[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]


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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, [email protected] 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: [email protected]. 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.

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                                                                     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.
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    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