[Federal Register Volume 63, Number 201 (Monday, October 19, 1998)]
[Notices]
[Pages 55877-55878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Opportunities for Cooperative Research 
and Development Agreements

    National Cancer Institute: Opportunities for Cooperative Research 
and Development Agreements (CRADAs) for the identification of analogues 
of wnt ligands that bind a novel soluble Frizzled-related receptor 
discovered at the National Cancer Institute (NCI) (the ``Technology''). 
Wnt proteins act as inducing agents during embryogenesis and have been 
implicated in the etiology of cancer. Frizzled proteins are integral 
membrane proteins that recently were shown to function as receptors for 
wnt signaling molecules. Currently, NCI has identified at least two 
applications for this Technology: research product and drug screening. 
The NCI is looking for a CRADA Collaborator with access to phage 
display peptide libraries for analogue screening to develop this 
Technology.

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. Sec. 3710; Executive Order 12591 of April 10, 1987 as amended 
by the National Technology Transfer and Advancement Act of 1995), the 
National Cancer Institute (NCI) of the National Institutes of Health 
(NIH) of the Public Health Service (PHS) of the Department of Health 
and Human Services (DHSS) seeks one or more CRADAs with pharmaceutical 
or biotechnology companies to develop this Technology.
    Any CRADA for the biomedical use of this technology will be 
considered. The CRADA would have an expected duration of one (1) to 
five (5) years. The goals of the CRADA include the rapid publication of 
research results and the timely commercialization of products, 
diagnostics and treatments that result from the research. The CRADA 
Collaborator will have an option to negotiate the terms of an exclusive 
or nonexclusive commercialization license to subject inventions arising 
under the CRADA.

ADDRESSES: Proposals and questions about these CRADA opportunities may 
be addressed to Vasant T. Gandhi, Technology Development and 
Commercialization Branch, National Cancer Institute, Executive Plaza 
South, Room 450, 6120 Executive Blvd., Rockville, MD 20852. Telephone: 
(301) 496-0477, Facsimile: (301) 402-2117. Background information, 
including abstracts and reprints, is available. In addition, pertinent 
information not yet publicly disclosed may be obtained under a 
confidential disclosure agreement.

EFFECTIVE DATE: In view of the high interest for developing the 
Technology, interested parties should notify the NCI Technology 
Development and Commercialization Branch in writing no later than 
November 18, 1998. Respondents will then be provided an additional 
thirty (30) days for submitting formal CRADA proposals.

SUPPLEMENTARY INFORMATION: A novel Frizzled-related soluble receptor 
has been expressed recombinantly and used in an ELISA format to bind 
protein ligand. The NCI Laboratory of Cellular and Molecular Biology 
(LCMB) would like to identify peptide analogs of a natural wnt ligand 
by using the recombinant receptor to pan phage display peptide 
libraries. To this end, the NCI LCMB would like to establish a CRADA 
with a biotechnology company possessing phage display peptide libraries 
and interested in participating in the screening effort. Analogs 
identified in this manner would be tested for agonist or antagonist 
activity, and might serve as prototypes of reagents capable of 
modulating wnt signaling associated receptor pathways.
    The role of the National Cancer Institute in this CRADA will 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Planning research studies and interpreting research results.
    3. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Possession of a phage display peptide library.
    2. Planning research studies and interpreting research results.
    3. Providing support for onging CRADA-related research in the 
development of the particular application of the Technology.
    (a) Financial support to facilitate scientific goals;
    (b) Technical or financial support for further design of 
applications.

[[Page 55878]]

    4. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on further research and 
development of this Technology. This ability can be demonstrated 
through experience and expertise in this or related areas of Technology 
indicating the ability to contribute intellectually to ongoing research 
and development.
    2. The ability to collaborate with NCI on further research and 
development of this Technology. This ability can be demonstrated 
through experience and expertise in this or related areas of Technology 
indicating the ability to contribute intellectually to ongoing research 
and development.
    3. The demonstration of adequate resources to perform the research, 
development and commercialization of this technology (e.g. facilities, 
personnel and expertise) and accomplish objectives according to an 
appropriate timetable to be outlined in the CRADA Collaborator's 
proposal.
    4. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this Technology.
    5. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
Technology.
    6. The level of financial support the CRADA Collaborator will 
provide for CRADA-related Government activities.
    7. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    8. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    9. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern the equitable distribution of patent rights to CRADA inventions. 
Generally, the rights 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 inventor.

    Dated: October 8, 1998.
Kathleen Sybert,
Acting Director, Technology Development and Commercialization Branch, 
National Cancer Institute, National Institutes of Health.
[FR Doc. 98-27963 Filed 10-16-98; 8:45 am]
BILLING CODE 4140-01-M