Government-Owned Inventions; Availability for Licensing, 50767-50768 [2010-20277]
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50767
Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Institutional Review Boards—21 CFR
56.115 (OMB Control Number 0910–
0130)—Extension
When reviewing clinical research
studies regulated by FDA, IRBs are
required to create and maintain records
describing their operations, and make
the records available for FDA inspection
when requested. These records include:
Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; the research
protocols, informed consent documents,
progress reports, and reports of injuries
to subjects submitted by investigators to
the IRB; minutes of meetings showing
attendance, votes, and decisions made
by the IRB, the number of votes on each
decision for, against, and abstaining,
and the basis for requiring changes in
research or for disapproving research;
records of continuing review activities;
copies of all correspondence between
investigators and the IRB; statement of
significant new findings provided to
subjects of the research; and a list of IRB
members by name, showing each
member’s earned degrees, representative
capacity, and experience in sufficient
detail to describe each member’s
contributions to the IRB’s deliberations,
and any employment relationship
between each member and the IRB’s
institution. This information is used by
FDA in conducting audit inspections of
IRBs to determine whether IRBs and
clinical investigators are providing
adequate protections to human subjects
participating in clinical research.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
CFR Section
56.115
Annual Frequency
of Recordkeeping
2,500
Total Annual
Records
14.6
Hours per
Recordkeeper
36,500
100
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
The recordkeeping requirement
burden is based on the following: The
burden for each of the paragraphs under
21 CFR 56.115 has been considered as
one estimated burden. FDA estimates
that there are approximately 2,500 IRBs.
The IRBs meet on an average of 14.6
times annually. The agency estimates
that approximately 100 hours of persontime per meeting are required to meet
the requirements of the regulation.
Dated: August 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20273 Filed 8–16–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jdjones on DSK8KYBLC1PROD with NOTICES
3,650,000
3,650,000
1 There
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Total Hours
Notice.
VerDate Mar<15>2010
15:16 Aug 16, 2010
Jkt 220001
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.
SUMMARY:
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.
ADDRESSES:
Glioblastoma Diagnostics and
Therapeutics
Description of Invention: Investigators
at the NIH have discovered an Anti-TNF
Induced Apoptosis (ATIA) protein,
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which protects cells against apoptosis.
ATIA is highly expressed in
glioblastoma and astrocytomas and its
inhibition results in increased cell
sensitivity to TNF-related apoptosisinducing ligand induced cell death.
Hence, ATIA assays may enable
clinicians to effectively stratify patients
for appropriate treatment. ATIA exists
in a soluble form that can be detected
in culture medium of ATIA expressing
cells indicating it could be used to
develop a non-invasive, blood based
diagnostic test such as an ELISA.
Glioblastomas and astrocytomas can be
diagnosed via MRI and CT scans;
however, these scans cannot detect
tumor type, i.e. glioblastoma vs.
medulloblastoma. The investigators
found that ATIA is induced in cells
under hypoxia conditions. More
importantly, knockdown of ATIA in
human glioblastoma cells renders cells
to apoptosis under hypoxia conditions.
Therefore, ATIA is a potential novel
therapeutic target for treating human
glioblastoma.
Glioblastoma arise from astrocytes,
cells that provide neurons structural
and metabolic support. Glioblastomas
E:\FR\FM\17AUN1.SGM
17AUN1
50768
Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
account for twenty percent of primary
brain tumors and fifty percent of
astrocytomas. These indications are
designated as rare diseases as there is an
annual 2–3 newly diagnosed cases of
glioblastoma per 100,000 people in the
United States whereas the astrocytoma
incidence rate is 1.22 cases per 100,000
for individuals aged 0–19 years in the
United States.
Applications:
• Blood based diagnostic assays.
• Assay for clinicians to choose
effective treatments.
• Therapy to treat human
glioblastoma.
Advantages:
• Non-invasive diagnostics.
• Easy, ready to use assays.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market: Brain cancer market was
worth an estimated $1,094 million in
2009 and expected to reach $1.3 billion
by 2016.
Inventor: Zheng-gang Liu (NCI).
