80 FR 32388 - 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)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 109 (June 8, 2015)

Page Range		32388-32389
FR Document		2015-13837

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.

Federal Register, Volume 80 Issue 109 (Monday, June 8, 2015)

[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Pages 32388-32389]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13837]



[[Page 32388]]

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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: [email protected]. 
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

32388 Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices

DEPARTMENT OF HEALTH AND nhlbi.nih.gov. Formal requests for and HIV have different illnesses than
HUMAN SERVICES additional plans and instruments must patients who have SCD- or HIV-only.
be requested in writing. The proposed study will seek to
National Institutes of Health DATES: understand the risk of HIV in the SCD
Comments Due Date: Comments population, describe HIV outcomes in
Proposed Collection; 60 Day Comment regarding this information collection are patients with SCD and compare SCD
Request Characterization of Risk of best assured of having their full effect if complications between HIV-positive
HIV and HIV Outcomes in the Brazilian received within 60 days of the date of and HIV-negative patients with SCD
Sickle Cell Disease (SCD) Population this publication. using the infrastructure established by
and Comparison of SCD Outcomes Proposed Collection: Characterization the REDS–III SCD Cohort study.
Between HIV Sero-Positive and of risk of HIV and HIV outcomes in the
Negative SCD Patients (NHLBI) The limited studies focused on HIV in
Brazilian Sickle Cell Disease (SCD) SCD have suggested that HIV may not
population and comparison of SCD occur as frequently in patients with SCD
SUMMARY: In compliance with the
outcomes between HIV sero-positive as in people who do not have SCD.
requirement of Section 3506(c)(2)(A) of
and negative SCD patients 0925–NEW, While it has been hypothesized that
the Paperwork Reduction Act of 1995,
National Heart, Lung, and Blood perhaps SCD pathophysiology has a
for opportunity for public comment on
Institute (NHLBI), the National unique effect on HIV infection or
proposed data collection projects, the
Institutes of Health (NIH).
National Heart, Lung, and Blood replication, none of the studies have
Need and Use of Information
Institute (NHLBI), the National adequately measured risk factors for
Collection: The National Heart, Lung,
Institutes of Health (NIH), will publish and Blood Institute (NHLBI) Recipient HIV in patients with SCD. The first
periodic summaries of proposed Epidemiology and Donor Evaluation objective of the proposed study is to
projects to the Office of Management Study-III (REDS–III) program conducts compare HIV risk factors between 150
and Budget (OMB) for review and research focused on the safety of the patients with SCD (cases) randomly
approval. blood supply, the patients who are in selected from the REDS–III SCD Cohort
Written comments and/or suggestions need of transfusions, and the study and 150 individuals without SCD
from the public and affected agencies epidemiology of transfusion- (controls) from a demographically
are invited on one or more of the transmissible infections such as human similar population. An assessment that
following points: (1) Whether the immunodeficiency virus (HIV). Sickle has been well validated in previous
proposed collection of information is cell disease (SCD) is a blood disorder studies has been modified for the SCD
necessary for the proper performance of that affects thousands of people in the population and will be used to collect
the function of the agency, including United States and Brazil. Many patients data regarding HIV risk behaviors. The
whether the information will have with SCD need to be chronically second objective of the proposed study
practical utility; (2) The accuracy of the transfused with red blood cells and the will seek to enroll approximately 25
agency’s estimate of the burden of the REDS–III research program has patients with SCD and HIV who consent
proposed collection of information, established in Brazil a cohort of patients to have detailed information regarding
including the validity of the with SCD to study transfusion outcomes their diseases retrieved from their
methodology and assumptions used; (3) and infectious diseases such as HIV in medical records. This will allow for an
Ways to enhance the quality, utility, and the SCD population. in-depth evaluation of how patients
clarity of the information to be Sickle cell disease predominantly with both diseases fare. Additionally,
collected; and (4) Ways to minimize the affects persons with sub-Saharan Africa patients who have SCD but not HIV will
burden of the collection of information and other malaria-endemic regions be compared to patients who have both
on those who are to respond, including ancestry because people who carry one diseases to better understand how one
the use of appropriate automated, sickle cell disease gene (you need 2 to disease affects the other disease.
electronic, mechanical, or other have sickle cell disease) have a survival Information on the HIV-negative
technological collection techniques or advantage for malaria. Sub-Saharan patients with SCD has already been
other forms of information technology. Africa, where most people with SCD in collected because they participated in
TO SUBMIT COMMENTS AND FOR FURTHER the world live, remains one of the the REDS–III SCD Cohort study. This
INFORMATION: To obtain a copy of the regions most severely affected by HIV, study will provide critical information
data collection plans and instruments, with nearly 1 in every 20 adults living to guide the management and future
submit comments in writing, or request with the virus. In the United States, HIV research for patients with HIV and SCD
more information on the proposed also disproportionately affects persons in Brazil, the United States, and
project, contact: Simone Glynn, MD, with African ancestry. Despite the worldwide.
Project Officer/ICD Contact, Two diseases’ occurrence in similar OMB approval is requested for 3
Rockledge Center, Suite 9142, 6701 populations and the fact that both HIV years. There are no costs to respondents
Rockledge Drive, Bethesda, MD 20892, and SCD are independent predictors of other than their time. The total
or call non-toll-free number (301) 435– outcomes such as stroke, there is a lack estimated annualized burden hours are
0065, or Email your request to: glynnsa@ of data to evaluate if patients with SCD 325.

