[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56618-56620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20115]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


A National Elastomeric Half Mask Respirator (EHMR) Strategy for 
Use in Healthcare Settings During an Infectious Disease Outbreak/
Pandemic

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information and comment.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC), within 
the Department of Health and Human Services (HHS), announces this 
request for information regarding the deployment and use of elastomeric 
half-mask respirators in healthcare settings and emergency medical 
services (EMS) organizations during the COVID-19 crisis.

DATES: Comments must be received October 14, 2020.

ADDRESSES: Responses should be submitted to Dr. Lee Greenawald, NIOSH, 
626 Cochrans Mill Road, Building 141, Pittsburgh, PA 15236, or 
[email protected].

FOR FURTHER INFORMATION CONTACT: Lee Greenawald, NIOSH, 626 Cochrans 
Mill Road, Building 141, Pittsburgh, PA 15236; phone: (412) 386-6465 
(not a toll-free number, email: [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation

    Informational submissions in response to this request for 
information (RFI) are due no later than October 14, 2020. Please limit 
informational submissions for each of the two sections to five pages or 
less (for a total of 10 pages or less).
    NIOSH will not respond to individual informational submissions or 
publish

[[Page 56619]]

publicly a compendium of responses. An informational submission in 
response to this RFI does not create any commitment on or behalf of CDC 
or HHS to develop or pursue the program or ideas discussed.
    Respondents are requested to provide the following information at 
the start of their informational submission in response to this RFI:
     Company/institution name;
     Company/institution contact;
     Contact's address, phone number, and email address.
    Please provide any additional relevant background information about 
yourself or your organization but note that submissions will not be 
redacted.

Introduction

    An elastomeric half-mask respirator (EHMR) is a non-powered air-
purifying respirator that has a tight-fitting facepiece that covers the 
nose and mouth. The facepieces are made of synthetic or natural rubber 
material permitting repeated cleaning, disinfection, storage, and 
reuse. EHMRs use replaceable filters or cartridges, and they provide at 
least the same level of protection as single-use N95 filtering 
facepiece respirators (FFRs). As outlined in the Code of Federal 
Regulations,\1\ all EHMR models used in U.S. workplaces must be 
evaluated and approved by NIOSH's National Personal Protective 
Technology Laboratory (NPPTL). In 2018, NIOSH/NPPTL sponsored a 
National Academies of Sciences, Engineering, and Medicine Consensus 
Study Report \2\ that discussed the feasibility of reusable respirator 
use (including EHMRs) for routine and surge situations in U.S. 
healthcare organizations. The National Academies' report also 
recommended various EHMR-related research activities related to 
cleaning/disinfection, fit testing, cost/market analyses for EHMRs 
introduced to healthcare, and healthcare user acceptability 
considerations.
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    \1\ 42 CFR part 84--Approval of Respiratory Protective Devices. 
https://ecfr.io/Title-42/Part-84.
    \2\ https://www.nap.edu/catalog/25275/reusable-elastomeric-respirators-in-health-care-considerations-for-routine-and.
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    Although EHMRs have been used routinely in healthcare settings, 
they are not considered medical devices pursuant to the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) and thus are not typically authorized 
for use as U.S. Food and Drug Administration (FDA)-approved medical 
devices. However, in response to the COVID-19 crisis, FDA has issued an 
emergency use authorization (EUA) authorizing the ``emergency use of 
medical devices, including alternative products used as medical 
devices, pursuant to section 564 of the FD&C Act,'' including EHMRs.\3\ 
The Strategic National Stockpile (SNS) plans to purchase EHMRs to be 
deployed to and used by healthcare organizations in order to diversify 
the respiratory protection options available to healthcare workers and 
emergency responders during the COVID-19 crisis.
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    \3\ 85 FR 17335 (March 27, 2020).
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    NIOSH anticipates that the widespread use of EHMRs will ease the 
demand for single-use N95 FFRs in healthcare settings experiencing high 
numbers of COVID-19 patients. In media reports about the COVID-19 
crisis, medical professionals have noted that the use of EHMRs has been 
critical to the response, especially during shortages of N95 FFRs. 
Wearers note that EHMRs are comfortable to wear, and that given their 
low cost, ease of use, and ability to be cleaned and decontaminated, 
hospitals have found these devices to be valuable in keeping workers 
safe.\4\
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    \4\ Hamby C. May 2020. They Evoke Darth Vader, but These Masks 
May Save your Doctor's Life. https://www.nytimes.com/2020/05/27/us/coronavirus-masks-elastomeric-respirators.html.
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    In order to gather more information from EHMR users in healthcare 
and emergency response settings, NIOSH is seeking input on two related 
endeavors: A deployment of EHMRs across the nation from the SNS, and 
future NIOSH EHMR demonstration projects. NIOSH's specific information 
needs are described below.

