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

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice.

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 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 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: Kimberly.Rumping@va.gov.