[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64050-64052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-22ER]


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 ``Formative Respirator and Protective 
Clothing Laboratory Testing'' 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 May 6, 2022, to obtain comments from the public and affected 
agencies. One public comment was received. 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

[[Page 64051]]

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 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

    Formative Respirator and Protective Clothing Laboratory Testing--
NEW--National Institute for Occupational Safety and Health (NIOSH), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), is requesting 
approval of a New Generic Information Collection Request (ICR) for a 
period of three years under the project titled ``Formative Respirator 
and Protective Clothing Laboratory Testing.'' The National Personal 
Protective Technology Laboratory (NPPTL) is a division of the NIOSH 
which operates within the CDC. NIOSH is the federal institute 
specifically dedicated to generating new knowledge in the field of 
occupational safety and health and responsible for transferring that 
knowledge into practice for the betterment of workers.
    NPPTL was established in 2001, at the request of Congress, with the 
mission of preventing disease, injury, and death for the millions of 
working men and women relying on personal protective technology (PPT). 
PPT plays an important role in keeping many workers within various 
industries safe while performing their professional duties. To achieve 
the Laboratory's mission, NPPTL conducts scientific research, develops 
guidance and authoritative recommendations, disseminates information, 
and responds to requests for workplace health hazard evaluations. The 
development of NPPTL filled a need for improved personal protective 
equipment (PPE) and focused research into PPT.
    Respiratory protection, a specific type of PPE commonly tested by 
NPPTL, is the cornerstone of NPPTL's efforts. One of the primary 
responsibilities of the Laboratory is to test and approve respirators 
used in U.S. occupational settings. This function ensures a standard 
level of quality and filtration efficiency for all respirators used 
within a U.S. workplace setting. The NPPTL Respirator Approval Program 
exists to increase the level of worker protection from airborne 
particulates, chemicals, and vapors. In addition to respirators, NPPTL 
conducts research on other types of PPE, including chemical-resistant 
clothing, hearing protection, gloves, eye and face protective devices, 
hard hats, sensors to detect hazardous substances, and communication 
devices used for safety deployment of emergency workers. NPPTL PPE 
research examines exposure to inhalation hazards, dermal hazards, and 
any other hazardous environmental threats within an occupational 
setting.
    PPE performance requirements and test methods are specified within: 
(1) federal regulations by NIOSH, Food and Drug Administration (FDA), 
and the Mine Safety and Health Administration (MSHA); and (2) voluntary 
consensus standards published by organizations such as the American 
National Standards Institute (ANSI), American Society for Testing and 
Materials (ASTM) International, and International Organization for 
Standardization (ISO). Thus, the information collected from human 
subjects in a laboratory setting are generally consistent across NPPTL 
studies with only the boundary conditions changing (e.g., environmental 
conditions such as heat or humidity, human subject activity such as 
simulated surgery or climbing a ladder, distance between two subjects 
communicating by spoken word, various PPE use durations, or the use of 
novel PPE designs). Considering these consistent data collection 
methods employed with only changes in boundary conditions specified to 
a specific industry or standard, NPPTL requests a Generic ICR package 
for laboratory-collected information for testing respirators and 
protective clothing.
    The resulting data will benefit the federal government in that the 
performance standards and test methods supported will directly aid in 
ensuring the adequate protection via PPE of workers across a variety of 
industry sectors. Furthermore, the continued research in these methods 
will ensure the performance standards and test methods are up to date 
with an ever-evolving workplace safety climate, as well as 
technological advancements in PPE. Through this data collection, the 
federal government will ultimately be able to efficiently react to the 
PPE protection needs of workers across the country thereby fulfilling 
CDC/NIOSH's mission.
    The methods used to collect the information from human participants 
will include health screenings, demographic information collection 
instruments, psychometrically supported surveys of user experience and 
perception of PPE, direct physiological measurements of response to 
PPE, biological measures of physiological responses, anthropometric 
measures of body size and shape, measures of PPE fit, and measures of 
the body's movement through space (biomechanics). The respondent 
universe for the proposed data collection will be recruited from the 
general population but their demographic characteristics are expected 
to be reflective of the full spectrum of the U.S. workforce and from 
industries that rely heavily on PPE to protect workers (e.g., 
healthcare and social assistance, public safety and emergency response, 
and agriculture). Because the U.S. worker population in some cases 
includes children down to the age of eight years in certain industries 
such as agriculture, it is expected that studies included in this data 
collection may also include children. Because respondents will be 
recruited via a variety of different avenues (email, flyers, 
advertisements, etc.), it is expected that the respondent pool will 
vary in gender, age, race/ethnicity, persons residing in rural and/or 
urban locations, and/or in specific regions or health jurisdictions. 
Additionally, pregnant women may also be a focus of these data 
collection efforts as pregnant women are regular users of PPE which 
must be considered due to

[[Page 64052]]

specific needs related to changes in body shape and size.
    CDC estimates that up to 1,750 individuals could be burdened per 
year with an estimated annualized burden of 15,591 hours. There is no 
cost to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Members of the general public......  Informed Consent...........             970               1           30/60
                                     Health Screening                        970               6               1
                                      Questionnaire:
                                      Standardized form w/
                                      decision logic allowing
                                      some questions to be
                                      omitted.
                                     Demographics Questionnaire:             970               1           30/60
                                      Standardized form w/
                                      decision logic allowing
                                      some questions to be
                                      omitted, W-9 Tax Form, etc.
                                     Job-related Data:                       970               1           15/60
                                      Occupational tasks,
                                      postures used, duration of
                                      exposure, etc.
                                     Physiological Measurements:             200               6             1.5
                                      Chest-worn heart rate
                                      monitor strap, COSMED Kb5,
                                      SQ2020-1F8 temperature
                                      logger, TOSCA 500 pulse
                                      oximeter, koken breathing
                                      waveform recording mask,
                                      etc.
                                     Biological Measurements:                100               6           15/60
                                      Cortisol (stress) levels,
                                      pregnancy tests, hydration
                                      status, lipids,
                                      inflammatory markers, heat
                                      shock proteins, etc.
                                     Anthropometric                          750               1           15/60
                                      Measurements: Calipers/
                                      digital measuring of
                                      facial and body dimensions.
                                     Respirator Fit                          225             100           15/60
                                      Measurements: Filter
                                      cassettes with air
                                      pumps,fit-testing
                                      equipment, QLFT/sodium
                                      saccharin solution etc.
                                     Self-Perception Data: Level             500               6           15/60
                                      of exertion, perceived
                                      comfort level, heat
                                      sensation, fatigue, etc.
                                     Biomechanics Measurements:               30               3           30/60
                                      Force plate, stopwatch,
                                      accelerometers, etc.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-22928 Filed 10-20-22; 8:45 am]
BILLING CODE 4163-18-P