Partnership Opportunity To Develop New Designs of Powered Air-Purifying Respirators for Healthcare Workers, 31321-31323 [2019-13958]
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Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
studies on the health effects of toxic
substances (CERCLA Section
104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B))); to
respond to requests for health
consultations (CERCLA Section
104(i)(4)); 42 U.S.C. 9604(i)(4)); and to
support the site-specific response
actions conducted by the agency.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[Docket No. ATSDR–2014–0001]
Availability of Toxicological Profiles
for Tetrachloroethylene and
Trichloroethylene
Public Comment
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Agency for Toxic
Substances and Disease Registry
(ATSDR), within the Department of
Health and Human Services (HHS),
announces the release of the final
Toxicological Profiles for
Tetrachloroethylene and
Trichloroethylene. The present profiles
supersede any previously released
drafts.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Susan Ingber, Agency for Toxic
Substances and Disease Registry,
Division of Toxicology and Human
Health Sciences, 1600 Clifton Rd., NE,
Mail Stop S102–1, Atlanta, GA, 30329–
4027, Email: ATSDRToxProfileFRNs@
cdc.gov; Phone: 1–800–232–4636.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
Legislative Background
The Superfund Amendments and
Reauthorization Act of 1986 (SARA) [42
U.S.C. 9601 et seq.] amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) [42
U.S.C. 9601 et seq.] by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) regarding hazardous substances
that are most commonly found at
facilities on the CERCLA National
Priorities List (NPL). Among these
statutory requirements is a mandate for
the Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the priority list of
hazardous substances [also called the
Substance Priority List (SPL)]. This list
identifies 275 hazardous substances that
ATSDR and EPA have determined pose
the most significant potential threat to
human health. The SPL is available
online at www.atsdr.cdc.gov/spl.
In addition, CERCLA provides ATSDR
with the authority to prepare
toxicological profiles for substances not
found on the SPL. CERCLA authorizes
ATSDR to establish and maintain an
inventory of literature, research, and
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19:58 Jun 28, 2019
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ATSDR released the draft
Toxicological Profiles for
Tetrachloroethylene and
Trichloroethylene for public comment
December 15, 2014(79 FR 74093). The
comment period ended on March 16,
2015. ATSDR received multiple
comments on the draft
Tetrachloroethylene profile from a
professional association and multiple
comments on the draft
Trichloroethylene profile from three
professional associations and one law
firm. ATSDR carefully reviewed and
considered all comments in the
preparation of the final profiles.
The Toxicological Profile for
Tetrachloroethylene received comments
related to the use of specific studies for
the profile, potential omission of
studies, and derivation of the minimal
risk level (MRL). ATSDR addressed
these comments by correcting,
clarifying, or updating data in the final
toxicological profiles.
The Toxicological Profile for
Trichloroethylene received comments
centered on the methods and data used
for deriving the MRLs, as well as
suggestions for inclusion of additional
studies. ATSDR clarified areas of
scientific uncertainty and modeling
techniques used to derive the MRLs.
ATSDR updated the profile with several
additional studies.
For both profiles, ATSDR also
conducted a second peer review of the
epidemiological carcinogenicity
sections of the profile by external peer
reviewers. A list of peer reviewers and
the peer review comments are available
at ATSDR’s Peer Review Agenda web
page at (https://www.atsdr.cdc.gov/sites/
peer_review/).
Availability
The Final Toxicological Profiles for
Tetrachloroethylene and
Trichloroethylene are available online at
www.regulations.gov, Docket No.
ATSDR–2014–0001 and https://
www.atsdr.cdc.gov/ToxProfiles.
Pamela I. Protzel Berman,
Director, Office of Policy, Partnerships and
Planning, Agency for Toxic Substances and
Disease Registry.
[FR Doc. 2019–13980 Filed 6–28–19; 8:45 am]
BILLING CODE 4163–70–P
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31321
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Partnership Opportunity To Develop
New Designs of Powered Air-Purifying
Respirators for Healthcare Workers
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH), of the Centers for Disease
Control and Prevention (CDC),
announces the opportunity for
inventors, researchers, and/or respirator
manufacturers to participate, through a
collaborative agreement, in a project
titled ‘‘New Generation Powered AirPurifying Respirators,’’ to develop new
designs of powered air-purifying
respirators (PAPRs) for healthcare
workers.
