Government-Owned Inventions; Availability for Licensing, 4152-4153 [E6-877]
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4152
Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices
for the opportunity for public comment
on proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK)
of the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Proposed Collection: Title: A Survey
of Estimated GFR Reporting Practices of
Clinical Laboratories: Type of
Information Collection Request: New.
Need and Use of Information Collection:
This study will assess the level of U.S.
clinical laboratory reporting of
estimated GFR as a measure of kidney
function. This will be accomplished
through baseline and follow-up surveys
of a representative sample of clinical
laboratories in the U.S. Information will
be used to establish baseline data
necessary to measure an anticipated
increased in use of estimated GFR,
following the implementation of the
NKDEP’s communications and Lab
Working Group (LWG) activities
promoting use of estimated GFR for
patients at risk for kidney disease. The
LWG, whose members are experts in
their field, strongly believes that routine
reporting of estimated GFR will result in
a significant increase in early detection
of chronic kidney disease, therefore
enabling treatment that can slow or
prevent patients’ progression to kidney
failure. Frequency of Response: Baseline
survey only. Affected Public: Clinical
laboratory community. Type of
Respondents: Laboratory directors. The
annual reporting burden is as follow:
Estimated Number of Respondents:
Estimated
number of respondents
Type of respondents
Estimated
number of responses per
respondent
Average burden hours per
response
4,126
4,126
1.0
1.0
.083
.083
wwhite on PROD1PC61 with NOTICES
Clinical Laboratory Directors ............................................................................
Total ..........................................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to responded, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Elisa Gladstone,
MPH, Project Officer, Associate
Director, National Kidney Disease
Education Program, National Institute of
Diabetes and Digestive and Kidney
Diseases, National Institutes of Health,
Building 31, Center Dr., Room 9A06,
Bethesda, MD 20892, or call non-toll
free number (301) 435–8116 or e-mail
your request, including your address to,
gladstonee@niddk.nih.gov.
VerDate Aug<31>2005
18:26 Jan 24, 2006
Jkt 208001
Anticipate 4,126 completed surveys;
Estimated Number of Responses per
Respondent: Respondents will complete
one paper-and-pencil or online survey;
Average Burden Hours Per Response:
.083 hours [5 minutes]; and Estimated
Total Annual Burden Hours Requested:
342.46 hours. The annualized total cost
to respondents is estimated at
$11,759.10. (Note: Completing this
survey is similar to other data reporting
carried out by lab directors. Since lab
directors will be able to responded to
the survey within their usual workday,
this collection of information will not
cost labs.employers additional time and
money.) There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: January 17, 2006.
Elisa H. Gladstone,
MPH, Project Officer, Associate Director,
National Kidney Disease Education Program,
National Institute of Diabetes and Digestive
and Kidney Diseases, National Institutes of
Health.
[FR Doc. 06–704 Filed 1–24–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Annual total
burden hours
requested
342.46
342.46
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.
Intraperitoneal Injection of
Pseudovirions Carrying a Toxin Leads
to Significantly Reduced Tumor Size
Michael M. Gottesman et al. (NCI)
U.S. Provisional Application filed 01
Dec 2005 (HHS Reference No. E–163–
2005/0–US–01)
Licensing Contact: Michelle A. Booden;
301/451–7337;
boodenm@mail.nih.gov
SV40-based pseudovirions show great
promise in the cancer gene therapy
field. SV40 vectors very efficiently
deliver genes such as anti-viral agents,
DNA vaccine, genes for
chemoprotection, suicide genes, and
antiangiogenic genes. The immediate
application for this technology is to
target plasmid DNA to cancerous cells
as a gene therapy treatment for various
human carcinomas. In previous studies,
NCI investigators Chava Kimchi-Sarfaty
and Michael Gottesman have
E:\FR\FM\25JAN1.SGM
25JAN1
Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices
wwhite on PROD1PC61 with NOTICES
demonstrated that SV40 infectious
particles delivering DNA encoding a
toxin to tumors can be used as a novel
cancer treatment.
This invention discloses a method for
delivering a toxin such as Pseudomonas
extotoxin (PE38) to tumor cells.
Administration of the SV40 infectious
particle can be by parenteral
administration, which includes
intraperitoneal, intravenous,
intramuscular, subcutaneous,
intraorbital, intracapsular, intraspinal,
or intrasternal. This disclosure also
provides a combined method of use of
SV40 infectious particle/PE38 with a
chemotherapeutic agent, such as
doxorubicin. Interestingly, this
combination is very effective at
reducing tumor size while eliminating
many of the side effects of conventional
chemotherapy. This delivery system has
a commercial advantage as a new
method to increase efficacy and reduce
side effects of standard chemotherapies.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Transcytosis of Adeno-Associated
Viruses
John A. Chiorini and Giovanni Di
Pasquale (NIDCR)
PCT Application No. PCT/US2005/
03183 filed 08 Sep 2005 (HHS
Reference No. E–298–2004/0–PCT–
02)
Licensing Contact: Jesse Kindra; 301/
435–5559; kindraj@mail.nih.gov.
