60d FRN - published

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
releases and determine their health
statuses;
2. Identify needs (i.e., medical and
basic) of those exposed during the
releases to aid in planning interventions
in the community;
3. Assess the impact of the incidents
on health services use and share lessons
learned for use in hospital, local, and
state planning for chemical incidents;
and
4. Identify cohorts may be followed
and assessed for persistent health effects
resulting from acute releases.
Because each chemical incident is
different, it is not possible to predict in
advance exactly what type of and how
many respondents will be consented
and interviewed too effectively evaluate
the incident. Respondents typically
include, but are not limited to
emergency responders such as police,
fire, hazardous material technicians,
emergency medical services, and
personnel at hospitals where patients
from the incident were treated.

Incidents may occur at businesses or in
the community setting; therefore,
respondents may also include business
owners, managers, workers, customers,
community residents, pet owners, and
those passing through the affected area.
The multidisciplinary ACE team
consisting of staff from ATSDR, the
Centers for Disease Control and
Prevention (CDC), and the requesting
agencies that will be collecting data.
ATSDR has developed a quickly tailored
series of draft survey forms used in the
field to collect data that will meet the
goals of the investigation. ATSDR
collections will be administered based
on time permitted and urgency. For
example, it is preferable to administer
the general survey to as many
respondents as possible. However, if
there are time constraints, the shorter
household survey or the ACE Short
Form may be administered instead. The
individual surveys collect information
about exposure, acute health effects,
health services use, medical history,

needs resulting from the incident,
communication during the release,
health impact on children and pets, and
demographic data. Hospital personnel
are asked about the surge, response and
communication, decontamination, and
lessons learned.
Depending on the situation, data
collected by face-to-face interviews,
telephone interviews, written surveys,
mailed surveys, or on-line surveys can
be consider collected. Medical and
veterinary charts may also be consider
for review. In rare situations, an
investigation might involve collection of
clinical specimens.
ATSDR anticipates up to four ACE
investigations per year. The number of
participants has ranged from 30–715,
averaging about 300 per year. Therefore,
the total annualized estimated burden
will be 591 hours per year. Participation
in ACE investigations is voluntary and
there are no anticipated costs to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Residents, first responders, business
owners, employees, customers.
Residents ..........................................
Hospital staff .....................................
Staff from state, local, or tribal health
agencies.

General Survey ................................
ACE Short Form ...............................
Household Survey ............................
Hospital Survey ................................
Medical Chart Abstraction Form ......

800
50
120
40
250

1
1
1
1
1

30/60
7/60
15/60
30/60
30/60

400
6
30
20
125

Veterinary Chart Abstraction Form ..

30

1

20/60

10

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

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

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

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

591

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. 2017–18404 Filed 8–29–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–1190; Docket No. CDC–2017–
0073]
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Number of
respondents

Type of respondents

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Jkt 241001

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.’’

SUMMARY:

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

ADDRESSES:

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

VerDate Sep<11>2014

Notice with comment period.

DATES:

Proposed Data Collection Submitted
for Public Comment and
Recommendations
AGENCY:

ACTION:

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• 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

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

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—

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17:40 Aug 29, 2017

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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

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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

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
questionnaires and provide samples for
laboratory testing.
Researchers will follow all studyparticipating 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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Form name

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

Pregnant women eligibility questionnaire ....
Pregnant women enrollment questionnaire
Adult symptoms questionnaire .....................
Pregnant women follow-up questionnaire ....
Infant symptoms questionnaire ....................
Ages and Stages Questionnaire: 2, 4, 6
Month.
Ages and Stages Questionnaire: 12, 18, 24
Month.
Center for Epidemiologic Studies Depression—10.
Male partner eligibility questionnaire ...........
Male enrollment questionnaire .....................
Adult symptoms questionnaire .....................

3,125
2,500
2,500
2,500
2,250
2,250
300
300

1
1
15
8
14
2
3
3

5/60
35/60
10/60
15/60
10/60
15/60
15/60
5/60

260
1,458
6,250
5,000
5,250
1,125
225
75

2,500
625
625

1
1
7

5/60
25/60
10/60

208
260
729

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

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

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

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

20,840

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. 2017–18405 Filed 8–29–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–0004]

Agency Forms Undergoing Paperwork
Reduction Act Review

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Number of
respondents

Respondents

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.

VerDate Sep<11>2014

17:40 Aug 29, 2017

Jkt 241001

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

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send an email to [email protected]. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
National Disease Surveillance
Program II. Disease Summaries (OMB
Control Number 0920–0004, Expires
10/31/2017)—Revision—National
Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC requests a three-year approval for
the proposed revision of the ‘‘National
Disease Surveillance Program II. Disease
Summaries’’ information collection
project.
As with the previous approval, these
data are essential for measuring trends
in diseases, evaluating the effectiveness
of current preventive strategies, and
determining the need to modify current
preventive measures.

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