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


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