Government-Owned Inventions; Availability for Licensing, 64700-64701 [E9-29250]
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Federal Register / Vol. 74, No. 234 / Tuesday, December 8, 2009 / Notices
[FR Doc. E9–29248 Filed 12–7–09; 8:45 am]
BILLING CODE 4210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Announcement of the Soy Formula
Expert Panel Meeting: Amended Notice
AGENCY: National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Availability of telephone
conferencing and extension of
registration period.
The CERHR announces the
availability of a teleconference line to
allow presentation of oral comments at
the expert panel meeting on December
16–18, 2009, at the Hilton Alexandria
Old Town, 1767 King Street,
Alexandria, VA. Information regarding
the soy formula expert panel meeting
was announced in the Federal Register
(74 FR 53508) published on October 19,
2009, and is available on the CERHR
Web site (https://cerhr.niehs.nih.gov).
The guidelines and deadlines published
in this Federal Register notice still
apply, except that the deadline for
registering to attend or to present oral
comments by telephone is now
December 11, 2009.
DATES: The expert panel meeting for soy
formula will be held on December 16–
18, 2009, and convene each day at 8:30
a.m. EST. Persons wishing to attend are
asked to register by December 11, 2009,
via the CERHR Web site (https://
cerhr.niehs.nih.gov). Time is set-aside at
the expert panel meeting on December
16, 2009, for oral public comments.
Individuals wishing to make oral public
comments are asked to register online
(https://cerhr.niehs.nih.gov) or contact
Dr. Kristina A. Thayer, CERHR Acting
Director, by December 11, 2009, and if
possible, send a copy of the statement
at that time.
ADDRESSES: The meeting will be held at
the Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA. Access to
on-line registration to either attend the
meeting in person or participate by
teleconference line is available on the
CERHR Web site (https://
cerhr.niehs.nih.gov). Public comments
and any other correspondence should be
submitted to Dr. Kristina A. Thayer,
CERHR Acting Director, NIEHS, P.O.
Box 12233, Mail Drop K2–04, Research
Triangle Park, NC 27709 (mail), 919–
541–5021 (telephone), or
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SUMMARY:
VerDate Nov<24>2008
15:16 Dec 07, 2009
Jkt 220001
thayer@niehs.nih.gov (e-mail). Courier
address: NIEHS, 530 Davis Drive, Room
K2154, Morrisville, NC 27560.
FOR FURTHER INFORMATION CONTACT: Dr.
Kristina A. Thayer (telephone: 919–541–
5021 or e-mail: thayer@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Teleconferencing
To allow greater public participation
at the soy formula expert panel meeting,
the NTP will provide a teleconference
line to access the public comment
session of the meeting. The NTP has
reserved a limited number of telephone
lines for this call and access availability
will be on a first-come, first-served
basis. Individuals interested in
participating in the meeting by
teleconference line must register by
December 11, 2009. Those registering to
present oral comments by telephone
will be provided the access number
prior to the meeting. The formal public
comment period is scheduled for
December 16, 2009, at approximately 9
a.m. until 10 a.m. EST. Oral public
comments should not exceed 7 minutes
in length and each organization is
allowed only one comment slot (in
person or by telephone). Every effort
will be made to accommodate the
public, but the total time allotted for
oral comments and the time allotted per
speaker by telephone will depend on
the number of people who register
online to speak. In addition,
teleconference participants are
encouraged to send a copy of their oral
statement or talking points, which can
supplement and/or expand the oral
presentation, for distribution at the
meeting and for the meeting record.
Dated: December 1, 2009.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. E9–29249 Filed 12–7–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
PO 00000
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Sfmt 4703
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Human Renal Cell Carcinoma (RCC)
Cell Lines Derived From Surgically
Removed Tumors
Description of Technology: Scientists
at the National Institutes of Health (NIH)
have developed three cell lines obtained
from renal cell carcinoma (RCC)
patients. The cell lines, designated 1581
RCC, 1764 RCC, and 2194 RCC, were
derived from human tumor samples
surgically resected from patients in the
inventors’ clinic. Each cell line is
human leukocyte antigen-A2 (HLA–A2)
negative and expresses a variety of
known tumor antigens. The 1764 RCC
cell line is known to express the HLA–
A3 antigen and high levels of
nonmutated fibroblast growth factor 5
(FGF–5). These cell lines can be widely
used in molecular biology for various
assays and to screen for potential
therapeutics with activity against RCC.
