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68144 Federal Register / Vol. 67, No.

217 / Friday, November 8, 2002 / Notices

Therapeutics Program (DTP), Screening Cancer Institute-Frederick, Fairview the National Cancer Institute-Screening
Technologies Branch (STB), on further Center, Room 500, Frederick, MD 21701 Technologies Branch in this CRADA
research and development to optimize (phone: 301–846–5465, fax: 301–846– will include, but not be limited to:
chemical structures of lead compounds 6820). 1. Providing intellectual, scientific,
exhibiting molecular-targeted Scientific inquiries should be directed and technical expertise and experience
anticancer, antiviral and/or to: Robert Shoemaker, Ph.D., Chief, to the research project.
antimicrobial activities. Screening Technologies Branch, 2. Providing the Collaborator with
AGENCY: National Cancer Institute, Developmental Therapeutics Program, pertinent available reagents (such as
National Institutes of Health, PHS, Bldg. 440, P.O. Box B, National Cancer authentic standards for lead molecules)
DHHS. Institute, Frederick, MD 21702 (phone for investigation/evaluation.
301–846–6845; FAX 301–846–6844; 3. Planning research studies and
ACTION: Notice of opportunities for
e-mail: interpreting research results.
cooperative research and development. 4. Publishing research results.
DATES: Inquiries regarding CRADA
SUMMARY: Pursuant to the Federal
The role of the CRADA Collaborator
proposals and scientific matters may be may include, but not be limited to:
Technology Transfer Act of 1986 (FTTA, forwarded at any time. Confidential 1. Providing significant intellectual,
15 U.S.C. 3710, as amended; and CRADA proposals, preferably two pages scientific, and technical expertise or
Executive Order 12591 of April 10, or less, must be submitted to the NCI. experience to the research project.
1987), the National Cancer Institute Review of proposals will begin within 2. Planning research studies and
(NCI) of the National Institutes of Health 90 days from date of this publication interpreting research results.
(NIH) of the Public Health Service (PHS) and will continue until a suitable 3. Providing technical expertise as
of the Department of Health and Human collaborator(s) is identified. Guidelines outlined in the CRADA Research Plan.
Services (DHHS) seeks a Cooperative for preparing full CRADA proposals will 4. Accomplishing objectives
Research and Development Agreement be communicated shortly thereafter to according to an appropriate timetable to
(CRADA) for collaborative optimization all respondents with whom initial be outlined in the CRADA
of small-molecule screening leads for confidential discussions will have Collaborator’s proposal.
potency and pharmaceutical properties established sufficient mutual interest. 5. The willingness to commit best
consistent with clinical development. SUPPLEMENTARY INFORMATION: effort and demonstrated resources to the
The leads have been identified by STB research, development and
using high-throughput screening and Technology Available commercialization of this technology.
preliminary structure/activity study of DTP scientists within the STB have 6. The demonstration of expertise in
>140,000 samples from the NCI extensive experience with both cell-free the commercial development,
Repository addressing a number of and cell-based molecular targeted production, marketing and sales of
molecular targets of potential screens and a track record of moving products related to this area of
therapeutic significance. More screening discoveries into clinical technology.
specifically, a medicinal chemistry testing. Targeting the HIF–1–a (Hypoxia 7. The willingness to cooperate with
partner is sought for collaborative R&D Inducible Factor-1) and CEBP–a the National Cancer Institute in the
to identify and resolve potential (CCAAT/Enhancer Binding Protein a) timely publication of research results.
structural problems/features related to signaling pathways relevant to cancer 8. The agreement to be bound by the
toxicity, formulation, chemical stability, are among the current top priorities. appropriate DHHS regulations relating
metabolism, etc. Based on this analysis, Substantial effort has also been directed to human subjects, and all PHS policies
lead compounds may be directly recently towards identification of novel relating to the use and care of laboratory
subjected to secondary and in vivo inhibitors of HIV–1 assembly. animals.
testing or a series of derivatives/analogs Additional opportunities are 9. The willingness to accept the legal
may be designed to obviate problems. In anticipated. provisions and language of the CRADA
a second stage, in vivo active with only minor modifications, if any.
compounds will be subjected to Technology Sought These provisions govern patent rights to
additional analysis and analogs will be Accordingly, DHHS now seeks CRADA inventions.
synthesized to further optimize collaborative arrangements for chemical Dated: November 1, 2002.
structure/activity properties. Any optimization of drug screening leads. Kathleen Sybert,
CRADA for the biomedical use of this The successful Collaborator should Chief, Technology Transfer Branch, National
technology will be considered. The possess experience in the following Cancer Institute, National Institutes of Health.
CRADA would have an expected areas at a minimum: Evaluation of [FR Doc. 02–28540 Filed 11–7–02; 8:45 am]
duration of one to five years. The goals structural features of lead molecules, BILLING CODE 4140–01–P
of the CRADA include the rapid design of derivative molecules with
publication of research results and advantageous properties, solid and
timely commercialization of products, solution phase synthesis of individual DEPARTMENT OF HEALTH AND
diagnostics and treatments that result compounds and focused libraries, HUMAN SERVICES
from the research. The CRADA molecular modeling of ADME drug
Collaborator will have an option to elect properties, etc. For collaborations with National Institutes of Health
a non-exclusive or exclusive the commercial sector, a Cooperative
commercialization license to subject Research and Development Agreement Government-Owned Inventions;
inventions arising under the CRADA (CRADA) will be established to provide Availability for Licensing
and which are subject of the CRADA equitable distribution of intellectual AGENCY: National Institutes of Health,
Research Plan. property rights developed under the Public Health Service, DHHS.
ADDRESSES: Proposals and questions CRADA. CRADA aims will include ACTION: Notice.
about this CRADA opportunity may be rapid publication of research results as
addressed to Bjarne Gabrielsen, Ph.D., well as development of the technology SUMMARY: The inventions listed below
Technology Transfer Branch, National toward commercialization. The role of are owned by agencies of the U.S.

