Government-Owned Inventions; Availability for Licensing, 70788-70791 [2012-28630]
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wreier-aviles on DSK5TPTVN1PROD with
tracking quality improvement over time
(for example, measure selection criteria,
data collection and reporting
requirements)? What strategies
(including those related to health
information technology) could mitigate
these challenges?
3. Describe current public reporting or
transparency efforts that states and
private entities use to display health
care quality information.
4. How do health insurance issuers
currently monitor the performance of
hospitals and other providers with
which they have relationships? Do
health insurance issuers monitor patient
safety statistics, such as hospital
acquired conditions and mortality
outcomes, and if so, how? Do health
insurance issuers monitor care
coordination activities, such as hospital
discharge planning activities, and
outcomes of care coordination activities,
and if so, how?
Applicability to the Health Insurance
Exchange Marketplace
5. What opportunities exist to further
the goals of the National Quality
Strategy through quality reporting
requirements in the Exchange
marketplace?
6. What quality measures or measure
sets currently required or recognized by
states, accrediting entities, or CMS are
most relevant to the Exchange
marketplace?
7. Are there any gaps in current
clinical measure sets that may create
challenges for capturing experience in
the Exchange?
8. What are some issues to consider in
establishing requirements for an issuer’s
quality improvement strategy? How
might an Exchange evaluate the
effectiveness of quality improvement
strategies across plans and issuers?
What is the value in narrative reports to
assess quality improvement strategies?
9. What methods should be used to
capture and display quality
improvement activities? Which publicly
and privately funded activities to
promote data collection and
transparency could be leveraged (for
example, Meaningful Use Incentive
Program) to inform these methods?
10. What are the priority areas for the
quality rating in the Exchange
marketplace? (for example, delivery of
specific preventive services, health plan
performance and customer service)?
Should these be similar to or different
from the Medicare Advantage five-star
quality rating system (for example,
staying healthy: screenings, tests and
vaccines; managing chronic (long-term)
conditions; ratings of health plan
responsiveness and care; health plan
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members’ complaints and appeals; and
health plan telephone customer
service)? 3
11. What are effective ways to display
quality ratings that would be
meaningful for Exchange consumers and
small employers, especially drawing on
lessons learned from public reporting
and transparency efforts that states and
private entities use to display health
care quality information?
12. What types of methodological
challenges may exist with public
reporting of quality data in an
Exchange? What suggested strategies
would facilitate addressing these issues?
13. Describe any strategies that states
are considering to align quality
reporting requirements inside and
outside the Exchange marketplace, such
as creating a quality rating for
commercial plans offered in the nonExchange individual market.
14. Are there methods or strategies
that should be used to track the quality,
impact and performance of services for
those with accessibility and
communication barriers, such as
persons with disabilities or limited
English proficiency?
15. What factors should HHS consider
in designing an approach to calculate
health plan value that would be
meaningful to consumers? What are
potential benefits and limitations of
these factors? How should Exchanges
align their programs with value-based
purchasing and other new payment
models (for example, Accountable Care
Organizations) being implemented by
payers?
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 6, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: November 16, 2012.
Kathleen Sebelius,
Secretary.
AGENCY:
[FR Doc. 2012–28473 Filed 11–23–12; 11:15 am]
BILLING CODE 4120–01–P
3 For more information on Medicare Advantage
rating system domains see https://www.cms.gov/
Medicare/Health-Plans/HealthPlansGenInfo/
Downloads/2013-Call-Letter.pdf; https://
www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovGenIn/
PerformanceData.html.
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Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Cancellation of Meeting
Name: National Advisory Council on
Migrant Health.
Dates and Times: December 4, 2012,
8:30 a.m. to 5:00 p.m. December 5, 2012,
8:00 a.m. to 12:00 p.m.
STATUS: The meeting of the National
Advisory Council on Migrant Health,
scheduled for December 4 and 5, 2012,
is cancelled. This cancellation applies
to all sessions of the meeting. The
meeting was announced in the Federal
Register of November 8, 2012 (77 FR
67014).