The RCC cell lines can also serve as
negative control samples for HLA–A2
expression.
Applications:
• Research tools for examining the
common and diverse biological and
pathological features of RCC from
different patients in vitro.
• Research tools for testing the
activity of potential anti-cancer drugs
against RCC.
• Source for mRNA and protein
antigens expressed in kidney cancer.
• Negative control cell lines for HLA–
A2 expression in molecular biology.
• Possible starting material for
developing a cancer vaccine against
RCC.
Advantages:
• Cell lines are derived directly from
RCC patient samples: These cell lines
are anticipated to retain many features
of primary RCC samples. Studies
performed using these cell lines may
have a direct correlation to the
initiation, progression, treatment, and
prevention of RCC in humans.
E:\FR\FM\08DEN1.SGM
08DEN1
Federal Register / Vol. 74, No. 234 / Tuesday, December 8, 2009 / Notices
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
• Do not express the HLA–A2 allele:
A majority of the cancer vaccines and
immunotherapies developed to date
have focused on utilizing HLA–A2
restricted tumor epitopes since this HLA
allele is largely expressed in the human
population. However, therapies
restricted to HLA–A2 recognition will
not be successful in RCC patients that
do not express this allele. For these RCC
patients, additional therapies are
needed that are directed against
epitopes presented by different HLA
alleles.
Inventors: Ken-ichi Hanada, Qiong J.
Wang, James C. Yang (NCI).
Related Publication: K Hanada et al.
Identification of fibroblast growth
factor-5 as an overexpressed antigen in
multiple human adenocarcinomas.
Cancer Res. 2001 Jul 15;61(14):5511–
5516.
Patent Status: HHS Reference No. E–
005–2010/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Samuel E. Bish,
Ph.D.; 301–435–5282;
bishse@mail.nih.gov.
Small-Molecule Inhibitors of
Angiogenesis
Description of Technology:
Angiogenesis, the growth of new blood
vessels from existing vessels, is a
normal and vital process in growth and
development. Deregulation of
angiogenesis plays a role in many
human diseases, including cancer, agerelated macular degeneration, diabetic
retinopathy, and endometriosis.
NCI investigators have used a cellbased high-throughput screening
method to identify a set of antiangiogenic small molecules. These
compounds are highly active, inhibiting
both endothelial cell growth and tube
formation, and are not cytotoxic.
Structure-activity relationship analysis
has revealed that these compounds are
unrelated to known anti-angiogenic
compounds, and hence may operate
through a novel mechanism of action.
Thus, these compounds would be
promising candidates for the
development of new anti-angiogenesis
therapeutics.
Applications: Development of new
anti-angiogenesis therapeutics.
Advantages: These compounds are
structurally unrelated to other known
anti-angiogenesis compounds, and
exhibit high activity without
cytotoxicity.
Development Status: In vivo studies
using xenograft models are underway.
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15:16 Dec 07, 2009
Jkt 220001
Inventors: Enrique Zudaire Ubani et
al. (NCI).
Publication: In preparation.
Patent Status: HHS Reference No. E–
263–2009/0—U.S. Provisional
Application No. 61/230,667 filed 31 Jul
2009.
Related Technology: HHS Reference
No. E–281–2007/0—Multicolored
Fluorescent Cell Lines for HighThroughput Angiogenesis and
Cytotoxicity Screening.
Licensing Status: Available for
licensing.
Licensing Contact: Tara Kirby, Ph.D.;
301–435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Angiogenesis Core Facility is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize a new set of noncytotoxic antiangiogenic small
molecules. Please contact John D.
