[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Notices]
[Pages 42998-43000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of CRADA Opportunities

    National Cancer Institute: Nitric Oxide Technology: Opportunities 
for Cooperative Research and Development Agreements (CRADAs) for the 
development of medicinal agents useful for treating a variety of 
disorders arising from localized physiologic deficiencies of the 
multifaceted bioregulatory molecule, nitric oxide. The NCI is looking 
for multiple CRADA Collaborators to develop independently different 
aspects of their nitric oxide technology.

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice for CRADA opportunities.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. Sec. 3710, and 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 Cooperative Research and 
Development Agreements (CRADAs) with pharmaceutical or biotechnology 
companies to develop applications of nitric oxide technology. Any CRADA 
for the biomedical use of this technology will be considered. The 
CRADAs would have an expected duration of one (1) to five (5) years. 
The goals of the CRADAs include the rapid publication of research 
results and timely commercialization of products, diagnostics and 
treatments that result from the research. The CRADA Collaborators will 
have an option to negotiate the terms of an exclusive or nonexclusive 
commercialization license to subject inventions arising under the

[[Page 42999]]

CRADAs, and can apply for background licenses to the existing patents 
listed below, subject to any pre-existing licenses already issued for 
other fields of use.
    Please see accompanying announcement for Licensing opportunitites 
with this technology.

ADDRESSES: 1. CRADA opportunities--Dr. Thomas Stackhouse, National 
Cancer Institute, Fairview Center, Room 502, Frederick, MD 21701 
(phone: 301-846-5465, fax: 301-846-6820).
    2. Scientific inquiries--Dr. Larry Keefer, National Cancer 
Institute, Frederick Cancer and Research Development Center, Building 
538, Room 205E, Frederick, MD 21702-1201 (phone: 301-846-1467, fax: 
301-846-5946).

EFFECTIVE DATE: Inquiries regarding scientific matters may be forwarded 
at any time. Confidential CRADA proposals, preferably one page or less, 
must be submitted to NCI on or before October 10, 1997. Guidelines for 
preparing full CRADA proposals will be communicated shortly thereafter 
to all respondents who have been selected.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists are developing a variety of novel techniques for 
delivering nitric oxide (NO) to specific organs and cell types for 
therapeutic benefit. Methods for targeting lung, liver, and other 
tissues have been introduced to the literature, as have NO-releasing 
proteins and insoluble polymers. The compounds and drug delivery 
strategies developed thus far have shown promising antimicrobial, 
cytostatic, and antimetastatic activities; other activities that have 
been demonstrated in experimental animals include relief of respiratory 
distress, protection against toxic liver injury, radiosensitization of 
hypoxic tumors, and correction of genitourinary tract dysfunction. 
Publications outlining these developments are available on request, and 
descriptions of other (unpublished) advances can be obtained from Dr. 
Stackhouse via a Confidential Disclosure Agreement.
    DHHS now seeks collaborative arrangements for the joint evaluation 
and possible clinical exploitation of these agents. For collaborations 
with the commercial sector, a Cooperative Research and Development 
Agreement (CRADA) will be established to provide for equitable 
distribution of intellectual property rights developed under the CRADA. 
The successful CRADA awardee will collaboratively characterize 
compounds supplied by the Government with respect to the potential 
biomedical application(s) specified in the CRADA. CRADA aims will 
include rapid publication of research results as well as full and 
timely exploitation of any commercial opportunities.