FOR FURTHER INFORMATION CONTACT:
Gladys Cate, Office of Special
Population Health, Bureau of Primary
Health Care, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 15–74, Rockville, Maryland
20857; telephone (301) 594–0367.
Dated: November 20, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–28699 Filed 11–26–12; 8:45 am]
BILLING CODE 4165–15–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.
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.
FOR FURTHER INFORMATION CONTACT:
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,
SUMMARY:
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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Notices
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.
wreier-aviles on DSK5TPTVN1PROD with
Axon Regeneration After Brain or
Spinal Cord Injury
Description of Technology: The
invention is directed to modification of
a particular sugar by the enzyme
arylsulfatase B (ARSB), which results in
axon regeneration.
Following traumatic brain or spinal
cord injury, glial scars prevent
regeneration of axons. Chondroitin
sulfate proteoglycans (CSPGs) are major
components of glial scars. CSPGs are
made of a protein core containing
glycosaminoglycan (GAG) sugar side
chains, which, when sulfated, are
responsible for the inhibitory activity of
glial scars. Specifically, NIH researchers
have shown that the 4-sulfate unit on a
certain sugar on GAG is responsible for
inhibiting axon regrowth and, when the
4-sulfate unit is reduced, axon regrowth
is observed. Moreover, removal of this
4-sulfate unit by the ARSB enzyme
promotes axon regrowth.
As a potential therapy for spinal cord
injuries, researchers developed a vector
expressing ARSB and demonstrated that
this vector promotes axon regeneration
when injected into the spinal cord of a
mouse.
Potential Commercial Applications:
• Treatment of brain and spinal cord
injury.
• Treatment of other CNS injuries,
including stroke.
• Treatment of heart attack.
Competitive Advantages:
• There are no existing products for
treatment of traumatic spinal cord
injury.
• ARSB is already approved for
treatment of Mucopolysaccharoidosis
VI, a lysosomal storage disease.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Herbert M. Geller and
Yasuhiro Katagiri (NHLBI).
Publication: Wang H, et al.
Chondroitin-4-sulfation negatively
regulates axonal guidance and growth. J
Cell Sci. 2008 Sep 15;121(Pt 18):3083–
91. [PMID 18768934].
Intellectual Property: HHS Reference
No. E–214–2012/0—U.S. Provisional
Application No. 61/705,555 filed 25
Sept 2012.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
Lauren.Nguyen-antczak@nih.gov.
Collaborative Research Opportunity:
The NHLBI is seeking statements of
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capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the use of ARSB in
axonal regeneration after brain or spinal
cord injury using animal models. For
collaboration opportunities, please
contact Denise Crooks, Ph.D. at 301–
435–0103 or crooksd@mail.nih.gov.
Nitric Oxide-Releasing
Polyvinylpyrrolidone-Based Polymers
for Wound Healing and Related
Applications
Description of Technology: Novel
nitric oxide-releasing
polyvinylpyrrolidone-based polymers,
their compositions, and use in treating
wounds. The disclosed polymers appear
to be stable, biocompatible and
bioabsorbable, while providing for
extended nitric oxide release at
therapeutic levels. The invention also
encompasses medical devices, such as
wound dressings and bandages, which
include the polymers and are capable of
releasing nitric oxide when in use.
These devices may be used to treat a
wound, various infections, and
dermatological conditions.
The therapeutic efficacy of nitric
oxide has been demonstrated for many
indications, including wound healing.
As wounds are deficient in nitric oxide,
its application has been shown to have
beneficial effects on wound healing by
promoting angiogenesis and tissue
remodeling.
Potential Commercial Applications:
Wound healing, infections, and
dermatological conditions.
Competitive Advantages: The claimed
nitric oxide-releasing polymers are
bioabsorbable and release greater
amounts of nitric oxide over a greater
period of time than other NO-releasing
polymers.
Development Stage:
• Early-stage.
• Pre-clinical.
