[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
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Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
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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