[Federal Register Volume 61, Number 126 (Friday, June 28, 1996)]
[Notices]
[Pages 33752-33754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


National Cancer Institute: Opportunities for Cooperative Research 
and Development Agreements (CRADA) for the Development of Green 
Fluorescent Protein (GFP) Technology Applications

    Currently the National Cancer Institute (NCI) has identified at 
least five applications for this technology; GFP research products, 
gene therapy gene expression, analysis, diagnostics, and drug 
screening. The NCI is looking for multiple CRADA Collaborators to 
develop independently different aspects of the GFP 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. 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 (DHHS) seeks Cooperative Research and Development 
Agreements (CRADA) with pharmaceutical or biotechnology companies to 
develop application of GFP. Any CRADA for the biomedical use of this 
technology will be considered. The CRADAs would have an expected 
duration of one (1) to five (5) years. The goals of the CRADAs include 
the rapid publication of research results and their timely 
commercialization of products, diagnostics and treatments that result 
from the research. The CRADA Collaborators will have an option to 
negotiate the terms of an exclusive or nonexclusive commercialization 
license to subject inventions arising under the CRADAs.

ADDRESSES: Proposals and questions about these CRADA opportunities may 
be addressed to Steven P. Marquis, Office of Technology Development, 
National Cancer Institute-Frederick Cancer Research and Development 
Center, P.O. Box B, Frederic, MD 21702-1201, Telephone: (301) 846-5465, 
Facsimile: (301) 846-6820. Background information, including abstracts 
and reprints, is available. In addition, pertinent information not yet 
publicly disclosed may be obtained under a confidential disclosure 
agreement.
    Requests for license application form, or other questions and 
comments concerning the licensing of this technology should be directed 
to Steven M. Ferguson, Acting Chief, Infectious Disease Branch, Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804, Telephone: (301) 496-
7735 ext. 266, Facsimile: (301) 402-0220. A signed confidentiality 
agreement will be required to receive confidential information.

EFFECTIVE DATE: In view of the high interest for developing GFP for 
applications and diagnostics, interested parties should notify the NCI 
Office of Technology Development in writing no later than thirty (30) 
days from the date of this announcement. Respondents will then be 
provided an additional thirty (30) days for submitting formal CRADA 
proposals.

SUPPLEMENTARY INFORMATION: The Green Fluorescent Protein (GFP) from the 
jellyfish Aequorea Victoria is rapidly becoming an important reporter 
molecule for monitoring gene expression in vivo, in situ and in real 
time GFP emits a green light when excited with UV light. Unlike other 
bioluminescent reporters, GFP fluoresces in the absence of any other 
proteins, substrates, or cofactors. Currently there are several 
improved mutations of the GFP, which allow for sufficient detection of 
gene expression in various species cells, However, the current 
technology, in contrast to the wild type protein or other reported 
mutants allows detection of green fluorescence in living mammalian 
cells when present in few copies stably integrated into the genome. The 
current mutation increases the intensity of the fluorescent signal by 
more than tenfold over that of the wild type protein, which provide a 
fluorescence signal visible in mammalian cells.
    A U.S. Patent Application has been filed for this technology by the 
DHHS and is currently pending. Parties interested in submitting a CRADA 
proposal should be aware that it may be necessary to secure a license 
to this patent application in order to commercialize products arising 
from the CRADA.
    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. Contracting, as needed, support services at the NCI-FCRDC such 
as antigen and antibody production.
    4. Publishing research results.
    The role of the CRADA Collaborator may include, but not limited to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Planning research studies and interpreting research results.
    3. Providing support for ongoing CRADA-related research in the 
development of the particular application of GFP technology.
    (a) Financial support to facilitate scientific goals;
    (b) Technical or financial support for further design of 
applications.
    4. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not to 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 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.
    3.The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    4. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    5. The level of financial support the CRADA Collaborator will 
provide for CRADA-related Government activities.
    6. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    7. 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.
    8. 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 purpose 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

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nonexclusive license to the CRADA Collaborator when the Government 
employee is the sole inventor.

    Dated: June 18, 1996.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute, 
National Institutes of Health.
[FR Doc. 96-16493 Filed 6-27-96; 8:45 am]
BILLING CODE 4140-01-M