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)

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, 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.

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                                                                                      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.
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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