[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56028-56030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25495]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-1190]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ZEN Colombia Study: Zika in Pregnant Women
and Children in Colombia to the Office of Management and Budget (OMB)
for review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
August 30, 2017 to obtain comments from the public and affected
agencies. CDC did not receive comments related to the previous notice.
This notice serves to allow an additional 30 days for public and
affected agency comments.
[[Page 56029]]
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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, 725 17th
Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
(OMB Control Number 0920-1190, expires 07/31/2019)--Revision--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. Health officials observed sporadic evidence of human
ZIKV infection 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, health officials have found
evidence of ZIKV 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.
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 December 2016, Colombia has
reported over 106,000-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 to prevent ZIKV transmission; 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 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, 4,500 newborns, and a subset of 900 infants/children.
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.
Researchers will recruit male partners 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.
Researchers will follow all newborns of mothers participating in
the study every other week from birth to 6 months of age. At all
visits, infants will receive national recommended clinical care (at
birth and follow-up visits at 1, 2, 3, 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 and as part of clinical care, researchers will
abstract relevant information from medical records.
The revised information collection package includes the following
changes.
[[Page 56030]]
During the data collection period, researchers will follow a subset of
900 infants until 2-years of age. A parent of each of these infants
will answer a questionnaire at 6, 9, 12, 18, and 24 months, as well as
have other clinical assessments performed to examine developmental
delays.
CDC will use study results 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 and there are no costs to participants other than their time.
The total burden hours are 14,210.
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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Pregnant Women........................ Pregnant Women 600 1 5/60
Eligibility
Questionnaire.
Pregnant Women 500 1 35/60
Enrollment
Questionnaire.
Adult Symptoms 500 15 10/60
Questionnaire.
Pregnant Women Follow-up 500 8 15/60
Questionnaire.
Infant Symptoms 2,250 14 10/60
Questionnaire.
Parent-Child Eligibility 1,000 1 5/60
Questionnaire.
Parent-Child Enrollment 900 1 20/60
Questionnaire.
Parent-Child Follow-up 900 4 15/60
Questionnaire.
Ages and Stages 2,250 2 15/60
Questionnaire: 2 and 6
Month Visits.
Ages and Stages 900 2 15/60
Questionnaire: 12 and
24 Month Visits.
Bayley Scales of Infant 900 3 30/60
and Toddler Development.
Strengths and 900 1 5/60
Difficulties
Questionnaire.
Peabody Developmental 900 1 30/60
Motor Scales.
Parenting Stress Index 900 5 10/60
IV.
Center for Epidemiologic 900 5 5/60
Studies Depression
Scale.
Test of Nonverbal 900 1 20/60
Intelligence.
Male partners......................... Male Partner Eligibility 150 1 5/60
Questionnaire.
Male Enrollment 125 1 25/60
Questionnaire.
Adult Symptoms 125 7 10/60
Questionnaire.
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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. 2017-25495 Filed 11-24-17; 8:45 am]
BILLING CODE 4163-18-P