60d FRN - published

AttachmentB_60-day Federal Register Notice.pdf

Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) during Investigations of Foodborne Disease Clusters and Outbreaks

60d FRN - published

OMB: 0920-1198

Document [pdf]
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93937

Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
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
Feasibility of Social Distancing
Measures in K–12 Schools in the United
States—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Division of Global
Migration and Quarantine (DGMQ),
requests approval of a new information
collection to identify potential social
distancing strategies to reduce personto-person contact among students and
staff in K–12 schools that are
implementable without causing major
detrimental effects to ongoing education
activities. CDC is requesting a one-year
approval to collect information.
The information collection for which
approval is sought is in accordance with
DGMQ/CDC’s mission to reduce
morbidity and mortality in mobile
populations, and to prevent the
introduction, transmission, or spread of
communicable diseases within the
United States. Insights gained from this

information collection will assist in the
planning and implementation of CDC
Pre-Pandemic Community Mitigation
Guidance on the use of school-based
measures to slow transmission during
an influenza pandemic.
School-aged children are often the
main introducers and an important
transmission source of influenza and
other respiratory viruses in their
families, and school-based outbreaks
frequently pre-date wide-spread
influenza transmission in the
surrounding communities. Therefore,
infection control measures undertaken
to reduce virus transmission among
children at schools may also help
prevent or postpone influenza outbreaks
in communities. In respiratory
transmission of influenza, proximity to
the person with influenza plays a
significant role. Strategies that increase
physical distance between students and/
or reduce the duration of person to
person contact in school settings may,
theoretically, be effective in slowing
influenza transmission. There have been
no evaluations to date of feasibility of
implementing social distancing
measures other than school closures.
Therefore, there is a need to research
alternative social distancing strategies
that can help reduce influenza
transmission in schools while
minimizing social and economic
burdens on the community.
CDC staff proposes that the
information collection for this package

will target senior education officials,
senior health officials, and
representatives from the National
Association of School Nurses, school
safety organizations/law enforcement,
and National Distance Learning
Association. CDC will collect qualitative
data using focus group discussions on:
(a) Current knowledge, attitudes, and
potential practices with regard to
organizing and delivering K–12
instruction in ways that help increase
physical distance among students and/
or reduce duration of in-person
instruction at schools (including use of
distance learning options), while
preserving the normal education
process; and (b) facilitating and
inhibiting factors for implementing and
sustaining the potential social
distancing options in emergencies as an
alternative to the complete student
dismissal in K–12 schools.
Findings obtained from this
information collection will be used to
inform the update of CDC’s Prepandemic Community Mitigation
Guidance on the implementation of
school related measures to prevent the
spread of influenza. This Guidance is
used as an important planning and
reference tool for both State and local
health departments in the United States.
There are no costs to the respondents
other than their time. The maximum
total estimated annual burden hours are
640.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Senior educators; senior health officials; representatives
from the National Association of School Nurses, school
safety organizations/law enforcement, and National Distance Learning Association.

Focus Group Interview Guide
(semi-structured questionnaire).

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. 2016–30777 Filed 12–21–16; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17IM; Docket No. CDC–2016–
0120]

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BILLING CODE 4163–18–P

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

SUMMARY:

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320

Number of
responses per
respondent

Avg. burden
per response
(in hrs.)

1

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 Use of the Cyclosporiasis
National Hypothesis Generating
Questionnaire (CNHGQ) during
Investigations of Foodborne Disease
Clusters and Outbreaks. CDC seeks to
request Office of Management and
Budget (OMB) approval to collect
information via the CNHGQ from
persons who have developed

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2

sradovich on DSK3GMQ082PROD with NOTICES

93938

Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices

symptomatic cases of Cyclospora
infection during periods in which
increased numbers of such cases are
reported (typically, during spring and
summer months).
DATES: Written comments must be
received on or before February 21, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0120 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
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

VerDate Sep<11>2014

17:40 Dec 21, 2016

Jkt 241001

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
Use of the Cyclosporiasis National
Hypothesis Generating Questionnaire
(CNHGQ) during Investigations of
Foodborne Disease Clusters and
Outbreaks—New—Center for Global
Health (CGH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
An estimated 1 in 6 Americans per
year become ill with a foodborne
disease. Foodborne outbreaks of
cyclosporiasis—caused by the parasite
Cyclospora cayetanensis—have been
reported in the United States since the
mid-1990s and have been linked to
various types of fresh produce. During
the 15-year period of 2000–2014, 31
U.S. foodborne outbreaks of
cyclosporiasis were reported; the total
case count was 1,562. It is likely that
more cases (and outbreaks) occurred
than were reported; in addition, because
of insufficient data, many of the
reported cases could not be directly
linked to an outbreak or to a particular
food vehicle.
Collecting the requisite data for the
initial hypothesis-generating phase of
investigations of multistate foodborne
disease outbreaks is associated with
multiple challenges, including the need
to have high-quality hypothesisgenerating questionnaire(s) that can be