Defining a National Strategy To Inform the Purchase, Deployment, and 
Use of Reusable EHMRs in Healthcare Settings During an Infectious 
Disease Outbreak/Pandemic

    NIOSH seeks information and ideas that may be used by the SNS to 
conduct a program to solicit and obtain a diverse group of healthcare 
organizations to participate in a deployment of EHMRs across the 
nation.
    The intent is for the SNS to provide participating organizations 
with a fixed quantity of the EHMR devices it purchases to use in their 
healthcare activities. Each participating organization will also 
receive the EHMR Best Practice Guidelines/Hospital Implementation Guide 
prepared by NIOSH. Each participating organization will provide NIOSH a 
detailed report of its experiences using the EHMRs, including user 
acceptability and feasibility of implementation. These reports will 
inform future updates to the Best Practice Guidelines/Hospital 
implementation Guide.
    The types of potential participant organizations that will be 
sought include, but are not limited to, hospital systems, hospitals, 
hospital intensive care units (ICUs), hospital general wards, hospital 
emergency departments, outpatient care settings, nursing homes, dental 
organizations, and first responders, including, but not limited to, 
emergency medical services, police officers, and firefighters.
    Please provide responses to one or both of the following:
    1. Provide a Statement of Interest (SOI) to participate in the 
deployment of EHMRs across the nation:
    a. Describe the nature of the organization that desires to 
participate, including type, geographical location (including rural or 
urban), size (e.g., hospital beds, healthcare staff), and prior 
experience with the organizational use of EHMRs. Although prior 
experience with EHMRs is not required, any EHMR experience can be 
specified, including manufacturers, model numbers, and quantity of 
devices used;
    b. Describe the proposed approach regarding how the received EHMRs 
would be implemented into the organization (e.g., strategy for 
distribution to the appropriate staff and care settings); and
    c. Describe the interested participant's commitment to developing a 
report based on the EHMR experiences of staff.
    2. Provide information that will assist the SNS and NIOSH in the 
following:
    a. Defining the strategic parameters of this distribution program; 
for example, considerations about fit testing, training, education, 
filter change-out schedule, cleaning/disinfection, storage 
considerations, and appropriate clinical care settings for EHMR use; 
and
    b. The potential criteria to be used to determine how the purchased 
devices should be distributed; for example, the technical approach of 
the use of the EHMRs, and technical qualifications of key staff who 
would lead the initiative.

Interest in Participating and Refining Additional, Future, EHMR 
Demonstration Projects

    In addition to NIOSH's current EHMR research activities, NIOSH is 
considering conducting additional EHMR demonstration projects. These 
EHMR demonstration projects would consist of healthcare or EMS 
organizations using EHMRs in their respiratory protection programs and 
providing user acceptability feedback, such as on fit testing and 
disinfection protocols, among other implementation parameters. The full 
scope of these additional EHMR demonstration projects is still being 
defined. NIOSH

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seeks information on interest in participating as a future 
demonstration site to gauge interest in the nationwide implementation 
of using EHMRs in hospital and EMS settings to supplement current 
respiratory protection program activities, and to collect additional 
user input parameters not currently being collected in the current 
activities.
    The types of potential participant organizations that will be 
sought include, but are not limited to, hospital systems, hospitals, 
hospital intensive care units (ICUs), hospital general wards, hospital 
emergency departments, outpatient care settings, nursing homes, dental 
organizations, and first responders, including, but not limited to, 
EMS, police officers, and firefighters.
    Please provide responses to one or both of the following:
    1. Provide a Statement of Interest (SOI) describing interest in 
participating in future EHMR demonstration project activities. The SOI 
should describe the nature of the organization that desires to 
participate as a demonstration site, including type, geographical 
location (including rural or urban), size (e.g., hospital beds, 
healthcare staff), and prior organizational experience with the use of 
EHMRs. The SOI should also provide reasons for interest in 
participating as a demonstration site. Prior experience with the use of 
EHMRs will NOT be required to participate in the EHMR demonstration 
project activity. The description of an approach that has the potential 
to be effective for conducting a demonstration project will be 
required.
    2. Provide information that will assist NIOSH in the refinement of 
the EHMR demonstration projects, including the following:
    a. Defining the strategic parameters of this EHMR demonstration 
activity; for example, considerations of fit testing, training, 
education, filter change-out schedule, cleaning/disinfection, storage 
considerations, and appropriate clinical care settings for EHMR use; 
and
    b. The potential criteria to be used to determine how the EHMR 
devices should be distributed to the demonstration sites; for example, 
the technical approach of the use of the EHMRs, and technical 
qualifications of key staff who would lead the initiative.

No SNS Applications Will Be Accepted Through This RFI

    While the strategy for distribution of the purchased EHMRs is being 
developed, its details will only be finalized after consideration and 
analysis of the informational submissions in response to this RFI.

Disclaimer and Important Notes

    This RFI is for planning purposes; it does not constitute a formal 
announcement for comprehensive applications. In accordance with Federal 
Acquisition Regulation 48 CFR 15.201(e), responses to this RFI are not 
offers and cannot be accepted by the Government to form a binding 
award. NIOSH will not provide reimbursement for costs incurred in 
responding to this RFI.

    Dated: September 8, 2020.
John J. Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention, Department of Health and 
Human Services.
[FR Doc. 2020-20115 Filed 9-11-20; 8:45 am]
BILLING CODE 4163-18-P