SUMMARY:
Interested parties must submit a
letter of intent, electronically or written,
by July 31, 2019.
DATES:
FOR FURTHER INFORMATION AND TO SUBMIT
A LETTER OF INTENT CONTACT: Dr. Ziqing
Zhuang, NIOSH National Personal
Protective Technology Laboratory, 626
Cochrans Mill Road, Pittsburgh, PA
15236, 412–386–4055 (not a toll-free
number), zaz3@cdc.gov.
Letters of intent should be sent
electronically to Dr. Zhuang at the email
address listed.
SUPPLEMENTARY INFORMATION:
Additional Information: The National
Institute for Occupational Safety and
Health (NIOSH) is seeking to identify
inventors, researchers, and/or respirator
manufacturers with the respirator
design and manufacturing capabilities
to construct a new respirator prototype,
based on the characteristics included in
this notice.
This research endeavor grew from
recommendations issued by the
National Academies, Institute of
Medicine’s (now known as the National
Academy of Medicine) 2008 report,
‘‘Preparing for an Influenza Pandemic:
Personal Protective Equipment for
Healthcare Workers;’’ 2011 report,
‘‘Respiratory Diseases: Personal
Protective Equipment for Healthcare
Workers: Update 2010;’’ and 2015
report, ‘‘The Use and Effectiveness of
Powered Air Purifying Respirators in
Health Care: Workshop Summary.’’
These reports outline the next steps
E:\FR\FM\01JYN1.SGM
01JYN1
khammond on DSKBBV9HB2PROD with NOTICES
31322
Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
toward better respiratory protection for
healthcare workers.
This project aims to create and
develop new concepts in PAPR design
targeted for healthcare workers using a
government-private partnership
development model.
During the first phase of the project,
a team of researchers from NIOSH’s
National Personal Protective
Technology Laboratory will develop a
set of consensus recommendations for
this project, that, if implemented, are
expected to improve the function and
utility of respiratory protective devices
used by healthcare workers. The
consensus recommendations for
respirator design will be comprised of
desirable characteristics of the PAPR
and respiratory protection programs,
which fall into one of four actionable
categories:
• Respirators should perform their
intended functions effectively and
safely.
• Respirators should support, not
interfere with, healthcare worker
activities.
• Respirators should be comfortable
and tolerable.
• Respirators should support
healthcare system policies and
practices.
The following presents the plan for
this phase of the study:
• The consensus recommendations
developed by the National Personal
Protective Technology Laboratory will
be shared during partnership meetings.
• The candidate organizations will
then use the guidance to build the
respirator prototype(s).
• NIOSH researchers will evaluate, to
the extent possible, the respirator
prototype(s), to determine whether the
respirator(s) under evaluation meets or
exceeds the performance requirements
identified in the consensus
recommendations.
• NIOSH researchers will seek the
collective expertise of related
stakeholders regarding optimal product
development.
• NIOSH researchers will pursue, to
the extent possible, field evaluation of
resulting respirator prototype(s),
including feedback from healthcare
workers.
Collaborative efforts may be made via
a Cooperative Research and
Development Agreement (CRADA)
under the authority of the Federal
Technology Transfer Act, 15 U.S.C.
3710a, or another appropriate
agreement. No federal funds will be
provided under this project.
NIOSH may select one or more
partnering candidates with respirator
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19:58 Jun 28, 2019
Jkt 247001
design and commercial manufacturing
capabilities using the following criteria:
• The candidate organization has
adequate and sustained resources and/
or funding, as appropriate, to develop a
new PAPR prototype(s) or modify
existing PAPR models.
• The candidate organization has
scientific advisors and staff with a
demonstrated record of new product
development and knowledge to
construct the desired new respirator
prototype(s) within 24 months of the
effective date of the CRADA or other
appropriate agreement.
• The candidate organization is
capable of providing up to five units of
the prototype for laboratory and limited
field-testing.
Note: Preference is for substantial U.S.
manufacture of resultant product.
• A candidate organization who has
prior experience with respiratory
protection products is preferred, but this
experience is not required.
