Government-Owned Inventions; Availability for Licensing, 50215-50216 [E9-23590]
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
50215
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Section of the Federal Food, Drug,
and Cosmetic Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
520(m)(6)(A)(ii)
3
1
3
50
150
520(m)(6)(A)(iii)
1
1
1
100
100
520(m)(6)(C)
5
1
5
100
500
Total
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
1There
1,250
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of original HDE applications
that the Center for Devices and
Radiological Health (CDRH) received in
the period between October 1, 2004, and
September 30, 2007. During that time,
CDRH received 16 original HDE
applications or about 5 per year.
FDA estimates that for each year,
CDRH will receive five HDE
applications and that three of these
applications will be indicated for
pediatric use. One HDE holder will
notify the agency that the number of
devices distributed in the year has
exceeded the ADN and five HDE holders
will petition to have the ADN modified
due to additional information on the
number of individuals affected by the
disease of condition.
The draft guidance refers also to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 803 have been approved under
OMB control number 0910–0437; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
the collections of information in part
814, subparts A, B, and C have been
approved under OMB control number
0910–0231; the collection of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in part 814, subpart H have
been approved under OMB control
number 0910–0332; and the collection
of information requirements in 21 CFR
10.30 have been approved under OMB
control number 0910–0183.
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23521 Filed 9–29–09; 8:45 am]
BILLING CODE 4160–01–S
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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.
Immortalized Transformed
Lymphoblastoid Cell Lines From
Patients with Francois-Neetens
¸
´
Mouchetee Fleck Corneal Dystrophy
(CFD)
Description of Invention: Researchers
at the National Eye Institute, NIH, have
made available a set of immortalized
transformed lymphoblastoid cell lines
created from human T-lymphocytes
obtained from patients with Francois¸
´
Neetens Mouchetee Fleck Corneal
Dystrophy (CFD). The cells were
transformed with defective Epstein-Barr
virus using established methods.
CFD is a rare, autosomal dominant
corneal dystrophy characterized by
numerous small white flecks scattered
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
in all layers of the stroma. CFD has been
associated with mutations in the PIP5K3
protein, which is important for postGolgi vesicle processing.
Applications:
• Useful in the study of proteins
expressed by lymphocytes, including in
some cases the protein encoded by the
mutant gene KCNJ13.
• Useful as a renewable source of
DNA for genetic studies related to CFD
or the PIP5K3 protein.
Inventors: J. Fielding Hejtmancik and
Xiaodong Jiao (NEI).
Relevant Publications:
1. S Li et al. Mutations in PIP5K3 are
associated with Francois-Neetens
¸
´
mouchetee fleck corneal dystrophy. Am
J Hum Genet. 2005 Jul;77(1):54–63.
2. X Jiao et al. Genetic linkage of
´
Francois-Neetens fleck (mouchetee)
corneal dystrophy to chromosome 2q35.
Hum Genet. 2003 May; 112(5–6):593–
599.
Patent Status: HHS Reference No. E–
270–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a biological material
license.
Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Novel Chemoattractant-Based Toxins to
Improve Vaccine Immune Responses
for Cancer and Infectious Diseases
Description of Invention: Cancer is
one of the leading causes of death in
United States and it is estimated that
there will be more than half a million
deaths caused by cancer in 2009. A
major drawback of the current
chemotherapy-based therapeutics is the
cytotoxic side-effects associated with
them. Thus there is a dire need to
develop new therapeutic strategies with
fewer side-effects. Immunotherapy has
taken a lead among the new therapeutic
approaches. Enhancing the innate
immune response of an individual has
been a key approach for the treatment
against different diseases such as cancer
and infectious diseases.
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50216
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
This technology involves the
generation of novel chemoattractant
toxins that deplete the T regulatory cells
(Treg) or other immunosuppressive or
hyperactivated cells locally. Treg
controls activation of immune responses
by suppressing the induction of
adaptive immune responses,
particularly T cell responses.
