Notice2025-20578
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 21, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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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]
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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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response
respondent (in hours)
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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.
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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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