Government-Owned Inventions; Availability for Licensing, 16691-16694 [E8-6316]
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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices
a deeming organization for HHAs. In the
proposed notice, we detailed our
evaluation criteria. Under section
1865(b)(2) of the Act and our regulations
at § 488.4 (Application and
reapplication procedures for
accreditation organizations), we
conducted a review of The Joint
Commission’s application in accordance
with the criteria specified by our
regulation, which include, but are not
limited to the following:
• An onsite administrative review of
The Joint Commission’s (1) Corporate
policies; (2) financial and human
resources available to accomplish the
proposed surveys; (3) procedures for
training, monitoring, and evaluation of
its surveyors; (4) ability to investigate
and respond appropriately to
complaints against accredited facilities;
and (5) survey review and decisionmaking process for accreditation.
• A comparison of The Joint
Commission’s HHA accreditation
standards to our current Medicare HHA
conditions for participation.
• A documentation review of The
Joint Commission’s survey processes to:
++ Determine the composition of the
survey team, surveyor qualifications,
and the ability of The Joint Commission
to provide continuing surveyor training.
++ Compare The Joint Commission’s
processes to those of State survey
agencies, including survey frequency,
and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ Evaluate The Joint Commission’s
procedures for monitoring providers or
suppliers found to be out of compliance
with The Joint Commission program
requirements. The monitoring
procedures are used only when The
Joint Commission identifies
noncompliance. If noncompliance is
identified through validation reviews,
the survey agency monitors corrections
as specified at § 488.7(d).
++ Assess The Joint Commission’s
ability to report deficiencies to the
surveyed facilities and respond to the
facility’s plan of correction in a timely
manner.
++ Establish The Joint Commission’s
ability to provide us with electronic
data in ASCII-comparable code and
reports necessary for effective validation
and assessment of The Joint
Commission’s survey process.
++ Determine the adequacy of staff
and other resources.
++ Review The Joint Commission’s
ability to provide adequate funding for
performing required surveys.
++ Confirm The Joint Commission’s
policies with respect to whether surveys
are announced or unannounced.
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++ Obtain The Joint Commission’s
agreement to provide us with a copy of
the most current accreditation survey
together with any other information
related to the survey as we may require,
including corrective action plans.
In accordance with section
1865(b)(3)(A) of the Act, the October 26,
2007 proposed notice (72 FR 60855) also
solicited public comments regarding
whether The Joint Commission’s
requirements met or exceeded the
Medicare conditions of participation for
HHAs. We received no public comments
in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the Joint
Commission’s Standards and
Requirements for Accreditation and
Medicare’s Conditions and Survey
Requirements
We compared the standards contained
in The Joint Commission’s
Comprehensive Accreditation Manual
for Home Care and its survey process in
The Joint Commission’s Application for
Continued Home Health Deeming
Authority with the Medicare HHA
conditions for participation and our
State Operations Manual (SOM). Our
review and evaluation of The Joint
Commission’s deeming application,
which were conducted as described in
section III of this final notice, yielded
the following:
• To meet the requirements for initial
home health certification surveys listed
in the SOM at 2200A5, The Joint
Commission revised its standards to
reflect the requirement that HHAs must
have provided care to a minimum of ten
patients and at least seven of the ten
patients are receiving care at the time of
the initial survey.
• To meet the requirements for initial
certification surveys listed in the SOM
at 2200A5, The Joint Commission
revised it standards to reflect the
requirement that HHAs must provide
nursing and at least one other
therapeutic service.
• To meet the requirements listed in
the SOM at 2200C4, The Joint
Commission updated its home care
surveyor activity guide to reflect that all
patients (private pay and Medicare
beneficiaries) are included in the
clinical record review or selection of
home visits for a Medicare certification
survey.
• To meet the requirements of
§ 488.28(a), The Joint Commission will
no longer issue supplemental findings
for HHAs seeking deemed status. All
deficiencies identified during a
certification survey will be cited as
requirements for improvement which
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the HHA will be required to submit a
written plan of correction.
• To meet the requirements at
488.8(a)(3), The Joint Commission has
agreed to provide CMS with a copy of
its most current accreditation survey
along with any other related information
that CMS requires, including corrected
action plans, when requested.