The invention relates to a method for
delivering nucleic acids to a variety of
cells including those of the gut, kidney,
lung and central nervous system. The
underlying cells of such organs are
covered by a barrier of endothelial or
epithelial cells which can limit the
transfer of nucleic acids, or other
potentially therapeutic agents, to the
underlying target cells. To overcome
this limitation, the method employs
certain members of the parvovirus
family to transcytose the barrier cells.
During transcytosis, the virus passes
through these barrier cells and can
infect cells of the underlying layer.
Therefore, this method could facilitate
the transfer of nucleic acids to cells that
currently available viral vectors are
unable to reach.
The method could be applied to the
treatment of neurodegenerative diseases
such as Parkinson’s, Alzheimer’s,
Huntington’s, lysosomal storage
diseases, the dominant spinal cerebellar
ataxias, and Krabbe’s disease without
the need for stereotactic injection. The
method could potentially also be used
VerDate Aug<31>2005
18:26 Jan 24, 2006
Jkt 208001
in the treatment of genetic muscle
disorders such as muscular dystrophy.
Several of the viruses described in the
invention are serologically distinct and
could be used in patients who have
developed an immune response to other
vectors. This work is part of an ongoing
effort to development AAV vectors for
gene transfer. Other key technology
related to this invention, such as several
vector platforms, production,
purification methods, and target cell
tropism is available for licensing.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Treatment of Hyperproliferative
Epithelial Skin Diseases by Topical
Application of Hydroxylated Aromatic
Protein Cross-Linking Compounds
Caroline Stanwell et al. (NCI)
U.S. Patent No. 5,610,185 issued 11 Mar
1997 (HHS Reference No. E–067–
1995/0–US–01)
Licensing Contact: George Pipia; 301/
435–5560; pipiag@mail.nih.gov
In recent years there has been a
dramatic increase in the incidence of
skin disease. Increase in exposure to UV
light has contributed to the increase in
premalignant skin lesions such as
actinic keratoses. In the U.S. over
700,000 individuals suffer from
superficial squamous and basal cell
carcinoma. In addition, other skin
diseases such as plantar and genital
warts are extremely common. Currently,
the treatment for these types of skin
diseases include surgical resection or
freezing the tissue to destroy the desired
cells. Topical treatments, for example
acidic compounds or cytotoxic agents,
are also employed. However, none of
the above treatments are without
drawbacks. Surgical methods may be
painful and the current topical
treatments are not selective for
hyperproliferative cells, not always
curative, and may be toxic. This
invention embodies a series of
compounds, hydroxylated aromatic
protein cross-linking agents, that can be
applied topically and are useful for
premalignant and malignant superficial
neoplasias of the skin and for the
treatment of basal and squamous cell
carcinomas.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
4153
Pharmaceutical Compositions and
Methods for Preventing Skin Tumor
Formation and Causing Regression of
Existing Tumors
Stuart R. Yuspa et al. (NCI)
U.S. Patent Application No. 10/445,251
filed 27 May 2003, claiming priority
to 29 Mar 1991 (HHS Reference No.
E–014–1991/0–US–08)
Licensing Contact: George Pipia; 301/
435–5560; pipiag@mail.nih.gov.
Toxic drugs used to treat epithelial
cancers often kill both normal and
tumorous cells whereas retinoids used
to prevent tumor formation appear to
have a suppressive rather than a
curative effect. The compositions and
methods of administration described in
this invention are based on indole
carbazole, which causes terminal
differentiation of tumor cells by
exploiting a normal physiologic
pathway. They can be used to regress as
well as prevent skin tumors.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: January 17, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–877 Filed 1–24–06; 8:45 am]
BILLING CODE 4167–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4152-4153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-877]
-----------------------------------------------------------------------
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.
Intraperitoneal Injection of Pseudovirions Carrying a Toxin Leads to
Significantly Reduced Tumor Size
Michael M. Gottesman et al. (NCI)
U.S. Provisional Application filed 01 Dec 2005 (HHS Reference No. E-
163-2005/0-US-01)
Licensing Contact: Michelle A. Booden; 301/451-7337;
boodenm@mail.nih.gov
SV40-based pseudovirions show great promise in the cancer gene
therapy field. SV40 vectors very efficiently deliver genes such as
anti-viral agents, DNA vaccine, genes for chemoprotection, suicide
genes, and antiangiogenic genes. The immediate application for this
technology is to target plasmid DNA to cancerous cells as a gene
therapy treatment for various human carcinomas. In previous studies,
NCI investigators Chava Kimchi-Sarfaty and Michael Gottesman have
[[Page 4153]]
demonstrated that SV40 infectious particles delivering DNA encoding a
toxin to tumors can be used as a novel cancer treatment.
