[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

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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
----------------------------------------------------------------------------------------------------------------
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 *.
----------------------------------------------------------------------------------------------------------------
* 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