[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Pages 25219-25220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: VHL and MET Mutation Detection 
Technology: Opportunities for Cooperative Research and Development 
Agreements (CRADAs) for the Joint Evaluation and Development of Methods 
to Detect Mutation in Both Gene Sequences Using Nucleic Acid Array 
Technology

    The methods may include but are not limited to spectroscopic 
partitioning techniques and DNA chip technology. The NCI is looking for 
multiple CRADA Collaborators to develop independently different aspects 
of this VHL and MET mutation detection technology.

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

ACTION: Notice for CRADA Opportunities.

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SUMMARY: Pursuant to 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 Cooperative Research and Development 
Agreements (CRADAs) with pharmaceutical or biotechnology companies to 
evaluate and develop methods to detect mutations in both the MET and 
VHL gene sequences using nucleic acid array 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 publications of research results and 
timely commercialization of products, diagnostics and treatments that 
result from the research. The CRADA Collaborators will have an option 
to elect a non-exclusive or exclusive commercialization license to 
subject inventions arising under the CRADAs that are related to the DNA 
array technology of the collaborators, which are the subject of the 
CRADA Research Plan, for diagnostics and research supply 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. 
Licensing by NIH is subject to 35 U.S.C. 207 and 37 CFR Part 404.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Thomas M. Stackhouse, 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).
    Scientitific inquiries--Dr. Berton Zbar, Chief, Laboratory of 
Immunobiology, National Cancer Institute-Frederick Cancer Research & 
Development Center, P.O. Box B, Building 560, Room 12-68, Frederick MD, 
21702-1201 (phone: 301-846-1288 FAX: 301-846-6145).

EFFECTIVE DATE: Inquiries regarding licensing and scientific matters 
may be forwarded at any time. Confidential CRADA proposals, preferably 
one page or less, must be submitted to NCI on or before July 6, 1998. 
Guidelines for preparing full CRADA proposals will be communicated 
shortly thereafter to all respondents who have been selected.
SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists have identified mutations in the proto-oncogene c-
MET, and the von Hippel-Lindau disease (VHL) tumor suppressor gene in 
human cancers. c-MET is the receptor for hepatocyte growth factor/
scatter factor. Germline mutations in the MET gene have been detected 
in affected members of families with an inherited predisposition to 
develop papillry renal carcinomas; somatic mutations in the MET gene 
have been detected in a subset of papillary renal carcinomas. All 
mutations detected in the MET gene to date were located in the tyrosine 
kinase domain; all mutations were missense.
    The VHL gene is mutated in patients with von Hippel-Lindau disease, 
and in sporadic clear cell carcinomas of the kidney. Disease-causing 
mutations include gender deletions (partial or complete), missense and 
nonsense and frame shift mutations.
    About 30,000 individuals develop kidney cancer each year. We 
anticipate that the novel mutation detection techniques for the MET and 
VHL genes will be used in patients with sporadic and inherited 
predispositions to renal cancer. Possible uses would include diagnosis 
and prognosis of kidney cancer. In addition, these new methods might be 
applied to the study of other types of human neoplasia.
    DHHS now seeks collaborative arrangements for the joint evaluation 
and development of methods to detect mutations in both gene sequences 
using nucleic acid array technology. The methods may include but are 
not limited to spectroscopic partitioning techniques and DNA chip 
technology. For collaborations with the commercial sector, a 
Cooperative Research and Development Agreement (CRADA) will be 
established to provide equitable distribution of intellectual property 
rights developed under the CRADA. The successful CRADA partner will 
collaboratively develop and test known mutations within the genes from 
samples provided by the government. CRADA aims will include rapid 
publication of research results as well as full and timely exploitation 
of any commercial opportunities.

NCI's VHL/MET Patents and Patent Applications

    1. Von Hippel-Lindau(VHL) Disease Gene and Corresponding cDNA and 
Methods for Detecting Carriers of the VHL Disease Gene; United States 
Patent 5,654,138, issued August 5, 1997.
    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 gene 
sequences for 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.

[[Page 25220]]

    3. Providing technical expertise and/or financial support for (e.g. 
facilities, personnel and expertise) for CRADA-related Government 
activities.
    4. Accomplishing objectives according to an appropriate timetable 
to be outlined in the CRADA Collaborator's proposal.
    5. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    6. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    8. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    9. The agreement to be bound by the appropriate DHHS regulating to 
human subjects, and all PHS policies relating to the use and care of 
laboratory animals.
    10. 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.

    Dated: April 26, 1998.
Kathleen Sybert,
Acting Director, Technology Development & Commercialization Branch, 
National Cancer Institute, National Institutes of Health.
[FR Doc. 98-12110 Filed 5-6-98; 8:45 am]
BILLING CODE 4140-01-M