• A candidate organization who has
the capacity to transform a proof-ofconcept prototype into a commercially
viable model is preferred, but such
capacity is not required.
Candidate organizations will be
evaluated against the selection criteria
above, which indicate an organization’s
capability to incorporate the consensus
recommendations, when they are
developed, into the prototype(s). The
partnership also requires the candidate
organization to (a) abide by HHS
policies regarding testing in human
subjects, as applicable, and (b) support
the advancement of scientific research,
as evidenced by a written agreement to
publish jointly research results in a
prompt manner.
This announcement does not obligate
HHS, CDC, or NIOSH to enter into a
contractual or collaborative agreement
with any respondents.
Background: The 2003 severe acute
respiratory syndrome (SARS), 2009
H1N1 influenza, and 2014 Ebola
outbreaks highlighted the ongoing need
for effective respiratory protective
devices for healthcare workers. Powered
air-purifying respirators are an
important type of respiratory protection
to defend against high-level respiratory
hazards and infectious body fluids.
Challenges that have limited
widespread utilization of PAPRs in
healthcare settings remain.
PAPRs were originally developed to
protect industrial workers (primarily in
mining) for a typical 8-hour work shift.
Changes in PAPR design can be made to
better meet the needs in the healthcare
environment. Compared to industrial
settings, ambient particulate and toxic
gas/vapor levels in typical U.S.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
healthcare environments are lower. As a
result, the silica dust test, which was
designed for a mining or other dusty
environment, may not apply to
healthcare settings. Additionally,
because the typical work rates of
healthcare workers are significantly
lower than those of industrial workers,
a lower PAPR air flow rate may be
justified to provide a sufficient level of
protection.
Potential issues related to the
protection, performance, and usability
of PAPRs include particle leakage
during strenuous activity, noise, overall
bulkiness, visual impairment,
interference with tasks, and issues
related to decontamination, among other
problems associated with their use.
Beginning in 2006, NIOSH requested
the Institute of Medicine (now the
National Academy of Medicine) review,
and a follow- up review, of personal
protective equipment (PPE) with the
explicit purpose of recommending how
to best protect healthcare workers
during an influenza pandemic (IOM,
2007, 2011). In the reports, ‘‘Preparing
for an Influenza Pandemic: Personal
Protective Equipment for Healthcare
Workers’’ and ‘‘Respiratory Diseases:
Personal Protective Equipment for
Healthcare Workers: Update 2010’’, the
Institute of Medicine noted a lack of
evidence behind respirator protective
measures, including minimal attention
placed on the development of
equipment meeting the unique needs of
the healthcare workforce. The Institute
of Medicine recommended revisiting
elemental aspects of respirator design
and development, including distinct
attention to respirators tailored to the
jobs performed by healthcare workers,
and pursuing an evidence-based
approach for equipment design to the
extent possible.
In 2014, at NIOSH’s request, the
Institute of Medicine convened a
workshop, titled, ‘‘The Use and
Effectiveness of Powered Air-Purifying
Respirators in Health Care’’, to help
prioritize and accelerate NIOSH
activities to update certification
requirements for PAPRs. The
proceedings of the workshop are
available on the IOM website (linked
above).
Some of the research over the past 10
years at NIOSH’s National Personal
Protective Technology Laboratory has
focused on breathing patterns of
healthcare workers, barriers and
usability of PAPRs in healthcare
settings, and development of new
testing methods for evaluating
protective performance. The National
Personal Protective Technology
Laboratory previously developed a set of
E:\FR\FM\01JYN1.SGM
01JYN1
Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
consensus recommendations, under the
Better Respiratory Equipment using
Advanced Technologies for Healthcare
Employees project (Project BREATHE),
to improve respiratory protective
equipment used by healthcare workers.
These earlier consensus
recommendations will be modified as
NIOSH develops the consensus
recommendations for the project New
Generation PAPRs.
