[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32554-32556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-1140]
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) (OMB Control Number 0920-1140,
Expiration Date 10/31/2017)--Revision--National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is seeking a one-year OMB approval to extend the ZIPER Study
information collection.
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 study 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
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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.
The study will include baseline and follow-up questionnaires and
the collection of the following specimens: blood, saliva, urine from
participants of all ages, and semen/vaginal secretions from adults
(ages 21 years or older) and legally emancipated minors (support
themselves financially, live independent of their parents, are
pregnant, or have children).
Individuals with RT-PCR positive ZIKV infection will be recruited
through the Sentinel Enhanced Dengue Surveillance System (SEDSS) at
Saint Luke's Episcopal Hospital in Ponce, Puerto Rico and through
passive surveillance in selected municipalities in Puerto Rico. SEDSS
was established in 2012 through a cooperative agreement between the
hospital in Consortium with the Ponce School of Medicine and Ponce
Research Institute from the Ponce Health Sciences University and the
CDC (Protocol #6214).
Specimens will be tested for the presence of ZIKV RNA by RT-PCR at
the CDC Dengue Branch Laboratory in San Juan, and positive specimens
will be further tested for virus isolation to evaluate infectivity.
Each body fluid will be collected on a weekly basis for four weeks and
biweekly thereafter until two consecutive negative RT-PCR results are
obtained from all specimens. Irrespective of RNA detection, body fluids
will also be collected for RT-PCT at 2, 4, and 6 months to investigate
intermittent shedding. Analyses of antibody response through titers of
IgM and IgG will be performed at baseline and repeated at 2, 4, and 6
months.
Among symptomatic participants seven milliliters of blood will be
drawn at each study visit split into a tiger top tube (5ml) and a
purple top tube (2ml) for a total not to exceed 50 ml during any given
8-week period. At enrollment healthy non-pregnant adults will have 20
ml of blood collected following standard procedures. Two tiger top
tubes of 8.5 ml and one 3ml purple top tubes will be collected. These
procedures will be repeated at each follow-up visit.
RT-PCR-positive participants will be asked to refer up to five
household members to establish the percentage of household members with
detectable and potentially infectious Zika virus RNA in body fluids.
Household members who are found to be ZIKV RT-PCR-positive in any body
fluid will be invited to participate in the cohort study. A second
study visit will be scheduled with household contact at 2 or 4 months,
to detect new infections and estimate incidence. Because the original
study consent forms do not include this visit, household contacts will
be contacted by study staff and will be consented again using the same
consent form.
Since gaining OMB approval in October 2016, the project has
enrolled 295 Zika virus-infected individuals into the Zika virus
Persistence study, which is 55 individuals below the target enrollment
of 350 individuals.
Preliminary findings have been published in New England Journal of
Medicine, where we also expect that the final report that includes the
full sample size will be published.
This is a request to continue information collection with minor
modifications. Modifications have been made to reflect the developing
nature of the science surrounding Zika virus infection and potential
outcomes associated with infection, as well as additional questions
that were best answered by taking advantage of the existing study
platform. Specifically, CDC proposes the addition of two components to
the collection of data under this study, one of which has already
begun:
1. A follow-up household visit has been added to determine how many
household members of Zika virus-infected participants become infected
during the 4 months following initial screening. For any household
members that had no evidence of Zika virus infection at the initial
visit, the same questionnaires used at the initial household visit will
again be completed ~4 months later. Such information will provide
additional information regarding the incidence of Zika virus infections
among households with a Zika-positive household member.
2. Additionally, CDC proposes following up with men with Zika
virus-positive semen specimens to better understand the effect of Zika
virus infection on sperm. To do this, 8-14 semen ejaculates from 10-20
men participating in the ZIPER study will be used to determine the
presence and/or detection of the Zika virus in different fractions of
the semen ejaculate (i.e., seminal plasma, cellular debris, including
White Blood Cells and spermatozoa). CDC has received Institutional
Review Board approval for this modification, but information collection
has not begun.
Authorizing legislation comes from Section 301 of the Public Health
Service Act (42 U.S.C. 241). The total estimated annualized number of
burden hours is 243. There is no cost to respondents other than the
time to participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Public health personnel......... Shedding Questionnaire.. 18 30 15/60
General public.................. Shedding Questionnaire 55 8 10/60
(Symptomatics).
Shedding Questionnaire 100 1 10/60
(Cross-Sectional
Asymptomatics).
Questionnaire for men in 30 1 20/60
Semen sub-study.
Shedding Eligibility 160 1 2/60
Form.
Contact Information Form 32 1 2/60
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[[Page 32556]]
Leroy A. Richardson,
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. 2017-14790 Filed 7-13-17; 8:45 am]
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