Notice2021-15228
Proposed Data Collection Submitted for Public Comment and Recommendations
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
July 19, 2021
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 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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 135 (Monday, July 19, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 38098-38100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15228]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <a href="http://Regulations.gov">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-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 <a href="http://Regulations.gov">Regulations.gov</a>.
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 19, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.