B. Term of Approval
Based on the review and observations
described in section III of this final
notice, we have determined that The
Joint Commission’s requirements for
HHAs meet or exceed our requirements.
Therefore, we approve The Joint
Commission as a national accreditation
organization for HHAs that request
participation in the Medicare program,
effective March 31, 2008 through March
31, 2014.
V. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplemental Medical Insurance
Program)
Dated: January 25, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–5074 Filed 3–27–08; 8:45 am]
BILLING CODE 4120–01–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
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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices
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.
sroberts on PROD1PC70 with NOTICES
Cell Line PE, Developed From Mouse
Skin Tumors, Demonstrates Unique
Qualities
Description of Technology: Available
for licensing is the mouse skin tumor
cell line PE. These skin tumor cells were
isolated from papilloma cells induced
by chemical carcinogens. The PE cell
lines differ from normal keratinocytes in
their ability to maintain a proliferating
population under conditions favoring
terminal differentiation, their consistent
proliferative response to phorbol esters
under these same conditions, and their
reduced sensitivity to phorbol esterinduced terminal differentiation. All of
these properties should provide a
growth advantage to these cells during
tumor promotion. The PE cell line is
one of the studied cell lines.
Applications: The PE cell lines could
be used for assays for cancer treatment
and prevention or study of several
aspects of cutaneous biology.
PE cells could be used in the cosmetic
industry to study response to
cosmaceuticals or fragrances.
PE cells also demonstrated robust
expression of phase 2 detoxification
enzymes in response to a variety of
inducing agents.
Advantage: The various properties of
papilloma cells (PE cell line) differ from
keratinocytes which will provide a
growth advantage to the PE cell lines
during tumor promotion.
Market: In the U.S., there was an
estimated 59,940 new cases of
melanoma cancer in 2007 and an
estimated 8,110 melanoma deaths in
2007. There were nearly one million
cases of non-melanoma skin cancers
diagnosed in the U.S. in 2007.
Cosmetics industry is a $30 billion
industry with a 20% annual growth rate.
Inventors: Stuart H. Yuspa and Henry
Hennings (NCI).
Publication: SH Yuspa et al.
Cultivation and characterization of cells
derived from mouse skin papillomas
induced by an initiation-promotion
protocol. Carcinogenesis 1986
Jun;7(6):949–958.
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Patent Status: HHS Reference No. E–
100–2008/0—Research Tool. Patent
protection is not being sought for this
technology.
Availability: Available for nonexclusive licensing.
Licensing Contact: Adaku
Nwachukwu, J.D.; 301–435–5560;
madua@mail.nih.gov.
Mucin Binding Lectin Imaging Agents
for Colonic Polyp Imaging
Description of Technology: Available
for licensing and commercial
development is an imaging agent
specific for colonic polyps that
overexpress glycoprotein a-L-fucose
containing mucins. Colon cancer is the
second leading cause of cancer related
deaths in the United States. The legume
protein Ulex europaeus agglutinin I
(UEA–1) has shown high specificity to
a-L-fucose glycoproteins. Colonic
mucosal neoplasia and/or polyps with
high surface expression of a-L-fucosyl
terminal residues can be specifically
targeted with UEA–1 contrast agents. In
one example, a computer tomography
(CT) agent made from Iodine-127 (127I)
labeled UEA–1 (I–UEA–1) and
encapsulated into polymeric liposome
nanoparticles was used to image murine
colonic polyps. Ideally, the inventors
envision a contrast agent that can be
administered orally (e.g., liquid or pill
form) and that would eliminate a
patient’s need to drink harsh enema/
contrast solutions prior to CT imaging.
Applications: Colon cancer; Cancer
Imaging; Contrast Agents; CT
colonography
Inventors: Ronald M. Summers,
Jianwu Xie, Celeste Roney (CC).
Relevant Publications:
1. J Xie et al. Oral contrast enhanced
MicroCT virtual colonoscopy of APC
knockout mouse colon polyp model.
Gastroenterology. 2007 Apr;132(4),
Suppl. 1, Abstract No. M1063, pp A353–A-354.
