[Federal Register Volume 74, Number 238 (Monday, December 14, 2009)]
[Notices]
[Pages 66198-66200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29709]


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DEPARTMENT OF VETERANS AFFAIRS


Project Better Respiratory Equipment Using Advanced Technologies 
for Healthcare Employees (B.R.E.A.T.H.E.)

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: The National Center for Occupational Health and Infection 
Control, [administered by the Office of Public Health and Environmental 
Hazards, Veterans Health Administration (VHA), Department of Veterans 
Affairs (VA)], is seeking to partner with commercial organizations that 
have respirator design and manufacturing capabilities through a 
Cooperative Research and Development Agreement (CRADA), under the 
authority of the Federal Technology Transfer Act of 1986, Public Law 
99-502, 100 Stat. 1785 (codified as amended in scattered sections of 15 
U.S.C. (the FTTA). The CRADA is on a research endeavor called Better 
Respiratory Equipment using Advanced Technologies for Healthcare 
Employees (or Project B.R.E.A.T.H.E.) that aims to develop a new 
respirator for health care workers. The genesis and emphasis of Project 
B.R.E.A.T.H.E. grew from recommendations issued by the Institute of 
Medicine in November 2007 in its report Preparing for an Influenza 
Pandemic: Personal Protective Equipment for Healthcare Workers, which 
articulates the next steps to be taken toward better respiratory 
protection for health care workers.

SUPPLEMENTARY INFORMATION: The Project B.R.E.A.T.H.E. Working Group 
constitutes an interagency effort of the U.S. Federal Government, 
initiated and chaired by VA and co-chaired by the National Institute 
for Occupational Safety and Health (NIOSH), in the Centers for Disease 
Control and Prevention, the Department of Health

[[Page 66199]]

