[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46677-46678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-16-16AVB]


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

[[Page 46678]]

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

    US Zika Pregnancy Registry--New--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    In May 2015, the World Health Organization reported the first local 
transmission of Zika virus in the Western Hemisphere, with 
autochthonous cases identified in Brazil. As of March 16, 2016, local 
transmission has been identified in at least 32 countries or 
territories in the Americas. Further spread to other countries in the 
region is likely. Local vectorborne transmission of Zika virus has not 
been documented in the 50 U.S. states or the District of Columbia, but 
has occurred in U.S. territories, including in Puerto Rico, the U.S. 
Virgin Islands, and American Samoa. However, Zika virus infections have 
been reported in travelers returning to the United States from areas 
with active Zika virus transmission. Zika virus infection also has 
occurred through sexual transmission, which may pose an additional risk 
to non-travelling pregnant women whose partners may have traveled to 
areas at high risk for Zika virus acquisition. With the ongoing 
outbreak in the Americas, the number of Zika virus disease cases among 
travelers returning to the United States likely will increase, and 
sexual transmission from male travelers to their sex partners in the 
United States will likely continue to occur. In addition, mosquito-
borne local transmission may occur in states where Aedes species 
mosquitoes are present.
    In some Brazilian states where Zika virus transmission has 
occurred, there has been an increase in cases of infants born with 
microcephaly. Zika virus infections have been confirmed in several 
infants with microcephaly and in fetal losses in women infected during 
pregnancy. In addition to microcephaly, a range of other problems have 
been detected among fetuses and infants infected with Zika virus before 
birth, such as absent or poorly developed brain structures, defects of 
the eye, hearing deficits, and impaired growth. The Ministry of Health 
in Brazil, with support from the Pan American Health Organization 
(PAHO), the U.S. Centers for Disease Control and Prevention (CDC), and 
other partners, is investigating the association between Zika virus 
infection and microcephaly, as well as other adverse pregnancy and 
infant outcomes.
    As part of the public health response to the Zika virus disease 
outbreak, CDC will conduct supplemental surveillance of antenatal 
diagnostic testing and clinical outcomes among pregnant women with 
laboratory evidence of Zika virus or unspecified flavivirus infection 
and their infants through the U.S. Zika Pregnancy Registry. It is 
anticipated that the Registry will provide critical information to 
direct CDC clinical recommendations and public health guidance and 
messages.
    The objective of this Registry is to monitor the frequency and 
types of pregnancy and infant outcomes following Zika virus infection 
during pregnancy, so as to inform ongoing response efforts for this 
Zika virus disease outbreak, including recommendations for clinical 
care, planning for services for pregnant women and infants affected by 
Zika virus, and improved prevention of Zika virus infections during 
pregnancy.
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours are 2,167.

                                        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 hrs.)
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State, Territorial and Local Health  Maternal Health History                 100              10           30/60
 Departments.                         Form.
                                     Supplemental Imaging Form..             100              10           10/60
                                     Laboratory Results Form....             100              10           15/60
Clinicians and Other Providers.....  Assessment at Delivery Form             100              10           30/60
                                     Infant Health Follow-Up                 100              30           15/60
                                      Form.
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Jeffrey M. Zirger,
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. 2016-16872 Filed 7-15-16; 8:45 am]
 BILLING CODE 4163-18-P