This invention discloses a method for delivering a toxin such as
Pseudomonas extotoxin (PE38) to tumor cells. Administration of the SV40
infectious particle can be by parenteral administration, which includes
intraperitoneal, intravenous, intramuscular, subcutaneous,
intraorbital, intracapsular, intraspinal, or intrasternal. This
disclosure also provides a combined method of use of SV40 infectious
particle/PE38 with a chemotherapeutic agent, such as doxorubicin.
Interestingly, this combination is very effective at reducing tumor
size while eliminating many of the side effects of conventional
chemotherapy. This delivery system has a commercial advantage as a new
method to increase efficacy and reduce side effects of standard
chemotherapies.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Transcytosis of Adeno-Associated Viruses
John A. Chiorini and Giovanni Di Pasquale (NIDCR)
PCT Application No. PCT/US2005/03183 filed 08 Sep 2005 (HHS Reference
No. E-298-2004/0-PCT-02)
Licensing Contact: Jesse Kindra; 301/435-5559; kindraj@mail.nih.gov.
The invention relates to a method for delivering nucleic acids to a
variety of cells including those of the gut, kidney, lung and central
nervous system. The underlying cells of such organs are covered by a
barrier of endothelial or epithelial cells which can limit the transfer
of nucleic acids, or other potentially therapeutic agents, to the
underlying target cells. To overcome this limitation, the method
employs certain members of the parvovirus family to transcytose the
barrier cells. During transcytosis, the virus passes through these
barrier cells and can infect cells of the underlying layer. Therefore,
this method could facilitate the transfer of nucleic acids to cells
that currently available viral vectors are unable to reach.
The method could be applied to the treatment of neurodegenerative
diseases such as Parkinson's, Alzheimer's, Huntington's, lysosomal
storage diseases, the dominant spinal cerebellar ataxias, and Krabbe's
disease without the need for stereotactic injection. The method could
potentially also be used in the treatment of genetic muscle disorders
such as muscular dystrophy. Several of the viruses described in the
invention are serologically distinct and could be used in patients who
have developed an immune response to other vectors. This work is part
of an ongoing effort to development AAV vectors for gene transfer.
Other key technology related to this invention, such as several vector
platforms, production, purification methods, and target cell tropism is
available for licensing.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Treatment of Hyperproliferative Epithelial Skin Diseases by Topical
Application of Hydroxylated Aromatic Protein Cross-Linking Compounds
Caroline Stanwell et al. (NCI)
U.S. Patent No. 5,610,185 issued 11 Mar 1997 (HHS Reference No. E-067-
1995/0-US-01)
Licensing Contact: George Pipia; 301/435-5560; pipiag@mail.nih.gov
In recent years there has been a dramatic increase in the incidence
of skin disease. Increase in exposure to UV light has contributed to
the increase in premalignant skin lesions such as actinic keratoses. In
the U.S. over 700,000 individuals suffer from superficial squamous and
basal cell carcinoma. In addition, other skin diseases such as plantar
and genital warts are extremely common. Currently, the treatment for
these types of skin diseases include surgical resection or freezing the
tissue to destroy the desired cells. Topical treatments, for example
acidic compounds or cytotoxic agents, are also employed. However, none
of the above treatments are without drawbacks. Surgical methods may be
painful and the current topical treatments are not selective for
hyperproliferative cells, not always curative, and may be toxic. This
invention embodies a series of compounds, hydroxylated aromatic protein
cross-linking agents, that can be applied topically and are useful for
premalignant and malignant superficial neoplasias of the skin and for
the treatment of basal and squamous cell carcinomas.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Pharmaceutical Compositions and Methods for Preventing Skin Tumor
Formation and Causing Regression of Existing Tumors
Stuart R. Yuspa et al. (NCI)
U.S. Patent Application No. 10/445,251 filed 27 May 2003, claiming
priority to 29 Mar 1991 (HHS Reference No. E-014-1991/0-US-08)
Licensing Contact: George Pipia; 301/435-5560; pipiag@mail.nih.gov.
Toxic drugs used to treat epithelial cancers often kill both normal
and tumorous cells whereas retinoids used to prevent tumor formation
appear to have a suppressive rather than a curative effect. The
compositions and methods of administration described in this invention
are based on indole carbazole, which causes terminal differentiation of
tumor cells by exploiting a normal physiologic pathway. They can be
used to regress as well as prevent skin tumors.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Dated: January 17, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-877 Filed 1-24-06; 8:45 am]
BILLING CODE 4167-01-P
