82 FR 18464 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 74 (April 19, 2017)

[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18464-18465]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07879]


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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.
    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 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 research questions we aim to address with the ZEN 
Colombia study are:
    1. Evaluate associations between ZIKV in pregnancy and adverse 
pregnancy or maternal outcomes, such as preterm birth, preeclampsia, 
maternal death, postpartum hemorrhage, and intrapartum fetal demise, 
among others. Effect modification by gestational age of infection will 
also be explored.
    2. Quantify the magnitude of the association between ZIKV infection 
in pregnancy and major birth defects, with specific focus on 
microcephaly and congenital Zika syndrome. The prospective design of 
the study will allow estimation of both absolute and relative risk for 
microcephaly for women with ZIKV infection during pregnancy.
    3. Identify risk factors for symptomatic ZIKV infection in 
pregnancy among all women with laboratory-confirmed ZIKV in pregnancy. 
A spectrum of risk factors will be considered, including maternal 
demographics, ZIKV infection characteristics, and other potential risk 
factors such as smoking and medication use.
    4. Identify risk factors for ZIKV infection in infancy. A spectrum 
of risk factors will be explored, including maternal infection factors 
and birth and pregnancy factors.
    5. Identify risk factors for symptomatic ZIKV infection in infancy 
among infants with laboratory-confirmed ZIKV born to women enrolled in 
the study. A spectrum of risk factors will be considered, including 
maternal ZIKV infection in pregnancy factors, co-infections, 
sociodemographic characteristics and birth factors.

[[Page 18465]]

    6. Investigate associations between ZIKV infection in utero or in 
infancy and hearing loss and other physical, neurologic, and 
neurodevelopmental outcomes at 6 months of age.
    7. Estimate survival of infants born to ZIKV infected mothers.
    Secondary research questions we aim to address with the ZEN 
Colombia study are:
    1. Identify risk factors for ZIKV infection in pregnant women, 
partners and infants. A spectrum of risk factors will be explored, 
including mosquito bites and mosquito bite preventive measures, sexual 
transmission, sociodemographic characteristics, and medical risk 
factors. The results of this analysis will provide information on the 
reduction in risk associated with adherence to recommended preventive 
measures and risk factors for infection in pregnant women.
    2. Identify characteristics associated with taking preventive 
measures (mosquito bite prevention, sexual transmission) against 
contracting Zika virus among pregnant women and their partners. The 
results of this analysis will assist in targeting education or 
intervention to individuals at greatest risk for Zika infection.
    3. Describe symptoms associated with ZIKV and estimate the positive 
predictive value of certain symptoms or constellations of symptoms in 
pregnant women, men, and infants to allow for refinement of clinical 
diagnosis of ZIKV infection in a setting in which testing and/or 
results might not be readily available.
    4. Assess the duration of viremia following ZIKV infection and 
investigate risk factors (such as sociodemographics, comorbidities, and 
co-infections) associated with prolonged viremia among pregnant women, 
men, and infants with laboratory-confirmed ZIKV infection in blood.
    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 at or within 72 hours of delivery. 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, 3, and 6 months), provide samples for laboratory 
testing, and mothers will complete study-specific questionnaires about 
infant ZIKV symptoms. Infants will also have cranial ultrasounds at 
birth, their head circumference measured (birth, 72 hours, 1, 2, 3, and 
6 months of age), and enhanced hearing/vision tests at 1 and 6 months 
old. 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 
total estimated annualized burden hours are 19,415, and there are no 
costs to participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondents                       Form name           respondents   responses  per   response  (in
                                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Pregnant women........................  Pregnant women                     3,125               1            5/60
                                         eligibility
                                         questionnaire.
                                        Pregnant women                     2,500               1           35/60
                                         enrollment
                                         questionnaire.
                                        Adult symptom                      2,500              15           10/60
                                         questionnaire.
                                        Pregnant women follow-up           2,500               8           15/60
                                         questionnaire.
                                        Infant symptoms                    2,250              14           10/60
                                         questionnaire.
Male partners.........................  Male partner eligibility           2,500               1            5/60
                                         questionnaire.
                                        Male enrollment                      625               1           25/60
                                         questionnaire.
                                        Adult symptom                        625               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. 2017-07879 Filed 4-18-17; 8:45 am]
 BILLING CODE 4163-18-P