58404 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

ErbB4 in interneurons, but not 

pyramidal cells, of the rodent 

hippocampus. 2009 J Neurosci. Sep 

30;29(39):12255–12264. [PubMed: 

19793984]. 

4. Buonanno, A. The neuregulin 

signaling pathway and schizophrenia: 

From genes to synapses and neural 

circuits. Brain Res Bull. 2010 Aug 3; 

Epub ahead of print. [PubMed: 

20688137]. 

Patent Status 

• U.S. Provisional Application No. 

60/837,449 filed 11 Aug 2006 (HHS 

Reference No. E–304–2005/0–US–01). 

• International Application No. PCT/ 

US07/75724 filed 10 Aug 2007, which 

published as WO 2008/019394 on 14 

Feb 2008 (HHS Reference No. E–304– 

2005/0–PCT–02). 

• U.S. Patent Application No. 12/ 

377,025 filed 10 Feb 2009 (HHS 

Reference No. E–304–2005/0–US–03). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey Clark Klein, 

PhD; 301–594–4697; 

kleinjc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institutes of Child Health 

and Human Development, Section on 

Molecular Neurobiology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact John D. Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: September 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–23977 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

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. 

Use of Adenosine Agonists To Prevent 

Arterial Vascular Calcification 

Disorder 

Description of Invention: Scientists at 

the National Human Genome Research 

Institute (NHGRI) and the National 

Heart Lung and Blood Institute (NHLBI) 

at the National Institutes of Health (NIH) 

have discovered a genetic defect in the 

Ecto-5’-nucleotidase (NT5E) gene which 

results in Cluster of Differentiation 73 

(CD73) deficiency that leads to a 

decrease in adenosine, and ultimately, 

an increase in vascular calcification. 

NT5E encodes CD73, an enzyme that 

converts adenosine monophosphate 

(AMP) to adenosine in the extracellular 

region of the vascular endothelium. 

Normally, extracellular adenosine binds 

to one of the several receptors on the 

surface decreasing the production of 

cyclic AMP (cAMP) resulting in an 

inhibition of vascular calcification. 

The discovery of this genetic mutation 

leading to a decrease in adenosine 

provides a method of treating or 

preventing the disorder by using 

adenosine receptor agonists as 

therapeutic agents. Adenosine receptor 

agonists can be used to treat or prevent 

disorders associated with vascular and/ 

or joint capsule calcification, including 

for example atherosclerosis, 

Monkeberg’s medial sclerosis, CD74 

deficiency, Ehlers Danlos syndrome 

(EDS), Marfan/Loewe Dietz syndrome, 

fibromuscular dysplasia, Kawasaki 

syndrome, pseudoxanthoma elasticum, 

and premature placental calcification. 

Applications: Treatment for vascular 

calcification disorder by using 

adenosine receptor agonist agents. 

Development Status: Early-stage. 

Inventors: William A. Gahl (NHGRI), 

Thomas C. Markello (NHGRI), Shira G. 

Ziegler (NHGRI), Manfred Boehm 

(NHLBI), Cynthia Hillaire (NHLBI). 

Publication: C St. Hilaire, et al. NT5E 

Mutations are Associated with Arterial 

Calcifications. New Engl J Med., 

Submitted 2010. 

Patent Status: U.S. Provisional 

Application No. 61/319,336 filed 31 Mar 

2010 (HHS Reference No. E–094–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Steve Standley, 

301–435–4074, sstand@od.nih.gov. 

Collaborative Research Opportunity: 

The NHGRI is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize adenosine receptor 

agonist compounds for therapeutic use 

including as a treatment of certain 

common as well as rare vascular 

calcification-related disorders (see 

above Description of Invention). Please 

contact NHGRI Technology 

Development Coordinator Claire T. 

Driscoll at cdriscol@mail.nih.gov for 

more information. 

