[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 38098-38100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21GO; Docket No. CDC-2021-0068]


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 and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Evaluating the use of EHMRs in 
health settings to improve organizational implementation and worker 
adoption during and after the COVID-19 pandemic. NIOSH proposes using 
surveys and interviews to understand how elastomeric half mask 
respirators (EHMRs) are being perceived and used by healthcare and 
first responder settings during the COVID-19 pandemic.

DATES: CDC must receive written comments on or before September 17, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0068 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) 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,

[[Page 38099]]

Information Collection Review Office, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; 
phone: 404-639-7570; Email: <a href="/cdn-cgi/l/email-protection#1b7476795b787f78357c746d"><span class="__cf_email__" data-cfemail="5b3436391b383f38753c342d">[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 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

    Evaluating the use of EHMRs in health settings to improve 
organizational implementation and worker adoption during and after the 
COVID-19 pandemic--New--National Institute of Occupational Safety and 
Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC/NIOSH is requesting approval of a new data collection for a 
period of two years under the project titled ``Evaluating the use of 
EHMRs in health settings to improve organizational implementation and 
worker adoption during and after the COVID-19 pandemic.'' The data 
collection activities were initiated under the Public Health Emergency 
PRA waiver. NIOSH has the responsibility to conduct research relating 
to innovative methods, techniques, and approaches dealing with 
occupational safety and health problems. Additionally, OSHA's Emergency 
Temporary Standard (ETS) for COVID-19 in Healthcare released in June 
2021 (29 CFR 1910, Subpart U) is facilitating the need for this work. 
Finally, during the nationwide shortage of filtering facepiece 
respirators (FFRs), the Food and Drug Administration (FDA) issued an 
emergency use authorization (EUA), allowing the use of all NIOSH-
approved respiratory protective devices in healthcare settings during 
the pandemic--of which elastomeric half mask respirators (EHMRs) were 
included (85 FR 17335, March 27, 2020). This EUA was provided for 
alternative FFR use in healthcare settings to prevent wearer (i.e., 
worker) exposure to airborne particulates because of the COVID-19 
pandemic and the life-threatening illness it can cause (FDA, 2020).
    Currently, organizations are being confronted with the use of new 
respiratory protection and questions on how to best support its 
implementation during the pandemic. To that end, the purpose of this 
demonstration research study is to assess the integration of EHMRs in 
various healthcare and first responder settings and subsequently update 
and enhance EHMR best practices and implementation guidelines to 
encourage adoption and consequently, reduce PPE supply shortages during 
the current and future pandemics.
    This project is supported through a NIOSH Federal Register Notice 
(FRN) that posted in September 2020, titled, ``A National Elastomeric 
Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings 
During an Infectious Disease Outbreak/Pandemic.''--Vol. 85, No. 178. 
The announcement requested information regarding the deployment and use 
of EHMRs in healthcare settings and first responder organizations 
during the COVID-19 crisis.
    This proposed study involves conducting surveys and interviews. 
Individual workers who receive EHMRs from their organization will have 
the option to voluntarily participate in a pre-/post-survey. Voluntary 
data collection at the organizational level with members of management 
will occur using an interview format that follows a semi-structured 
approach to capture information throughout the duration of NIOSH's 
research study. Individual workers (via surveys) and organization 
management (via interviews) will participate in data collection 
activities over a period of approximately 4-9 months to assess 
perceptions, knowledge, attitudes, and experiences using EHMRs as well 
as best practices for adoption and implementation of EHMRs at their 
organizations. Individuals who are asked to respond are those who 
notified NIOSH of their interest of participating in the study. 
Respondents are expected to include a variety of job types including 
industrial hygienists, occupational health professionals, infection 
control professionals, physicians, nurse practitioners, nurses, 
infection preventionists, fire department chiefs, battalion chiefs, 
sheriffs, shift supervisors, firefighters, police officers, and 
paramedics.
    A multi-site approach is necessary to answer and further validate 
findings related to the study objectives. By conducting several studies 
at healthcare and first responder locations, NIOSH researchers can make 
the case for research progression, which enhances the reliability and 
validity of any revised guidance.
    NIOSH requests approval for a total of 42,877 estimated burden 
hours. There are no costs 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 respondent            Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Organizational manager/POC....  Informed Consent             150               3            5/60              38
                                Time 1 Interview             150               1           45/60             113
                                Time 2 Interview             150               1           45/60             113
                                Time 3 Interview             150               1           45/60             113

[[Page 38100]]

 
Individual Healthcare/First     Informed Consent          51,000               2            5/60           8,500
 Responder.
                                Baseline Survey.          51,000               1           20/60          17,000
                                Follow-up Survey          51,000               1           20/60          17,000
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          42,877
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-15228 Filed 7-16-21; 8:45 am]
BILLING CODE 4163-18-P


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