[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14499-14501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                      Number      Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent        (hours)
----------------------------------------------------------------------------------------------------------------
                                                   Field study
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
                                                  Chamber study
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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