2. C Roney et al. Glycoprotein
expression by adenomatous polyps of
the colon. SPIE 2008 (in press).
3. SD O’Connor et al. Oral contrast
adherence to polyps on CT
colonography. J Comput Assist Tomogr.
2006 Jan–Feb;30(1):51–57.
Patent Status: U.S. Provisional
Application filed 15 Feb 2008 (HHS Ref.
No. E–254–2007/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5010;
shmilovm@mail.nih.gov.
N–Acetyl Mannosamine as a
Therapeutic Agent
Description of Technology: N–Acetyl
Mannosamine is a precursor for the
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synthesis of sugar molecules known as
sialic acids which play an important
role in specific biological processes
such as cellular adhesion, cellular
communication and signal transduction.
Lack of sialic acids also play an
important role in disease processes such
as cancer, inflammation and immunity.
This invention relates to methods of
administering N–Acetyl Mannosamine
or its derivative (to produce sialic acid
in patients who are deficient in the
sugar molecule) to treat muscular
atrophy including hereditary inclusion
body myopathy (HIBM) and distal
myopathy with rimmed vacuoles
(Nonaka myopathy). Certain kidney
conditions such as those arising from
hyposialytion of kidney membranes
may be treated by this method as well.
Applications: Treatment of rare
diseases such as HIBM and Nonaka
myopathy.
Treatment of kidney conditions
involving sialic acid deficiencies
resulting in proteinuria and hematuria.
May be useful in treating other
diseases involving sialic acid
deficiencies.
Publication: B Galeano et al. Mutation
in the key enzyme of sialic acid
biosynthesis causes severe glomerular
proteinuria and is rescued by N–
acetylmannosamine. J Clin Invest. 2007
Jun;117(6):1585–1594.
Inventors: Marjan Huizing et al.
(NHGRI).
Patent Status: U.S. Provisional
Application No. 60/932,451 filed 31
May 2007 (HHS Reference No. E–217–
2007/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The National Human Genome Research
Institute, Medical Genetics Branch, Cell
Biology of Metabolic Disorders unit is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize N–
acetylmannosamine as a therapeutic
agent. Please contact Marjan Huizing at
301–402–2797or
mhuizing@mail.nih.gov for more
information.
Nitrite Adjunctive Therapy to Enhance
Efficacy of Reperfusion Therapy for
Acute Myocardial Infarction
Description of Technology: The
treatment of coronary heart disease is a
multi-billion dollar market. In the case
of acute myocardial infarction (MI),
more commonly known as a heart
attack, the patient receives a number of
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diagnostic tests to determine the type
and location of the heart damage. Most
patients with ST segment elevation are
treated with percutaneous coronary
intervention (PCI) or thrombolysis.
While current therapies, that attempt to
reestablish the blood flow and limit
ischemia, can be effective, practical
delays between symptom presentation
and intervention compromise the
amount of myocardial salvage.
Moreover, the elapsed time prior to PCI
is closely related to the clinical
outcome. This has resulted in a
mortality rate of 7% after MI and nearly
all patients suffer from some degree of
myocardial necrosis. However, the use
of adjunctive pharmacological therapies
can improve myocardial salvage
following acute percutaneous
reperfusion of an acute MI and
substantially impact cardiac function.
This technology is a method of using
nitrite as an adjunctive therapy to
enhance efficacy of reperfusion therapy
for acute MI. Evidence suggests that
anion nitrite (NO2) is a physiological
signaling molecule with roles in
intravascular endocrine nitric oxide
(NO) transport, hypoxic vasodilation,
signaling, and cytoprotection. In
addition, nitrite has the characteristics
of an ideal adjunctive therapy that now
appears ready for translation to human
clinical trials. The benefits of nitrite
therapy include (1) Significant
cardioprotection after prolonged
ischemia, (2) simple administration, (3)
low dose for pharmacological action, (4)
short half-life (5) minimal side effects,
(6) low expense, (7) rapid onset of
action. Additionally, the therapy
utilizes a cardioprotective mechanism
that is not dependent on vasodilation or
pressure rate changes. The use and
dosing protocols of nitrite, as described
by this technology, could limit MI and
apoptosis in the reperfusion phase of
injury and provide a remarkable degree
of cardioprotection.