Inventors: Joseph A. Hrabie and Larry
K. Keefer (NCI).
Intellectual Property: HHS Reference
No. E–157–2012/0—US Provisional
Application No. 61/672,486 filed 17 Jul
2012.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Gag-Based DNA Vaccines Against HIV
Description of Technology: Novel
DNA vaccine constructs against HIV
that express highly conserved elements
(CE) within the HIV Gag protein and
elicit strong, cross-clade cellular and
humoral responses. The DNA vaccine
vectors were engineered to express CEs
for protection against different clades of
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HIV and prevention of
immunodominance, two issues
associated with current HIV vaccine
candidates.
In vivo studies of Rhesus macaques
vaccinated with variants of these
constructs expressing seven highly CEs
covering >99 of all known Gag
sequences elicited strong, cellular T-cell
and humoral antibody immune
responses. The Gag-specific antibody
responses were high titer and crossclade. Cross-clade protection is
important given the sequence diversity
of HIV as is the absence of
immunodominant epitopes that generate
antibodies which are not protective
against HIV.
Potential Commercial Applications:
HIV vaccines.
Competitive Advantages: Addresses
two key hurdles faced by current HIV
vaccines: sequence diversity of HIV and
immunodominance.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: George N. Pavlakis (NCI),
Barbara K. Felber (NCI), James Mullins
(University of Washington).
Intellectual Property: HHS Reference
No. E–132–2012/0—U.S. Provisional
Application No. 61/606,265 filed 02 Mar
2012.
Related Technology: HHS Reference
No. E–308–2000/0—Patent family filed
in the U.S., Canada, Australia, Europe,
and Japan.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov.
Diagnostic Test and Therapeutic Target
for Sjogren’s Syndrome
¨
Description of Technology: Sjogren’s
syndrome is an autoimmune disease
that attacks salivary glands resulting in
chronic dry mouth and dry eyes.
Currently, there is no single diagnostic
¨
test to confirm the presence of Sjogren’s.
Physicians presently reach diagnosis
after conducting a series of blood and
functional tests for tear and salivary
production. Diagnosis is further
¨
complicated as Sjogren’s symptoms
frequently mimic those of other
autoimmune diseases (e.g., lupus,
rheumatoid arthritis, etc.) and is often
overlooked as dryness associated with
medications being taken by the patient.
Researchers at NIDCR have identified
overexpression of a growth factor, bone
morphogenetic protein 6 (BMP6), in
¨
patients with Sjogren’s. By detecting
BMP6 expression and/or activity, this
invention potentially presents a singular
confirmation to diagnose those suffering
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wreier-aviles on DSK5TPTVN1PROD with
and those at risk for developing
¨
Sjogren’s. BMP6 also presents a
potential therapeutic target for
¨
Sjogren’s, a disease for which there is
presently no cure.
Researchers have also discovered
unique expression profiles for two other
genes (XIST and MECP2) in male
¨
Sjogren’s patients. Detecting aberrant
expression and/or activity of these genes
also offer a potential singular test for
¨
diagnosing Sjogren’s in male subjects.
Potential Applications:
• Singular diagnostic test to diagnose
¨
Sjogren’s.
• Therapeutic target to develop
¨
treatment for Sjogren’s.
Competitive Advantages:
• Currently no single test available to
¨
diagnose Sjogren’s.
• Currently there is no cure for
¨
Sjogren’s; present palliative treatments
only reduce symptoms (e.g., moisture
replacement therapy for eyes and
mouth, and systemic anti-inflammatory
or immunosuppressive agents for more
advanced forms of disease).
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
• In vivo data available (human).
Inventor: John Chiorini (NIDCR).
Publication: Dix DJ, et al. Targeted
gene disruption of Hsp70–2 results in
failed meiosis, germ cell apoptosis, and
male infertility. Proc Natl Acad Sci
USA. 1996 Apr 16;93(8):3264–8. [PMID
8622925].
Intellectual Property: HHS Reference
No. E–232–2011/0–US–01—U.S.
Provisional Application No. 61/540,364
filed 28 Sep 2011.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
Lauren.Nguyen-antczak@nih.gov.
