[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2921-2923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-23BX; Docket No. CDC-2022-0144]


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 a proposed 
information collection, as required by the Paperwork Reduction Act of 
1995. This notice invites comment on a new proposed information 
collection project titled Pre-Shift Lighting Interventions to Improve 
Miner Safety and Well-Being. 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.

DATES: Written comments must be received on or before March 20, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0144 by any of the following methods:
     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: 404-639-7118; 
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;

[[Page 2922]]

    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

    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 (NIOSH) 
seeks a two-year approval from the Office of Management and Budget 
(OBM) to collect information needed to develop strategies and guidance 
to improve the safety, health, and well-being of underground shift 
workers 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 lack of exposure to daylight can lead to fatigue and 
circadian disruption (CD) that can result in sleep loss and reduced 
alertness. These factors can increase risk of accidents and 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 reaction time task 
performance, sleepiness and alertness, subjective well-being, sleep 
efficiency and circadian rhythms in underground mine workers.
    A 2 x 2 randomized crossover, mixed design will be used to test the 
efficacy and acceptability a human centric lighting (HCL) intervention 
using light-emitting eyewear delivered to shift workers at multiple 
mines within 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, sleep patterns, etc. of the individual participants. The 
other advantages include greater sample size efficiency with 
randomization of treatment order and all subjects receive all the 
treatments. Participants will be underground miners who regularly work 
the 1st, 2nd or 3rd shifts.
    NIOSH researchers will 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 properly wear the lighted eyewear, how to 
use the actigraphy device, and how to use a wearable temperature sensor 
device. During the course of the study, participants will be asked to 
complete eight short surveys: (1) demographic information; (2) the 
Checklist of Individual Strengths; (3) the Karolinska Sleepiness Scale 
(KSS); (4) PROMIS Sleep Related Impairment Questionnaire (PSRIQ); (5) 
PROMIS Sleep Disturbance Questionnaire (PSDQ); (6) Shiftwork Disorder 
Screening Questionnaire; (7F) the Lighted Eyeglasses Intervention 
Acceptability survey; and (8) Morning-Eveningness Questionnaire. They 
will also be asked to take the NASA Psychomotor Vigilance Test (PVT), 
log caffeine intake and sleep, wear an actigraphy wristband, and on 
certain occasions wear a temperature sensing device.
    Intervention lighting doses will be administered via commercially 
available lightweight, light-emitting glasses during the nonworking 
periods or 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-light exposure, 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 PSRIQ, PSDQ, 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, participants will wear a 
temperature sensor device to derive core body temperature. It is 
estimated that at-home data collection time will be no more than eight 
minutes per instance 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. 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 
mining companies.
    CDC requests OMB approval for an estimated 1,007 annualized burden 
hours. There are no costs to respondents other than their time to 
participate.

[[Page 2923]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Underground Mineworkers.......  Informed consent              90               1           30/60              45
Underground Mineworkers.......  Participant                   90               1           30/60              45
                                 Training.
Underground Mineworkers.......  Demographics....              90               1            1/60               2
Underground Mineworkers.......  Checklist of                  90               1            2/60               3
                                 Individual
                                 Strengths.
Underground Mineworkers.......  Karolinska                    90              36            1/60              54
                                 Sleepiness
                                 Scale.
Underground Mineworkers.......  Lighted Eyewear.              90               2            2/60               6
Underground Mineworkers.......  Lighted                       90               2            1/60               3
                                 Eyeglasses
                                 Intervention
                                 Acceptability
                                 Survey.
Underground Mineworkers.......  PROMIS Sleep                  90               4           10/60              60
                                 Related
                                 Impairment
                                 Questionnaire.
Underground Mineworkers.......  PROMIS Sleep                  90               4            5/60              30
                                 Disturbance
                                 Questionnaire.
Underground Mineworkers.......  Psychomotor                   90              36            6/60             324
                                 Vigilance Test.
Underground Mineworkers.......  Shiftwork                     90               1            8/60              12
                                 Disorder
                                 Screening.
Underground Mineworkers.......  Actigraphy Don                90              49            3/60             221
                                 and Remove.
Underground Mineworkers.......  Caffeine log....              90              49            1/60              74
Underground Mineworkers.......  Temperature                   90              12            3/60              54
                                 Sensor Device
                                 (on and remove).
Underground Mineworkers.......  Sleep Log.......              90              49            1/60              74
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,007
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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. 2023-00808 Filed 1-17-23; 8:45 am]
BILLING CODE 4163-18-P