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Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices
ESTIMATED ANNUAL REPORTING BURDEN
Average
burden per
response
(in hours)

Total burden
hours

Form name

Adult Poison Center Callers .............
Adolescent Poison Center Callers ....
Parent or Guardian Poison Center
Callers.

Call-back Questionnaire for Self ......
Call-back Questionnaire for Self ......
Call-back Questionnaire for Proxy ...

210
30
60

1
1
1

40/60
40/60
40/60

140
20
40

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

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

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

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

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

200

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. 2016–14726 Filed 6–21–16; 8:45 am]
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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 Using the Standardized
National Hypothesis Generating
Questionnaire during Multistate
Investigations of Foodborne Disease
Clusters and Outbreaks.
DATES: Written comments must be
received on or before August 22, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0054 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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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
FOR FURTHER INFORMATION CONTACT:

[60Day–16–0997; Docket No. CDC–2016–
0054]

SUMMARY:

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

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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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
Standardized National Hypothesis
Generating Questionnaire (0920–0997,
Expiration Date 10/31/2016)—
Revision—National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
It is estimated that each year roughly
1 in 6 Americans gets sick, 128,000 are
hospitalized, and 3,000 die of foodborne
diseases. CDC and partners ensure rapid
and coordinated surveillance, detection,
and response to multistate outbreaks, to
limit the number of illnesses, and to
learn how to prevent similar outbreaks
from happening in the future.
Conducting interviews during the
initial hypothesis-generating phase of
multistate foodborne disease outbreaks
presents numerous challenges. In the
U.S. there is not a standard, national
form or data collection system for
illnesses caused by many enteric

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40701

Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices
pathogens. Data elements for hypothesis
generation must be developed and
agreed upon for each investigation. This
process can take several days to weeks
and may cause interviews to occur long
after a person becomes ill.
CDC requests a revision to this project
to collect standardized information,
called the Standardized National
Hypothesis-Generating Questionnaire,
from individuals who have become ill
during a multistate foodborne disease
event. Since the questionnaire is
designed to be administered by public
health officials as part of multistate
hypothesis-generating interview
activities, this questionnaire is not
expected to entail significant burden to
respondents.
The Standardized National
Hypothesis-Generating Core Elements
Project was established with the goal to
define a core set of data elements to be
used for hypothesis generation during
multistate foodborne investigations.
These elements represent the minimum
set of information that should be
available for all outbreak-associated
cases identified during hypothesis
generation. The core elements would
ensure that similar exposures would be

vehicles out of commerce. In almost all
instances, the SNHGQ or iterations of
the SNHGQ have been instrumental in
the successful investigation of these
outbreaks. The questionnaire has
allowed investigators to more efficiently
and effectively interview ill persons as
they are identified. Because these
exposures are captured in a common,
standard format, we have been able to
share and analyze data rapidly across
jurisdictional lines. Faster interview
response and analysis times have
allowed for more rapid epidemiologic
investigation and quicker regulatory
action, thus helping to prevent
thousands of additional illnesses from
occurring and spurring industry to
adopt and implement new food safety
measures in an effort to prevent future
outbreaks.
The total estimated annualized
burden for the Standardized National
Generating Questionnaire is 3,000 hours
(approximately 4,000 individuals
identified during the hypothesisgenerating phase of outbreak
investigations with 45 minutes/
response).
There are no costs to respondents
other than their time.

ascertained across many jurisdictions,
allowing for rapid pooling of data to
improve the timeliness of hypothesisgenerating analyses and shorten the
time to pinpoint how and where
contamination events occur.
The Standardized National
Hypothesis Generating Questionnaire
was designed as a data collection tool
for the core elements, to be used when
a multistate cluster of enteric disease
infections is identified. The
questionnaire is designed to be
administered over the phone by public
health officials to collect core elements
data from case-patients or their proxies.
Both the content of the questionnaire
(the core elements) and the format were
developed through a series of working
groups comprised of local, state, and
federal public health partners.
Since implementation of the SNHGQ
in 2013, ORPB has investigated over 700
multistate foodborne and enteric
clusters of infection involving over
26,000 ill people. Of which, an outbreak
vehicle has been identified in 200 of
these investigations. These outbreaks
have led to over 50 recalls and countless
regulatory actions that have removed
millions of pounds of contaminated

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hrs)

Total burden
(in hrs)

Form name

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

Standardized National Hypothesis Generating Questionnaire (Core Elements).

4,000

1

45/60

3,000

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

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

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

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

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

3,000

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. 2016–14727 Filed 6–21–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Number of
respondents

Type of respondents

Advisory Committee on Immunization
Practices (ACIP)
Amendment: A notice of this meeting
was published in the Federal Register
on May 24, 2016, Volume 81, Number
100, Pages 32754–32755. The original
notice is amended to include Matters for
Discussion as follows:

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Matters for Discussion: The agenda
will include discussions on
meningococcal vaccines; human
papillomavirus vaccines; influenza;
cholera vaccine; hepatitis vaccines;
safety of maternal Tdap vaccination;
Respiratory Syncytial Virus (RSV) and
vaccine supply. A recommendation vote
is scheduled for meningococcal
vaccines, influenza vaccine, and cholera
vaccine. A VFC vote is scheduled for
meningococcal vaccines, and influenza.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Stephanie Thomas, National Center for
Immunization and Respiratory Diseases,
CDC, 1600 Clifton Road NE., MS–A27,
Atlanta, Georgia 30329, telephone 404/
639–8836; Email [email protected].
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of

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meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
[FR Doc. 2016–14787 Filed 6–21–16; 8:45 am]
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