2015.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Identification of
Novel Targets and Pathways Mediating
Weight Loss, Diabetes Resolution and Related
Metabolic Disease after Bariatric Surgery in
Humans (R01).
Date: July 27, 2015.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
1
Total annual
burden hours
45/60
244
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: June 2, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–13839 Filed 6–5–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Subcommittee.
Date: June 30, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3F30A, 5601 Fisher Lane, Rockville, MD
20892.
Contact Person: Ellen S. Buczko, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 5601
Fishers Lane, Bethesda, MD 20892–7616,
240–669–5028, ebuczko1@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Pages 32388-32389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13837]
[[Page 32388]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60 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 Patients (NHLBI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Heart, Lung, and
Blood Institute (NHLBI), the National Institutes of Health (NIH), will
publish periodic summaries of proposed projects to the Office of
Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on 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 assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be 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.
To Submit Comments and for Further Information: To obtain a copy of the
data collection plans and instruments, submit comments in writing, 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 non-toll-free
number (301) 435-0065, or Email your request to: glynnsa@nhlbi.nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
DATES:
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
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 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.
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent 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.
[[Page 32389]]
Objectives 1 and 2 Risk Factor Adult SCD cases 325 1 45/60 244
Assessment. and controls,
and Adult
previously
enrolled REDS-
II and III HIV
SCD patients.
----------------------------------------------------------------------------------------------------------------
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-13837 Filed 6-5-15; 8:45 am]
BILLING CODE 4140-01-P
