[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)
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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]
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