60d FRN - published

0920-17AHW 60d FRN published.pdf

Zika Virus Enhanced Surveillance of Selected Populations

60d FRN - published

OMB: 0920-1192

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Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
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[FR Doc. 2017–11018 Filed 5–26–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17AHW; Docket No. CDC–2017–
0052]

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 an information collection
titled ‘‘Zika Virus Enhanced
Surveillance of Selected Populations.’’
This information collection will help
state health departments better define
the public health burden and clinical
characteristics of Zika virus disease.
DATES: Written comments must be
received on or before July 31, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0052 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

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SUMMARY:

19:59 May 26, 2017

Total burden
(in hours)

Daily Surveys ...................................
Annual End of Year Survey .............
Final Survey .....................................

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.

VerDate Sep<11>2014

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Form name

Jkt 241001

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
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)

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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
Zika Virus Enhanced Surveillance of
Selected Populations—Emergency ICR—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
Zika virus is a mosquito-borne
flavivirus primarily transmitted to
humans by Aedes mosquitoes. Zika
virus infections can also be transmitted
congenitally, at the time of birth from a
viremic mother to her newborn,
sexually, through blood transfusion, and
through inadvertent laboratory
exposure. Most Zika virus infections are
asymptomatic. Clinical illness, when it
occurs, is generally mild and
characterized by acute onset of fever,
maculopapular rash, arthralgia, and/or
nonpurulent conjunctivitis. As routine
surveillance data have been reported to
CDC, it has become apparent that the

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Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices

full spectrum of Zika virus disease may
have been underestimated. In addition,
there has been recent recognition that
some non-congenital infections are quite
severe. Guillain-Barre syndrome, other
neurologic manifestations, and
thrombocytopenia have been reported
following Zika virus infections, but
specific clinical findings and outcomes
are not well described. Additionally,
there are few published reports
describing postnatally-acquired Zika
virus disease among children, but there
is some indication that the disease
presentation in children may differ from
that seen in adults. Identifying risk
factors for developing more severe
disease with Zika virus infections and
better describing the full spectrum of
Zika virus disease is important to obtain
prior to the next transmission season in
order develop or revise existing
guidance used by clinicians and public
health officials.
This information is essential to the
CDC’s ongoing Zika response in order to
be able to develop more specific
guidance and other informational tools
for clinicians who care for patients and
assist public health officials in targeting
prevention messages towards high risk
groups. This information will help
healthcare providers recognize Zika
virus disease among their patients and
allow them to alert their state or local

departments from patients/guardians,
providers, or medical records as
appropriate. Many of the data elements
included in the Enhanced Surveillance
Forms are standard ArboNET variables
covered by OMB Control No. 0920–
0728.
Additional data elements requested
for this enhanced surveillance project
are sometimes already routinely
collected by health departments but are
not reported to CDC.
Once eligible cases are identified by
participating health departments, staff
will extract data already collected using
pre-existing case report forms and
available medical records.
If data are missing in existing records,
patients/caregivers or healthcare
providers will be contacted
telephonically using a standard script
and the case investigation form to
collect any additional data elements
needed.
Once data are collected, participating
sites will submit data to CDC through
secure means. Data will be coded prior
to submission to CDC for analysis
purposes.
There is no cost to respondents other
than the time to participate.
Authorizing legislation comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241).

health department of suspect cases to
facilitate diagnosis and mitigate the risk
for local transmission.
CDC cannot reasonably comply with
the normal OMB clearance procedures
given the need for these data to evaluate
and revise existing guidance documents
and informational products prior to the
summer months when we anticipate
that Zika virus transmission in the
Americas will substantially increase.
CDC will request an accelerated OMB
review to give CDC the ability to rapidly
answer urgent remaining questions that
will shape the course of this public
health emergency response.
The specific goals and objectives are:
1. Describe the clinical manifestations
and outcomes among:
a. Patients hospitalized for Zika virus
disease.
b. Children <18 years of age with
postnatally acquired Zika virus disease.
c. Children of different age groups.
d. Persons with neurologic symptoms
associated with Zika virus disease.
2. Assess for unique clinical feature of
Zika virus disease in children <18 years
of age.
3. Compare demographics, underlying
medical conditions, and acute
symptoms among cases hospitalized and
not hospitalized for Zika virus disease.
Basic demographic information,
clinical, and laboratory data will be
collected by participating health

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Health Departments ..........................

Zika Virus Disease Enhanced Surveillance—Neurologic symptoms
associated with Zika virus disease.
Zika Virus Disease Enhanced Surveillance—Postnatally
acquired
Zika virus disease among children
aged <18 years.
Zika Virus Disease Enhanced Surveillance—Hospitalization associated with Zika virus disease.