[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44865-44866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16297]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16ARP]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Zika Virus Persistence in Body Fluids of Patients with Zika Virus
Infection in Puerto Rico (ZIPER Study)--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Zika virus (ZIKV) is a mosquito-borne flavivirus that has recently
emerged in the Americas. Previously, outbreaks had occurred in Asia and
islands in the South Pacific. In addition to mosquito-to-human
transmission, ZIKV infections have been documented through sexual
transmission, blood transfusion, laboratory exposure, intrauterine
transmission resulting in congenital infection, and intrapartum
transmission from a viremic mother to her newborn. Along with serum,
ZIKV RNA has been detected in semen, urine, breast milk, and amniotic
fluid. ZIKV IgM antibodies are generally first detectable at 4 to 8
days after onset of illness and likely persist for weeks to months;
however, the duration of persistence of anti-ZIKV IgM antibodies is
unknown as well as the timing from infection to the development of IgG
antibodies. The prevalence of ZIKV RNA in various body fluids among
patients with acute ZIKV infection and the length of time that ZIKV RNA
might persist in these body fluids is not well understood, nor the
frequency with which it is infectious. Characterizing these parameters
has implications both for diagnosis of ZIKV infection using specimens
other than blood than may be more convenient to collect, as well as for
potential human-to-human transmission.
The Zika PERsistence (ZIPER) study will help inform the presence
and duration of ZIKV shedding in several body fluids among RT-PCR-
positive ZIKV cases from Puerto Rico. It will also provide information
regarding the duration of detection of anti-ZIKV IgM antibodies and the
time for development of IgG antibodies among the same population. In
addition, this protocol will determine the prevalence of anti-ZIKV IgM
and IgG, and virus shedding in body fluids among household contacts of
ZIKV cases.
We propose to investigate the persistence (shedding) of ZIKV in
different body fluids and its relation to
[[Page 44866]]
immune response to provide a basis for development of non-blood-based
diagnostic tools, and target and refine public health interventions to
arrest ongoing spread of infection. To do so, we will conduct a
prospective cohort study of individuals with reverse transcription-
polymerase chain reaction (RT-PCR) positive ZIKV infection and a cross-
sectional study of their household contacts. Results and analyses will
be used to update relevant counseling messages and recommendations from
the CDC.
There are no costs to the respondents other than their time. The
total estimated annual burden hours are 374.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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Public Health Personnel............ Shedding Questionnaire 200 8 10/60
(Symptomatics).
Shedding Questionnaire 400 1 10/60
(Cross-Sectional
Asymptomatics).
General Public..................... Shedding Eligibility Form.. 1,000 1 2/60
Contact Information Form... 200 1 2/60
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Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016-16297 Filed 7-8-16; 8:45 am]
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