82 FR 41265 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 167 (August 30, 2017)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed project titled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.''

[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41265-41267]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1190; Docket No. CDC-2017-0073]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
project titled ``ZEN Colombia Study: Zika in Pregnant Women and 
Children in Colombia.''

DATES: Written comments must be received on or before October 30, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0073 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection

[[Page 41266]]

Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    ZEN Colombia Study: Zika in Pregnant Women and Children in 
Colombia, (OMB No. 0920-1190, expires 07/31/2019)--Revision--Pregnancy 
and Birth Defects Task Force, National Center for 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 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 1000 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

[[Page 41267]]

questionnaires and provide samples for laboratory testing.
    Researchers will follow all study-participating mothers' newborns 
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, 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, 
researchers will abstract relevant clinical care information from 
medical records.
    The revised information collection package includes the following 
changes. During the data collection period, researchers will follow a 
subset of 300 infants until 2-years of age. These infants will have 
answer questionnaires at 6, 12, 18, and 24 months, as well as have 
other clinical assessments performed to exam developmental delays.
    Researchers will use the study results use 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.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Respondents               Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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Pregnant women................  Pregnant women             3,125               1            5/60             260
                                 eligibility               2,500               1           35/60           1,458
                                 questionnaire.            2,500              15           10/60           6,250
                                Pregnant women             2,500               8           15/60           5,000
                                 enrollment                2,250              14           10/60           5,250
                                 questionnaire.
                                Adult symptoms
                                 questionnaire.
                                Pregnant women
                                 follow-up
                                 questionnaire.
                                Infant symptoms
                                 questionnaire.
                                Ages and Stages            2,250               2           15/60           1,125
                                 Questionnaire:              300               3           15/60             225
                                 2, 4, 6 Month.              300               3            5/60              75
                                Ages and Stages
                                 Questionnaire:
                                 12, 18, 24
                                 Month.
                                Center for
                                 Epidemiologic
                                 Studies
                                 Depression--10.
Male partners.................  Male partner               2,500               1            5/60             208
                                 eligibility                 625               1           25/60             260
                                 questionnaire.              625               7           10/60             729
                                Male enrollment
                                 questionnaire.
                                Adult symptoms
                                 questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          20,840
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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. 2017-18405 Filed 8-29-17; 8:45 am]
 BILLING CODE 4163-18-P