Average
Number of
Number of burden per Total annual
Form name Type of respondents responses per
respondents response burden hours
mstockstill on DSK4VPTVN1PROD with NOTICES

respondent (in hours)

Objective 1 Risk Factor Informed Adult SCD cases and controls ......... 300 1 15/60 75
Consents.
Objective 2 Risk Factor Informed Adult previously enrolled REDS–II 25 1 15/60 6
Consent. and III HIV SCD patients.

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Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices 32389

Average
Number of
Number of burden per Total annual
Form name Type of respondents responses per
respondents response burden hours
respondent (in hours)

Objectives 1 and 2 Risk Factor As- Adult SCD cases and controls, and 325 1 45/60 244
sessment. Adult previously enrolled REDS–II
and III HIV SCD patients.

Lynn Susulske, Boulevard, Bethesda, MD 20892, (Telephone (Catalogue of Federal Domestic Assistance
NHLBI Project Clearance Liaison, National Conference Call). Program Nos. 93.847, Diabetes,
Institutes of Health. Contact Person: Paul A. Rushing, Ph.D., Endocrinology and Metabolic Research;
Scientific Review Officer, Review Branch, 93.848, Digestive Diseases and Nutrition
[FR Doc. 2015–13837 Filed 6–5–15; 8:45 am]
DEA, NIDDK, National Institutes of Health, Research; 93.849, Kidney Diseases, Urology
BILLING CODE 4140–01–P Room 747, 6707 Democracy Boulevard, and Hematology Research, National Institutes
Bethesda, MD 20892–5452, (301) 594–8895, of Health, HHS)
rushingp@extra.niddk.nih.gov.
DEPARTMENT OF HEALTH AND Dated: June 2, 2015.
Name of Committee: National Institute of
HUMAN SERVICES Diabetes and Digestive and Kidney Diseases David Clary,
Special Emphasis Panel; R13 Conference Program Analyst, Office of Federal Advisory
National Institutes of Health Grant Applications. Committee Policy.
Date: July 16, 2015. [FR Doc. 2015–13839 Filed 6–5–15; 8:45 am]
National Institute of Diabetes and Time: 11:00 a.m. to 12:30 p.m. BILLING CODE 4140–01–P
Digestive and Kidney Diseases; Notice Agenda: To review and evaluate grant
of Closed Meetings applications.
Place: National Institutes of Health, Two
Pursuant to section 10(d) of the Democracy Plaza, 6707 Democracy DEPARTMENT OF HEALTH AND
Federal Advisory Committee Act, as Boulevard, Bethesda, MD 20892, (Telephone HUMAN SERVICES
amended (5 U.S.C. App.), notice is Conference Call).
Contact Person: Jian Yang, Ph.D., Scientific National Institutes of Health
hereby given of the following meetings.
Review Officer, Review Branch, DEA,
The meetings will be closed to the NIDDK, National Institutes of Health, Room National Institute of Allergy and
public in accordance with the 755, 6707 Democracy Boulevard, Bethesda, Infectious Diseases; Notice of Closed
provisions set forth in sections MD 20892–5452, (301) 594–7799, yangj@ Meeting
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., extra.niddk.nih.gov.
as amended. The grant applications and Name of Committee: National Institute of Pursuant to section 10(d) of the
the discussions could disclose Diabetes and Digestive and Kidney Diseases Federal Advisory Committee Act, as
confidential trade secrets or commercial Special Emphasis Panel; Psychosocial and amended (5 U.S.C. App.), notice is
property such as patentable material, Behavioral Aspects of Bariatric Surgery hereby given of the following meeting.
and personal information concerning (R01).
Date: July 23, 2015.
The meeting will be closed to the
individuals associated with the grant Time: 12:00 p.m. to 4:00 p.m. public in accordance with the
applications, the disclosure of which Agenda: To review and evaluate grant provisions set forth in sections