Collaborative Research Opportunity:
The NIDCR is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize BMP6 Based Diagnosis
¨
and Treatment of Sjogren’s. For
collaboration opportunities, please
contact David W. Bradley, Ph.D. at
bradleyda@nidcr.nih.gov.
Use of PAMP (Proadrenomedullin NTerminal 20 Peptide) and PAMP
Inhibitors for the Treatment of Cancer,
Cardiovascular Disease, and Other
Angiogenesis-Related Diseases
Description of Technology: This
technology details the use of PAMP or
PAMP derivatives as a means to induce
angiogenesis in tissue, as well as the use
of PAMP inhibitors to inhibit
angiogenesis.
PAMP (Proadrenomedullin Nterminal 20 peptide) is a 20 amino-acid
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molecule originating from the posttranslational processing of preproadrenomedullin. PAMP is known as
a potent hypotensive and vasodilatory
agent; however, in addition to these
properties, the inventors have
discovered that PAMP also functions as
a potent angiogenic factor. The
inventors have also shown that an
inhibitory fragment of PAMP, PAMP
(12–20), is able to delay tumor growth
in xenograft models of tumor
progression. The ability to promote
angiogenesis can be used as a means to
increase vascularization in specific
tissue areas or to treat patients with
ischemic diseases. In contrast, the
ability to inhibit this process can be
used to limit growth of solid tumors and
as a therapy for retinopathies,
endometriosis, or arthritis.
Potential Commercial Applications:
• PAMP and derivatives may be used
as treatments for ischemic disease or
coronary artery disease and to promote
vascularization in graft tissues.
• PAMP inhibitors may be used as
treatments to limit growth of solid
tumors or other angiogenesis-related
disease.
Competitive Advantages:
• PAMP exhibits a potent angiogenic
potential at femtomolar concentrations,
as opposed to nanomolar concentrations
of other growth factors such as bFGF
and VEGF.
• PAMP and PAMP inhibitors
provide a new mechanism for
modulation of angiogenesis and
treatment of angiogenesis-related
diseases.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventor: Frank F Cuttitta (NCI).
Publication: Martinez A, et al.
Proadrenomedullin NH2-terminal 20
peptide is a potent angiogenic factor,
and its inhibition results in reduction of
tumor growth. Cancer Res. 2004 Sep
15;64(18):6489–94. [PMID 15374959].
Intellectual Property: HHS Reference
No. E–294–2002/0—
• US Patent No. 7,462,593, Issued 09
Dec 2008.
• US Patent No. 7,862,815, Issued 04
Jan 2011.
• Foreign counterparts in Australia,
Canada, and Japan.
Licensing Contact: Tara Kirby, Ph.D.;
301–435–4426; tarak@mail.nih.gov.
Methods for Measuring
Adrenomedullin and Monitoring and
Treating Adrenomedullin-Mediated
Diseases, Such as Diabetes and Cancer
Description of Technology: The
technology includes methods for
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utilizing purified adrenomedullin (AM)binding proteins, or functional portions
thereof, to diagnose, treat, and monitor
AM-related diseases such as diabetes
and cancer. Antibodies and smallmolecule antagonists, which can downregulate the function of AM,
Complement Factor-H (CFH), and the
AM–CFH complex, have also been
isolated.
AM is a ubiquitously-expressed
peptide that functions as a universal
autocrine growth factor. AM drives cell
proliferation, acts as a vasodilator, can
protect cells against oxidative stress in
hypoxic injury, and acts as a dosedependent inhibitor of insulin secretion.
Methods for measuring in vivo levels of
AM accurately and regulating the
activity of available AM may be
critically important in diagnosis and
treatment of many conditions, such as
heart disease, pulmonary disease,
cirrhosis, cancer, diabetes, sepsis, and
inflammation.
This technology centers on the
observation that AM binds to CFH in
vivo. Without a means to determine the
amount of AM that is bound to CFH,
measurements of AM are inaccurate.
