60-day Federal Register Notice

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Federal Register / Vol. 85, No. 37 / Tuesday, February 25, 2020 / Notices

where the study will be conducted.
Participants will perform alternating
resistance and aerobic exercises
followed by brief surveys to evaluate
sleepiness (Karolinska Sleepiness
Scale), affect (Positive and Negative
Affect Schedule), and fatigue. Following
these surveys, two cognitive tests (PVT
and N-back, which measures vigilance,
working memory, and complex tracking)
will be administered. Testing will occur
at room temperature and in hot
conditions to compare cognitive test
results between conditions. Participants
will swallow temperature pills and wear

physiologic and cognitive
measurements at different core body
temperatures to evaluate factors
contributing to individual variability in
cognitive and physiologic responses to
heat and to evaluate whether core body
temperature thresholds exist above
which cognitive deficits are observed.
The total estimated burden hours are
109 for the field study and 77 for the
environmental chamber study for a total
of 186. There are no costs to
respondents other than their time.

bio-harnesses to enable the collection of
real-time core body temperature and
heart rate data. An initial health
screening questionnaire as well as
additional questionnaires administered
prior to each test will be used to ensure
that participants are able to withstand
the physical demands of testing and to
provide information on factors that
affect individual variability to heat
tolerance. Additionally, a physical
examination and fingerstick blood tests
will be used for health screening. The
purpose of collecting data in the
environmental chamber is to compare

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Miners ...............................................

Informed consent form (field) ...........
Initial health screening questionnaire
(field).
Mid-shift field questionnaire .............
PVT cognitive test ............................
Post-shift field questionnaire ............
Informed consent form (chamber) ...

Miners/firefighters/construction workers.

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

30/60
30/60

30
30

59
59
59
30

4
5
2
1

1/60
5/60
10/60
30/60

4
25
20
15

Physical examination form ...............
Initial health screening questionnaire
(chamber).
Release of information form .............
TSS and RPE ...................................
PANAS and KSS ..............................
Cognitive test: PVT ..........................
Cognitive test: N-back ......................
Pre-testing health questionnaire ......

30
30

1
1

10/60
30/60

5
15

5
30
30
30
30
30

1
5
5
5
5
2

1/60
1/60
2/60
10/60
1/60
5/60

1
3
5
25
3
5

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

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

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

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

186

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–1198; Docket No. CDC–2020–
0014]

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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Total burden
(hours)

1
1

[FR Doc. 2020–03652 Filed 2–24–20; 8:45 am]

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public

SUMMARY:

20:34 Feb 24, 2020

Average
burden per
response
(hours)

59
59

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

VerDate Sep<11>2014

Number
responses per
respondent

Number of
respondents

Type of respondent

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burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Cyclosporiasis National
Hypothesis Generating Questionnaire’’.
The Cyclosporiasis National Hypothesis
Generating Questionnaire (CNHGQ)
facilitates the collection of standard data
during investigations of outbreaks of
cyclosporiasis, thereby increasing the
likelihood that outbreaks will be
recognized and sources will be
identified.
CDC must receive written
comments on or before April 27, 2020.

DATES:

You may submit comments,
identified by Docket No. CDC–2020–
0014 by any of the following methods:

ADDRESSES:

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• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
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 Jeffery M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.

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10699

Federal Register / Vol. 85, No. 37 / Tuesday, February 25, 2020 / Notices
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.

SUPPLEMENTARY INFORMATION:

Proposed Project
Cyclosporiasis National Hypothesis
Generating Questionnaire (OMB Control

No. 0920–1198 Exp. 9/30/2020)–
Revision—Centers for Global Health
(CGH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
An estimated one in six Americans
per year becomes 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
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 1875 hours (approximately
2,500 individuals interviewed × 45
minutes/response). There will be no
costs to respondents other than their
time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

Ill individuals identified as part of an
outbreak investigation.

Cyclosporiasis National Hypothesis
Generating Questionnaire.

2,500

1

45/60

1875

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

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

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

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

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

1875

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–03656 Filed 2–24–20; 8:45 am]
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