Small Molecule Neuropeptide S 

Receptor (NPSR) Antagonists for the 

Treatment of Addictive Disorders, 

Mood, Anxiety and Sleep Disorders 

Description of Invention: The 

inventors, who work for the National 

Human Genome Research Institute 

(NHGRI) and the National Institute on 

Alcohol Abuse and Alcoholism 

(NIAAA) at the National Institutes of 

Health (NIH), have developed NPSR 

antagonists that hold the potential for 

being clinically useful treatments for 

alcohol and drug addiction. 

Neuropsychiatric disorders including, 

for example, mood, anxiety, eating, and 

sleep related disorders, as well as 

alcoholism and drug addiction, are 

major causes of mortality and morbidity. 

Patient relapse into drug seeking and 

use, after an interval of sobriety, is a key 

component of the addictive syndrome, 

with approximately two-thirds of 

patients relapsing within three months 

of initiating abstinence. Therefore, 

relapse prevention is a major treatment 

objective. 

Neuropeptide S (NPS), an endogenous 

ligand for the Neuropeptide S receptor 

(NPSR) has recently been shown to play 

a key role in relapse-like behavior. In 

addition, because mood, anxiety, eating, 

and sleep related behaviors are often 

closely linked with the addictive 

process, and are also affected by the 

NPS system, it is believed that the NPSR 

antagonist will also be promising as a 

useful therapeutic target in these 

clinical areas as well. 

Applications: Development of a NPSR 

antagonist for the therapies of alcohol 

and drug addiction. 

Development Status: Early-stage. 

Market: More than 700,000 Americans 

receive alcoholism treatment on any 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58405 

given day by using the traditional 

alcoholism therapy based on clinical 

experience and intuition, with little 

rigorous validation of their effectiveness 

(http://health.nih.gov/topic/Alcoholism/ 

SubstanceAbuse). About 18% of 

American adults have anxiety disorders 

(www.nimh.nih.gov). More than 40 

million Americans suffer from chronic, 

long-term sleep disorders, and an 

additional 20 million report sleeping 

problems occasionally (http:// 

www.adaa.org). 

Inventors: Juan J. Marugan, Ke Liu, 

Samarjit Patnaik, Noel T. Southall, Wei 

Zheng (all with NHGRI); Markus Heilig 

(NIAAA). 

Related Publication: N Cannella et al. 

Persistent increase of alcohol-seeking 

evoked by neuropeptide S: An effect 

mediated by the hypothalamic 

hypocretin system. 

Neuropsychopharmacology. 2009 Aug; 

34(9): 2125–2134. [PubMed: 19322167]. 

Patent Status: U.S. Provisional 

Application No. 61/328,900 filed 28 Apr 

2010 (HHS Reference No. E–041–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Steve Standley, 

PhD; 301–435–4074; 

sstand@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIH Chemical Genomics Center 

(NCGC), NHGRI, NIH is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize these NPSR antagonist 

small molecule compounds for various 

therapeutic uses including treatment of 

neuropsychiatric disorders and alcohol 

and drug addiction. Please contact Dr. 

Juan J. Marugan at 

maruganj@mail.nih.gov for more 

information. 

A Rapid, Peripheral Blood Gene 

Expression Biomarker Panel for 

Diagnosis of Acute Ischemic Stroke 

Description of Invention: There are 

presently no rapid, accurate diagnostic 

procedures or methods that can be used 

to determine whether a patient has 

suffered an acute ischemic stroke (AIS). 

Current technologies for diagnosis of 

AIS are limited by speed and resources 

as well as inaccuracy and generally 

require a high level of training to 

interpret the results for medical 

technicians. In contrast, this invention 

may lead to the development of a rapid 

and accurate clinical diagnostic kit that 

would require very little training for 

proper use and could be used in the 

field or the emergency room setting. 