Furthermore, therapies focused on the
AM–CFH complex may have advantages
over therapies focused on AM alone.
Potential Commercial Applications:
• Methods for diagnosis and
treatment of conditions, such as cancer,
diabetes, or other conditions influenced
by AM levels.
• AM-specific antibodies could be
used in a diagnostic assay to measure
levels of AM.
Competitive Advantages:
• More accurate measurements of
serum adrenomedullin than current
tests.
• Targeting AM–CFH decreases
bioavailable AM, provides an additional
pathway for modulating angiogenesis.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventor: Frank F Cuttitta (NCI).
Publications:
´
1. Martınez A, et al. Mapping of the
adrenomedullin-binding domains in
human complement factor H. Hypertens
Res. 2003 Feb;26 Suppl:S55–9. [PMID
12630812 ]
2. Pio R, et al. Complement factor H
is a serum-binding protein for
adrenomedullin, and the resulting
complex modulates the bioactivities of
both partners. J Biol Chem. 2001 Apr
13;276(15):12292–300. [PMID 11116141]
3. Miller MJ, et al. Adrenomedullin
expression in human tumor cell lines.
Its potential role as an autocrine growth
factor. J Biol Chem. 1996 Sep
20;271(38):23345–51. [PMID 8798536]
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Intellectual Property: HHS Reference
No. E–256–1999/0—
• PCT Application No. PCT/US00/
24722 filed 08 Sep 2000.
• US Patent No. 7,659,081 issued 09
Feb 2010.
• US Patent No. 7,993,857 issued 09
Aug 2011.
Licensing Contact: Tara Kirby, Ph.D.;
301–435–4426; tarak@mail.nih.gov.
Dated: November 20, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–28630 Filed 11–26–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
wreier-aviles on DSK5TPTVN1PROD with
Pursuant to section 10(d) of the
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amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
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provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Planning (R34) Grants and Implementation
Cooperative Agreements (U01).
Date: December 19, 2012.
Time: 12:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities/
NIAID, National Institutes of Health, 6700B
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Research, National Institutes of Health, HHS)
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Dated: November 20, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28633 Filed 11–26–12; 8:45 am]
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National Institute of Diabetes and
Digestive and Kidney Diseases Notice
of Closed Meetings
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Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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as amended. The grant applications and
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would constitute a clearly unwarranted
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Name of Committee: National Institute of
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Awards Review.
Date: December 13, 2012.
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Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
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Conference Call).
Contact Person: Carol J. Goter-Robinson,
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Branch, DEA, NIDDK, National Institutes of
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This notice is being published less than 15
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Name of Committee: National Institute of
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Date: February 4–5, 2013.
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Agenda: To review and evaluate grant
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Place: Melrose Hotel, 2430 Pennsylvania
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Contact Person: Carol J. Goter-Robinson,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 748, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
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70791
594–7791,
goterrobinsonc@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
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Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 20, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28632 Filed 11–26–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institute of Neurological
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Meetings
Pursuant to section 10(d) of the
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amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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 materials,
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
Neurological Disorders and Stroke Special
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Date: November 30, 2012.
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Place: National Institutes of Health,
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Name of Committee: National Institute of
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Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70788-70791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28630]
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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.
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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.
FOR FURTHER INFORMATION CONTACT: 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,
[[Page 70789]]
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.
Axon Regeneration After Brain or Spinal Cord Injury
Description of Technology: The invention is directed to
modification of a particular sugar by the enzyme arylsulfatase B
(ARSB), which results in axon regeneration.
Following traumatic brain or spinal cord injury, glial scars
prevent regeneration of axons. Chondroitin sulfate proteoglycans
(CSPGs) are major components of glial scars. CSPGs are made of a
protein core containing glycosaminoglycan (GAG) sugar side chains,
which, when sulfated, are responsible for the inhibitory activity of
glial scars. Specifically, NIH researchers have shown that the 4-
sulfate unit on a certain sugar on GAG is responsible for inhibiting
axon regrowth and, when the 4-sulfate unit is reduced, axon regrowth is
observed. Moreover, removal of this 4-sulfate unit by the ARSB enzyme
promotes axon regrowth.
