[Federal Register Volume 69, Number 41 (Tuesday, March 2, 2004)]
[Notices]
[Pages 9830-9831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute (NHLBI); Opportunity 
for a Cooperative Research and Development Agreement (CRADA) for the 
Development of a Novel Endotracheal Tube Cleaning System and Improved 
Endotracheal Tube Design and Conditions of Use

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The Pulmonary--Critical Care Medicine Branch (P-CCMB) in 
National Heart, Lung, and Blood Institute (NHLBI) conducts research on 
lung disease that includes development of new technologies for the 
prevention of nosocomial pneumonia and ventilator-induced injury.
    The great majority of mechanically ventilated patients are 
intubated with an endotracheal tube (ETT). Millions of endotracheal 
tubes are used in the United States every year. VAP is the most common 
nosocomial infection in Intensive Care Unit (ICU) patients, afflicting 
8 to 28% of patients receiving mechanical ventilation (MV). VAP is also 
the leading cause of death from hospital-acquired infection. NHLBI data 
indicate that improved design of the ETT and conditions of use can 
significantly reduce the incidence of VAP.
    After a few days of MV, the lumen of an ETT is coated with a thick 
bacterial biofilm, which is a major source for bacterial colonization 
of the lower respiratory tract, and VAP. Accumulation of mucus/
secretions on the interior of the ETT effectively lowers the cross 
section of the ETT and increases significantly the work of breathing in 
intubated patients, who then require increased MV support, with 
prolonged intubation and ICU stay.
    In experimental studies, NHLBI showed that it is possible to 
prevent bacterial colonization of the trachea, bronchi, lungs, ETT, and 
ventilator circuit over a prolonged time of MV (168 hours), to decrease 
ETT resistance and therefore the work of breathing, and to avoid 
tracheal mucosal injury or decrease mucus-clearance following inflation 
of the cuff, when: (1) The ETT is cleaned with a novel cleaning system 
to remove all mucus from the lumen of the ETT; (2) the ETT is coated 
with bactericidal agents (silver-sulfadiazine with or without 
chlorhexidine in polyurethane); (3) low resistance thin-walled ETT is 
used; (4) the cuff of the ETT is replaced with gills; and (5) the ETT 
and trachea are kept horizontal, through a tilting bed that allows 
lateral body rotation.
    This CRADA project is with the Pulmonary and Cardiac Assist Devices 
Section within P-CCMB in NHLBI. The NHLBI is seeking capability 
statements from parties interested in entering into a CRADA to further 
develop, evaluate, and commercialize new design and management of ETTs 
in patients intubated, and mechanically ventilated, that include a 
novel ETT cleaning device and a low resistance ultra-thin ETT coated 
with bactericidal agents, with gills. The goals are to use the 
respective strengths of both parties to achieve the following:
    (1) Preparation of an IDE for FDA approval for the coating of the 
tube and of the mucus cleaning system;
    (2) Assistance in conducting clinical trials to determine the 
performance of this multi-task strategy in the prevention of 
Ventilator-associated Pneumonia and improvement of care of patients 
intubated and mechanically ventilated;
    (3) Manufacture of the ultra-thin coated ETT with gills, 
bactericidal coated tubes, and the cleaning system.
    The collaborator may also be expected to contribute financial 
support under this CRADA for personnel, supplies, travel, and equipment 
to support these projects.
    The tilting bed noted in the experimental studies above will be the 
subject of a concurrent CRADA announcement issued by NHLBI. Interested 
parties are encouraged to inquire using the contact information below.
    CRADA capability statements should be submitted to Marianne Lynch, 
JD, Technology Transfer Specialist, National Heart, Lung, and Blood 
Institute (NHLBI), Office of Technology Transfer and Development, 
National Institutes of Health, 6705 Rockledge Drive, Suite 6018, MSC 
7992, Bethesda, MD 20892-7992; Phone: (301) 594-4094; Fax: (301) 594-
3080; e-mail: [email protected]. Capability statements must be 
received on or before May 3, 2004.
    The NHLBI has applied for patents claiming the core of the 
technology. Non-exclusive and/or exclusive licenses for these patents 
covering core aspects of this project are available to interested 
parties.
    Licensing inquiries regarding this technology should be addressed 
to Michael Shmilovich, JD, Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Phone: (301) 435-
5019; Fax: (301) 402-0220; e-mail: [email protected]. Information 
about Patent Applications and pertinent information not yet publicly 
described can be obtained under the terms of a Confidential Disclosure 
Agreement.
    Respondents interested in submitting a CRADA Proposal should be 
aware that it may be necessary to secure a license to the above-
mentioned patent rights in order to commercialize products arising from 
a CRADA.


[[Page 9831]]


    Dated: February 19, 2004.
Dr. Carl Roth,
Associate Director for Scientific Program Operations, National Heart, 
Lung, and Blood Institute.
[FR Doc. 04-4532 Filed 3-1-04; 8:45 am]
BILLING CODE 4140-01-M