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Identification of Colorectal Cancer
Biomarkers by Serum Protein Profiling
Description of Technology: This
invention describes serum features that
distinguish colorectal carcinoma
malignant patient samples versus
healthy samples using surface-enhanced
laser desorption ionization time-of-flight
(SELDI–TOF) mass spectrometry. By
comparing healthy versus malignant
samples, the investigators were able to
identify thirteen (13) serum features that
have been validated using an
independently collected, blinded
validation set of 55 sera samples. The
features are characterized by the mass to
charge ratio (m/z ratio). The
investigators have shown that SELDI–
TOF based serum marker protein
profiling enables minimally invasive
detection of colon cancer with 96.7
percent sensitivity and 100 percent
specificity.
Colorectal cancer is the third most
common cancer and the third leading
cause of cancer-related mortality in the
United States. Current diagnostic
methods for colorectal cancer have a
large non-compliance rate because of
discomfort, e.g., sigmoidoscopy or
colonoscopy, or have a high rate of false
positive results, e.g., fecal occult blood
tests. The claimed invention has the
potential to be a widely used, easy-touse, and inexpensive diagnostic.
Inventors: Thomas Ried and Jens
Habermann (NCI).
Patent Status: U.S. Patent Application
No. 11/886,886 filed 21 Sep 2007 (HHS
Reference No. E–106–2005/0–US–03).
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64701
Licensing Status: Available for
licensing.
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076;
vathyams@mail.nih.gov.
Dated: December 2, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–29250 Filed 12–7–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Oncologic Drugs Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of a meeting of the Oncologic
Drugs Advisory Committee. This
meeting was announced in the Federal
Register of November 17, 2009 (74 FR
59195). The amendment is being made
to reflect a change in the Date and Time,
Agenda, and Procedure portions of the
document. We also are cancelling a
session regarding supplemental new
drug application (sNDA) 022–059/S–
007, TYKERB (lapatinib) tablets, by
SmithKline Beecham Ltd. d/b/a
GlaxoSmithKline. This portion of the
meeting has been cancelled because the
issues for which FDA was seeking the
scientific input of the Committee have
been resolved.
FOR FURTHER INFORMATION CONTACT:
Nicole Vesely, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–6793, FAX: 301–827–
6776, e-mail: nicole.vesely@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington DC
area), code 3014512542. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 17, 2009
(74 FR 59195), FDA announced that a
meeting of the Oncologic Drugs
Advisory Committee would be held on
December 16, 2009. On page 59195, in
the first column, the Date and Time
portion of the document is changed to
read as follows:
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 74, Number 234 (Tuesday, December 8, 2009)]
[Notices]
[Pages 64700-64701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29250]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Human Renal Cell Carcinoma (RCC) Cell Lines Derived From Surgically
Removed Tumors
Description of Technology: Scientists at the National Institutes of
Health (NIH) have developed three cell lines obtained from renal cell
carcinoma (RCC) patients. The cell lines, designated 1581 RCC, 1764
RCC, and 2194 RCC, were derived from human tumor samples surgically
resected from patients in the inventors' clinic. Each cell line is
human leukocyte antigen-A2 (HLA-A2) negative and expresses a variety of
known tumor antigens. The 1764 RCC cell line is known to express the
HLA-A3 antigen and high levels of nonmutated fibroblast growth factor 5
(FGF-5). These cell lines can be widely used in molecular biology for
various assays and to screen for potential therapeutics with activity
against RCC. The RCC cell lines can also serve as negative control
samples for HLA-A2 expression.
Applications:
Research tools for examining the common and diverse
biological and pathological features of RCC from different patients in
vitro.
Research tools for testing the activity of potential anti-
cancer drugs against RCC.
Source for mRNA and protein antigens expressed in kidney
cancer.
Negative control cell lines for HLA-A2 expression in
molecular biology.
Possible starting material for developing a cancer vaccine
against RCC.
Advantages:
Cell lines are derived directly from RCC patient samples:
These cell lines are anticipated to retain many features of primary RCC
samples. Studies performed using these cell lines may have a direct
correlation to the initiation, progression, treatment, and prevention
of RCC in humans.