As a potential therapy for spinal cord injuries, researchers
developed a vector expressing ARSB and demonstrated that this vector
promotes axon regeneration when injected into the spinal cord of a
mouse.
Potential Commercial Applications:
Treatment of brain and spinal cord injury.
Treatment of other CNS injuries, including stroke.
Treatment of heart attack.
Competitive Advantages:
There are no existing products for treatment of traumatic
spinal cord injury.
ARSB is already approved for treatment of
Mucopolysaccharoidosis VI, a lysosomal storage disease.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Herbert M. Geller and Yasuhiro Katagiri (NHLBI).
Publication: Wang H, et al. Chondroitin-4-sulfation negatively
regulates axonal guidance and growth. J Cell Sci. 2008 Sep 15;121(Pt
18):3083-91. [PMID 18768934].
Intellectual Property: HHS Reference No. E-214-2012/0--U.S.
Provisional Application No. 61/705,555 filed 25 Sept 2012.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; Lauren.Nguyen-antczak@nih.gov.
Collaborative Research Opportunity: The NHLBI is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize the use of ARSB
in axonal regeneration after brain or spinal cord injury using animal
models. For collaboration opportunities, please contact Denise Crooks,
Ph.D. at 301-435-0103 or crooksd@mail.nih.gov.
Nitric Oxide-Releasing Polyvinylpyrrolidone-Based Polymers for Wound
Healing and Related Applications
Description of Technology: Novel nitric oxide-releasing
polyvinylpyrrolidone-based polymers, their compositions, and use in
treating wounds. The disclosed polymers appear to be stable,
biocompatible and bioabsorbable, while providing for extended nitric
oxide release at therapeutic levels. The invention also encompasses
medical devices, such as wound dressings and bandages, which include
the polymers and are capable of releasing nitric oxide when in use.
These devices may be used to treat a wound, various infections, and
dermatological conditions.
The therapeutic efficacy of nitric oxide has been demonstrated for
many indications, including wound healing. As wounds are deficient in
nitric oxide, its application has been shown to have beneficial effects
on wound healing by promoting angiogenesis and tissue remodeling.
Potential Commercial Applications: Wound healing, infections, and
dermatological conditions.
Competitive Advantages: The claimed nitric oxide-releasing polymers
are bioabsorbable and release greater amounts of nitric oxide over a
greater period of time than other NO-releasing polymers.
Development Stage:
Early-stage.
Pre-clinical.
Inventors: Joseph A. Hrabie and Larry K. Keefer (NCI).
Intellectual Property: HHS Reference No. E-157-2012/0--US
Provisional Application No. 61/672,486 filed 17 Jul 2012.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Gag-Based DNA Vaccines Against HIV
Description of Technology: Novel DNA vaccine constructs against HIV
that express highly conserved elements (CE) within the HIV Gag protein
and elicit strong, cross-clade cellular and humoral responses. The DNA
vaccine vectors were engineered to express CEs for protection against
different clades of HIV and prevention of immunodominance, two issues
associated with current HIV vaccine candidates.
In vivo studies of Rhesus macaques vaccinated with variants of
these constructs expressing seven highly CEs covering >99 of all known
Gag sequences elicited strong, cellular T-cell and humoral antibody
immune responses. The Gag-specific antibody responses were high titer
and cross-clade. Cross-clade protection is important given the sequence
diversity of HIV as is the absence of immunodominant epitopes that
generate antibodies which are not protective against HIV.
Potential Commercial Applications: HIV vaccines.
Competitive Advantages: Addresses two key hurdles faced by current
HIV vaccines: sequence diversity of HIV and immunodominance.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: George N. Pavlakis (NCI), Barbara K. Felber (NCI), James
Mullins (University of Washington).
Intellectual Property: HHS Reference No. E-132-2012/0--U.S.
Provisional Application No. 61/606,265 filed 02 Mar 2012.
