[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Pages 61361-61362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Drug Research and Development of a 
Novel Vacuolar-Type (H+)-ATPase-Inhibitory Compound Class

AGENCY: National Cancer Institute, National Institute of Health, PHS, 
DHHS.

ACTION: Notice of opportunity for cooperative research and development 
(CRADA).

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    An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
NCI intramural Laboratory of Drug Discovery Research & Development 
(LDDRD) on further research and development of U.S. government-owned 
technology encompassed within U.S. Patent Application Serial No. 60/
122,953, entitled ``Novel Vacuolar-Type (H+)-ATPase-Inhibitory 
Compounds and Compositions, and Uses Thereof.''

SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 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 a Cooperative Research and Development 
Agreement ((CRADA) with a pharmaceutical or biotechnology company to 
develop new drugs, therapeutic and/or preventative methods based on 
selective inhibition of vacuolar-type (H+) ATPases. The CRADA would 
have an expected duration of one (1) to five (5) years. The goals of 
the CRADA include the rapid publication of research results and timely 
commercialization of products, methods of treatment or prevention that 
may result from the research. The CRADA Collaborator will have an 
option to negotiate the terms of an exclusive or non-exclusive 
commercialization license to subject inventions arising under the CRADA 
and which are subject of the CRADA Research Plan, and can apply for 
background licenses to the existing patent described above, subject to 
any pre-existing licenses already issued for other fields of use.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Development & 
Commercialization Branch, National Cancer Institute-Frederick Cancer 
Research & Development Center, Fairview Center, Room 502, Frederick, MD 
21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries should be directed to Dr. Michael R. Boyd, 
Chief Laboratory of Drug Discovery Research & Development, National 
Cancer Institute- Frederick Cancer Research & Development Center, Bldg. 
1052, Rm 121, Frederick, MD 21702-1201 (phone: 301-846-5391; fax: 301-
846-6919; e-mail [email protected]).

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential preliminary CRADA 
proposals, preferably two pages or less,

[[Page 61362]]

must be submitted to the NCI on or before December 10, 1999. Guidelines 
for preparing final CRADA proposals will be communicated shortly 
thereafter to all respondents with whom initial confidential 
discussions will have established sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists within the LDDRD, NCI have discovered a novel class 
of compounds that may have diverse uses in therapy of prophylaxis, or 
other medical uses, that require inhibition of pathophysiological or 
physiological processes mediated by vacuolar-type (H+)-ATPases (V-
ATPases). Details are in U.S. Patent Application Serial No. 60/122,953, 
available under an appropriate Confidential Disclosure Agreement.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements for the 
joint elucidation, evaluation and development of novel compounds and 
methods to selectively inhibit phyiological and/or disease processes 
that are mediated, at least in part, through specific isoform(s) of V-
ATPases. For collaboration 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. CRADA aims will include rapid publication of 
research results as well as full and timely exploitation of any 
commercial opportunities.

NCI and Collaborator Responsibilities

    The role of the LDDRD, NCI 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 pertinent available compounds 
for investigation/evaluation.
    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 expertise and/or financial support for 
CRADA-related research as outlined in the CRADA Research Plan.
    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 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 on-going 
research and development.
    2. Expertise and experience in the following areas: preclinical 
research and drug development of selective vacuolar-type ATPase-
inhibitory compounds; ability to perform appropriate chemical synthetic 
efforts to support V-ATPase-directed structure/activity (SAR) studies, 
lead-optimization, drug candidate selection and development; 
performance of in vitro and/or in vivo assays of V-ATPase inhibition 
employing distinctive V-ATPases from diverse human and other mammalian 
tissues and cells.
    3. 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.
    4. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    5. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    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 non-exclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: October 29, 1999.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 99-29367 Filed 11-9-99; 8:45 am]
BILLING CODE 4140-01-M