A National Elastomeric Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings During an Infectious Disease Outbreak/Pandemic, 56618-56620 [2020-20115]

Download as PDF 56618 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Form name HOPS study Patients ........................ HOPS Study Patients ....................... Behavioral survey ............................. Consent form .................................... 2,500 450 Total ........................................... ........................................................... 405 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–20214 Filed 9–11–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Center for Preparedness and Response Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting that is open to the public, limited only by the number of net conference access available, which is 500. Pre-registration is required by accessing the link at https://cdc.zoomgov.com/webinar/ register/WN_bV_ Jrvp4QZGHZFao0moqPg. DATES: The meeting will be held on October 26, 2020, from 12:30 p.m. to 3:30 p.m., EDT. ADDRESSES: Zoom Virtual Meeting. If you wish to attend the virtual meeting, please pre-register by accessing the link at https://cdc.zoomgov.com/webinar/ register/WN_bV_ Jrvp4QZGHZFao0moqPg. Instructions to access the Zoom virtual meeting will be provided in the link following registration. FOR FURTHER INFORMATION CONTACT: Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop-H21–6, Atlanta, Georgia 30329–4027, Telephone: (404) 639–7450; Facsimile: (404) 471–8772; Email: OPHPR.BSC.Questions@cdc.gov. SUPPLEMENTARY INFORMATION: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Number of respondents Type of respondent VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 Purpose: This Board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health (ASH), the Director, Centers for Disease Control and Prevention (CDC), and the Director, Center for Preparedness and Response (CPR), concerning strategies and goals for the programs and research within CPR, monitoring the overall strategic direction and focus of the CPR Divisions and Offices, and administration and oversight of peer review for CPR scientific programs. For additional information about the Board, please visit: https://www.cdc.gov/cpr/bsc/ index.htm. Matters To Be Considered: The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates. Agenda items are subject to change as priorities dictate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–20187 Filed 9–11–20; 8:45 am] BILLING CODE 4163–18–P PO 00000 Number of responses per respondent 1 1 Average burden per response (in hr) Total burden (in hr) 7/60 15/60 292 113 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 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. AGENCY: 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 halfmask 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 ppeconcerns@cdc.gov. 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: ppeconcerns@ cdc.gov. SUPPLEMENTARY INFORMATION: SUMMARY: 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 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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. 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 1 42 CFR part 84—Approval of Respiratory Protective Devices. https://ecfr.io/Title-42/Part-84. 2 https://www.nap.edu/catalog/25275/reusableelastomeric-respirators-in-health-careconsiderations-for-routine-and. VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 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. 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 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. 3 85 FR 17335 (March 27, 2020). 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. 4 Hamby PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 56619 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 E:\FR\FM\14SEN1.SGM 14SEN1 56620 Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 17:51 Sep 11, 2020 Jkt 250001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–20–0106] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Preventive Health and Health Services Block Grant to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on 05/21/2020 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 (d) 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 submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/ do/PRAMain Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Preventive Health and Health Services Block Grant (OMB Control No. 0920– 0106, Exp.08/31/2022)—Revision— Center for State, Tribal, Local, and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC’s Center for State, Tribal, Local, and Territorial Support (CSTLTS) plays a vital role in helping health agencies work to enhance their capacity and improve their performance to strengthen the public health system on all levels. CSTLTS is CDC’s primary connection to health officials and leaders of state, tribal, local, and territorial public health agencies, as well as to other government leaders who work with health departments. CSTLTS administers the Preventive Health and Health Services (PHHS) Block Grant funding for health promotion and disease prevention programs. Sixty-one recipients (50 states, the District of Columbia, two American Indian tribes, five U.S. territories, and three freely associated states) receive block grant funds to address locally defined public health needs in innovative ways. The PHHS Block Grant allows recipients to prioritize the use of funds to fill funding gaps in programs that deal with leading E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ 85 FR 17335 (March 27, 2020).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 56620]]

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


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