Immunosuppressive cells such as tumor
infiltrating macrophages, regulatory T
cells, regulatory B cells, or NKT and
other cells down regulate antitumor
immune responses. The chemoattractant
toxins consist of a toxin moiety fused
with a chemokine receptor ligand, such
as chemokines and various
chemoattractants, that enables specific
targeting and delivery to the regulatory
cells. This technology is advantageous
over the more harmful antibodies and
chemicals that are currently used for the
systemic depletion of regulatory cells.
The current technology can be used
therapeutically in a variety of ways.
They can be used together with vaccines
to increase efficacy of the vaccine for
the treatment of cancer, and can be used
to locally deplete Treg, Bregs, or other
immunosuppressive cells to induce
cytolytic cell responses at the tumor site
or to eliminate chronic infectious
diseases such as HIV and tuberculosis.
Applications:
• New chemoattractant based toxins
targeted towards Treg cells.
• New chemoattractant based toxins
targeted towards immunosuppressive B
cells, NKT and macrophages.
• New chemoattractant based toxins
targeted towards local depletion of
hyperactivated CD4 T cells to treat
autoimmune diseases.
• Chemoattractant based toxins
depleting Treg cells or other
immunosuppressive cells causing
enhanced vaccine immune responses.
• Novel immunotherapy by
increasing vaccine efficacy against
cancer and infectious diseases.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market:
• The technology platform involving
novel chemo-attractant based toxins can
be used to improve vaccine immune
responses.
• The technology platform has an
additional market in treating several
other clinical problems such as
autoimmune diseases.
Inventors: Arya Biragyn (NIA), Dolgor
Bataar (NIA), et al.
Related Publications:
1. D Baatar, P Olkhanud, D Newton,
K Sumitomo, A Biragyn. CCR4expressing T cell tumors can be
specifically controlled via delivery of
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14:56 Sep 29, 2009
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toxins to chemokine receptors. J
Immunol. 2007 Aug 1;179(3):1996–
2004.
2. D Baatar, P Olkhanud, K Sumitomo,
D Taub, R Gress, A Biragyn. Human
peripheral blood T regulatory cells
(Tregs), functionally primed CCR4+
Tregs and unprimed CCR4- Tregs,
regulate effector T cells using FasL. J
Immunol. 2007 Apr 15;178(8):4891–900.
3. M Coscia, A Biragyn. Cancer
immunotherapy with chemoattractant
peptides. Semin Cancer Biol. 2004 Jun;
14(3):209–218.
4. R Schiavo et al. Chemokine
receptor targeting efficiently directs
antigens to MHC class I pathways and
elicits antigen-specific CD8+ T-cell
responses. Blood 2006 Jun 15;
107(12):4597–4605.
Patent Status: U.S. Patent Application
No. 11/992,880 filed 28 Mar 2008 (HHS
Reference No. E–027–2005/0–US–06)
Licensing Status: Available for
licensing.
Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The Immunotherapeutics Unit, National
Institute on Aging, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Chemotoxin technology
for clinical use or as a laboratory tool for
depletion of cells. Please contact Nicole
Darack, PhD at 301–435–3101 or
darackn@mail.nih.gov for more
information.
Novel Agents Exhibiting Cytotoxicity
Against Human Tumor Cell Lines
Description of Invention: Researchers
at the National Cancer Institute have
developed novel agents that inhibit the
growth of several human tumor cell
lines. The new compounds are phenyl
maleimides, some of which show
cytotoxicity against human liver cancer
cells in vitro in the low micromolar
range.
Applications:
• Therapeutics for treating a broad
range of cancers.
• Use as pharmacologic probes for
specific biochemical pathways.
Advantages:
• Demonstrated selective inhibition
for cancer cells vs. untransformed cells
in vitro and in vivo.
• Potent growth inhibition of several
human tumor cell lines.
Development Status: Pre-clinical stage
of development.
Market: Cancer therapeutics.
Inventors: Christophr J. Michejda and
Wei Yao (NCI) et al.; Terrence R. Burke
Jr. (NCI).
