[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Notices]
[Pages 28719-28720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 National Institutes of Health


Opportunity for a Cooperative Research and Development Agreement 
(CRADA) Partner To Develop a Diagnostic System for Identifying 
Infectious Agents

SUMMARY: The Department of Health and Human Services (DHHS), National 
Institute of Health Clinical Center (NIHCC) is seeking a Cooperative 
Research and Development Agreement (CRADA) partner to further develop a 
collaboration with NIHCC, a diagnostic system for identifying 
infectious agents.
    Investigators at the National Institute of Health, Clinical Center 
(NIHCC) and University of Maryland have been developing a reliable and 
easy to use detection system for identifying various infectious agents. 
The detection system can identify, with high specificity, infectious 
agents by type and subtype (e.g. HIV, HCV and HIV-1 type A, HIV-2 type 
B respectively. This technology is based upon enzyme recognition and 
site-directed cleavage of a DNA oligo probe, whose sequence allows for 
hybridization with an RNA or DNA target strand. Further development is 
needed to improve sensitivity for diagnostic use via signal 
amplification methodologies.

ADDRESSES: For more information, please contact John Gill (Tel# 301-
496-0477, Fax # 301-402-2117), Office of Technology Development, 
National Cancer Institute, 6120 Executive Plaza South, Ste. 450; 
Bethesda, MD 20892-7182. For hand carry or overnight delivery please 
substitute ``Rockville, MD 20852'' for ``Bethesda, MD 20892-7182'' in 
the above address.

DATES: In view of the important priority of developing the diagnostic 
systems, interested parties should notify this office in writing no 
later than July 28, 1997.

SUPPLEMENTARY INFORMATION: A Cooperative Research and Development 
Agreement of ``CRADA'' means the anticipated joint agreement to be 
entered into by NIHCC pursuant to the Federal Technology Transfer Act 
(``FTTA'') of 1986 and amendments (including 104 P.L. 113) to 
collaborate on the specific research project described below. As 
provided by the FTTA, the selected CRADA partner is granted an option 
to elect an exclusive or non-exclusive license to a field of use for 
subject invention(s) arising under and within the scope the CRADA 
research plan.

NIHCC Will--

    Provide assay information, protocol(s) and/or method(s) for the 
detection and subtyping of various infectious agents;
    Provide intellectual guidance and assistance for improving assay 
sensitivity by signal amplification;
    Provide facilities and biological materials for evaluation and 
validation of the assay;
    Provide information on nuclei acid sequence and expression of the 
enzyme;
    Provide assistance with subcloning, over-expression and 
purification of the enzyme;
    Provide personnel to support and facilitate completion of the 
studies.

[[Page 28720]]

Collaborator Will--

    Identify, through appropriate means, gene(s) encoding a 
thermostable enzyme;
    Perform subcloning and over-expression of gene(e) encoding a 
thermostable enzyme;
    Purify to homogeneity adequate quantities of thermostable enzyme(s) 
to complete the studies;
    Conduct assays to measure enzyme activity at various temperatures 
and substrate concentrations;
    Develop a method for improving assay sensitivity by signal 
amplification using a thermostable enzyme having certain selected for 
characteristics.

Selection Criteria

    Demonstrated ability in protein engineering and molecular biology. 
Particular expertise in cloning, over-expression and purification of a 
thermal stable enzyme;
    Scientific expertise and demonstrated commitment to the development 
of diagnostic systems;
    Experience in preclinical and clinical diagnostic development;
    Experience and ability to produce, package, market and distribute 
pharmaceutical products;
    Willingness to cooperate with NIHCC in the collection, evaluation, 
publication and maintenance of data from pre-clinical studies and 
clinical trials regarding the diagnostic system.

    Dated: May 15, 1997.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute, 
National Institutes of Health.
[FR Doc. 97-13831 Filed 5-23-97; 8:45 am]
BILLING CODE 4410-01-M