[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Notices]
[Pages 14924-14926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21DS; Docket No. CDC-2021-0026]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Lighting 
Interventions for Improving the Health, Safety, and Well-Being of 
Underground Mineworkers. The purpose of this information collection is 
to examine the effect of human centric lighting (HCL) interventions on 
circadian disruption (CD) and well-being in underground mineworkers via 
survey administration and biometric data collection.

DATES: Written comments must be received on or before May 18, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0026 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

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: 404-639-7118; 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

    Pre-shift Lighting Interventions to Improve Miner Safety and Well-
being--New--National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Institute for Occupational Safety and Health seeks a 
two-year approval from the Office of Management and Budget (OMB) to 
collect information needed to develop strategies and guidance to 
improve the safety, health, and well-being of underground coal and 
metal shiftworkers in the U.S. mining industry. Light has both visual 
and non-visual impacts on the human body, enabling us to visually 
perceive the world, and non-visually experience circadian entrainment 
and acute effects that include alertness, concentration, and 
performance on cognitive tasks. Hence, light drives our fundamental 
physiological functioning.
    It is not surprising that underground miners have significant 
reductions in exposure to daylight--especially those miners working 
shifts. This lacking exposure can lead to fatigue and circadian 
disruption (CD) that can result in sleep loss and reduced alertness. 
This increases the risk of accidents, and can lead to health problems 
that include obesity, diabetes, and cancer.
    This study will evaluate the impacts of blue and red-light 
treatment at the beginning of the work shift on task performance, 
sleepiness and alertness, subjective well-being, sleep efficiency and 
circadian rhythms in underground mine workers. A 2x2 randomized 
crossover, mixed design will be used to test the efficacy and 
acceptability an HCL intervention using light-emitting eyewear 
delivered to shift workers over a two-year study period. A cross-over 
design has a significant advantage because the subjects serve as their 
own control, which serves to minimize variations caused by circadian 
phase differences and sleep patterns of the individual participants. 
The other advantages include greater sample size efficiency with 
randomization of treatment order, and all subjects will receive all the 
treatments. Participants will be divided between coal and metal miners, 
and will be those who regularly work the 1st, 2nd and 3rd shifts at one 
underground coal and one underground metal mine.
    NIOSH researchers will visit one underground coal mine and one 
underground metal mine to obtain informed consent from volunteer 
mineworkers to conduct an intervention study and administer both 
electronic and paper and pencil surveys. Before beginning the study, 
the respondents will provide their informed consent to participate, be 
given an overview of the demographic information that will be collected 
and will be instructed how to

[[Page 14925]]

properly wear the lighted eyewear and how to use the actigraphy device. 
Next, participants will be asked to complete six short surveys: (1) 
Demographic information; (2) the Checklist of Individual Strengths; (3) 
the Karolinska Sleepiness Scale (KSS); (4) the Munich Chronotype 
Questionnaire; (5) the Pittsburgh Sleep Quality Index (PSQI); (6) a 
shiftwork disorder screening; (7) the Lighted Eyeglasses Intervention 
Acceptability Survey, and (8) the NASA Psychomotor Vigilance Test 
(PVT). They will also be asked to log caffeine intake and sleep.
    Intervention lighting doses will be administered via commercially 
available lightweight, light-emitting glasses during the nonworking 
periods of pre-shift. Each participant will experience two lighting 
interventions: Treatment A is dim red light (10 lx, 3000 K, the placebo 
control), and treatment B is blue-enriched, polychromatic lighting, the 
treatment intervention. For each study group, half of the subjects will 
first experience the blue, and half will first experience the red-light 
exposure during a three-week experimental phase. After a two-week 
washout period designed to minimize carryover or residual learning 
effects from the prior treatments, subjects will experience the 
lighting treatment condition they did not yet experience for another 
three-week period. While wearing lighted eyewear the participants will 
evaluate comfort, glare and acceptability of the eyewear, while the 
KSS, the PSQI, and the NASA PVT will be re-administered at various 
intervals throughout the course of the study.
    The total number of responses for each data collection instrument 
are indicated in the estimated annualized burden hours table below. 
Survey data will be collected during pre-shift periods and at home on 
working days and at home on non-working days. Time for data collection 
at the beginning of the shift will be no more than 25 minutes. NIOSH 
researchers will collect data at participating sites in above ground 
facilities on working days. Participants will also complete brief 
caffeine and sleep logs and wear an actigraphy wristband that records 
activity and sleep patterns, and light/dark exposure while at home. At 
various intervals of the study for a total of 12 occasions, 
participants will swallow a remote temperature monitoring pill to 
assess circadian rhythms in core body temperature. It is estimated that 
at-home data collection time will be no more than five minutes per 
participant.
    This data collection will occur within a two-year period beginning 
after OMB approval and is designed to gather information not previously 
available. This lighting intervention with these data collection 
instruments is not being used in any other research in the mining 
industry. Potential impacts of this project include improvement of the 
health, safety, and well-being of underground mineworkers by reducing 
fatigue and CD through new recommendations and HCL-interventions. This 
project will also answer several research questions that will help 
establish the efficacy of the new HCL interventions so that they could 
be commercialized by mine lighting companies and used by underground 
coal and metal mining companies. The total estimated annualized burden 
hours are 910. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Underground Coal and Metal      Informed consent              90               1           10/60              15
 Mineworkers.
Underground Coal and Metal      Demographics....              90               1            1/60               2
 Mineworkers.
Underground Coal and Metal      Checklist of                  90               1            2/60               3
 Mineworkers.                    Individual
                                 Strengths.
Underground Coal and Metal      Karolinska                    90              36            1/60              54
 Mineworkers.                    Sleepiness
                                 Scale.
Underground Coal and Metal      Lighted Eyewear.              90               2            2/60               6
 Mineworkers.
Underground Coal and Metal      Lighted                       90               2            1/60               3
 Mineworkers.                    Eyeglasses
                                 Intervention
                                 Acceptability
                                 Survey.
Underground Coal and Metal      Munich                        90               1            5/60               8
 Mineworkers.                    Chronotype
                                 Questionnaire.
Underground Coal and Metal      Pittsburgh Sleep              90               4           10/60              60
 Mineworkers.                    Quality Index.
Underground Coal and Metal      Psychomotor                   90              36            6/60             324
 Mineworkers.                    Vigilance Test.
Underground Coal and Metal      Shiftwork                     90               1            8/60              12
 Mineworkers.                    Disorder
                                 Screening.
Underground Coal and Metal      Actigraphy don                90              49            3/60             221
 Mineworkers.                    and remove.
Underground Coal and Metal      Caffeine log....              90              49            1/60              74
 Mineworkers.
Underground Coal and Metal      Core body                    180              12            3/60              54
 Mineworkers.                    temperature
                                 pill--open
                                 package and
                                 swallow.
Underground Coal and Metal      Sleep log.......             180              49            1/60              74
 Mineworkers.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             910
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[[Page 14926]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-05764 Filed 3-18-21; 8:45 am]
BILLING CODE 4163-18-P