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Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Notices 68145

Government and are available for locus, which has been designated HPC1 35 U.S.C. 207 to achieve expeditious
licensing in the U.S. in accordance with due to its putative link to hereditary commercialization of results of
35 U.S.C. 207 to achieve expeditious prostate cancer. HPC1 may lead to an federally-funded research and
commercialization of results of early, sensitive and accurate method for development. Foreign patent
federally-funded research and detecting cancer or a predisposition to applications are filed on selected
development. Foreign patent cancer, especially prostate cancer, in a inventions to extend market coverage
applications are filed on selected mammal. In addition, such claimed for companies and may also be available
inventions to extend market coverage methods can be used to monitor onset for licensing.
for companies and may also be available and progression of cancer, as well as a ADDRESSES: Licensing information and
for licensing. patient’s response to a particular copies of the U.S. patent applications
ADDRESSES: Licensing information and treatment. listed below may be obtained by writing
copies of the U.S. patent applications Signal Transduction Inhibitor to the indicated licensing contact at the
listed below may be obtained by writing Compounds in Clinical Trials as Cancer Office of Technology Transfer, National
to the indicated licensing contact at the Therapeutics Institutes of Health, 6011 Executive
Office of Technology Transfer, National Boulevard, Suite 325, Rockville,
Institutes of Health, 6011 Executive Elise C. Kohn, Lance A. Liotta, Maryland 20852–3804; telephone: 301/
Boulevard, Suite 325, Rockville, Christian C. Felder (NCI); 496–7057; fax: 301/402–0220. A signed
Maryland 20852–3804; telephone: 301/ U.S. Patent 5,359,078 issued October Confidential Disclosure Agreement will
496–7057; fax: 301/402–0220. A signed 25, 1994; be required to receive copies of the
Confidential Disclosure Agreement will U.S. Patent 5,482,954 issued January patent applications.
be required to receive copies of the 9, 1996;
patent applications. U.S. Patent 5,498,620 issued March Tissue Microosmometer
12, 1996; Ferenc Horkay, Peter J. Basser, Adam
New Gene Expressed in Prostate Cancer U.S. Patent 5,705,514 issued January Berman (NICHD)
and Methods of Use 6, 1998; DHHS Reference No. E–280–2002/0
TK Bera, C Wolfgang, I Pastan (NCI), U.S. Patent 5,880,129 issued March 9, filed Aug. 07, 2002
B Lee, J Vincent; 1999; Licensing Contact: Dale Berkley; 301/
DHHS Reference No. E–005–2002 Licensing Contact: Brenda Hefti; 301/ 435–5019;
filed Nov. 14, 2001; 435–4632; This new tissue microosmometer
Licensing Contact: Jonathan Dixon; The above issued patents relate to allows for the quantification of minor
301/435–5559; azole, diazole, and triazole compounds changes in the swelling properties of
A new polypeptide is described in that appear to inhibit signal different tissues (e.g. cartilage) using
this invention that is specifically transduction and inhibit invasion and very small amounts of tissue, and can be
detected in the cells of the prostate. This metastasis of malignant solid tumors. A used as a potential diagnostic technique