Patent Status: PCT Patent Application
No. PCT/US2010/36394 filed 27 May
2010 (HHS Reference No. E–178–2009/
0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Cell and
Cancer Biology Branch, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact John Hewes, Ph.D. at 301–435–
3131 or hewesj@mail.nih.gov for more
information.
jdjones on DSK8KYBLC1PROD with NOTICES
Inflammatory Genes and MicroRNA–21
as Biomarkers for Colon Cancer
Prognosis
Description of Invention: Colon
adenocarcinoma is the leading cause of
cancer mortality world-wide and
accounts for approximately 50,000
deaths annually in the United States.
Adjuvant therapies improve survival for
stage III colon cancer patients; however,
it remains controversial if stage II
patients should be given these therapies.
Some stage II patients will benefit from
therapy (such as patients with
undetectable micro-metastases where
surgery will not be curative); but
therapy for others will harm quality of
life with little therapeutic benefit (such
as patients where surgery removed all
cancerous tissue and therefore do not
need additional therapy). Thus, there is
a need to for biomarkers capable of
accurately identifying high risk, stage II
VerDate Mar<15>2010
15:16 Aug 16, 2010
Jkt 220001
patients that are suitable for therapeutic
intervention.
The investigators have identified an
inflammatory gene and microRNA
biomarker portfolio that can predict
aggressive colon cancer, colon cancer
patient survival, and patients that are
candidates for adjuvant therapy. These
biomarkers provide clinicians with a
powerful tool to diagnose colon cancer
patients and chose effective treatment
methods.
Applications:
• Method to predict aggressive form
of colon cancer, especially in stage II
cancer patients.
• Method to determine appropriate
colon cancer patients for adjuvant
therapy.
• Diagnostic arrays.
Advantages:
• Rapid, easy to use arrays to
accurately predict colon cancer and
patients suitable for adjuvant therapy.
• Method to stratify colon cancer
patients for adjuvant therapy to
minimize negative side effects.
• Method to identify stage II patients
that are likely to have undetectable
micro-metastases.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market:
• Global cancer market is worth more
than eight percent of total global
pharmaceutical sales.
• Cancer industry is predicted to
expand to $85.3 billion by 2010.
Inventors: Curtis C. Harris and Aaron
J. Schetter (NCI).
Relevant Publication: AJ Schetter et
al. MicroRNA expression profiles
associated with prognosis and
therapeutic outcome in colon
adenocarcinoma. JAMA. 2008 Jan
30;299(4):425–436. [PubMed:
18230780].
Patent Status: PCT Application No.
PCT/US09/058425 filed 25 Sep 2009,
which published as WO/2010/036924
on 01 Apr 2010 (HHS Reference No. E–
314–2008/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Laboratory of Human.
Carcinogenesis is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize cancer biomarkers and
therapeutic targets. Please contact
Curtis_Harris@nih.gov for more
information.
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Dated: August 11, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–20277 Filed 8–16–10; 8:45 am]
BILLING CODE 4140–01–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:
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.
SUMMARY:
A Novel Scaffold for Multivalent
Display of Ligands
Description of Invention: Multivalent
interactions are important in cell
attachment, wound healing and immune
responses. Such interactions are
associated with cancer metastasis, blood
clotting and the generation of antibodies
from a vaccination. Mimicking
multivalent interactions on a synthetic
scaffold is challenging especially when
large numbers of ligands (such as 5 or
more) need to be displayed. There are
numerous synthetic scaffolds that have
been developed, but there are significant
limitations that remain.
Scientists at the NIH have designed a
novel multivalent scaffold that can
display anywhere from 1 to 200 ligands.
This system allows different types of
ligands to be displayed in a controlled,
spatially-addressable manner. This
system uses peptide nucleic acids
(PNAs) containing g-substituted side
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50767-50768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20277]
-----------------------------------------------------------------------
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.