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used effectively in multijurisdictional
investigations. Such a questionnaire was
developed in the past for use in the
context of foodborne outbreaks caused
by bacterial pathogens; that
questionnaire is referred to as the
Standardized National Hypothesis
Generating Questionnaire (SNHGQ).
However, not all of the data elements in
the SNHGQ are relevant to the parasite
Cyclospora (e.g., questions about
consumption of meat and dairy
products); on the other hand, additional
data elements (besides those in the
SNHGQ) are needed to capture
information pertinent to Cyclospora and
to fresh produce vehicles of infection.
Therefore, the Cyclosporiasis National
Hypothesis Generating Questionnaire
(CNHGQ) has been developed, by using
core data elements from the SNHGQ and
incorporating modifications pertinent to
Cyclospora.
The core data elements from the
SNHGQ were developed by a series of
working groups comprised of local,
state, and federal public health partners.
Subject matter experts at CDC have
developed the CNHGQ, by modifying
the SNHGQ to include and focus on
data elements pertinent to Cyclospora/
cyclosporiasis. Input also was solicited
from state public health partners.
Because relatively few data elements in
the SNHGQ needed to be modified, a
full vetting process was determined not
to be necessary. The CNHGQ has been
designed for administration over the
telephone by public health officials, to
collect data elements from case-patients
or their proxies. The data that are
collected will be pooled and analyzed at
CDC, to generate hypotheses about
potential vehicles/sources of infection.
CDC requests OMB approval to collect
information via the CNHGQ from
persons who have developed
symptomatic cases of Cyclospora
infection during periods in which
increased numbers of such cases are
reported (typically, during spring and
summer months). In part because
molecular typing methods are not yet
available for C. cayetanensis, it is
important to interview all case-patients
identified during periods of increased
reporting, to help determine if their
cases could be part of an outbreak(s).
The CNHGQ is not expected to entail
substantial burden for respondents. The
estimated total annualized burden
associated with administering the
CNHGQ is 750 hours (approximately
1,000 individuals interviewed x 45
minutes/response). There will be no
costs to respondents other than their
time.

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93939

Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS

Individuals .....................

Cyclosporiasis National Hypothesis Generating
Questionnaire.

1,000

1

45/60

750

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

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

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

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

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

750

[FR Doc. 2016–30778 Filed 12–21–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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 the National Notifiable
Diseases Surveillance System (NNDSS).
The NNDSS is the nation’s public health
surveillance system that monitors the
occurrence and spread of diseases and
conditions that are nationally notifiable
or under national surveillance.
DATES: Written comments must be
received on or before February 21, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0119 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

17:40 Dec 21, 2016

Jkt 241001

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
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
FOR FURTHER INFORMATION CONTACT:

[60Day–17–0728; Docket No. CDC–2016–
0119]

VerDate Sep<11>2014

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.

Centers for Disease Control and
Prevention

SUMMARY:

Number of
respondents

Avg. burden
per response
(in hrs.)

Form name

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.

sradovich on DSK3GMQ082PROD with NOTICES

Number of
responses
per
respondent

Type of
respondents

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Frm 00059

Fmt 4703

Sfmt 4703

Total burden
(in hrs.)

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
National Notifiable Diseases
Surveillance System (OMB Control
Number 0920–0728, expires 1/31/
2019)—Revision—Center for
Surveillance, Epidemiology and
Laboratory Services, CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. The Nationally
Notifiable Diseases Surveillance System
(NNDSS) is based on data collected at
the state, territorial and local levels as
a result of legislation and regulations in
those jurisdictions that require health
care providers, medical laboratories,
and other entities to submit healthrelated data on reportable conditions to
public health departments. These
reportable conditions, which include
infectious and non-infectious diseases,
vary by jurisdiction depending upon
each jurisdiction’s health priorities and
needs. Infectious disease agents and
environmental hazards often cross
geographical boundaries. Each year, the

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