Scientists at the National Institutes of 

Health have discovered that expression 

levels of a set of nine genes may be used 

as biomarkers for diagnosis of AIS as 

well as outcome prediction. These 

biomarkers may be rapidly identified 

using peripheral whole blood and may 

form the basis of a rapid and accurate 

clinical point of care diagnostic kit. 

Further, if validation is positive, this 

technology may enable rapid differential 

diagnosis between acute ischemic stroke 

and hemorrhagic stroke, transient 

ischemic attack, or any pathology 

mimicking a stroke. Not only can this be 

used to identify stroke earlier in the 

course of treatment, this panel may also 

help to better characterize stroke 

subtype, and identify new pathways for 

stroke treatment. This is important as 

the only FDA approved treatment for 

acute ischemic stroke is tissue 

plasminogen activator (tPA) and tPA 

must not be given to hemorrhagic stroke 

patients since it could increase 

intracranial bleeding. To effectively 

treat AIS, tPA must be administered 

intravenously within 3–4 hours of 

known stroke onset. Because the 

differential diagnosis of AIS versus 

hemorrhagic stroke is difficult without 

specialized imaging equipment such as 

a CT scan with contrast or an MRI 

image, only a small percentage of stroke 

patients (3–5%) are ever given tPA. So, 

a rapid and accurate clinical diagnostic 

kit based on this invention would have 

a profound public health benefit and 

likely a large commercial potential. 

Applications: 

• A rapid and accurate clinical 

diagnostic kit for acute ischemic stroke. 

• Differentiation between acute 

ischemic stroke and a hemorrhagic 

stroke, transient ischemic attack, or any 

pathology mimicking a stroke. 

• Aid in the prediction of outcome 

and identify new pathways for ischemic 

stroke treatment. 

Advantages: Faster, more accurate, 

and requires less training than currently 

available diagnostic procedures. 

Development Status: Clinical 

Validation Pilot Study: Whole blood 

was collected in a clinical setting and 

gene expressions were subsequently 

profiled. 

Market: Every year, about 795,000 

people in the United States have a 

stroke, and about 675,000 of those 

strokes are ischemic. In 2006, 137,000 

people in the United States died of 

stroke (http://www.cdc.gov/stroke/). 

Inventors: Taura L. Barr (NINR), Maria 

Del Mar Matarin Jimenez (NIA), Steven 

J. Warach (NINDS), Andrew B. 

Singleton (NIA), Jinhui Ding (NIA), 

Allissa A. Dillman (NIA), Mark P. 

Cookson (NIA), Yvette Conley 

(University of Pittsburgh). 

Publication: Barr, T.L.; Conley, Y.; 

Ding, J.; Dillman, A.; Warach, S.; 

Singleton, A.; Matarin, M. Genomic 

biomarkers and cellular pathways of 

ischemic stroke by RNA gene expression 

profiling; Neurology, Volume 75(11), 14 

September 2010, pp 1009–1014. 

Patent Status: U.S. Provisional 

Application No. 61/307,233 filed 23 Feb 

2010 (HHS Reference No. E–023–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey Clark Klein, 

PhD; 301–594–4697; 

kleinjc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NINR is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize a point of care test for 

ischemic stroke diagnostics and 

outcome prediction. Please contact Dr. 

Taura Barr at 304–293–0503 or 

barrt@mail.nih.gov for more 

information. 

Dated: September 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–23957 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7019–N] 

Medicare Program; Meeting of the 

Advisory Panel on Medicare 

Education, October 13, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

meeting of the Advisory Panel on 

Medicare Education (the Panel) in 

accordance with the Federal Advisory 

Committee Act. The Panel advises and 

makes recommendations to the 

Secretary of Health and Human Services 

and the Administrator of the Centers for 

Medicare & Medicaid Services on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning the Medicare 

program. This meeting is open to the 

public. 

DATES: Meeting Date: Wednesday, 

October 13, 2010 from 1 p.m. to 4 p.m., 

eastern daylight time (e.d.t.). 


srobinson on DSKHWCL6B1PROD with NOTICES