NCI's Nitric Oxide Patents

    1. Keefer, L. K., et al.: Complexes of nitric oxide with 
polyamines. U.S. Patent 5,155,137, October 13, 1992.
    2. Keefer, L. K., et al.: Complexes of nitric oxide with 
polyamines. U.S. Patent 5,250,550, October 5, 1993.
    3. Keefer, L. K., et al.: Oxygen-substituted derivatives of 
nucleophile-nitric oxide adducts as nitric oxide donor prodrugs. U.S. 
Patent 5,366,997, November 22, 1994.
    4. Christodoulou, D. D., et al.: Mixed ligand metal complexes of 
nitric oxide nucleophile adducts useful as cardiovascular agents. U.S. 
Patent 5,389,675, February 14, 1995.
    5. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile 
adduct compositions, pharmaceutical compositions and methods of 
treating biological disorders. U.S. Patent 5,405,919, April 11, 1995.
    6. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile 
adduct compositions, pharmaceutical compositions incorporating same and 
methods of treating biological disorders using same. U.S. Patent 
5,525,357, June 11, 1996.
    7. Mitchell J. B. et al.: Use of nitric oxide releasing compounds 
as hypoxic cell radiation sensitizers. U.S. Patent Application 08/
133,574, filed October 8, 1993
    8. Korthuis, R. J., et al.: Use of nitric oxide-releasing agents 
for reducing metastasis risk. U.S. Patent Application 08/344,341, filed 
November 22, 1994.
    9. Saavedra, J. E., et al.: Biopolymer-bound nitric oxide-releasing 
compositions, pharmaceutical compositions incorporating same and 
methods of treating biological disorders using same. U.S. Patent 
Application 08/344,157, filed November 22, 1994.
    10. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile 
adduct compositions, pharmaceutical compositions incorporating same and 
methods of treating biological disorders using same. U.S. Patent 
Application 08/417,913, filed April 6, 1995.
    11. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile 
adduct compositions, pharmaceutical compositions incorporating same and 
methods of treating biological disorders using same. U.S. Patent 
Application 08/417,917, filed April 6, 1995.
    12. Keefer, L. K., et al.: Use of nitric oxide-releasing agents to 
treat impotency. U.S. Patent Application 08/419,044, filed April 10, 
1995.
    13. Smith, D. J., et al.: Polysaccharide-bound nitric oxide/
nucleophile adducts. U.S. Patent Application 08/419,424, filed April 
10, 1995.
    14. Keefer, L. K., et al.: Pharmaceutical compositions of secondary 
amine-nitric oxide adducts. U.S. Patent Application 08/476,601, filed 
June 6, 1995.
    15. Keefer, L. K., et al.: N-substituted piperazine NONOates. U.S. 
Patent Application 08/475,732, filed June 7, 1995.
    16. Saavedra, J. E., et al.: Selective prevention of organ injury 
in sepsis and shock using selective release of nitric oxide in 
vulnerable organs. U.S. Patent Application 08/509,558, filed July 31, 
1995.
    17. Hrabie, J. A., et al.: Method of generating nitric oxide gas 
using nitric oxide complexes. U.S. Patent Application 08/522,405, filed 
September 12, 1995.
    18. Saavedra, J. E., et al.: O\2\-aryl substituted 
diazeniumdiolates. U.S. Patent Application 60/026,816, filed September 
27, 1996.
    19. Green, S. et al.: Encapsulated and non-encapsulated nitric 
oxide generators used as antimicrobial agents. U.S. Patent Application 
08/428,632, filed April 24, 1995.
    The role of the National Cancer Institute in this CRADA will 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with samples of the subject compounds 
for pharmacological evaluation and assist in the development of new 
compounds, as determined by the research project.
    3. Planning research studies and interpreting research results.
    4. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Planning research studies and interpreting research results.
    3. Providing technical and/or financial support for ongoing CRADA-
related research in the development of the particular application of 
nitric oxide technology outlined in the agreement.
    4. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on further research and 
development of

[[Page 43000]]

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, 
production, marketing and sales of 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 license 
for research and other Government purposes to the Government when the 
CRADA Collaborator's employee is the sole inventor, or (2) the grant of 
an option to elect an exclusive or nonexclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: July 21, 1997.
Kathleen Sybert,
Acting Director, Office of Technology Development, National Cancer 
Institute, National Institutes of Health.
[FR Doc. 97-21148 Filed 8-8-97; 8:45 am]
BILLING CODE 4140-01-P