Applications: Treatment or
amelioration of myocardial salvage
following acute percutaneous
reperfusion of an acute MI.
Development Status: Clinical
Development.
Inventors: Mark T. Gladwin et al.
(NHLBI).
Relevant Publications:
1. MT Gladwin, JH Shelhamer, AN
Schechter, ME Pease-Fye, MA
Waclawiw, JA Panza, FP Ognibene, RO
Cannon 3rd. Role of circulating nitrite
and S–nitrosohemoglobin in the
regulation of regional blood flow in
humans. Proc Natl Acad Sci U S A. 2000
Oct 10;97(21):11482–11487.
2. RO Cannon 3rd, AN Schechter, JA
Panza, FP Ognibene, ME Pease-Fye, MA
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Waclawiw, JH Shelhamer, MT Gladwin.
Effects of inhaled nitric oxide on
regional blood flow are consistent with
intravascular nitric oxide delivery. J
Clin Invest. 2001 Jul;108(2):279–287.
Patent Status: U.S. Provisional
Application No. 60/911,026 filed 10 Apr
2007 (HHS Reference No. E–023–2007/
0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The NHLBI Pulmonary and Vascular
Medicine Branch is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize nitrite adjunctive
therapy to enhance efficacy of
reperfusion therapy for acute
myocardial infarction. Please contact Dr.
Mark Gladwin at 301–435–2310 for
more information.
Compositions and Methods for
Increasing Recombinant Protein Yields
Through the Modification of Cellular
Properties
Description of Technology: This
technology relates to compositions and
methods for improving the growth
characteristics of cells engineered to
produce biologically active products
such as antibodies or glycosylated
proteins. Featured is a method that uses
gene candidates (e.g., cdkl3, siat7e, or
lama4), or their expressed or inhibited
products in cell lines, such as Human
Embryonic Kidney (including HEK–
293), HeLa, or Chinese Hamster Ovary
(CHO). The gene expression modulates
growth characteristics, such as adhesion
properties, of the cell lines thereby
increasing recombinant protein yields
and reducing product production costs.
Applications: This technology may be
used to improve production of
therapeutic and/or diagnostic
compounds, including therapeutic
proteins or monoclonal antibodies from
mammalian cells. Optimization of
mammalian cells for use as expression
systems in the production of
biologically active products is very
difficult. For certain applications,
anchorage-independent cell lines may
be preferred, whereas for other
applications, a cell line that adheres to
a surface, e.g., is anchorage-dependent,
may be preferable. This technology
provides a method for identifying a gene
whose expression modulates such
cellular adhesion characteristics. This
method thus leads to an increase in the
expression or yield of polypeptides,
including therapeutic biologicals, such
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as antibodies, cytokines, growth factors,
enzymes, immunomodulators,
thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences
encoding such polypeptides and a
reduction in the associated costs of such
biological products.
Advantages: This technology offers
the ability to improve yields and reduce
the cost associated with the production
of recombinant protein products
through the selection of cell lines
having: Altered growth characteristics;
altered adhesion characteristics; altered
rate of proliferation; improvement in
cell density growth; improvement in
recombinant protein expression level.
Market: Biopharmaceuticals,
including recombinant therapeutic
proteins and monoclonal antibodybased products used for in vivo medical
purposes and nucleic acid based
medicinal products now represent
approximately one in every four new
pharmaceuticals on the market. The
market size has been estimated at $33
billion in 2004 and is projected to reach
$70 billion by the end of the decade.
The list of approved biopharmaceuticals
includes recombinant hormones and
growth factors, mAB-based products
and therapeutic enzymes as well as
recombinant vaccines and nucleic acid
based products.
Mammalian cells are widely used
expression systems for the production of
biopharmaceuticals. Human embryo
kidney (including HEK–293) and
Chinese hamster ovary (CHO) are host
cell of choice. The genes identified in
this technology (e.g., cdkl3, sia7e, or
lama4) can be used to modify these
important cell based systems.
