[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