Related Technology: HHS Reference No. E-308-2000/0--Patent family
filed in the U.S., Canada, Australia, Europe, and Japan.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov.
Diagnostic Test and Therapeutic Target for Sjogren's Syndrome
Description of Technology: Sj[ouml]gren's syndrome is an autoimmune
disease that attacks salivary glands resulting in chronic dry mouth and
dry eyes. Currently, there is no single diagnostic test to confirm the
presence of Sj[ouml]gren's. Physicians presently reach diagnosis after
conducting a series of blood and functional tests for tear and salivary
production. Diagnosis is further complicated as Sj[ouml]gren's symptoms
frequently mimic those of other autoimmune diseases (e.g., lupus,
rheumatoid arthritis, etc.) and is often overlooked as dryness
associated with medications being taken by the patient.
Researchers at NIDCR have identified overexpression of a growth
factor, bone morphogenetic protein 6 (BMP6), in patients with
Sj[ouml]gren's. By detecting BMP6 expression and/or activity, this
invention potentially presents a singular confirmation to diagnose
those suffering
[[Page 70790]]
and those at risk for developing Sj[ouml]gren's. BMP6 also presents a
potential therapeutic target for Sj[ouml]gren's, a disease for which
there is presently no cure.
Researchers have also discovered unique expression profiles for two
other genes (XIST and MECP2) in male Sj[ouml]gren's patients. Detecting
aberrant expression and/or activity of these genes also offer a
potential singular test for diagnosing Sj[ouml]gren's in male subjects.
Potential Applications:
Singular diagnostic test to diagnose Sj[ouml]gren's.
Therapeutic target to develop treatment for
Sj[ouml]gren's.
Competitive Advantages:
Currently no single test available to diagnose
Sj[ouml]gren's.
Currently there is no cure for Sj[ouml]gren's; present
palliative treatments only reduce symptoms (e.g., moisture replacement
therapy for eyes and mouth, and systemic anti-inflammatory or
immunosuppressive agents for more advanced forms of disease).
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
In vivo data available (human).
Inventor: John Chiorini (NIDCR).
Publication: Dix DJ, et al. Targeted gene disruption of Hsp70-2
results in failed meiosis, germ cell apoptosis, and male infertility.
Proc Natl Acad Sci USA. 1996 Apr 16;93(8):3264-8. [PMID 8622925].
Intellectual Property: HHS Reference No. E-232-2011/0-US-01--U.S.
Provisional Application No. 61/540,364 filed 28 Sep 2011.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; Lauren.Nguyen-antczak@nih.gov.
Collaborative Research Opportunity: The NIDCR is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize BMP6 Based
Diagnosis and Treatment of Sj[ouml]gren's. For collaboration
opportunities, please contact David W. Bradley, Ph.D. at
bradleyda@nidcr.nih.gov.
Use of PAMP (Proadrenomedullin N-Terminal 20 Peptide) and PAMP
Inhibitors for the Treatment of Cancer, Cardiovascular Disease, and
Other Angiogenesis-Related Diseases
Description of Technology: This technology details the use of PAMP
or PAMP derivatives as a means to induce angiogenesis in tissue, as
well as the use of PAMP inhibitors to inhibit angiogenesis.
PAMP (Proadrenomedullin N-terminal 20 peptide) is a 20 amino-acid
molecule originating from the post-translational processing of pre-
proadrenomedullin. PAMP is known as a potent hypotensive and
vasodilatory agent; however, in addition to these properties, the
inventors have discovered that PAMP also functions as a potent
angiogenic factor. The inventors have also shown that an inhibitory
fragment of PAMP, PAMP (12-20), is able to delay tumor growth in
xenograft models of tumor progression. The ability to promote
angiogenesis can be used as a means to increase vascularization in
specific tissue areas or to treat patients with ischemic diseases. In
contrast, the ability to inhibit this process can be used to limit
growth of solid tumors and as a therapy for retinopathies,
endometriosis, or arthritis.
