[Federal Register Volume 64, Number 74 (Monday, April 19, 1999)]
[Notices]
[Pages 19184-19185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9758]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute (NCI); Opportunity for a Cooperative
Research Agreement (CRADA) for the Scientific and Commercial
Development of an Improved Cytologic Sampler for the Early Detection of
Esophageal Cancer
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice of a Cooperative Research and Development Agreement
(CRADA) opportunity.
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[[Page 19185]]
SUMMARY: The National Cancer Institute seeks a company to
collaboratively pursue the preclinical and clinical development of an
orally administered cytologic sampler for the early detection of
esophageal cancer. The National Cancer Institute has preclinical data
and evidence that currently available sampling devices need to be and
can be improved. Thus, the overall goal of this research project is to
develop an improved cytologic sampler for the early detection of
esophageal cancer.
ADDRESSES: Inquiries and statements of interest regarding this
opportunity should be addressed to Rita Khanna, Technology Development
and Commercialization Branch, National Cancer Institute, Executive
Plaza South, Suite 450, 6120 Executive Blvd., Rockville, MD 20852 (Tel.
# 301-496-0477 Fax # 301-402-2117).
DATE TO RESPOND: In view of the important priority of developing an
orally administered cytologic sampler for the early detection of
esophageal cancer, interested parties should notify this office in
writing no later than thirty (30) days from date of publication of this
announcement.
SUPPLEMENTARY INFORMATION: Cooperative Research and Development
Agreement or ``CRADA'' means the anticipated joint agreement to be
entered into by NCI pursuant to the Federal Technology Transfer Act of
1986 and Executive Order 12591 of October 10, 1987 as amended by the
National Technology Transfer Advancement Act of 1995. The goal of this
CRADA will be to collaborate on the specific research project described
below. Under the present proposal, the Government is seeking a
collaborator, who can develop an improved cytologic sampler to a
marketable status to meet the public need for the early detection of
esophageal cancer. The expected duration of the CRADA will be four
years.
Currently, the most widely used esophageal screening method is to
obtain a cytologic sample of the esophageal mucosa using an inflatable
balloon or an encapsulated sponge. Although cytologic screening of
asymptomatic high-risk individuals remains a promising method for the
early detection of curable squamous esophageal dysplasia and cancer, a
recent study by the NCI Division of Cancer Prevention and Control
showed that current cytologic samplers had a low sensitivity for
identifying these lesions.
Under a CRADA, the NCI can offer the selected collaborator access
to facilities, staff, materials, and expertise. The collaborator may
contribute facilities, staff, materials, expertise and funding to the
collaboration. the NCI 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 a co-inventor of new technology developed
under the CRADA.
The role of the National Cancer Institute, the Division of Clinical
Sciences under the CRADA will include the following;
1. Providing intellectual expertise in the form of cytologic and
histologic evaluation of biological samples for preneoplastic and
neoplastic lesions;
2. Making suggestions regarding sampler design based on its
clinical experience with existing cytologic samplers;
3. Arranging field studies to test the efficacy of new samplers;
4. Evaluating each of the active studies as they progress to ensure
that the appropriate questions are being addressed and to ensure that
the studies are modified as required based on the developing data; and
5. Providing technological considerations for patient safety,
position and comfort.
The role of the successful corporate partner under the CRADA will
include the following:
1. Understanding the biological and physiological obstacles that
need to be overcome and contributing its expertise in innovative
engineering toward overcoming these obstacles;
2. Providing proven competence to carry out the work of developing
an improved cytologic sampler;
3. Providing technical support including design concepts,
engineering analysis, detailed design, fabrication management and
contribution to experimental design;
4. Performing studies to assess the physical properties of new
designs in an effort to improve patient tolerance and design efficacy;
and
5. Commercializing the resulting device including providing the
necessary resources.
Criteria for choosing the collaborating company will include the
following:
1. Experience in aspects of innovative engineering necessary for
the development of cytologic samplers;
2. Scientific expertise and demonstrated commitment to the
development of cytologic samplers;
3. Willingness to cooperate with the NCI in the collection and
evaluation of data;
4. Experience and track record of taking such products to market;
5. Nature of resources to be contributed to the collaboration;
6. Willingness to accept the legal provisions and language of the
CRADA with only minor modifications, if any. These provisions govern
the distribution of patent rights to CRADA inventions. Generally, the
right of ownership are retained by the organization that is the
employer of the inventor, with (1) the grant of a license for research
and other Government purposes to the Government when the CRADA
Collaborator's employee is the sole inventor, or (2) the grant of an
option to elect an exclusive or nonexclusive license to the CRADA
Collaborator when the Government employee is the sole of inventor;
7. Willingness to cooperate with the National Cancer Institute in
the timely publication of research results;
8. Level of financial support the CRADA Collaborator will provide
for CRADA-related Government activities; and
9. Willingness to commit best effort and demonstrated resources to
the research and development of this technology, as outlined in the
CRADA Collaborator's proposal.
Dated: April 9, 1999.
Kathleen Sybert,
Director, Technology Development & Commercialization Branch, National
Cancer Institute, National Institutes of Health.
[FR Doc. 99-9758 Filed 4-16-99; 8:45 am]
BILLING CODE 4140-01-M