[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10696-10698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20HO; Docket No. CDC-2020-0017]


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 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 Heat-related Changes in Cognitive 
Performance. The purpose of this study is to collect information on 
burden of heat strain among miners as well as factors related to 
personal risk and core body temperature that contribute to individual 
variability in heat tolerance and to declines in heat-related worker 
performance.

DATES: CDC must receive written comments on or before April 27, 2020.

[[Page 10697]]


ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0017 by any of the following methods:
     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 Jeffrey 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: 
[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; 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.

Proposed Project

    Heat-related Changes in Cognitive Performance--New--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 PL 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 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

[[Page 10698]]

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.
    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.

                                        Estimated Annualized 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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Miners........................  Informed consent              59               1           30/60              30
                                 form (field).
                                Initial health                59               1           30/60              30
                                 screening
                                 questionnaire
                                 (field).
                                Mid-shift field               59               4            1/60               4
                                 questionnaire.
                                PVT cognitive                 59               5            5/60              25
                                 test.
                                Post-shift field              59               2           10/60              20
                                 questionnaire.
Miners/firefighters/            Informed consent              30               1           30/60              15
 construction workers.           form (chamber).
                                Physical                      30               1           10/60               5
                                 examination
                                 form.
                                Initial health                30               1           30/60              15
                                 screening
                                 questionnaire
                                 (chamber).
                                Release of                     5               1            1/60               1
                                 information
                                 form.
                                TSS and RPE.....              30               5            1/60               3
                                PANAS and KSS...              30               5            2/60               5
                                Cognitive test:               30               5           10/60              25
                                 PVT.
                                Cognitive test:               30               5            1/60               3
                                 N-back.
                                Pre-testing                   30               2            5/60               5
                                 health
                                 questionnaire.
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    Total.....................  ................  ..............  ..............  ..............             186
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-03652 Filed 2-24-20; 8:45 am]
 BILLING CODE 4163-18-P