Potential Commercial Applications:
PAMP and derivatives may be used as treatments for
ischemic disease or coronary artery disease and to promote
vascularization in graft tissues.
PAMP inhibitors may be used as treatments to limit growth
of solid tumors or other angiogenesis-related disease.
Competitive Advantages:
PAMP exhibits a potent angiogenic potential at femtomolar
concentrations, as opposed to nanomolar concentrations of other growth
factors such as bFGF and VEGF.
PAMP and PAMP inhibitors provide a new mechanism for
modulation of angiogenesis and treatment of angiogenesis-related
diseases.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventor: Frank F Cuttitta (NCI).
Publication: Martinez A, et al. Proadrenomedullin NH2-terminal 20
peptide is a potent angiogenic factor, and its inhibition results in
reduction of tumor growth. Cancer Res. 2004 Sep 15;64(18):6489-94.
[PMID 15374959].
Intellectual Property: HHS Reference No. E-294-2002/0--
US Patent No. 7,462,593, Issued 09 Dec 2008.
US Patent No. 7,862,815, Issued 04 Jan 2011.
Foreign counterparts in Australia, Canada, and Japan.
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
tarak@mail.nih.gov.
Methods for Measuring Adrenomedullin and Monitoring and Treating
Adrenomedullin-Mediated Diseases, Such as Diabetes and Cancer
Description of Technology: The technology includes methods for
utilizing purified adrenomedullin (AM)-binding proteins, or functional
portions thereof, to diagnose, treat, and monitor AM-related diseases
such as diabetes and cancer. Antibodies and small-molecule antagonists,
which can down-regulate the function of AM, Complement Factor-H (CFH),
and the AM-CFH complex, have also been isolated.
AM is a ubiquitously-expressed peptide that functions as a
universal autocrine growth factor. AM drives cell proliferation, acts
as a vasodilator, can protect cells against oxidative stress in hypoxic
injury, and acts as a dose-dependent inhibitor of insulin secretion.
Methods for measuring in vivo levels of AM accurately and regulating
the activity of available AM may be critically important in diagnosis
and treatment of many conditions, such as heart disease, pulmonary
disease, cirrhosis, cancer, diabetes, sepsis, and inflammation.
This technology centers on the observation that AM binds to CFH in
vivo. Without a means to determine the amount of AM that is bound to
CFH, measurements of AM are inaccurate. Furthermore, therapies focused
on the AM-CFH complex may have advantages over therapies focused on AM
alone.
Potential Commercial Applications:
Methods for diagnosis and treatment of conditions, such as
cancer, diabetes, or other conditions influenced by AM levels.
AM-specific antibodies could be used in a diagnostic assay
to measure levels of AM.
Competitive Advantages:
More accurate measurements of serum adrenomedullin than
current tests.
Targeting AM-CFH decreases bioavailable AM, provides an
additional pathway for modulating angiogenesis.
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventor: Frank F Cuttitta (NCI).
Publications:
1. Mart[iacute]nez A, et al. Mapping of the adrenomedullin-binding
domains in human complement factor H. Hypertens Res. 2003 Feb;26
Suppl:S55-9. [PMID 12630812 ]
2. Pio R, et al. Complement factor H is a serum-binding protein for
adrenomedullin, and the resulting complex modulates the bioactivities
of both partners. J Biol Chem. 2001 Apr 13;276(15):12292-300. [PMID
11116141]
3. Miller MJ, et al. Adrenomedullin expression in human tumor cell
lines. Its potential role as an autocrine growth factor. J Biol Chem.
1996 Sep 20;271(38):23345-51. [PMID 8798536]
[[Page 70791]]
Intellectual Property: HHS Reference No. E-256-1999/0--
PCT Application No. PCT/US00/24722 filed 08 Sep 2000.
US Patent No. 7,659,081 issued 09 Feb 2010.
US Patent No. 7,993,857 issued 09 Aug 2011.
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
tarak@mail.nih.gov.
Dated: November 20, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-28630 Filed 11-26-12; 8:45 am]
BILLING CODE 4140-01-P