This technology is ready for use in
drug/vaccine discovery, production and
development. The technology provides
methods for identification of specific
gene targets useful for altering the
production properties of either existing
cell lines to improve yields or with new
cell lines for the production of
therapeutic and or diagnostic
compounds from mammalian cells.
Companies that are actively seeking
production platforms based on
mammalian cell lines that offer high
efficiency, high throughput systems for
protein production or analysis at lower
cost and ease of scale-up would be
potential licensors of this technology.
Development Status: Late Stage—
Ready for Production.
Inventors: Joseph Shiloach (NIDDK),
Pratik Jaluria (NIDDK).
Related Publication: P Jaluria et al.
Application of microarrays to identify
and characterize genes involved in
attachment dependence in HeLa cells.
Metab Eng. 2007 May;9(3):241–251.
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Patent Status: U.S. Provisional
Application No. 60/840,381 filed 24
Aug 2006 (HHS Reference No. E–149–
2006/0–US–01); PCT Application No.
PCT/US2007/018699 filed 24 Aug 2007
(HHS Reference No. E–149–2006/0–
PCT–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases,
Biotechnology Core Laboratory, is
seeking parties interested in
collaborative research projects directed
toward the use of this technology with
cells for drug and vaccine production
and development, including growth
optimization, production and product
recovery processes. For more
information, please contact Dr. Joseph
Shiloach, josephs@intra.niddk.nih.gov,
or Rochelle S. Blaustein at
Rochelle.Blaustein@nih.gov.
March 20, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–6316 Filed 3–27–08; 8:45 am]
BILLING CODE 4140–01–P
sroberts on PROD1PC70 with NOTICES
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2) 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 purpose of this
meeting is to evaluate proposals for
support through the RAID program by
making available to the research
community, on a competitive basis, NCI
new agent development contract
resources for the preclinical
development of drugs and biologics.
The outcome of the evaluation will be
a decision whether NCI should support
the request and make available contract
resources for support through the RAID
program to the research community and
NCI new agent development for the
preclinical development of drugs and
biologics. The research proposals and
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 20, 2008.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–6196 Filed 3–27–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4140–01–M
National Institutes of Health
17:57 Mar 27, 2008
Name of Committee: National Cancer
Institute Special Emphasis Panel; Rapid
Access to Intervention Development.
Date: May 2, 2008.
Time: 8:30 a.m.–5 p.m.
Agenda: To evaluate the Rapid Access to
Intervention Development Portfolio.
Place: National Institutes of Health,
Executive Plaza North, Conference Room G,
6130 Executive Boulevard, Rockville, MD
20852.
Contact Person: Phyllis G. Bryant,
Executive Secretary, Program Analyst,
Developmental Therapeutics Program,
National Cancer Institute, NIH, 6130
Executive Boulevard, Rm. 8022, Bethesda,
MD 20892, (301) 496–8720.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Institutional Training Mechanism
Review Committee.
Date: June 19–20, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Admiral Fell Inn, 888 South
Broadway, Baltimore, MD 21231.
Contact Person: Charles Joyce, PhD,
Scientific Review Administrator,
Review Branch/DERA, National Heart,
Lung, and Blood Institute, 6701
Rockledge Drive, Room 7196, Bethesda,
MD 20892–7924, 301–435–0288,
cjoyce@nhlbi.nih.gov.
Dated: March 20, 2008.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–6198 Filed 3–27–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Aug<31>2005
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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.
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel To Review Contract
Proposals.
Date: April 16–17, 2008.
Time: 7:30 a.m. to 7 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hilton Washington DC/Silver
Spring; 8727 Colesville Road, Silver Spring,
MD 20910.
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[Federal Register Volume 73, Number 61 (Friday, March 28, 2008)]
[Notices]
[Pages 16691-16694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6316]
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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
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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.
Cell Line PE, Developed From Mouse Skin Tumors, Demonstrates Unique
Qualities
Description of Technology: Available for licensing is the mouse
skin tumor cell line PE. These skin tumor cells were isolated from
papilloma cells induced by chemical carcinogens. The PE cell lines
differ from normal keratinocytes in their ability to maintain a
proliferating population under conditions favoring terminal
differentiation, their consistent proliferative response to phorbol
esters under these same conditions, and their reduced sensitivity to
phorbol ester-induced terminal differentiation. All of these properties
should provide a growth advantage to these cells during tumor
promotion. The PE cell line is one of the studied cell lines.