This project seeks to improve
respirator tolerability, comfort, and
other functional characteristics, while
maintaining a level of protection
equivalent to or greater than current
standards. The design changes
contemplated in this project could
increase compliance with respiratory
protection guidelines and standards
among healthcare workers.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2019–13958 Filed 6–28–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of the Intent To Issue
One OPDIV-Initiated Supplement to
BCFS Health and Human Services
Under the Standing Announcement for
Residential (Shelter) Services for
Unaccompanied Alien Children, HHS–
2017–ACF–ORR–ZU–1132
Unaccompanied Alien
Children’s (UAC) Program, Office of
Refugee Resettlement (ORR),
Administration for Children and
Families (ACF), U.S Department of
Health and Human Services (HHS).
ACTION: Notice of intent to issue one
OPDIV-Initiated Supplement to BCFS
Health and Human Services, San
Antonio, Texas under the UAC Program.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces
the intent to issue one OPDIV-Initiated
Supplement to BCFS Health and Human
Services, San Antonio, Texas in the
amount of up to $300,800,000. ORR
announces the issuance of the first
installment for 60 days in the amount of
up to $50,000,000.
ORR has been identifying additional
capacity to provide shelter for potential
increases in apprehensions of
Unaccompanied Alien Children at the
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SUMMARY:
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19:58 Jun 28, 2019
Jkt 247001
U.S. Southern Border. Planning for
increased shelter capacity is a prudent
step to ensure that ORR is able to meet
its responsibility, by law, to provide
shelter for Unaccompanied Alien
Children referred to its care by the
Department of Homeland Security
(DHS).
To ensure sufficient capacity to
provide shelter to unaccompanied alien
children referred to HHS, ORR is
requesting that BCFS provide up to
1,300 temporary shelter beds at Carrizo
Springs, Texas over a graduated
timeframe.
DATES: Supplemental award funds will
support activities until January 31,
2020. The first installment will support
activities for 60 days.
FOR FURTHER INFORMATION CONTACT:
Stephen Antowiak, Office of Refugee
Resettlement, Division of
Unaccompanied Alien Children
Operations, 330 C Street SW,
Washington, DC 20201. Phone: 202–
260–6165. Email: stephen.antkowiak@
acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is
continuously monitoring its capacity to
shelter the unaccompanied alien
children referred to HHS, as well as the
information received from interagency
partners, to inform any future decisions
or actions.
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
experience, and appropriate level of
trained staff to meet those requirements.
The expansion of the existing program
and its services through this
supplemental award is a key strategy for
ORR to be prepared to meet its
responsibility to provide shelter for
Unaccompanied Alien Children referred
to its care by DHS and so that the U.S.
Border Patrol can continue its vital
national security mission to prevent
illegal migration, trafficking, and protect
the borders of the United States.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of Unaccompanied
Alien Children from the Commissioner
of the former Immigration and
Naturalization Service (INS) to the
Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement,
Case No. CV85–4544RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
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31323
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996), pertinent
regulations and ORR policies and
procedures.
Karen Shields,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2019–13992 Filed 6–26–19; 4:15 pm]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Intent To Award a Single-Source
Supplement for the National Center for
Benefits Outreach and Enrollment
ACTION:
Notice.
The Administration for Community
Living (ACL) announces the intent to
award a single-source supplemental to
the current cooperative agreement held
by the National Council on Aging
(NCOA) for the National Center for
Benefits Outreach and Enrollment
(NCBOE). The purpose of the NCBOE is
to provide technical assistance to states,
area agencies on aging, and service
providers to provide outreach and lowincome benefits enrollment assistance,
particularly to older individuals with
greatest economic need for federal and
state programs. The administrative
supplement for FY 2019 will be for
$390,861, bringing the total award for
FY 2019 to $11,390,861. With this
supplemental funding, NCOA will
develop specialized training and tools
around integrated care models that can
be used by SHIPs, MIPPA grantees, and
other partners of ACL like Centers for
Independent Living (CILs) and the
Aging and Disability Resource Centers
(ADRCs) to expand the NCBOE’s
outreach and education efforts targeting
older adults with the greatest economic
need. This includes reaching out to
current MIPPA grantees to evaluate their
needs and to determine what the
grantees believe would be helpful and
conducting other stakeholder group
meeting(s) to discuss what should be
created around these integrated care
models. Stakeholders could include
MIPPA and other ACL grantees, health
plans, CMS, and other non-federal
partners. Additionally, NCOA will
continue, expand, and complete the
work they are currently undertaking
with the NCBOE award without
disrupting services.
