Notice2024-03883
Agency Forms Undergoing Paperwork Reduction Act Review
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
February 27, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 39 (Tuesday, February 27, 2024)</title>
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[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14499-14501]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03883]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-1331]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Heat-related Changes in Cognitive
Performance'' to the Office of Management and Budget (OMB) for review
and approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on June 16,
2023 to obtain comments from the public and affected agencies. CDC did
not receive comments related to the previous notice related to the
previous notice. This notice serves to allow an additional 30 days for
public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy
[[Page 14500]]
of the information collection plan and instruments, call (404) 639-
7570. Comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function. Direct written
comments and/or suggestions regarding the items contained in this
notice to the Attention: CDC Desk Officer, Office of Management and
Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
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 in order 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.
Additionally, it is 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 6-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 pre- and 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 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.
We are requesting an extension for this study, because the COVID
pandemic substantially delayed the ability to begin data collection.
Additionally, we are requesting a Revision because of minor changes to
the wording or order of questions in several 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.
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)
[[Page 14501]]
of the Public Health Service Act, a Certificate of Confidentiality
(CoC) applies to this research. The total estimated burden hours are
109 for the field study and 77 for the environmental chamber study.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (hours)
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Field study
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Miners................................ Informed consent form 59 1 30/60
(field).
Miners................................ Initial health screening 59 1 30/60
questionnaire (field).
Miners................................ Pre-shift field 59 2 5/60
questionnaire.
Miners................................ Mid-shift field 59 4 1/60
questionnaire.
Miners................................ PVT cognitive test...... 59 5 5/60
Miners................................ Post-shift field 59 2 5/60
questionnaire.
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Chamber study
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Miners/firefighters/construction Informed consent form 30 1 30/60
workers. (chamber).
Miners/firefighters/construction Physical examination 30 1 10/60
workers. form.
Miners/firefighters/construction Initial health.......... 30 1 30/60
workers. screening questionnaire
(chamber).
Miners/firefighters/construction Release of information 5 1 1/60
workers. form.
Miners/firefighters/construction TSS and RPE............. 30 5 1/60
workers.
Miners/firefighters/construction PANAS and KSS........... 30 5 2/60
workers.
Miners/firefighters/construction Cognitive test: PVT..... 30 5 10/60
workers.
Miners/firefighters/construction Cognitive test: N-back.. 30 5 1/60
workers.
Miners/firefighters/construction Pre-testing health 30 2 5/60
workers. questionnaire.
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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. 2024-03883 Filed 2-26-24; 8:45 am]
BILLING CODE 4163-18-P
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