Notice2023-12940
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Heat-related Changes in Cognitive Performance. This data collection is designed to evaluate and assess the cognitive impacts of heat exposure on workers.
Full Text
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<title>Federal Register, Volume 88 Issue 116 (Friday, June 16, 2023)</title>
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[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39433-39435]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12940]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1331; Docket No. CDC-2023-0050]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Heat-related Changes in Cognitive Performance. This data
collection is designed to evaluate and assess the cognitive impacts of
heat exposure on workers.
DATES: CDC must receive written comments on or before August 15, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0050 by either of the following methods:
[[Page 39434]]
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#81eeece3c1e2e5e2afe6eef7"><span class="__cf_email__" data-cfemail="88e7e5eac8ebeceba6efe7fe">[email protected]</span></a>.
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 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;
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; and
5. Assess information collection costs.
Proposed Project
Heat-related Changes in Cognitive Performance (OMB Control No.
0920-1331, Exp. 3/31/2024)--Revision--National Institute for
Occupational Safety and Health (NIOSH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
NIOSH, under Public Law 91-173 as amended by Public Law 95 -164
(Federal Mine Safety and Health Act of 1977), and Public Law 109-236
(Mine Improvement and New Emergency Response Act of 2006) has the
responsibility to conduct research to improve working conditions and to
prevent accidents and occupational diseases in U.S. mines. Heat strain
is one of these occupational diseases and is an increasing problem
among many industries, including mining. As mines expand into deeper
and hotter environments, and as heat waves occur with increasing
frequency and severity, heat strain among underground and surface
miners is likely to increase. Not only can heat strain lead to heat
illness, but studies have demonstrated associations between heat
exposure and work injuries. Although the underlying mechanism between
heat exposure and injury is not known, reduced cognitive function is
likely contributory. Despite the increasing importance of heat strain
in mining, few studies have focused on heat strain among U.S. miners.
The few studies that are available have demonstrated that miners often
exceed a core body temperature of 38 [deg]C during work activities,
which is above the recommended threshold, but more information on
frequency, duration, and intensity of elevated core body temperatures
is needed to focus future heat strain research to better serve the
mining industry.
In addition to determining the patterns of duration and intensity
of heat strain among U.S. miners, investigating the additional effects
of heat strain beyond the risk of heat illness is an important step in
improving miner health and safety. Studies have demonstrated
associations between heat stress and cognitive deficits, but
substantial inter- and intra-individual variability exists in the
physiologic and cognitive responses to heat exposure. More information
is needed about the most important factors (e.g., age, sex, chronic
disease, fitness level, hydration) contributing to individual
variability as well as interactions between these factors, because
individual variability likely affects the usefulness of one-size-fits-
all heat stress indices that are currently used in mining. It is also
unclear which characteristics of core body temperature (e.g., absolute
temperature thresholds vs. rising or falling temperatures vs rate of
temperature change) are most associated with cognitive dysfunction. A
better understanding of how individual variability and core body
temperature relate to cognitive deficits would assist in developing
strategies for screening and monitoring miners to mitigate or prevent
heat strain. Therefore, this study aims to assess the following
objectives: (1) Whether a core body temperature threshold exists at
which cognitive performance begins to decline, (2) What factors most
contribute to individual variability in cognitive and physiologic
responses to heat, and (3) What patterns of duration and intensity of
heat strain are most common among U.S. surface and underground miners.
To study these objectives, a dual-arm field and laboratory study
will be conducted. The field study will be conducted at surface and
underground mines. Data will be collected from miners working in warm
or hot areas of participating mines. Participants will swallow
temperature pills to measure core body temperature and will wear bio-
harnesses to measure heart rate. Two six-minute assessments will be
taken during each shift. The assessments include questions on
sleepiness and work tasks and a Psychomotor Vigilance Test (PVT) to
assess vigilant attention and reaction time. An initial screening
questionnaire as well as post-shift questionnaires will be used to
obtain information on risk factors for heat strain and cognitive
deficits. The purpose of collecting data at the field sites is to
evaluate the frequency, duration, and intensity of heat strain by
monitoring core body temperature and heart rate throughout two complete
shifts, as well as to assess associations between core body temperature
and cognitive deficits.
The laboratory study will be conducted in an environmental chamber,
in which environmental conditions can be highly controlled. Data will
be collected from miners, construction workers, and firefighters. These
three groups were chosen because of their risk of heat exposure and
their proximity to the NIOSH laboratory where the study will be
conducted. Participants will perform alternating resistance and aerobic
exercises
[[Page 39435]]
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 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
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.
NIOSH is requesting a Revision for this study, because the COVID
pandemic substantially delayed the ability to begin data collection. We
are also making minor changes to data collection instruments. These
questions were revised to improve flow and clarity, which will likely
decrease the amount of time spent on questionnaires and decrease the
interruptions required of field participants. The total estimated
burden hours requested are 109 for the field study and 77 for the
environmental chamber study. There are no costs to respondents other
than their time. All data collection activities will be conducted in
full compliance with the CDC regulations to maintain the privacy of
data obtained on persons and to protect the rights and welfare of human
subjects. Consistent with Section 301(d) of the Public Health Service
Act, a Certificate of Confidentiality (CoC) applies to this research.
Estimated Total Burden Hours
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Average
Number of Number burden per Total burden
Type of respondent Form name respondents responses per response (hours)
respondent (hours)
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Field study
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Miners........................ Informed consent 59 1 30/60 30
form (field).
Miners........................ Initial health 59 1 30/60 30
screening
questionnaire
(field).
Miners........................ Mid-shift field 59 4 1/60 4
questionnaire.
Miners........................ PVT cognitive 59 5 5/60 25
test.
Miners........................ Post-shift field 59 2 10/60 20
questionnaire.
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Chamber study
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Miners/firefighters/ Informed consent 30 1 30/60 15
construction workers. form (chamber).
Miners/firefighters/ Physical 30 1 10/60 5
construction workers. examination
form.
Miners/firefighters/ Initial health 30 1 30/60 15
construction workers. screening
questionnaire
(chamber).
Miners/firefighters/ Release of 5 1 1/60 1
construction workers. information
form.
Miners/firefighters/ TSS and RPE..... 30 5 1/60 3
construction workers.
Miners/firefighters/ PANAS and KSS... 30 5 2/60 5
construction workers.
Miners/firefighters/ Cognitive test: 30 5 10/60 25
construction workers. PVT.
Miners/firefighters/ Cognitive test: 30 5 1/60 3
construction workers. N-back.
Miners/firefighters/ Pre-testing 30 2 5/60 5
constructionworkers. health
questionnaire.
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Total..................... ................ .............. .............. .............. 186
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-12940 Filed 6-15-23; 8:45 am]
BILLING CODE 4163-18-P
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