Applications: The PE cell lines could be used for assays for cancer
treatment and prevention or study of several aspects of cutaneous
biology.
PE cells could be used in the cosmetic industry to study response
to cosmaceuticals or fragrances.
PE cells also demonstrated robust expression of phase 2
detoxification enzymes in response to a variety of inducing agents.
Advantage: The various properties of papilloma cells (PE cell line)
differ from keratinocytes which will provide a growth advantage to the
PE cell lines during tumor promotion.
Market: In the U.S., there was an estimated 59,940 new cases of
melanoma cancer in 2007 and an estimated 8,110 melanoma deaths in 2007.
There were nearly one million cases of non-melanoma skin cancers
diagnosed in the U.S. in 2007.
Cosmetics industry is a $30 billion industry with a 20% annual
growth rate.
Inventors: Stuart H. Yuspa and Henry Hennings (NCI).
Publication: SH Yuspa et al. Cultivation and characterization of
cells derived from mouse skin papillomas induced by an initiation-
promotion protocol. Carcinogenesis 1986 Jun;7(6):949-958.
Patent Status: HHS Reference No. E-100-2008/0--Research Tool.
Patent protection is not being sought for this technology.
Availability: Available for non-exclusive licensing.
Licensing Contact: Adaku Nwachukwu, J.D.; 301-435-5560;
madua@mail.nih.gov.
Mucin Binding Lectin Imaging Agents for Colonic Polyp Imaging
Description of Technology: Available for licensing and commercial
development is an imaging agent specific for colonic polyps that
overexpress glycoprotein [alpha]-L-fucose containing mucins. Colon
cancer is the second leading cause of cancer related deaths in the
United States. The legume protein Ulex europaeus agglutinin I (UEA-1)
has shown high specificity to [alpha]-L-fucose glycoproteins. Colonic
mucosal neoplasia and/or polyps with high surface expression of
[alpha]-L-fucosyl terminal residues can be specifically targeted with
UEA-1 contrast agents. In one example, a computer tomography (CT) agent
made from Iodine-127 (\127\I) labeled UEA-1 (I-UEA-1) and encapsulated
into polymeric liposome nanoparticles was used to image murine colonic
polyps. Ideally, the inventors envision a contrast agent that can be
administered orally (e.g., liquid or pill form) and that would
eliminate a patient's need to drink harsh enema/contrast solutions
prior to CT imaging.
Applications: Colon cancer; Cancer Imaging; Contrast Agents; CT
colonography
Inventors: Ronald M. Summers, Jianwu Xie, Celeste Roney (CC).
Relevant Publications:
1. J Xie et al. Oral contrast enhanced MicroCT virtual colonoscopy
of APC knockout mouse colon polyp model. Gastroenterology. 2007
Apr;132(4), Suppl. 1, Abstract No. M1063, pp A-353-A-354.
2. C Roney et al. Glycoprotein expression by adenomatous polyps of
the colon. SPIE 2008 (in press).
3. SD O'Connor et al. Oral contrast adherence to polyps on CT
colonography. J Comput Assist Tomogr. 2006 Jan-Feb;30(1):51-57.
Patent Status: U.S. Provisional Application filed 15 Feb 2008 (HHS
Ref. No. E-254-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5010;
shmilovm@mail.nih.gov.
N-Acetyl Mannosamine as a Therapeutic Agent
Description of Technology: N-Acetyl Mannosamine is a precursor for
the synthesis of sugar molecules known as sialic acids which play an
important role in specific biological processes such as cellular
adhesion, cellular communication and signal transduction. Lack of
sialic acids also play an important role in disease processes such as
cancer, inflammation and immunity.
This invention relates to methods of administering N-Acetyl
Mannosamine or its derivative (to produce sialic acid in patients who
are deficient in the sugar molecule) to treat muscular atrophy
including hereditary inclusion body myopathy (HIBM) and distal myopathy
with rimmed vacuoles (Nonaka myopathy). Certain kidney conditions such
as those arising from hyposialytion of kidney membranes may be treated
by this method as well.