Glioblastoma Diagnostics and Therapeutics
Description of Invention: Investigators at the NIH have discovered
an Anti-TNF Induced Apoptosis (ATIA) protein, which protects cells
against apoptosis. ATIA is highly expressed in glioblastoma and
astrocytomas and its inhibition results in increased cell sensitivity
to TNF-related apoptosis-inducing ligand induced cell death. Hence,
ATIA assays may enable clinicians to effectively stratify patients for
appropriate treatment. ATIA exists in a soluble form that can be
detected in culture medium of ATIA expressing cells indicating it could
be used to develop a non-invasive, blood based diagnostic test such as
an ELISA. Glioblastomas and astrocytomas can be diagnosed via MRI and
CT scans; however, these scans cannot detect tumor type, i.e.
glioblastoma vs. medulloblastoma. The investigators found that ATIA is
induced in cells under hypoxia conditions. More importantly, knockdown
of ATIA in human glioblastoma cells renders cells to apoptosis under
hypoxia conditions. Therefore, ATIA is a potential novel therapeutic
target for treating human glioblastoma.
Glioblastoma arise from astrocytes, cells that provide neurons
structural and metabolic support. Glioblastomas
[[Page 50768]]
account for twenty percent of primary brain tumors and fifty percent of
astrocytomas. These indications are designated as rare diseases as
there is an annual 2-3 newly diagnosed cases of glioblastoma per
100,000 people in the United States whereas the astrocytoma incidence
rate is 1.22 cases per 100,000 for individuals aged 0-19 years in the
United States.
Applications:
Blood based diagnostic assays.
Assay for clinicians to choose effective treatments.
Therapy to treat human glioblastoma.
Advantages:
Non-invasive diagnostics.
Easy, ready to use assays.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market: Brain cancer market was worth an estimated $1,094 million
in 2009 and expected to reach $1.3 billion by 2016.
Inventor: Zheng-gang Liu (NCI).
Patent Status: PCT Patent Application No. PCT/US2010/36394 filed 27
May 2010 (HHS Reference No. E-178-2009/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Cell and Cancer Biology Branch, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize this technology. Please contact
John Hewes, Ph.D. at 301-435-3131 or hewesj@mail.nih.gov for more
information.
Inflammatory Genes and MicroRNA-21 as Biomarkers for Colon Cancer
Prognosis
Description of Invention: Colon adenocarcinoma is the leading cause
of cancer mortality world-wide and accounts for approximately 50,000
deaths annually in the United States. Adjuvant therapies improve
survival for stage III colon cancer patients; however, it remains
controversial if stage II patients should be given these therapies.
Some stage II patients will benefit from therapy (such as patients with
undetectable micro-metastases where surgery will not be curative); but
therapy for others will harm quality of life with little therapeutic
benefit (such as patients where surgery removed all cancerous tissue
and therefore do not need additional therapy). Thus, there is a need to
for biomarkers capable of accurately identifying high risk, stage II
patients that are suitable for therapeutic intervention.
The investigators have identified an inflammatory gene and microRNA
biomarker portfolio that can predict aggressive colon cancer, colon
cancer patient survival, and patients that are candidates for adjuvant
therapy. These biomarkers provide clinicians with a powerful tool to
diagnose colon cancer patients and chose effective treatment methods.
Applications:
Method to predict aggressive form of colon cancer,
especially in stage II cancer patients.
Method to determine appropriate colon cancer patients for
adjuvant therapy.
Diagnostic arrays.
Advantages:
Rapid, easy to use arrays to accurately predict colon
cancer and patients suitable for adjuvant therapy.
Method to stratify colon cancer patients for adjuvant
therapy to minimize negative side effects.
Method to identify stage II patients that are likely to
have undetectable micro-metastases.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market:
Global cancer market is worth more than eight percent of
total global pharmaceutical sales.
Cancer industry is predicted to expand to $85.3 billion by
2010.
Inventors: Curtis C. Harris and Aaron J. Schetter (NCI).
Relevant Publication: AJ Schetter et al. MicroRNA expression
profiles associated with prognosis and therapeutic outcome in colon
adenocarcinoma. JAMA. 2008 Jan 30;299(4):425-436. [PubMed: 18230780].
Patent Status: PCT Application No. PCT/US09/058425 filed 25 Sep
2009, which published as WO/2010/036924 on 01 Apr 2010 (HHS Reference
No. E-314-2008/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The NCI Laboratory of Human.
Carcinogenesis is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize cancer biomarkers and therapeutic targets.
Please contact Curtis_Harris@nih.gov for more information.
Dated: August 11, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-20277 Filed 8-16-10; 8:45 am]
BILLING CODE 4140-01-P
