Notice2025-10866

Proposed Data Collection Submitted for Public Comment and Recommendations

Primary source

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Published
June 16, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

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.

Full Text

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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&#160;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)
----------------------------------------------------------------------------------------------------------------
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).
                                                    ------------------------------------------------------------
    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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