[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