[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: [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