[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