E:\FR\FM\01JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Notices]
[Pages 31321-31323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Partnership Opportunity To Develop New Designs of Powered Air-
Purifying Respirators for Healthcare Workers
AGENCY: National Institute for Occupational Safety and Health (NIOSH),
Centers for Disease Control and Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH), of the Centers for Disease Control and Prevention (CDC),
announces the opportunity for inventors, researchers, and/or respirator
manufacturers to participate, through a collaborative agreement, in a
project titled ``New Generation Powered Air-Purifying Respirators,'' to
develop new designs of powered air-purifying respirators (PAPRs) for
healthcare workers.
DATES: Interested parties must submit a letter of intent,
electronically or written, by July 31, 2019.
FOR FURTHER INFORMATION AND TO SUBMIT A LETTER OF INTENT CONTACT: Dr.
Ziqing Zhuang, NIOSH National Personal Protective Technology
Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236, 412-386-4055
(not a toll-free number), [email protected].
Letters of intent should be sent electronically to Dr. Zhuang at
the email address listed.
SUPPLEMENTARY INFORMATION:
Additional Information: The National Institute for Occupational
Safety and Health (NIOSH) is seeking to identify inventors,
researchers, and/or respirator manufacturers with the respirator design
and manufacturing capabilities to construct a new respirator prototype,
based on the characteristics included in this notice.
This research endeavor grew from recommendations issued by the
National Academies, Institute of Medicine's (now known as the National
Academy of Medicine) 2008 report, ``Preparing for an Influenza
Pandemic: Personal Protective Equipment for Healthcare Workers;'' 2011
report, ``Respiratory Diseases: Personal Protective Equipment for
Healthcare Workers: Update 2010;'' and 2015 report, ``The Use and
Effectiveness of Powered Air Purifying Respirators in Health Care:
Workshop Summary.'' These reports outline the next steps
[[Page 31322]]
toward better respiratory protection for healthcare workers.
This project aims to create and develop new concepts in PAPR design
targeted for healthcare workers using a government-private partnership
development model.
During the first phase of the project, a team of researchers from
NIOSH's National Personal Protective Technology Laboratory will develop
a set of consensus recommendations for this project, that, if
implemented, are expected to improve the function and utility of
respiratory protective devices used by healthcare workers. The
consensus recommendations for respirator design will be comprised of
desirable characteristics of the PAPR and respiratory protection
programs, which fall into one of four actionable categories:
Respirators should perform their intended functions
effectively and safely.
Respirators should support, not interfere with, healthcare
worker activities.
Respirators should be comfortable and tolerable.
Respirators should support healthcare system policies and
practices.
The following presents the plan for this phase of the study:
The consensus recommendations developed by the National
Personal Protective Technology Laboratory will be shared during
partnership meetings.
The candidate organizations will then use the guidance to
build the respirator prototype(s).
NIOSH researchers will evaluate, to the extent possible,
the respirator prototype(s), to determine whether the respirator(s)
under evaluation meets or exceeds the performance requirements
identified in the consensus recommendations.
NIOSH researchers will seek the collective expertise of
related stakeholders regarding optimal product development.
NIOSH researchers will pursue, to the extent possible,
field evaluation of resulting respirator prototype(s), including
feedback from healthcare workers.
Collaborative efforts may be made via a Cooperative Research and
Development Agreement (CRADA) under the authority of the Federal
Technology Transfer Act, 15 U.S.C. 3710a, or another appropriate
agreement. No federal funds will be provided under this project.
NIOSH may select one or more partnering candidates with respirator
design and commercial manufacturing capabilities using the following
criteria:
The candidate organization has adequate and sustained
resources and/or funding, as appropriate, to develop a new PAPR
prototype(s) or modify existing PAPR models.
The candidate organization has scientific advisors and
staff with a demonstrated record of new product development and
knowledge to construct the desired new respirator prototype(s) within
24 months of the effective date of the CRADA or other appropriate
agreement.
The candidate organization is capable of providing up to
five units of the prototype for laboratory and limited field-testing.
