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