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Frm 00055
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Relevant Publication: S Kar, M Wang,
W Yao, CJ Michejda, BI Carr. PM–20, a
novel inhibitor of Cdc25A, induces
extracellular signal-regulated kinase 1/2
phosphorylation and inhibits
hepatocellular carcinoma growth in
vitro and in vivo. Mol Cancer Ther.
2006 Jun; 5(6):1511–1519.
Patent Status: U.S. Patent No.
7,504,430 issued 17 Mar 2009 (HHS
Reference No. E–110–2004/0–US–06).
Licensing Status: Available for
licensing.
Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Dated: September 21, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–23590 Filed 9–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
Date: November 19, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: John K. Hayes, PhD,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 959, Democracy Two,
Bethesda, MD 20892, 301–451–3398,
hayesj@mail.nih.gov.
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50215-50216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23590]
-----------------------------------------------------------------------
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.
Immortalized Transformed Lymphoblastoid Cell Lines From Patients with
Fran[ccedil]ois-Neetens Mouchet[eacute]e Fleck Corneal Dystrophy (CFD)
Description of Invention: Researchers at the National Eye
Institute, NIH, have made available a set of immortalized transformed
lymphoblastoid cell lines created from human T-lymphocytes obtained
from patients with Fran[ccedil]ois-Neetens Mouchet[eacute]e Fleck
Corneal Dystrophy (CFD). The cells were transformed with defective
Epstein-Barr virus using established methods.
CFD is a rare, autosomal dominant corneal dystrophy characterized
by numerous small white flecks scattered in all layers of the stroma.
CFD has been associated with mutations in the PIP5K3 protein, which is
important for post-Golgi vesicle processing.
Applications:
Useful in the study of proteins expressed by lymphocytes,
including in some cases the protein encoded by the mutant gene KCNJ13.
Useful as a renewable source of DNA for genetic studies
related to CFD or the PIP5K3 protein.
Inventors: J. Fielding Hejtmancik and Xiaodong Jiao (NEI).
Relevant Publications:
1. S Li et al. Mutations in PIP5K3 are associated with
Fran[ccedil]ois-Neetens mouchet[eacute]e fleck corneal dystrophy. Am J
Hum Genet. 2005 Jul;77(1):54-63.
2. X Jiao et al. Genetic linkage of Francois-Neetens fleck
(mouchet[eacute]e) corneal dystrophy to chromosome 2q35. Hum Genet.
2003 May; 112(5-6):593-599.
Patent Status: HHS Reference No. E-270-2009/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing under a biological
material license.
Licensing Contact: Patrick P. McCue, PhD; 301-435-5560;
mccuepat@mail.nih.gov.
Novel Chemoattractant-Based Toxins to Improve Vaccine Immune Responses
for Cancer and Infectious Diseases
Description of Invention: Cancer is one of the leading causes of
death in United States and it is estimated that there will be more than
half a million deaths caused by cancer in 2009. A major drawback of the
current chemotherapy-based therapeutics is the cytotoxic side-effects
associated with them. Thus there is a dire need to develop new
therapeutic strategies with fewer side-effects. Immunotherapy has taken
a lead among the new therapeutic approaches. Enhancing the innate
immune response of an individual has been a key approach for the
treatment against different diseases such as cancer and infectious
diseases.
[[Page 50216]]
This technology involves the generation of novel chemoattractant
toxins that deplete the T regulatory cells (Treg) or other
immunosuppressive or hyperactivated cells locally. Treg controls
activation of immune responses by suppressing the induction of adaptive
immune responses, particularly T cell responses. Immunosuppressive
cells such as tumor infiltrating macrophages, regulatory T cells,
regulatory B cells, or NKT and other cells down regulate antitumor
immune responses. The chemoattractant toxins consist of a toxin moiety
fused with a chemokine receptor ligand, such as chemokines and various
chemoattractants, that enables specific targeting and delivery to the
regulatory cells. This technology is advantageous over the more harmful
antibodies and chemicals that are currently used for the systemic
depletion of regulatory cells. The current technology can be used
therapeutically in a variety of ways. They can be used together with
vaccines to increase efficacy of the vaccine for the treatment of
cancer, and can be used to locally deplete Treg, Bregs, or other
immunosuppressive cells to induce cytolytic cell responses at the tumor
site or to eliminate chronic infectious diseases such as HIV and
tuberculosis.
