81 FR 81144 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 222 (November 17, 2016)

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 a proposed information collection project entitled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.'' This collection intends to identify risk factors for Zika virus (ZIKV) infection in pregnant women and their infants, assess the risk for adverse maternal, fetal, and infant outcomes associated with ZIKV infection and, assess modifiers of the risk for adverse outcomes among pregnant women and their infants following ZIKV infection.

[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81144-81146]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-16BGA; Docket No. CDC-2016-0106]


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 a proposed 
information collection project entitled ``ZEN Colombia Study: Zika in 
Pregnant Women and Children in Colombia.'' This collection intends to 
identify risk factors for Zika virus (ZIKV) infection in pregnant women 
and their infants, assess the risk for adverse maternal, fetal, and 
infant outcomes associated with ZIKV infection and, assess modifiers of 
the risk for adverse outcomes among pregnant women and their infants 
following ZIKV infection.

DATES: Written comments must be received on or before January 17, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0106 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

[[Page 81145]]

proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection 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--New--Pregnancy and Birth Defects Task Force, National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), 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; sexual transmission, mother-
to-child transmission, and 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 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; 
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 August 2016, Colombia has 
reported over 102,000 suspected ZIKV cases, over 18,000 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 two 
to four cities in Colombia where ZIKV transmission is currently 
ongoing.
    The primary objectives of the study are to (1) 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; 
(2) Assess the risk for adverse maternal, fetal, and infant outcomes 
associated with ZIKV infection and; (3) 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.
    Pregnant women will be recruited in the first trimester of 
pregnancy at participating clinics in Colombia's private and public 
health care systems and followed through their pregnancy, delivery, and 
immediate postpartum period. Study visits will coincide with routine 
prenatal care clinic visits (monthly), and at these visits, mothers 
will be monitored for incident ZIKV infection by collection of blood. 
In addition, women will be asked to complete a questionnaire about 
behavioral, sexual, environmental, or other risk factors for ZIKV or 
adverse pregnancy outcomes and a ZIKV symptoms questionnaire. In 
between clinic visits (approximately two weeks after the clinic visit), 
a home visit will be conducted where a urine sample from the pregnant 
woman will be collected. Mothers will complete a ZIKV symptom 
questionnaire at the time of the home visit. Fetal ultrasound 
evaluation will occur once per trimester. If ZIKV is detected during 
pregnancy, monthly fetal ultrasounds will be conducted and women will 
provide

[[Page 81146]]

blood biweekly at the clinic or hospital until there are 2 consecutive 
negative blood tests for ZIKV. Fetal tissue will be collected for 
pregnancy losses to assess fetal ZIKV infection. All pregnancy outcomes 
and any additional testing during pregnancy or in the immediate 
neonatal period as part of clinical care will be abstracted from 
medical records.
    Male partners will be recruited via their pregnant partners around 
the time of their pregnant partners' enrollment into the study. At 
enrollment, men will complete a baseline questionnaire and ZIKV symptom 
questionnaire and provide a blood sample. Urine samples in men will be 
collected at home every 2 weeks through the second trimester of 
pregnancy to monitor for incident ZIKV infection. Men will complete a 
ZIKV symptom questionnaire at the time of each specimen collection. If 
a man becomes symptomatic, he will be asked to provide a blood sample 
at the clinic for ZIKV testing. If ZIKV is detected, semen collection 
at home will be scheduled every two weeks until there are 2 consecutive 
negative tests, or the end of pregnancy. In addition, if a man's at-
home urine sample is positive, he will again be asked to participate in 
semen collection at home every two weeks until there are 2 consecutive 
negative tests, or the end of pregnancy.
    All newborns of mothers participating in the study will be followed 
from birth to 6 months of age. A blood sample will be collected at 
delivery or no later than 3 days after delivery. Urine samples and 
information on infant's symptoms will be collected every 2 weeks at 
home visits to monitor for ZIKV infection in infancy. Additionally, any 
infant health conditions or results from medical testing during this 6-
month period conducted as part of routine clinical care will be 
abstracted from medical records.
    INS and CDC will use the study results to guide their 
recommendations 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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondents               Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Pregnant women................  Pregnant women             6,250               1            5/60             520
                                 eligibility
                                 questionnaire.
                                Pregnant women             5,000               1           20/60           1,666
                                 enrollment
                                 questionnaire.
                                Adult symptom              5,000              12            5/60           5,000
                                 questionnaire.
                                Pregnant women             5,000              12           15/60          15,000
                                 follow-up
                                 questionnaire.
                                Infant symptoms            4,500               4            5/60           1,500
                                 questionnaire.
Male partners.................  Male partner               5,000               1            5/60             417
                                 eligibility
                                 questionnaire.
                                Male enrollment            1,250               1           15/60             312
                                 questionnaire.
                                Adult symptom              1,250              12            5/60           1,250
                                 questionnaire.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          25,665
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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. 2016-27691 Filed 11-16-16; 8:45 am]
 BILLING CODE 4163-18-P