60d FRN - published

18462

Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs.)

Total burden
(in hrs.)

Form name

Women with recent births .................

Maternal hospital-based questionnaire.
Father hospital-based questionnaire
Follow-up phone questionnaire ........

2,760

1

25/60

1,150

1,104
2,868

1
1

15/60
15/60

276
717

...........................................................

........................

........................

........................

2,143

Fathers with recently born infants ....
Women with live births 2–10 months
prior.
Total ...........................................

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. 2017–07880 Filed 4–18–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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.

Centers for Disease Control and
Prevention

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.

[60Day–17–17NF; Docket No. CDC–2017–
0006]

FOR FURTHER INFORMATION CONTACT:

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 titled ‘‘ZIRP Puerto
Rico Study: Zika Virus RNA Persistence
in Pregnant Women and CongenitallyInfected Infants in Puerto Rico.’’
DATES: Written comments must be
received on or before June 19, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0006 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
SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondents

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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
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

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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
ZIRP Puerto Rico Study: Zika Virus
RNA Persistence in Pregnant Women
and Congenitally-Infected Infants in
Puerto Rico—New—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, 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.

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18463

Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices
In addition to mosquito-to-human
transmission, ZIKV infections have been
documented through sexual
transmission, blood transfusion,
laboratory exposure, intrauterine
transmission resulting in congenital
infection, and intrapartum transmission
from a viremic mother to her newborn.
Along with serum, ZIKV RNA has been
detected in semen, urine, breast milk,
and amniotic fluid. ZIKV IgM antibodies
are generally first detectable at 4 to 8
days after onset of illness and likely
persist for weeks to months; however,
the duration of persistence of anti ZIKV
IgM antibodies is unknown as well as
the timing form infection to the
development of IgG antibodies. The
prevalence of ZIKV RNA in various
body fluids among patients with acute
ZIKV infection and the length of time
that ZIKV RNA might persist in these
body fluids is not well understood, nor
the frequency with which it is
infectious.
A few small studies have suggested
that testing pregnant women for Zika
virus (ZIKV) more than seven days from
symptom onset might detect women
with persistence of ZIKV RNA. Less is
known about persistent ZIKV RNA in
congenitally-infected infants.
The Puerto Rico Department of Health
(PRDH) reported the first case of
autochthonous transmission of Zika
Virus (ZIKV) in December 2015. As of
December 16, 2016, 35,648 confirmed
ZIKV cases had been reported in Puerto
Rico, more than any other location in
the U.S., and the number is expected to
rise. Among the confirmed cases, 2,864
have been among pregnant women, and
the first case of microcephaly in a fetus
with confirmed ZIKV infection was
announced by the PRDH on May 13,
2016. Currently, testing for ZIKV

infection can be done by either using
rRT–PCR to detect the presence of ZIKV
RNA or by serologic testing to detect
IgM and neutralizing antibodies. rRT–
PCR testing has been the preferred and
suggested method for diagnosing ZIKV
infection, but has a shorter testing
window.
ZIKV RNA typically only persists in
serum for 3–7 days and is thought to be
cleared by 10 days. Currently, CDC
recommends that all pregnant women
living in areas with active ZIKV
transmission such as Puerto Rico be
tested. Symptomatic pregnant women
should have serum and urine tested for
the presence of ZIKV RNA by rRT–PCR
within two weeks of symptom onset.
Symptomatic pregnant women being
tested more than two weeks after
symptom onset and symptomatic
women with negative rRT–PCR test
results should have serologic testing.
Asymptomatic pregnant women are
recommended to have serologic testing
at the initiation of prenatal care and
again during their first and second
trimesters as a part of routine care;
serum and urine rRT–PCR testing
should be done after a positive or
equivocal serological test result.
Limited data from human studies
suggest that pregnant women have
persistent detection of ZIKV RNA. In
one case report, a pregnant woman
became symptomatic at 11 weeks
gestation and was rRT–PCR-positive at
16 weeks gestation. In another case
report, a pregnant woman tested
positive by rRT–PCR 107 days after
symptom onset. A recent case series
found persistent detection of ZIKV RNA
in five pregnant women. Symptomatic
women had detectable virus at 17, 23,
44, and 46 days post symptom onset and
one asymptomatic woman was still

rRT–PCR positive 53 days after
returning from travel. This pattern has
led to the hypothesis that persistent
detection of ZIKV RNA in pregnant
women may be a marker of fetal
infection and thus potentially a marker
of adverse fetal outcomes including
microcephaly.
Additionally, researchers have
speculated that fetal infection might be
influenced by viral load as well as
persistence. The increasing number of
cases and stage of the outbreak in Puerto
Rico provide an opportunity to collect
actionable information on a shorter
timeframe than is possible elsewhere.
The ZIRP Puerto Rico study aims to
determine the prevalence and duration
of ZIKV RNA persistence in pregnant
women and congenitally infected
infants. This information will be
essential for establishing guidance for
testing and clinical management of
pregnant women and congenitally
infected infants with exposure to ZIKV.
Moreover, this study is expected to
provide critical scientific information to
help the United States prepare for the
unprecedented challenges posed by
Zika and possible clinical guidelines
related to ZIKV RNA testing.
CDC is requesting emergency OMB
review for six months of clearance.
However, because information
collection is expected to take two years,
CDC will submit a non-emergency
information collection request to OMB
for an additional two years of clearance.
Authorizing Legislation for this
information collection comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241)
There is no cost to respondents other
than their time to participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Form name

ZIKV positive Pregnant women ........

Pregnant women screening form .....
Pregnant women enrollment questionnaire.
Pregnant women symptom questionnaire.
Pregnant women follow-up questionnaire.
Infant enrollment questionnaire ........
Infant sample collection questionnaire.
Infant follow-up questionnaire ..........

150
150

1
1

2/60
8/60

5
20

150

1

8/60

20

150

48

8/60

960

150
150

1
1

8/60
8/60

20
20

150

6

8/60

120

...........................................................

........................

........................

........................

1,165

Parents of ZIKV positive Infants .......
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Number of
respondents

Respondents

Total ...........................................

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18464

Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices

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. 2017–07881 Filed 4–18–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–17ABB]

jstallworth on DSK7TPTVN1PROD with NOTICES

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

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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.

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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 laboratoryconfirmed 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.

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