[Federal Register Volume 61, Number 214 (Monday, November 4, 1996)]
[Notices]
[Page 56697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28275]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Cancer Institute: Opportunity for a Cooperative Research
and Development Agreement (CRADA) for B-Cell Lymphoma Tumor Specific
Antigen Studies
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 a Cooperative Research and Development
Agreement (CRADA) with a pharmaceutical or biotechnology company. A
major goal of the CRADA is to develop strategies to isolate B-cell
lymphoma tumor specific antigen. 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 any products, diagnostics and treatments that
result from the research.
ADDRESSES: Proposals and questions about this CRADA opportunity may be
addressed to Gary Cuchural, Office of Technology Development, National
Cancer Institute-Frederick Cancer Research and Development Center, P.O.
Box B, Frederick, MD 21702-1201, Telephone: (301) 846-5465, Facsimile:
(301) 846-6820.
EFFECTIVE DATE: In view of the high interest in developing Anti-Cancer
Vaccines in general, interested parties should notify the NCI Office of
Technology Development in writing no later than December 4, 1996.
SUPPLEMENTARY INFORMATION: A major research goal of this CRADA is the
development of strategies for the isolation of lymphoma derived Ig
protein, including for example, the molecular cloning of Ig variable
regions for expression in eukaryotic and prokaryotic cells. Another
major research goal of this CRADA is the development and implementation
of procedures for the GMP production of Ig protein. GMP Ig protein will
be produced in sufficient quantities to support vaccine formulation
studies. Vaccine formulation studies with one of several carriers,
final vaccine production, and/or testing may also be among the research
goals of this CRADA.
The role of the National Cancer Institute in this CRADA will
include, but not be limited to:
1. Providing intellectual, scientific, and clinical expertise and
experience to the research project.
2. Planning and conducting research studies and interpreting
research results.
3. Publishing research results.
The role of the CRADA Collaborator may include, but not be limited
to:
1. Providing intellectual, scientific, and regulatory expertise and
experience to the research project.
2. Planning and conducting research studies and interpreting
research results.
3. Providing support for CRADA-related research. Such support may
include personnel and/or financial support to facilities scientific
goals. Such support should include the availability of GMP
manufacturing facilities for this effort, such support should also
include assuming the cost of production of GMP Ig protein in sufficient
quantities to support vaccine formulation studies. If vaccine
formulation studies with one of several carriers, final vaccine
production and/or testing are among the research goals of this CRADA,
such support should also include assuming the cost of production of GMP
vaccines in sufficient quantities to support these goals.
4. The experience and financial ability to support an IND.
5. 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 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,
GMP production, marketing and sales of patient-specific 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 non-
exclusive license to the Government when the CRADA Collaborator's
employee is the sole inventor, or (2) the grant of an option to elect
and exclusive or nonexclusive license to the CRADA Collaborator when
the Government employee is the sole inventor.
Dated: October 24, 1996.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute,
National Institutes of Health.
[FR Doc. 96-28275 Filed 11-1-96; 8:45 am]
BILLING CODE 4140-01-M