[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26930-26931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17ABB]


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]. Direct written comments 
and/or suggestions regarding the items contained in this notice 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

    ZEN Colombia Study: Zika in Pregnant Women and Children in 
Colombia--New--Pregnancy and Birth Defects Task Force, National Center 
on Birth Defects and Developmental Disabilities, Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Zika virus (ZIKV) infection is a mosquito-borne flavivirus 
transmitted by Aedes species mosquitoes, and also through sexual and 
mother-to-child transmission; laboratory-acquired infections have also 
been reported. Evidence of human ZIKV infection was observed 
sporadically in Africa and Asia prior to 2007, when an outbreak of ZIKV 
caused an estimated 5,000 infections in the State of Yap, Federated 
States of Micronesia. Since then, evidence of ZIKV has been found in 65 
countries and territories, mostly in Central and South America. Common 
symptoms of ZIKV in humans include rash, fever, arthralgia, and 
nonpurulent conjunctivitis. The illness is usually mild and self-
limited, with symptoms lasting for several days to a week; however, 
based on previous outbreaks, some infections are asymptomatic. The 
prevalence of asymptomatic infection in the current Central and South 
American epidemic is unknown.
    Although the clinical presentation of ZIKV infection is typically 
mild, ZIKV infection in pregnancy can cause microcephaly and related 
brain abnormalities when fetuses are exposed in utero. Other adverse 
pregnancy outcomes related to ZIKV infection remain under study, and 
include pregnancy loss, other major birth defects, arthrogryposis, eye 
abnormalities, and neurologic abnormalities.
    As the spectrum of adverse health outcomes potentially related to 
ZIKV infection continues to grow, large gaps remain in our 
understanding of ZIKV infection in pregnancy. These include the full 
spectrum of adverse health outcomes in pregnant women, fetuses, and 
infants associated with ZIKV infection; the relative contributions of 
sexual transmission and mosquito-borne transmission to occurrence of 
infections in pregnancy; and variability in the risk of adverse fetal 
outcomes by gestational week of maternal infection or symptoms of 
infection. There is an urgency to fill these large gaps in our 
understanding given the rapidity of the epidemic's spread and the 
severe health outcomes associated with ZIKV to date.

[[Page 26931]]

    Colombia's Instituto Nacional de Salud (INS) began surveillance for 
ZIKV in 2015, reporting the first autochthonous transmission in October 
2015 in the north of the country. As of October 2016, Colombia has 
reported over 105,000 suspected ZIKV cases, with over 19,000 of them 
among pregnant women. With a causal link established between ZIKV 
infection in pregnancy and microcephaly, there is an urgent need to 
understand: How ZIKV transmission can be prevented; the full spectrum 
of adverse maternal, fetal, and infant health outcomes associated with 
ZIKV infection; and risk factors for occurrence of these outcomes. To 
answer these questions, INS and the U.S. Centers for Disease Control 
and Prevention (CDC) will follow 5,000 women enrolled in the first 
trimester of pregnancy, their male partners, and their infants, in 
various cities in Colombia where ZIKV transmission is currently 
ongoing.
    The primary study objectives are to: (1) Describe the 
sociodemographic and clinical characteristics of the study population; 
(2) Identify risk factors for ZIKV infection in pregnant women and 
their infants. These include behaviors such as use of mosquito-bite 
prevention measures or condoms, and factors associated with maternal-
to-child transmission; (3) Assess the risk for adverse maternal, fetal, 
and infant outcomes associated with ZIKV infection; (4) Assess 
modifiers of the risk for adverse outcomes among pregnant women and 
their infants following ZIKV infection. This includes investigating 
associations with gestational age at infection, presence of ZIKV 
symptoms, extended viremia, mode of transmission, prior infections or 
immunizations, and co-infections.
    The project aims to enroll approximately 5,000 women, 1,250 male 
partners, and 4,500 newborns. Pregnant women will be recruited in the 
first trimester of pregnancy for study enrollment, followed by 
assessments during pregnancy (every other week until 32 weeks gestation 
and monthly thereafter), and within 10 days postpartum. At all visits, 
participants will complete visit-specific questionnaires. In addition 
to the questionnaires, at all pregnancy and delivery visits, 
participants will receive Colombian national recommended clinical care 
and provide samples for laboratory testing.
    Male partners will be recruited around the time of the pregnant 
partners' study enrollment, followed by monthly visits until his 
pregnant partner reaches the third trimester (approximately 27 weeks 
gestation). If the male partner contracts ZIKV during this time, visits 
will occur every other week until the partner has two negative 
consecutive tests for ZIKV or the pregnancy ends. At all study visits, 
male partners will complete visit-specific questionnaires and provide 
samples for laboratory testing.
    All newborns of mothers participating in the study will be followed 
every other week from birth to 6 months of age. At all visits, infants 
will receive national recommended clinical care (at birth and clinic 
visits at 1, 2, and 6 months), provide samples for laboratory testing, 
and mothers will complete study-specific questionnaires about infant 
ZIKV symptoms and developmental milestones. During follow-up, infants 
will also have cranial ultrasounds, their head circumference measured, 
and hearing and vision tests. For mothers and their infants, relevant 
information collected as part of clinical care will be abstracted from 
medical records. Study results will be used to guide recommendations 
made by both INS and CDC to prevent ZIKV infection; to improve 
counseling of patients about risks to themselves, their pregnancies, 
their partners, and their infants; and to help agencies prepare to 
provide services to affected children and families. Participation in 
this study is voluntary. The estimated number of annual Burden Hours 
are 20,548 and there are no costs to participants other than their 
time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
            Respondents                       Form name              Number of     responses per    per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Pregnant women.....................  Pregnant women eligibility            3,125               1            5/60
                                      questionnaire.
                                     Pregnant women enrollment             2,500               1           35/60
                                      questionnaire.
                                     Adult symptom questionnaire           2,500              15           10/60
                                     Pregnant women follow-up              2,500               8           15/60
                                      questionnaire.
                                     Infant symptoms                       2,250              14           10/60
                                      questionnaire.
                                     Infant Ages and Stages                2,250               1           15/60
                                      Questionnaire: 2 Month.
                                     Infant Ages and Stages                2,250               1           15/60
                                      Questionnaire: 6 Month.
Male partners......................  Male partner eligibility              2,500               1            5/60
                                      questionnaire.
                                     Male enrollment                         625               1           25/60
                                      questionnaire.
                                     Adult symptom questionnaire             625               7           10/60
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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. 2017-12059 Filed 6-9-17; 8:45 am]
BILLING CODE 4163-18-P