[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44866-44867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-16ASR]


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

    Persistence of Zika Virus in Semen and Urine of Adult Men in the 
United States with Confirmed Zika Virus Infection--New--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    Zika virus is an arthropod-borne flavivirus that has recently 
emerged in the Americas. Maternal infection has been linked to 
congenital microcephaly, fetal loss, and other adverse reproductive 
health outcomes. Although spread primarily by mosquitoes, recent 
reports have highlighted the potential for sexual transmission of Zika 
virus through the semen of infected men. Detection of viral RNA in 
semen 62 days after illness onset has been reported; however the 
frequency and duration of virus shedding is largely unknown. 
Information on these parameters is needed urgently to better inform 
public health recommendations, particularly for couples contemplating 
pregnancy.
    This study will fill gaps in the scientific knowledge base for Zika 
virus regarding the persistence and transmissibility of Zika virus in 
body fluids, and determine the frequency and duration of Zika virus 
shedding in semen and urine of infected men. Minimal health information 
and specimens from consenting men with recent Zika virus infection will 
be collected once every two weeks for up to 6 months post onset of 
symptoms (or up to 12 collections). Specimens will be tested for Zika 
RNA by reverse transcriptase polymerase chain reaction assay (RT-PCR) 
at CDC; those testing positive may be further evaluated by virus 
isolation techniques. Zika virus disease is a nationally notifiable 
condition, and participants will be recruited through contact with CDC 
personnel. Urine and semen specimens will be self-collected using home 
collection kits, a short questionnaire will be self-administered, and 
participants will be compensated for their time. Results of testing 
will be provided to participants at the conclusion of testing. The 
results of this study are expected to have immediate implications for 
public health recommendations and disease prevention.
    This is a prospective, descriptive cohort study. The prospective 
nature of the proposed cohort study allows for determining the 
persistence of shedding Zika virus in semen and urine through serial 
specimen collection from individuals with confirmed Zika virus.
    The results of this study will be of great relevance to provide 
evidence-based information to circumvent Zika virus transmission. They 
will inform the development of recommendations used in the current 
epidemic setting, as well as in future Zika virus situations. Results 
and analysis will be used to update and refine relevant counseling 
messages and recommendations.

[[Page 44867]]

Potential products include scientific abstracts and manuscripts, 
presentations, and guidance documents.
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours are 134.

                                        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)
----------------------------------------------------------------------------------------------------------------
General Public.....................  Introductory Survey........             250               1           20/60
                                     Follow-up survey...........             250              12            1/60
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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. 2016-16298 Filed 7-8-16; 8:45 am]
 BILLING CODE 4163-18-P