[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39433-39435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]]

     Federal eRulemaking Portal: www.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 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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 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: [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 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.
                                                 ---------------------------------------------------------------
    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