[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Notices]
[Pages 15529-15530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8120]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development:
Opportunity for a Cooperative Research and Development Agreement
(CRADA) for the Development of a Microbial Screen for Anti-Virals
Targeting PKR or Inhibitors of PKR
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: The National Institutes of Health is seeking one or more CRADA
partners for further development and evaluation of a microbial screen
in yeast to identify anti-viral agents that target regulators of and/or
the PKR kinase. The National Institute of Child Health and Human
Development has established a system in yeast to identify and
[[Page 15530]]
characterize viral regulators of the PKR kinase, that should also be
useful for identifying anti-viral agents that counteract the viral
regulators. To expedite research and development of this system, the
National Institutes of Health is seeking CRADAs with pharmaceutical or
biotechnology companies in accordance with the regulations governing
the transfer of Government-developed agents. Any proposal to use or
develop this system will be considered.
ADDRESSES: CRADA proposals and questions about this opportunity should
be addressed to: Dr. Gordon Guroff, Deputy Scientific Director,
National Institute of Child Health and Human Development, Building 49,
Room 5A64, Bethesda, MD 20892 (301/496-4751).
DATES: CRADA proposals should be received on or before July 30, 1997
for priority consideration. However, CRADA proposals submitted
thereafter will be considered until a suitable CRADA Collaborator is
selected.
SUPPLEMENTARY INFORMATION: The protein kinase PKR is a component of the
interferon-induced anti-viral defense mechanism in mammalian cells.
Upon activation by binding double-stranded RNA in infected cells, the
kinase down-regulates the cellular translational apparatus, and thus
impairs viral protein expression. To overcome the inhibitory effects of
PKR, viruses have developed efficient methods to prevent the activation
or function of the kinase. A potential site of therapeutic intervention
is to block viral inhibition of PKR.
The NICHD has developed a microbial system in the yeast
Saccharomyces cerevisiae in which expression of PKR inhibits growth by
down-regulating cellular protein synthesis. The toxicity of PKR in this
system can be relieved by co-expression of viral regulatory factors
including the vaccinia virus K3L protein. This simple microbial system
should be amenable to high through-put screens to identify anti-viral
agents that inactivate viral regulators of PKR, and thus restore PKR
toxicity in this system. In addition, agents that act on PKR and reduce
the sensitivity of PKR to viral regulatory factors could also be
identified. This system should also be useful to identify regulators of
PKR from other viruses, and then subsequently used to identify
inhibitors of these newly identified viral regulatory factors.
In an effort to expedite research and development of new anti-viral
agents targeting PKR, the National Institute of Child Health and Human
Development seeks a CRADA partner(s) for joint exploration. Any CRADA
proposals for use of this system will be considered.
The CRADA aims will include the rapid publication of research
results consistent with protection of proprietary information and
patentable inventions as well as the timely exploitation of commercial
opportunities. The CRADA partner will enjoy the benefits of first
negotiation for licensing Government rights to any inventions arising
under the agreement and will advance funds payable upon signing the
CRADA to help defray Government expenses for patenting such inventions
and other CRADA-related costs.
The role of the National Institute of Child Health and Human
Development will be as follows:
1. Provide the collaborator with the data on the system covered by
the agreement.
2. Provide the yeast strains and plasmids covered by the agreement.
3. Continue studies on the system to optimize growth tests for
screens.
4. Work cooperatively with the Collaborator to perform the
necessary controls to validate results from screens.
5. Jointly identify additional PKR inhibitors, and establish
necessary strains for anti viral screens.
The role of the Collaborator will be as follows:
1. Undertake studies to evaluate the usefulness of this system for
high through-put screens.
2. Cooperate to identify additional PKR inhibitors that could be
tested using this system.
3. Undertake studies using this system to identify agents that
inactivate viral inhibitors of PKR.
Selection criteria for choosing the CRADA Collaborator(s) will
include but are not limited to the following:
1. The ability to collaborate with the NICHD on further research
and development of this technology. This ability can be demonstrated
through experience and expertise in this and related areas of
technology.
2. The demonstration of adequate resources to perform the research
and development of this technology (e.g., personnel, expertise, and
facilities) and accomplish objectives according to an appropriate
timetable to be outlined in the CRADA Collaborator's proposal.
3. The level of financial support the CRADA Collaborator will
provide for CRADA related Government activities.
4. The willingness to cooperate with the NICHD in publication of
research results consistent with the protection of proprietary
information and patentable inventions which may arise during the period
of the agreement.
5. Agreement to be bound by DHHS rules and regulations regarding
human subjects, patent rights, ethical treatment of animals, and
randomized clinical trials.
6. Agreement with provisions for equitable distribution of patent
rights to any inventions developed under the CRADA(s). Generally, the
rights of ownership are retained by the organization which is the
employer of the inventor, with an irrevocable, non-exclusive, royalty
free license to the Government (when a company employee(s) is the sole
inventor) or an option to negotiate an exclusive license to the company
on terms that are appropriate (when the Government employee(s) are
either sole or joint inventors).
Dated: March 18, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-8120 Filed 3-31-97; 8:45 am]
BILLING CODE 4140-01-M