Note: Preference is for substantial U.S. manufacture of resultant
product.
A candidate organization who has prior experience with
respiratory protection products is preferred, but this experience is
not required.
A candidate organization who has the capacity to transform
a proof-of-concept prototype into a commercially viable model is
preferred, but such capacity is not required.
Candidate organizations will be evaluated against the selection
criteria above, which indicate an organization's capability to
incorporate the consensus recommendations, when they are developed,
into the prototype(s). The partnership also requires the candidate
organization to (a) abide by HHS policies regarding testing in human
subjects, as applicable, and (b) support the advancement of scientific
research, as evidenced by a written agreement to publish jointly
research results in a prompt manner.
This announcement does not obligate HHS, CDC, or NIOSH to enter
into a contractual or collaborative agreement with any respondents.
Background: The 2003 severe acute respiratory syndrome (SARS), 2009
H1N1 influenza, and 2014 Ebola outbreaks highlighted the ongoing need
for effective respiratory protective devices for healthcare workers.
Powered air-purifying respirators are an important type of respiratory
protection to defend against high-level respiratory hazards and
infectious body fluids. Challenges that have limited widespread
utilization of PAPRs in healthcare settings remain.
PAPRs were originally developed to protect industrial workers
(primarily in mining) for a typical 8-hour work shift. Changes in PAPR
design can be made to better meet the needs in the healthcare
environment. Compared to industrial settings, ambient particulate and
toxic gas/vapor levels in typical U.S. healthcare environments are
lower. As a result, the silica dust test, which was designed for a
mining or other dusty environment, may not apply to healthcare
settings. Additionally, because the typical work rates of healthcare
workers are significantly lower than those of industrial workers, a
lower PAPR air flow rate may be justified to provide a sufficient level
of protection.
Potential issues related to the protection, performance, and
usability of PAPRs include particle leakage during strenuous activity,
noise, overall bulkiness, visual impairment, interference with tasks,
and issues related to decontamination, among other problems associated
with their use.
Beginning in 2006, NIOSH requested the Institute of Medicine (now
the National Academy of Medicine) review, and a follow- up review, of
personal protective equipment (PPE) with the explicit purpose of
recommending how to best protect healthcare workers during an influenza
pandemic (IOM, 2007, 2011). In the reports, ``Preparing for an
Influenza Pandemic: Personal Protective Equipment for Healthcare
Workers'' and ``Respiratory Diseases: Personal Protective Equipment for
Healthcare Workers: Update 2010'', the Institute of Medicine noted a
lack of evidence behind respirator protective measures, including
minimal attention placed on the development of equipment meeting the
unique needs of the healthcare workforce. The Institute of Medicine
recommended revisiting elemental aspects of respirator design and
development, including distinct attention to respirators tailored to
the jobs performed by healthcare workers, and pursuing an evidence-
based approach for equipment design to the extent possible.
In 2014, at NIOSH's request, the Institute of Medicine convened a
workshop, titled, ``The Use and Effectiveness of Powered Air-Purifying
Respirators in Health Care'', to help prioritize and accelerate NIOSH
activities to update certification requirements for PAPRs. The
proceedings of the workshop are available on the IOM website (linked
above).
Some of the research over the past 10 years at NIOSH's National
Personal Protective Technology Laboratory has focused on breathing
patterns of healthcare workers, barriers and usability of PAPRs in
healthcare settings, and development of new testing methods for
evaluating protective performance. The National Personal Protective
Technology Laboratory previously developed a set of
[[Page 31323]]
consensus recommendations, under the Better Respiratory Equipment using
Advanced Technologies for Healthcare Employees project (Project
BREATHE), to improve respiratory protective equipment used by
healthcare workers. These earlier consensus recommendations will be
modified as NIOSH develops the consensus recommendations for the
project New Generation PAPRs.
This project seeks to improve respirator tolerability, comfort, and
other functional characteristics, while maintaining a level of
protection equivalent to or greater than current standards. The design
changes contemplated in this project could increase compliance with
respiratory protection guidelines and standards among healthcare
workers.
John J. Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2019-13958 Filed 6-28-19; 8:45 am]
BILLING CODE 4163-18-P