Applications:
New chemoattractant based toxins targeted towards Treg
cells.
New chemoattractant based toxins targeted towards
immunosuppressive B cells, NKT and macrophages.
New chemoattractant based toxins targeted towards local
depletion of hyperactivated CD4 T cells to treat autoimmune diseases.
Chemoattractant based toxins depleting Treg cells or other
immunosuppressive cells causing enhanced vaccine immune responses.
Novel immunotherapy by increasing vaccine efficacy against
cancer and infectious diseases.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market:
The technology platform involving novel chemo-attractant
based toxins can be used to improve vaccine immune responses.
The technology platform has an additional market in
treating several other clinical problems such as autoimmune diseases.
Inventors: Arya Biragyn (NIA), Dolgor Bataar (NIA), et al.
Related Publications:
1. D Baatar, P Olkhanud, D Newton, K Sumitomo, A Biragyn. CCR4-
expressing T cell tumors can be specifically controlled via delivery of
toxins to chemokine receptors. J Immunol. 2007 Aug 1;179(3):1996-2004.
2. D Baatar, P Olkhanud, K Sumitomo, D Taub, R Gress, A Biragyn.
Human peripheral blood T regulatory cells (Tregs), functionally primed
CCR4+ Tregs and unprimed CCR4- Tregs, regulate effector T cells using
FasL. J Immunol. 2007 Apr 15;178(8):4891-900.
3. M Coscia, A Biragyn. Cancer immunotherapy with chemoattractant
peptides. Semin Cancer Biol. 2004 Jun; 14(3):209-218.
4. R Schiavo et al. Chemokine receptor targeting efficiently
directs antigens to MHC class I pathways and elicits antigen-specific
CD8+ T-cell responses. Blood 2006 Jun 15; 107(12):4597-4605.
Patent Status: U.S. Patent Application No. 11/992,880 filed 28 Mar
2008 (HHS Reference No. E-027-2005/0-US-06)
Licensing Status: Available for licensing.
Licensing Contact: Patrick P. McCue, PhD; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The Immunotherapeutics Unit,
National Institute on Aging, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize Chemotoxin technology for clinical
use or as a laboratory tool for depletion of cells. Please contact
Nicole Darack, PhD at 301-435-3101 or darackn@mail.nih.gov for more
information.
Novel Agents Exhibiting Cytotoxicity Against Human Tumor Cell Lines
Description of Invention: Researchers at the National Cancer
Institute have developed novel agents that inhibit the growth of
several human tumor cell lines. The new compounds are phenyl
maleimides, some of which show cytotoxicity against human liver cancer
cells in vitro in the low micromolar range.
Applications:
Therapeutics for treating a broad range of cancers.
Use as pharmacologic probes for specific biochemical
pathways.
Advantages:
Demonstrated selective inhibition for cancer cells vs.
untransformed cells in vitro and in vivo.
Potent growth inhibition of several human tumor cell
lines.
Development Status: Pre-clinical stage of development.
Market: Cancer therapeutics.
Inventors: Christophr J. Michejda and Wei Yao (NCI) et al.;
Terrence R. Burke Jr. (NCI).
Relevant Publication: S Kar, M Wang, W Yao, CJ Michejda, BI Carr.
PM-20, a novel inhibitor of Cdc25A, induces extracellular signal-
regulated kinase 1/2 phosphorylation and inhibits hepatocellular
carcinoma growth in vitro and in vivo. Mol Cancer Ther. 2006 Jun;
5(6):1511-1519.
Patent Status: U.S. Patent No. 7,504,430 issued 17 Mar 2009 (HHS
Reference No. E-110-2004/0-US-06).
Licensing Status: Available for licensing.
Licensing Contact: Patrick P. McCue, PhD; 301-435-5560;
mccuepat@mail.nih.gov.
Dated: September 21, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-23590 Filed 9-29-09; 8:45 am]
BILLING CODE 4140-01-P
