Proposed Data Collection Submitted for Public Comment and Recommendations
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Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Occupational exposures to waste anesthetic gases in healthcare professionals. The purpose of the proposed data collection is to assess occupational exposures to waste anesthetic gases (WAGs) in healthcare and veterinary workers in postanesthetic care units (PACUs) and veterinary hospitals, examine associated adverse acute health effects of WAGs and recommend control measures to reduce WAG exposures for healthcare and veterinary workers in PACUs and veterinary hospitals.
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25281-25283]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10866]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0079; Docket No. CDC-2025-0022]
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 effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Occupational exposures to waste anesthetic gases in healthcare
professionals. The purpose of the proposed data collection is to assess
occupational exposures to waste anesthetic gases (WAGs) in healthcare
and veterinary workers in postanesthetic care units (PACUs) and
veterinary hospitals, examine associated adverse acute health effects
of WAGs and recommend control measures to reduce WAG exposures for
healthcare and veterinary workers in PACUs and veterinary hospitals.
DATES: CDC must receive written comments on or before August 15, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0022 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>. Please note: Submit all comments through the
Federal eRulemaking portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: 404-639-7570;
email: <a href="/cdn-cgi/l/email-protection#5b3436391b383f38753c342d"><span class="__cf_email__" data-cfemail="4f20222d0f2c2b2c61282039">[email protected]</span></a>.
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
[[Page 25282]]
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;
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
Occupational exposures to waste anesthetic gases in healthcare
professionals--New--National Institute for Occupational Safety and
Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Waste anesthetic gases (WAGs) refer to anesthetic gases and vapors
that are released or leaked into the surrounding areas during the
administration of anesthesia to patients in operating rooms (ORs),
recovery in postanesthetic care units (PACUs), and patient care in
intensive care units in human and veterinary hospitals. Common inhaled
anesthetics involve nitrous oxide (N<INF>2</INF>O) and halogenated
agents such as isoflurane, desflurane, and sevoflurane. These agents
may be used individually or in combination, depending on the type of
surgery being performed. While human and veterinary medical
environments differ, occupational exposure to WAGs is detrimental in
both sectors. Acute WAG exposure is linked to symptoms including
nausea, dizziness, headache, fatigue, irritability, drowsiness, and
difficulties with judgement and coordination. Chronic exposure health
effects include DNA damage, genotoxicity, increased oxidative stress,
cancer, and liver and kidney disease. However, adverse reproductive
outcomes of spontaneous abortion, premature delivery, genetic damage,
and birth defects (hereinafter called AROs) are a particular matter of
concern because of conflicting published results. Conflicting evidence
on WAGs and AROs are primarily attributed to methodological errors and
weak study designs, including lack of exposure data and related job
exposure matrices (JEMs), use of gas mixtures, insufficient sample
size, selection bias, etc. Accurate quantification of WAG exposures is
key to the epidemiologic study of AROs among healthcare and veterinary
workers (HCVWs) and in developing JEMs for healthcare workers in PACUs
in human hospitals and veterinary hospitals. However, only a few
studies have collected WAG exposures for HCVWs in PACUs of human
hospitals and veterinary hospitals.
In addition, most health effect studies were conducted when co-
exposure to halogenated agents and N<INF>2</INF>O, which often happens
in human hospitals, occurred. There is a need to determine whether
adverse health outcomes are caused from halogenated agents alone. To
our knowledge, this is the first study to investigate the relationship
between WAG exposure and acute symptoms in HCVWs. This is also one of
the few studies to assess halogenated agents without co-exposure to
N<INF>2</INF>O. Most veterinary hospitals use only a halogenated agent
during anesthesia and assessing WAG exposures and acute health symptoms
among workers in veterinary hospitals is critical to determine acute
health effect by halogenated agents only. Finally, limited data on HCVW
exposures to WAGs in PACUs and veterinary hospitals suggests that
recommending and implementing control strategies to minimize WAG
exposure is challenging.
The purpose of the proposed data collection is to assess
occupational exposures to WAGs in HCVWs in PACUs and veterinary
hospitals, examine associated adverse acute health effects of WAGs and
recommend control measures to reduce WAG exposures for healthcare and
veterinary workers in PACUs and veterinary hospitals. We will focus on
sevoflurane, desflurane, and isoflurane. Comprehensive exposure
assessment will be performed at multiple worksites by measuring
workers' exposure to WAGs in their breathing zone using sampling
devices including time-integrated instruments and a real-time
instrument (optional) and area air concentrations to WAGs using the
same devices used in personal exposure sampling. Additionally, room air
flows will be measured where appropriate, and detailed contextual
information on workplace characteristics will be systematically
collected on a standardized form based on workplace observations. At
the end of participant' shift, post-shift questionnaire will be
administered by a NIOSH staff in a private room to ensure
confidentiality.
The target number of total participants is 280--150 subjects for
the exposure assessment (75 each with PACUs/VHs) and 130 for the post-
shift questionnaire (65 each with PACUs/VHs)--covering multiple
hospitals. Ideally, we want a sample size of 150 participants (75
subjects each within PACUs/VHs) that complete both the exposure
assessment and post-shift questionnaire. In practice, some healthcare
workers might participate in the exposure assessment without completing
the post-shift questionnaire, and vice-versa. If this occurs, we need
150 workers (75 from PACUs and 75 from VHs) to complete the exposure
assessments, regardless of their participation in the questionnaire and
at least 130 workers to complete the questionnaires (65 from PACUs and
65 from VHs) regardless of their involvement in the exposure
assessment. Therefore, the maximum sample size for this study will be
280 (in the unlikely event that the 150 that complete the exposure
assessment are different from the 130 that complete the post-shift
questionnaires).
The burden hour estimates for the exposure assessment and post-
shift questionnaire are presented below. The anticipated duration of
worker contact is approximately 45 minutes: 10 minutes for obtaining
the informed consent document, 10 minutes for putting on and taking off
sampling devices, 20 minutes for completing the full post-shift
questionnaire, and five minutes for completing the questionnaire that
focuses solely on acute health symptoms. For workers participating in
our study over multiple days, the post-shift questionnaire will
concentrate solely on acute health symptoms related to that specific
sampling date, requiring less than five minutes to finish. However, due
to uncertainty regarding how many workers will participate in our study
[[Page 25283]]
across multiple days, we estimated the burden hours by assuming that
50% of participants would take part in the study at least twice.
The total respondent burden hours are 122 hours (61 hours for the
healthcare workers in PACUs and 61 for the healthcare workers in
veterinary hospitals). CDC is requesting OMB approval for three years.
There is no cost to respondents other than their time to participate.
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 hours)
respondent (in hours)
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Healthcare workers in PACUs.. Informed Consent.... 140 1 10/60 23
Donning/Doffing 75 1 10/60 13
sampling devices.
Post-shift 65 1 20/60 22
questionnaire
(full).
Post-shift 33 1 5/60 3
questionnaire
(acute symptoms
focused).
Healthcare workers in Informed Consent.... 140 1 10/60 23
veterinary hospitals.
Donning/Doffing 75 1 10/60 13
sampling devices.
Post-shift 65 1 20/60 22
questionnaire
(full).
Post-shift 33 1 5/60 3
questionnaire
(acute symptoms
focused).
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Total.................... .................... .............. .............. ........... 122
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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. 2025-10866 Filed 6-13-25; 8:45 am]
BILLING CODE 4163-18-P
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