would constitute a clearly unwarranted applications. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
invasion of personal privacy. Place: National Institutes of Health, Two as amended. The grant applications and
Name of Committee: National Institute of Democracy Plaza, 6707 Democracy the discussions could disclose
Boulevard, Bethesda, MD 20892, (Telephone confidential trade secrets or commercial
Diabetes and Digestive and Kidney Diseases
Conference Call).
Special Emphasis Panel; RFA–DK–14–022:
Contact Person: Paul A. Rushing, Ph.D.,
property such as patentable material,
Improving Diabetes Management in Young and personal information concerning
Scientific Review Officer, Review Branch,
Children with Type 1 Diabetes (DP3). individuals associated with the grant
DEA, NIDDK, National Institutes of Health,
Date: June 24, 2015. Room 747, 6707 Democracy Boulevard, applications, the disclosure of which
Time: 11:00 a.m. to 3:00 p.m. Bethesda, MD 20892–5452, (301) 594–8895, would constitute a clearly unwarranted
Agenda: To review and evaluate grant rushingp@extra.niddk.nih.gov.
applications.
invasion of personal privacy.
Place: National Institutes of Health, Two Name of Committee: National Institute of Name of Committee: Microbiology,
Democracy Plaza, 6707 Democracy Diabetes and Digestive and Kidney Diseases
Infectious Diseases and AIDS Initial Review
Special Emphasis Panel; Identification of
Boulevard, Bethesda, MD 20892, (Telephone Group; Microbiology and Infectious Diseases
Novel Targets and Pathways Mediating
Conference Call). B Subcommittee.
Weight Loss, Diabetes Resolution and Related
Contact Person: Ann A. Jerkins, Ph.D., Date: June 30, 2015.
Metabolic Disease after Bariatric Surgery in
Scientific Review Officer, Review Branch, Time: 8:00 a.m. to 5:00 p.m.
Humans (R01).
DEA, NIDDK, National Institutes of Health, Date: July 27, 2015. Agenda: To review and evaluate grant
Room 759, 6707 Democracy Boulevard, Time: 12:00 p.m. to 4:00 p.m. applications.
Bethesda, MD 20892–5452, 301–594–2242, Agenda: To review and evaluate grant Place: National Institutes of Health, Room
jerkinsa@niddk.nih.gov. applications. 3F30A, 5601 Fisher Lane, Rockville, MD
Name of Committee: National Institute of Place: National Institutes of Health, Two 20892.
Diabetes and Digestive and Kidney Diseases Contact Person: Ellen S. Buczko, Ph.D.,
mstockstill on DSK4VPTVN1PROD with NOTICES

Democracy Plaza, 6707 Democracy
Special Emphasis Panel; Ancillary Studies: Boulevard, Bethesda, MD 20892, (Telephone Scientific Review Officer, Scientific Review
Kramer. Conference Call). Program, Division of Extramural Activities,
Date: July 10, 2015. Contact Person: Paul A. Rushing, Ph.D., National Institutes of Health/NIAID, 5601
Time: 2:00 p.m. to 3:00 p.m. Scientific Review Officer, Review Branch, Fishers Lane, Bethesda, MD 20892–7616,
Agenda: To review and evaluate grant DEA, NIDDK, National Institutes of Health, 240–669–5028, ebuczko1@niaid.nih.gov.
applications. Room 747, 6707 Democracy Boulevard, (Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, Two Bethesda, MD 20892–5452, (301) 594–8895, Program Nos. 93.855, Allergy, Immunology,
Democracy Plaza, 6707 Democracy rushingp@extra.niddk.nih.gov. and Transplantation Research; 93.856,

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Document Created: 2018-02-22 10:12:49
Document Modified: 2018-02-22 10:12:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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.
FR Citation		80 FR 32388

80 FR 32388 - 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)

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 109 (June 8, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health