Notice2025-20578

Agency Forms Undergoing Paperwork Reduction Act Review

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Published
November 21, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

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<title>Federal Register, Volume 90 Issue 223 (Friday, November 21, 2025)</title>
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[Federal Register Volume 90, Number 223 (Friday, November 21, 2025)]
[Notices]
[Pages 52674-52675]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20578]



[[Page 52674]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-25-1381]


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 July 18, 2025, to obtain comments from the public and 
affected agencies. CDC received one comment to the previous notice. 
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 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 
(OMB Control No. 0920-1381, Exp. 1/31/2026)--Extension--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 an 
Extension of a previously approved 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 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 NPPTL 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 an Extension of this 
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, ultimately the 
federal government will 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,

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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 United 
States' 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 United States' 
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 sex, age, races/ethnicities, 
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 specific needs 
related to changes in body shape and size.
    CDC requests OMB approval for an estimated 1,750 respondents per 
year with an estimated annualized burden of 15,591 hours. There is no 
cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                       Average
                                                                         Number of      Number of     burden per
           Type of respondents                     Form name            respondents   responses per    response
                                                                                       respondent     (in hours)
----------------------------------------------------------------------------------------------------------------
Members of the general public \1\.......  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 Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2025-20578 Filed 11-20-25; 8:45 am]
BILLING CODE 4163-18-P


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Indexed from Federal Register on November 21, 2025.

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