[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Pages 9471-9473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03547]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-day Comment Request; Incident HIV/
Hepatitis B Virus Infections in South African Blood Donors: Behavioral
Risk Factors, Genotypes and Biological Characterization of Early
Infection
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
[[Page 9472]]
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 in Volume 78 on Friday, November 8, 2013, and page
67175, and allowed 60 days for public comment. One public comment was
received that was a personal opinion regarding protecting the safety of
the American blood donation system. 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: NIH Desk Officer.
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: Incident HIV/Hepatitis B virus (HBV)
infections in South African blood donors: Behavioral risk factors,
genotypes and biological characterization of early infection, 0925-New,
the National Heart, Lung, and Blood Institute (NHLBI), the National
Institutes of Health (NIH).
Need and Use of Information Collection: South Africa has one of the
highest burdens for HIV infection in the world. The HIV epidemic in
South Africa is largely heterosexual, but risk factors for infections
can change and so identifying factors that contribute to the recent
spread of HIV in a broad cross-section of the otherwise unselected
general population, such as blood donors, is highly important for
obtaining a complete picture of the epidemiology of HIV infection in
Africa. Small previous studies suggest that the risk factors for HIV
among more recently acquired (incident) infections in blood donors may
differ from those of more distant (prevalent) infections. Similarly
risk factors for recently acquired HBV may be different than for
prevalent HBV infections. The demographic and behavioral risks
associated with incident HIV and incident HBV infection have, as yet,
not been formally assessed in South African blood donors using
analytical study designs. Due to the high rates of HIV and HBV
infection in South African blood donors, a better understanding of
these risk factors can be used to modify donor screening questionnaires
so as to more accurately exclude high-risk blood donors and contribute
to transfusion safety. Risk factor data from this research may also
provide critical information for blood banking screening strategies in
other countries.
This study which provides a contemporary understanding of the
current risk profiles for HIV and separately for HBV will also
prospectively monitor genetic characteristics of recently acquired
infections through genotyping and drug resistance profile testing, thus
serving a US, South African, and global public health imperative to
monitor the genotypes of HIV and HBV that have recently been
transmitted. For HIV, the additional monitoring of drug resistance
patterns in newly acquired infection is critical to determine if
currently available antiretroviral medicines are capable of combating
infection. Because the pace of globalization means these infections can
cross borders easily, these study objectives have direct relevance for
HIV and HBV control in the U.S. and globally. Further, the ability to
identify recent HIV infections provides a unique opportunity to study
the biology, host response and evolution of HIV disease at time points
proximate to virus acquisition. Genotyping and host response
information is scientifically important not only to South Africa, but
to the U.S. and other nations since it will provide a broader global
understanding of how to most effectively manage and potentially prevent
HIV (e.g. through vaccine development). Efforts to develop vaccines
funded by the National Institutes of Health and other US-based
organizations may directly benefit from the findings of this study.
The South African National Blood Service (SANBS) uses both
individual donation Nucleic Acid Testing (ID-NAT) and serology tests
(either antibody or antigen detection tests) to screen blood donors for
HIV and Hepatitis-B Virus (HBV), among other infections. A positive NAT
test precedes HIV antibody detection or HBV surface antigen detection
by days to weeks in newly acquired HIV and HBV infections. A combined
testing strategy using NAT and serology tests therefore confers the
ability to detect most acute infections and discriminate between recent
(incident) and more remotely acquired (prevalent) infection. Additional
tests that exploit antibody maturation kinetics such as the HIV
Limiting Antigen Avidity assay (LAg Avidity) can further assist to
classify persons with an HIV antibody positive test as having a
recently acquired (incident) or longer-term (prevalent) infection.
Hepatitis B core antibody (anti-HBc) testing of NAT-positive and NAT
and Hepatitis B Virus Surface Antigen (HBsAg) positive HBV infections
allows classification of HBV infections as recently acquired or
prevalent infections. Infections that are anti-HBc negative are
recently acquired (incident).
Leveraging this ability to classify HIV and HBV infections as
incident or prevalent leads to three study objectives:
1. Objective 1 consists of evaluating the risk factors associated
with having an incident HIV or HBV infection. To that end, a frequency
matched case-control study will be conducted with two case groups:
Incident HIV infected blood donors and incident HBV infected blood
donors, respectively. Risk factors in these two case groups will be
compared to the risk factors provided by a group of controls (blood
donors whose infectious tests are all negative). Cases and controls
will be accrued from a geographically diverse donor pool.
2. Objective 2 consists of characterizing HIV clade and drug
resistance profiles and determining viral loads in all cases of
incident HIV infection, as well as characterizing HBV genotype and
viral load in all incident HBV infections.
3. Objective 3 consists of following persons with incident and
``elite controller'' HIV infections prospectively for three additional
visits at 2, 3, and 6 months following the index positive test(s). The
term ``elite controllers'' refers to those who are HIV antibody
positive, but with undetectable viral RNA (NAT negative) who are
believed to have a natural ability to control viral replication without
therapy. These studies will be useful in identifying appropriate HIV
drug therapy regimens for this condition, as well as strategies
[[Page 9473]]
for producing an effective HIV vaccine, which has eluded 30 years of
HIV research.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden for Objectives 1 and 2 will be 395 hours for 483 respondents
(participants). The total estimated annualized burden for Objective 3
will be 32 hours for 35 respondents.
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
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Objectives 1 and 2 consent Adult Donors.... 483 1 15/60 121
form.
Objectives 1 and 2--ACASI Adult Donors.... 483 1 34/60 274
Questionnaire.
Objective 3 consent form--Year Adult Donors.... 35 1 15/60 9
1.
Objective 3--Clinical Follow- Adult Donors.... 35 4 10/60 23
up Questionnaire--Year 1 *.
Objective 3 consent form*-- Adult Donors.... 35 1 15/60 9
Year 2.
Objective 3--Clinical Follow- Adult Donors.... 35 4 10/60 23
up Questionnaire--Year 2 *.
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* The Objective 3 respondents are a subset of the respondents included in Objectives 1 and 2.
Dated: February 3, 2014.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: February 6, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-03547 Filed 2-18-14; 8:45 am]
BILLING CODE 4140-01-P