[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