[Federal Register Volume 63, Number 219 (Friday, November 13, 1998)]
[Notices]
[Pages 63478-63479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)


National Institutes of Health Clinical Center (NIHCC); 
Opportunity for Cooperative Research and Development Agreement (CRADA) 
in the Fields of Rehabilitation Medicine and Speech-Language Pathology 
Using Ultrasound Imaging or Similar Technology

AGENCY: Rehabilitation Medicine Department, NIHCC, NIH, DHHS.

ACTION: Notice of a Cooperative Research and Development Agreement 
(CRADA) opportunity.

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SUMMARY: The Rehabilitation Medicine Department, Speech-Language 
Pathology Section, of the National Institutes of Health Clinical Center 
(NIHCC), seeks a Cooperative Research and Development Agreement (CRADA) 
with one or more collaborators in the ultrasound imaging or related 
technology fields. The purpose of the collaboration will be to develop 
a method to examine the movements of the oral pharynx including the 
tongue base, pharynx, and soft palate during

[[Page 63479]]

sleep using ultrasound imaging. The objectives of the research include 
the development of a noninvasive and reliable procedure to examine the 
components of sleep apnea and the development of an ultrasound 
transducer that can be used to assist the physician in determining 
which patients will benefit from tongue base or palatal reduction 
procedures.
    Obstructive sleep apnea currently affects more than four (4) 
percent of the population, causing significant morbidity and mortality. 
Due to a current deficiency in methods of examination and diagnosis, 
the location of the obstruction(s) and the physiology of the response 
remain unknown. Because surgical procedures are considered as possible 
treatment for this disorder, it is necessary to know the anatomical and 
structural location of the obstruction. Currently, there is no 
inexpensive, noninvasive method for visualizing this entity. Therefore, 
a noninvasive ultrasonic device for the examination and diagnosis of 
sleep apnea is necessary to fill the current void.
    The anticipated term of the CRADA is four (4) years.
    Sponsors will be selected based upon their ability to collaborate 
with NIHCC for the development of the ultrasonic diagnostic device.

DATES: Interested parties should submit a one paragraph statement of 
interest addressing the collaborator's ability to perform the 
collaboration responsibilities. The statement of interest should be 
submitted to NIHCC in writing no later than December 14, 1998.

ADDRESSES: Inquiries and statements of interest regarding this 
opportunity should be addressed to Steven Galen, Technology Development 
Coordinator, National Institutes of Health, Warren Grant Magnuson 
Clinical Center. Phone: (301) 594-4509, FAX (301) 402-2143, 6011 
Executive Boulevard, Suite 511, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into the NIHCC pursuant to the Federal Technology 
Transfer Act of 1986 as amended by the National Technology Transfer and 
Advancement Act of 1995 (Pub. L. 104-113 (Mar. 7, 1996)) and by 
Executive Order 12591 of April 10, 1987.
    The CRADA objective is the rapid publication of research findings 
and the timely commercialization of improved diagnostic and treatment 
strategies in the field of ultrasound imaging or similar technology. 
Particular emphasis is placed on discoveries that enhance clinical 
research.
    Under a CRADA, the NIHCC can offer selected collaborators access to 
facilities, staff, materials, and expertise. The collaborator may 
contribute facilities, staff, materials, expertise and funding to the 
collaboration. The NIHCC cannot contribute funding. The CRADA 
collaborator may elect an option to an exclusive or non-exclusive 
license to Government intellectual property rights arising under the 
CRADA and may qualify as co-inventor of new technology developed under 
the CRADA.
    CRADA proposals will be evaluated under the following criteria:
     Corporate research and development competencies.
     Demonstrated abilities to productively collaborate in 
research programs.
     Expertise in performing clinical phase trials and 
regulatory affairs.
     The nature of resources to be contributed to the 
collaboration.
     Key staff expertise, qualifications and relevant 
experience.
     Willingness to assign technical staff to on-site 
collaborative efforts.
     Ability to effectively commercialize new discoveries.
    The role of the National Institutes of Health Clinical Center 
includes the following:
    (1) The NIHCC will provide:
    (a) Expertise in oral pharyngeal ultrasound imaging, including 
anatomy and physiology of the intra-oral structure;
    (b) Expertise in defining the abnormalities associated with 
obstructive sleep apnea;
    (c) Input on the design of the transducer;
    (d) Technological considerations for patient safety, position and 
comfort;
    (e) Ongoing evaluation of the technologic advances and designs;
    (f) Normal subjects and apnea patients for testing of equipment;
    (g) Use of existing transducers for comparison of technologic 
advances; and
    (h) Input from multidisciplinary researchers with expertise in 
apnea.
    (2) The NIHCC will provide an existing protocol or create a new 
protocol for the phase I clinical study of the resulting diagnostic 
devise.
    The role of the CRADA Collaborator includes the following:
    (1) The development of an ultrasound device which can be used to 
aid physicians in the examination, diagnosis and treatment of sleep 
apnea.
    (2) Conducting phase I clinical studies of the diagnostic device to 
be performed in compliance with the NIHCC protocol to be provided.
    (3) Commercialization of the resulting device including providing 
the resources necessary.

    Dated: November 5, 1998.
Kathleen Sybert,
Acting Director, Technology Development and Commercialization Branch, 
National Institutes of Health.
[FR Doc. 98-30433 Filed 11-12-98; 8:45 am]
BILLING CODE 4140-01-M