Applications: Treatment of rare diseases such as HIBM and Nonaka
myopathy.
Treatment of kidney conditions involving sialic acid deficiencies
resulting in proteinuria and hematuria.
May be useful in treating other diseases involving sialic acid
deficiencies.
Publication: B Galeano et al. Mutation in the key enzyme of sialic
acid biosynthesis causes severe glomerular proteinuria and is rescued
by N-acetylmannosamine. J Clin Invest. 2007 Jun;117(6):1585-1594.
Inventors: Marjan Huizing et al. (NHGRI).
Patent Status: U.S. Provisional Application No. 60/932,451 filed 31
May 2007 (HHS Reference No. E-217-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The National Human Genome
Research Institute, Medical Genetics Branch, Cell Biology of Metabolic
Disorders unit is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize N-acetylmannosamine as a therapeutic agent.
Please contact Marjan Huizing at 301-402-2797or mhuizing@mail.nih.gov
for more information.
Nitrite Adjunctive Therapy to Enhance Efficacy of Reperfusion Therapy
for Acute Myocardial Infarction
Description of Technology: The treatment of coronary heart disease
is a multi-billion dollar market. In the case of acute myocardial
infarction (MI), more commonly known as a heart attack, the patient
receives a number of
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diagnostic tests to determine the type and location of the heart
damage. Most patients with ST segment elevation are treated with
percutaneous coronary intervention (PCI) or thrombolysis. While current
therapies, that attempt to reestablish the blood flow and limit
ischemia, can be effective, practical delays between symptom
presentation and intervention compromise the amount of myocardial
salvage. Moreover, the elapsed time prior to PCI is closely related to
the clinical outcome. This has resulted in a mortality rate of 7% after
MI and nearly all patients suffer from some degree of myocardial
necrosis. However, the use of adjunctive pharmacological therapies can
improve myocardial salvage following acute percutaneous reperfusion of
an acute MI and substantially impact cardiac function.
This technology is a method of using nitrite as an adjunctive
therapy to enhance efficacy of reperfusion therapy for acute MI.
Evidence suggests that anion nitrite (NO2) is a physiological signaling
molecule with roles in intravascular endocrine nitric oxide (NO)
transport, hypoxic vasodilation, signaling, and cytoprotection. In
addition, nitrite has the characteristics of an ideal adjunctive
therapy that now appears ready for translation to human clinical
trials. The benefits of nitrite therapy include (1) Significant
cardioprotection after prolonged ischemia, (2) simple administration,
(3) low dose for pharmacological action, (4) short half-life (5)
minimal side effects, (6) low expense, (7) rapid onset of action.
Additionally, the therapy utilizes a cardioprotective mechanism that is
not dependent on vasodilation or pressure rate changes. The use and
dosing protocols of nitrite, as described by this technology, could
limit MI and apoptosis in the reperfusion phase of injury and provide a
remarkable degree of cardioprotection.
Applications: Treatment or amelioration of myocardial salvage
following acute percutaneous reperfusion of an acute MI.
Development Status: Clinical Development.
Inventors: Mark T. Gladwin et al. (NHLBI).
Relevant Publications:
1. MT Gladwin, JH Shelhamer, AN Schechter, ME Pease-Fye, MA
Waclawiw, JA Panza, FP Ognibene, RO Cannon 3rd. Role of circulating
nitrite and S-nitrosohemoglobin in the regulation of regional blood
flow in humans. Proc Natl Acad Sci U S A. 2000 Oct 10;97(21):11482-
11487.
2. RO Cannon 3rd, AN Schechter, JA Panza, FP Ognibene, ME Pease-
Fye, MA Waclawiw, JH Shelhamer, MT Gladwin. Effects of inhaled nitric
oxide on regional blood flow are consistent with intravascular nitric
oxide delivery. J Clin Invest. 2001 Jul;108(2):279-287.
Patent Status: U.S. Provisional Application No. 60/911,026 filed 10
Apr 2007 (HHS Reference No. E-023-2007/0-US-01)
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The NHLBI Pulmonary and
Vascular Medicine Branch is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize nitrite adjunctive therapy to
enhance efficacy of reperfusion therapy for acute myocardial
infarction. Please contact Dr. Mark Gladwin at 301-435-2310 for more
information.
