[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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