60d FRN - published

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Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices

investigation. After clinical reports and
field observation of a broader range of
health endpoints, this larger
investigation is now being undertaken
to expand the exploration of the
association of Zika virus infection with
not only Guillain-Barre syndrome but
also other severe neurologic illnesses.
Under this request, case and control
interviews similar to those conducted
under the previously approved
information collection will be
conducted using the questionnaire
developed by the investigation team. All
cases and controls will be asked
questions about activities, antecedent
signs and symptoms of illness, and
exposures in the two months prior to
onset of neurologic illness for cases and
the same time period for their matched
controls. A calendar will be used to
orient cases and controls to the time
period of interest.
As in the previously approved
information collection activities, sera,
urine, and saliva will be collected from
cases and controls at the time of

possible additional testing for GBSassociated biological markers or other
infectious pathogens as clinically
indicated. If a participant does not
provide consent to store the specimens,
all specimens for that participant will be
destroyed once testing for infectious
disease pathogens has been completed.
As with cases, written consent will also
be obtained to review controls’ medical
records, where applicable and available,
using a standardized chart abstraction
form. Diagnostic test results will be
securely transmitted from CDC to PRDH,
which will then transmit diagnostic test
results to participants by telephone or
mail, as they prefer.
Data analysis will focus on potential
demographic, environmental, and/or
medical risk factors for developing
neurologic illness, as well as laboratory
evidence for infection with the
aforementioned pathogens.
The total number of estimated
annualized burden hours for this project
is 90. There are no other costs to
respondents other than their time.

interview using standard techniques.
The sera will be tested for antibodies
against suspected infectious pathogens,
such as ZIKV, dengue virus,
chikungunya virus, influenza virus,
human immunodeficiency virus, and
Leptospira species bacteria. Urine
specimens will be tested by rRT–PCR to
identify ZIKV, dengue virus, or
chikungunya virus.
If any residual specimens are
available from cases, those will also be
obtained and undergo testing for
infectious pathogens. It is not expected
that matched controls will have any
previously collected clinical specimens;
however, in cases where controls had
specimens collected while seeking
medical care for an acute illness
experienced within two months of GBS
symptom onset of the matching case,
these specimens will also be collected
and tested for evidence of infection with
the aforementioned pathogens.
Residual samples will be stored after
infectious testing is complete at the U.S.
CDC with an identification number for

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Public Health Personnel ...................

Severe Neurologic Illness Chart Abstraction Questionnaire.
Severe Neurologic Illness Questionnaire for Cases and Controls.

General Public ..................................
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. 2016–27692 Filed 11–16–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–16BGA; Docket No. CDC–2016–
0106]
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

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:

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21:24 Nov 16, 2016

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6

1

60

120

1

15/60

30

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

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

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

90

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.

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

DATES:

Frm 00092

Fmt 4703

Total burden
(in hours)

10

SUMMARY:

PO 00000

Average
burden per
response
(in hours)

Number of
responses per
respondent

Sfmt 4703

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
ADDRESSES:

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Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
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].

Proposed Project

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.

Background and Brief Description

asabaliauskas on DSK3SPTVN1PROD with NOTICES

SUPPLEMENTARY INFORMATION:

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21:24 Nov 16, 2016

Jkt 241001

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).
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

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81145

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

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81146

Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices

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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total burden
hours

Form name

Pregnant women ...............................

Pregnant women eligibility questionnaire.
Pregnant women enrollment questionnaire.
Adult symptom questionnaire ...........
Pregnant women follow-up questionnaire.
Infant symptoms questionnaire ........
Male partner eligibility questionnaire
Male enrollment questionnaire .........
Adult symptom questionnaire ...........

6,250

1

5/60

520

5,000

1

20/60

1,666

5,000
5,000

12
12

5/60
15/60

5,000
15,000

4,500
5,000
1,250
1,250

4
1
1
12

5/60
5/60
15/60
5/60

1,500
417
312
1,250

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

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

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

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

25,665

Male partners ....................................

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. 2016–27691 Filed 11–16–16; 8:45 am]
BILLING CODE 4163–18–P

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

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 ‘‘Data Calls for the
Laboratory Response Network’’
collected from its members concerning
their capacity to respond to public
health threat emergencies.
Written comments must be
received on or before January 17, 2017.

DATES:

[60Day–17–0881; Docket No. CDC–2016–
0109]

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Respondents

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

SUMMARY:

VerDate Sep<11>2014

21:24 Nov 16, 2016

Jkt 241001

You may submit comments,
identified by Docket No. CDC–2017–
0109 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.

ADDRESSES:

Proposed Data Collection Submitted
for Public Comment and
Recommendations

PO 00000

Frm 00094

Fmt 4703

Sfmt 4703

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 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

E:\FR\FM\17NON1.SGM

17NON1