and Human Services. This multi-disciplinary team had a broad range of 
expertise, including pandemic and emergency preparedness, infectious 
disease medicine and epidemiology, respirator and personal protective 
equipment policy and regulation, occupational and environmental 
medicine, respirator and materials science, infection control, 
respirator physiology, physics, and biosecurity. The purpose of the 
Working Group is to bring a new respirator to the U.S. marketplace for 
health care workers using a government-academic-private partnership 
development model. During the first phase of Project B.R.E.A.T.H.E., a 
working group representing nine Federal agencies was convened and 
produced 28 consensus recommendations that, if implemented, would be 
expected to improve the function and utility of respiratory protective 
equipment used by health care workers employed by VHA and beyond. The 
consensus recommendations comprise desirable characteristics of a 
respirator, and respiratory protection programs, which fall into one of 
four (4) actionable categories:
     Respirators should perform their intended functions 
effectively and safely.
     Respirators should support, not interfere with, 
occupational activities.
     Respirators should be comfortable and tolerable.
     Respiratory protective programs should comply with Federal 
standards and guidelines, state regulations, and local policies.
    Under the CRADA, the duties of the Federal Government will include 
the following:
     the National Institute for Occupational Safety and Health 
(NIOSH) will evaluate, to the extent possible, the respirator 
prototype(s), to determine whether the respirator under evaluation 
meets or exceeds the performance requirements identified in the 
consensus recommendations.
     VA's Office of Public Health and Environmental Hazards 
will seek the collective expertise of some or all of the Project 
B.R.E.A.T.H.E. Working Group members regarding optimal product 
development.
     VA's National Center for Occupational Health and Infection 
Control will pursue, to the extent possible, clinical testing of 
resulting respirator prototype(s), including feedback from health care 
workers.
    VA is seeking to identify commercial organizations with the 
respirator design and manufacturing capabilities to construct a new 
respirator, based on the aforementioned characteristics. Collaboration 
will be made via a CRADA under the authority of the FTTA. 15 U.S.C. 
3710a. Under the FTTA, no Federal funds may be provided to the 
collaborator, but the Federal laboratory is authorized to grant to the 
collaborating party a license or an assignment to inventions made under 
the CRADA.
    Resource constraints may limit the number of candidate 
organizations that may be included and/or the extent of government 
supplied testing in this research program. VA will select one or more 
declared partnering candidates with respirator design and commercial 
manufacturing capabilities using the following criteria:
    (1) The candidate organization has the capability to develop a new 
respirator prototype(s) utilizing advanced technologies within 6 to 12 
months;
    (2) The candidate organization has the resources, or access to the 
technological resources, to construct the desired new respirator 
prototype(s) through commercial models.
    (3) The candidate organization has the capabilities to mass produce 
the successful respirator model within 6 months of final pre-commercial 
model approval; and
    (4) The candidate organization has prior experience with, and 
received prior certification from, NIOSH for respiratory protection 
products.
    Candidate organizations will be evaluated based on their capability 
to incorporate the identified consensus characteristics into the 
prototype(s) and meet the established criteria. Candidates selected 
most likely will be requested to enter into a CRADA with VA and/or 
other Federal agencies. In considering candidates, special 
consideration will be given to small business firms and consortia 
involving small business firms; and preference will be given to 
businesses located in the United States which agree that products 
embodying inventions made under the CRADA will be manufactured 
substantially in the United States. 15 U.S.C. 3710a(c)(4). This 
announcement does not obligate VA to enter into a contractual agreement 
with any respondents. VA reserves the right to establish a partnership 
based on scientific analysis and capabilities found by way of this 
announcement or other searches, if determined to be in the best 
interest of the government.
    Discomfort and intolerance were frequent complaints of health care 
workers in Toronto, Ontario, Canada who wore respiratory protection 
during the 2003 Severe Acute Respiratory Syndrome crisis. During the 
outbreak, many Canadian public health organizations advised health care 
workers to use respiratory protection throughout the course of their 
work shifts, which often lasted 12 hours or longer. Notwithstanding the 
ostensible protection provided by respirators, workers complained about 
headaches, facial heat and pressure, shortness of breath, interference 
with occupational duties, among other problems associated with their 
use. Respirator-associated discomfort and occupational interference 
were viewed as significant limiting factors in work performance. 
Concerns have been raised about the same or similar events occurring in 
the U.S. during future epidemics.
    In 2006, the National Personal Protective Technology Laboratory at 
NIOSH made a request to the Institute of Medicine for a review of 
personal protective equipment, with the explicit purpose of 
recommending how to best protect health care workers during an 
influenza pandemic. In its report, Preparing for an Influenza Pandemic: 
Personal Protective Equipment for Healthcare Workers, the Institute of 
Medicine noted a conspicuous lack of evidence behind respirator 
protective measures, including minimal attention placed on the 
development of equipment meeting the unique needs of the health care 
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 health care 
workers, and pursuing an evidence-based approach to equipment design to 
the extent that this is possible. Further, the Report stressed the need 
for urgent action, emphasizing that the next influenza pandemic could 
occur in the near future.
    An extensive research network and immense health care system make 
VHA uniquely poised to marshal the development of one or more new 
respirators to the U.S. marketplace in partnership with other Federal 
partners. VA hospitals should provide for an excellent test environment 
to assess and guide prototype design, development and revision. VA 
health care workers, who stand to receive the most benefit from a new 
respirator, are poised to assist with development. The Nation's VA 
medical centers employ approximately 118,000 health care workers who 
wear and discard approximately 1.6 million respirators per year at its 
900+ outpatient clinics, 150+ hospitals and some 136 nursing homes. 
Provision of a safe workplace where health care workers can carry-out 
their occupational duties in a secure

[[Page 66200]]

environment without undue risk, during both periods of routine 
operations and times of crisis, is mission critical.

DATES: Submit letters of interest within 30 days after the date of 
publication of this notice in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Interested commercial organizations 
with respirator design and manufacturing capabilities should submit a 
letter of interest with information about their capabilities to: 
Attention: Kimberly Rumping, The National Center for Occupational 
Health and Infection Control, Office of Public Health and Environmental 
Hazards, Veterans Health Administration, 1601 SW Archer Road (151B), 
Gainesville, Florida 32608, E-mail: [email protected].

    Approved: December 8, 2009.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. E9-29709 Filed 12-11-09; 8:45 am]
BILLING CODE 8320-01-P