81 FR 44865 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 132 (July 11, 2016)

[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44865-44866]
From the Federal Register Online  [www.thefederalregister.org]
[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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P