[[Page 64701]]
Do not express the HLA-A2 allele: A majority of the cancer
vaccines and immunotherapies developed to date have focused on
utilizing HLA-A2 restricted tumor epitopes since this HLA allele is
largely expressed in the human population. However, therapies
restricted to HLA-A2 recognition will not be successful in RCC patients
that do not express this allele. For these RCC patients, additional
therapies are needed that are directed against epitopes presented by
different HLA alleles.
Inventors: Ken-ichi Hanada, Qiong J. Wang, James C. Yang (NCI).
Related Publication: K Hanada et al. Identification of fibroblast
growth factor-5 as an overexpressed antigen in multiple human
adenocarcinomas. Cancer Res. 2001 Jul 15;61(14):5511-5516.
Patent Status: HHS Reference No. E-005-2010/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing under a Biological
Materials License Agreement.
Licensing Contact: Samuel E. Bish, Ph.D.; 301-435-5282;
bishse@mail.nih.gov.
Small-Molecule Inhibitors of Angiogenesis
Description of Technology: Angiogenesis, the growth of new blood
vessels from existing vessels, is a normal and vital process in growth
and development. Deregulation of angiogenesis plays a role in many
human diseases, including cancer, age-related macular degeneration,
diabetic retinopathy, and endometriosis.
NCI investigators have used a cell-based high-throughput screening
method to identify a set of anti-angiogenic small molecules. These
compounds are highly active, inhibiting both endothelial cell growth
and tube formation, and are not cytotoxic. Structure-activity
relationship analysis has revealed that these compounds are unrelated
to known anti-angiogenic compounds, and hence may operate through a
novel mechanism of action. Thus, these compounds would be promising
candidates for the development of new anti-angiogenesis therapeutics.
Applications: Development of new anti-angiogenesis therapeutics.
Advantages: These compounds are structurally unrelated to other
known anti-angiogenesis compounds, and exhibit high activity without
cytotoxicity.
Development Status: In vivo studies using xenograft models are
underway.
Inventors: Enrique Zudaire Ubani et al. (NCI).
Publication: In preparation.
Patent Status: HHS Reference No. E-263-2009/0--U.S. Provisional
Application No. 61/230,667 filed 31 Jul 2009.
Related Technology: HHS Reference No. E-281-2007/0--Multicolored
Fluorescent Cell Lines for High-Throughput Angiogenesis and
Cytotoxicity Screening.
Licensing Status: Available for licensing.
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
tarak@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Angiogenesis Core Facility is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize a new set of non-cytotoxic
antiangiogenic small molecules. Please contact John D. Hewes, Ph.D. at
301-435-3121 or hewesj@mail.nih.gov for more information.
Identification of Colorectal Cancer Biomarkers by Serum Protein
Profiling
Description of Technology: This invention describes serum features
that distinguish colorectal carcinoma malignant patient samples versus
healthy samples using surface-enhanced laser desorption ionization
time-of-flight (SELDI-TOF) mass spectrometry. By comparing healthy
versus malignant samples, the investigators were able to identify
thirteen (13) serum features that have been validated using an
independently collected, blinded validation set of 55 sera samples. The
features are characterized by the mass to charge ratio (m/z ratio). The
investigators have shown that SELDI-TOF based serum marker protein
profiling enables minimally invasive detection of colon cancer with
96.7 percent sensitivity and 100 percent specificity.
Colorectal cancer is the third most common cancer and the third
leading cause of cancer-related mortality in the United States. Current
diagnostic methods for colorectal cancer have a large non-compliance
rate because of discomfort, e.g., sigmoidoscopy or colonoscopy, or have
a high rate of false positive results, e.g., fecal occult blood tests.
The claimed invention has the potential to be a widely used, easy-to-
use, and inexpensive diagnostic.
Inventors: Thomas Ried and Jens Habermann (NCI).
Patent Status: U.S. Patent Application No. 11/886,886 filed 21 Sep
2007 (HHS Reference No. E-106-2005/0-US-03).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
vathyams@mail.nih.gov.
Dated: December 2, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-29250 Filed 12-7-09; 8:45 am]
BILLING CODE 4140-01-P