Compositions and Methods for Increasing Recombinant Protein Yields
Through the Modification of Cellular Properties
Description of Technology: This technology relates to compositions
and methods for improving the growth characteristics of cells
engineered to produce biologically active products such as antibodies
or glycosylated proteins. Featured is a method that uses gene
candidates (e.g., cdkl3, siat7e, or lama4), or their expressed or
inhibited products in cell lines, such as Human Embryonic Kidney
(including HEK-293), HeLa, or Chinese Hamster Ovary (CHO). The gene
expression modulates growth characteristics, such as adhesion
properties, of the cell lines thereby increasing recombinant protein
yields and reducing product production costs.
Applications: This technology may be used to improve production of
therapeutic and/or diagnostic compounds, including therapeutic proteins
or monoclonal antibodies from mammalian cells. Optimization of
mammalian cells for use as expression systems in the production of
biologically active products is very difficult. For certain
applications, anchorage-independent cell lines may be preferred,
whereas for other applications, a cell line that adheres to a surface,
e.g., is anchorage-dependent, may be preferable. This technology
provides a method for identifying a gene whose expression modulates
such cellular adhesion characteristics. This method thus leads to an
increase in the expression or yield of polypeptides, including
therapeutic biologicals, such as antibodies, cytokines, growth factors,
enzymes, immunomodulators, thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences encoding such polypeptides and a
reduction in the associated costs of such biological products.
Advantages: This technology offers the ability to improve yields
and reduce the cost associated with the production of recombinant
protein products through the selection of cell lines having: Altered
growth characteristics; altered adhesion characteristics; altered rate
of proliferation; improvement in cell density growth; improvement in
recombinant protein expression level.
Market: Biopharmaceuticals, including recombinant therapeutic
proteins and monoclonal antibody-based products used for in vivo
medical purposes and nucleic acid based medicinal products now
represent approximately one in every four new pharmaceuticals on the
market. The market size has been estimated at $33 billion in 2004 and
is projected to reach $70 billion by the end of the decade. The list of
approved biopharmaceuticals includes recombinant hormones and growth
factors, mAB-based products and therapeutic enzymes as well as
recombinant vaccines and nucleic acid based products.
Mammalian cells are widely used expression systems for the
production of biopharmaceuticals. Human embryo kidney (including HEK-
293) and Chinese hamster ovary (CHO) are host cell of choice. The genes
identified in this technology (e.g., cdkl3, sia7e, or lama4) can be
used to modify these important cell based systems.
This technology is ready for use in drug/vaccine discovery,
production and development. The technology provides methods for
identification of specific gene targets useful for altering the
production properties of either existing cell lines to improve yields
or with new cell lines for the production of therapeutic and or
diagnostic compounds from mammalian cells.
Companies that are actively seeking production platforms based on
mammalian cell lines that offer high efficiency, high throughput
systems for protein production or analysis at lower cost and ease of
scale-up would be potential licensors of this technology.
Development Status: Late Stage--Ready for Production.
Inventors: Joseph Shiloach (NIDDK), Pratik Jaluria (NIDDK).
Related Publication: P Jaluria et al. Application of microarrays to
identify and characterize genes involved in attachment dependence in
HeLa cells. Metab Eng. 2007 May;9(3):241-251.
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Patent Status: U.S. Provisional Application No. 60/840,381 filed 24
Aug 2006 (HHS Reference No. E-149-2006/0-US-01); PCT Application No.
PCT/US2007/018699 filed 24 Aug 2007 (HHS Reference No. E-149-2006/0-
PCT-02).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases, Biotechnology Core
Laboratory, is seeking parties interested in collaborative research
projects directed toward the use of this technology with cells for drug
and vaccine production and development, including growth optimization,
production and product recovery processes. For more information, please
contact Dr. Joseph Shiloach, josephs@intra.niddk.nih.gov, or Rochelle
S. Blaustein at Rochelle.Blaustein@nih.gov.
March 20, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-6316 Filed 3-27-08; 8:45 am]
BILLING CODE 4140-01-P
