[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]


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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.

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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