polypeptide has been termed Novel number of these compounds are in to detect early stages of cell or tissue
Gene Expressed In Prostate (NGEP). phase I, II and III clinical trials for injury such as cartilage degeneration or
There are potential claims to the NGEP specific indications, and might be useful disorder. Varying the vapor pressure in
gene, polynucleotides encoding NGEP, in other indications as well. the environment of the device induces
antibodies to NGEP, methods for using These issued patents claim a number controlled changes in the osmotic
an NGEP polypeptide, polynucleotide, of compositions of matter, pressure of a tissue layer attached to the
or antibody, and pharmaceutical pharmaceutical compositions of said surface of a flat quartz crystal. Variation
compositions containing any of the compounds, and methods of using said in the swelling degree is measured with
above NGEP-related molecules. This compounds. high sensitivity and reliability by
invention might be useful in prostate
Dated: November 4, 2002. monitoring the change in resonance
cancer diagnostics, such as an assay to
Jack Spiegel, frequency of the quartz crystal. The
detect prostate cancer, or as a
Director, Division of Technology, device requires less than one microgram
therapeutic directed towards prostate
Development and Transfer, Office of of sample, and the small tissue sample
Technology Transfer, National Institutes of allows for an extremely fast response
Use of Interferon-Inducible 2’,5’- Health. time. The device is well suited to the
Oligoadenylate-Dependent RNase in the [FR Doc. 02–28536 Filed 11–7–02; 8:45 am] study of expensive or limited
Diagnosis, Prognosis, and Treatment of BILLING CODE 4140–01–P availability biological or
Prostate Cancer macromolecular samples.
J. Carpten (NHGRI), J. Trent (NHGRI), Method for Convection Enhanced
J. Smith, P. Walsh, W. Isaacs, D. DEPARTMENT OF HEALTH AND
HUMAN SERVICES Delivery of Therapeutic Agents
Stephan, and N. Nupponen (NHGRI);
PCT Application PCT/US02/19516 Edward H. Oldfield (NINDS)
National Institutes of Health DHHS Reference No. E–202–2002/0
(DHHS Ref. E–196–01/1), claiming
priority to a U.S. Provisional Patent filed Sep. 24, 2002
Government-Owned Inventions; Licensing Contact: Dale Berkley; 301/
Application filed on June 20, 2001; Availability for Licensing
Licensing Contact: Brenda Hefti; 301/ 435–5019;
435–4632; AGENCY: National Institutes of Health, The invention is a method for
This invention pertains to the use of Public Health Service, HHS. monitoring the spatial distribution of
interferon-inducible 2’,5’- ACTION: Notice. therapeutic substances by MRI or CT
oligoadenlyate-dependent RNase L in that have been administered to tissue
the diagnosis, prognosis and treatment SUMMARY: The inventions listed below using convection-enhanced delivery, a
of cancer, particularly prostate cancer. are owned by agencies of the U.S. technique that is the subject of NIH-
The inventors have identified a Government and are available for owned U.S. Patent No. 5,720,720. In one
potential prostate cancer susceptibility licensing in the U.S. in accordance with embodiment, the tracer is a molecule,

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