[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25402]


[[Page Unknown]]

[Federal Register: October 14, 1994]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Cancer Institute; Opportunity for a Cooperative Research 
and Development Agreement (CRADA) for the Development of a Fluorescent 
Guanosine Analog To Be Used in the Visualization of Polymerase Chain 
Reaction (PCR) Products

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Cancer Institute (NCI) seeks an agreement with a 
biotechnology company for the purpose of joint development of a 
technique for visualizing polymerase chain reaction (PCR) products by 
utilizing a novel, highly fluorescent guanosine analog. NCI will enter 
into CRADA negotiations with the sponsor(s) of selected proposal(s).

ADDRESSES: Questions about this CRADA opportunity may be addressed to 
Mr. Eric Hale, Office of Technology Development, National Cancer 
Institute, Building 31, Room 4A34, 9000 Rockville Pike, Bethesda, 
Maryland 20892, Tel (301) 496-0477, Fax (301) 402-2117.

DATES: Proposals must be received by 5 p.m., November 30, 1994.

SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development 
Agreement'' or ``CRADA'' means the anticipated joint agreement to be 
entered into by NCI pursuant to the Federal Technology Transfer Act of 
1986 and Executive Order 12591 of October 10, 1987 to collaborate on 
the specific research project described below.
    The compound (2-amino-3-methyl-8-(2-deoxy--D-
ribofuranosyl)pteridine-4,7-dione) has been investigated in aqueous 
media at physiologic pH levels and found to be highly fluorescent under 
those conditions. It has also been found that the phosphoramidite form 
of this compound may be incorporated into an oligonucleotide through 
the use of an automated DNA synthesizer. Site-specifically incorporated 
into an oligonucleotide and annealed to its complement, the compound is 
accepted by the endonuclease HIV-1 integrase in place of guanosine in 
the sequence specific cleavage site of a short double strand of DNA. It 
is hypothesized that the triphosphate form of the monomer may be taken 
up by polymerase in place of guanosine triphosphate to a sufficient 
degree to allow detection of a PCR product by monitoring for 
fluorescence in the product. NCI is interested in establishing a CRADA 
with a biotechnology company to assist in the continuing investigation 
of this potential for PCR detection and its possible commercialization 
as a kit for PCR applications. The expected duration of the CRADA is 
less than or equal to five (5) years. Pertinent information not yet 
publicly disclosed may be obtained under a NCI Confidential Disclosure 
Agreement. For this and further CRADA information, contact Mr. Eric 
Hale at the above address.
    Background patent rights to this technology are available for 
licensing through the Office of Technology Transfer, NIH. Pertinent 
patent application claims may be obtained under a NIH Confidentiality 
Agreement for the Purpose of Reviewing Patent Application Claims. For 
this and further licensing information contact Ms. Carol Lavrich, 
Office of Technology Transfer, National Institutes of Health, Suite 
325, 6011 Executive Boulevard, Rockville, Maryland 20852, Tel (301) 
496-7057, Fax (301) 402-0220.
    The role of the Pharmacology and Experimental Therapeutics Section, 
Pediatric Branch of NCI under the CRADA(s) will include:

    1. The government will provide expertise and information 
available to date relevant to the compound.
    2. The government will continue the ongoing development of 
techniques to phosphorylate this compound, and will investigate the 
fluorescence characteristics of the phosphorylated form.
    3. The government will provide to the CRADA partner the 
triphosphate form of this compound as soon as it becomes available.
    4. The government will collaborate in the development of a large 
scale synthesis and purification of the triphosphate form of this 
compound.
    5. The government will collaborate in CRADA research study 
design and data evaluation.

    The role of the successful biotechnology company under the CRADA(s) 
will include:

    1. Providing materials and support, including analytical 
support, to further investigate the phosphorylation of the compound, 
and otherwise further the CRADA research;
    2. Providing assistance in the development of a large scale 
synthesis and purification of the triphosphate form of the compound;
    3. Providing collaboration in CRADA research study design and 
data evaluation;
    4. Providing funds for assistance in supporting the research;
    5. Providing an active research and development plan for the 
application of the triphosphate form of the compound to current PCR 
technology; and
    6. Providing for the commercialization of resulting 
biotechnology products.

    Selection criteria for choosing the CRADA partners will include but 
not be limited to:

    1. Ability to complete the testing and evaluation of the 
phosphorylated form of the compound in PCR application(s);
    2. Experience in PCR related assay development;
    3. Experience and ability to produce, package, market and 
distribute diagnostic products in the United States;
    4. Ability to provide the necessary materials and support 
according to an appropriate timetable to be outlined in the 
biotechnology company's proposal;
    5. The level of financial support the biotechnology company will 
supply for CRADA-related government activities;
    6. A willingness to cooperate with the NCI in the publication of 
results; and
    7. Provisions for equitable distribution of patent rights to any 
inventions generated in the performance of research under the CRADA. 
Generally, the rights of ownership are retained by the organization 
which is the employer of the inventor, with (1) an irrevocable, 
nonexclusive, royalty-free license to the government when a company 
employee is the sole inventor or (2) the grant of an option to 
negotiate for an exclusive or a nonexclusive license to the 
Collaborator when a government employee is the sole inventor.

    Dated: October 6, 1994.
Thomas Mays,
Director, Office of Technology Development, National Cancer Institute, 
National Institutes of Health.
[FR Doc. 94-25402 Filed 10-13-94; 8:45 am]
BILLING CODE 4140-01-P