10280 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

Information Collection: Intermediate 

Care Facility (ICF) for the Mentally 

Retarded (MR) or Persons with Related 

Conditions Survey Report Form and 

Supporting Regulations at 42 CFR 

442.30, 483.410, 483.420, 483.440, 

483.450 and 483.460; Use: This survey 

form is needed to ensure ICF/MR 

provider and client characteristics are 

available and updated annually for the 

Federal government’s Online Survey 

Certification and Reporting (OSCAR) 

system. It is required for the provider to 

fill out at the time of the annual 

recertification or initial certification 

survey conducted by the State Medicaid 

agency. The team leader for the State 

survey team must review and approve 

the completed form before completion 

of the survey. The State Medicaid 

survey agency is responsible for 

transferring the 3070 information into 

OSCAR. Form Number: CMS–3070 

(OMB#: 0938–0062); Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector: Business or other forprofits and Not-for-profit institutions; 

Number of Respondents: 6,437; Total 

Annual Responses: 6,437; Total Annual 

Hours: 19,311. (For policy questions 

regarding this collection contact Kelley 

Tinsley at 410–786–6664. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Annual Early 

and Periodic Screening, Diagnostic and 

Treatment (EPSDT) Services 

Participation Report; Form Number: 

CMS–416 (OMB#: 0938–0354); Use: 

States are required to submit an annual 

report on the provision of EPSDT 

services pursuant to section 

1902(a)(43)(D) of the Social Security 

Act. These reports provide CMS with 

data necessary to assess the 

effectiveness of State EPSDT programs, 

to determine a State’s results in 

achieving its participation goal and to 

respond to inquiries. Respondents are 

State Medicaid Agencies. The data is 

due April 1 of every year so States need 

to have the form and instructions as 

soon as possible in order to report 

timely. Frequency: Yearly; Affected 

Public: State, Tribal and Local 

governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 504. (For policy 

questions regarding this collection 

contact Cindy Ruff at 410–786–5916. 

For all other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on April 5, 2010. 

OMB, Office of Information and 

Regulatory Affairs. 

Attention: CMS Desk Officer. 

Fax Number: (202) 395–6974. 

E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: February 24, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–4313 Filed 3–4–10; 8:45 am] 

BILLING CODE 4120–01–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. 

Monoclonal Antibody to Mouse TollLike Receptor 3 (TLR3) Extracellular 

Domain 

Description of Invention: The best 

available antibody for labeling cells 

expressing mouse TLR3 is now available 

for licensing. It is a rat IgG2a 

monoclonal antibody that was generated 

to the extracellular domain of mouse 

TLR3 and specifically binds mouse 

TLR3 in permeabilized cells. TLR3 is 

located in endosomes and recognizes 

double-stranded RNA, a molecular 

signature of many viruses. This 

antibody would be of interest to anyone 

studying TLR3 distribution and 

localization in studies related to innate 

immunity and dendritic cell function. 

Applications: 

• Fluorescence-Activated Cell Sorting 

(FACS). 

• Immunofluorescence. 

• Immunocytochemistry. 

Inventors: David M. Segal, Yan Wang, 

Ivett Jelinek (NCI). 

Related Publication: Unpublished. 

Patent Status: HHS Reference No. E– 

038–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: This technology is 

available as a research tool (hybridoma) 

under a Biological Materials License. 

Licensing Contact: Steve Standley, 

Ph.D.; 301–435–4074; 

sstand@od.nih.gov. 

Haptoglobin for Control of the Blood 

Pressure Response to Plasma Free 

Hemoglobin 

Description of Invention: Release of 

hemoglobin into the blood is a central 

pathophysiologic event contributing to 

morbidity and mortality in chronic and 

acute hemolytic anemias and severe 

malaria. These toxicities arise from 

hemoglobin-related scavenging of nitric 

oxide, a blood vessel vasodilator, and 

peroxidative chain reactions that lead to 

damage of the surrounding tissues. 

Animal models have demonstrated both 

an attenuation of the hypertensive 

response due to nitric oxide scavenging 

and a prevention of peroxidative 

toxicity. Compartmentalization of 

hemoglobin, rather than short-lived 

nitric oxide-based drugs, may represent 

a new therapeutic paradigm in 

countering the pathophysiological side 

effects associated with free hemoglobin. 

This technology identifies 

haptoglobin and haptoglobin mimetics 

as potential therapeutics for high blood 

pressure and intravascular toxicity due 

to release of hemoglobin from red blood 

cells. It provides a novel process in 

which free hemoglobin is 

compartmentalized within the 

haptoglobin molecule. Therapeutic 

proof-of-principle has been 

demonstrated for this technology in dog 

and guinea pig models. 

Potential Applications and 

Advantages: 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 10281 

• A therapeutic for high blood 

pressure and intravascular toxicity 

resulting from free hemoglobin in the 

blood (as associated with hemolytic 

anemias such as sickle cell disease, 

paroxysmal nocturnal hemoglobinuria, 

and thalassemia, as well as cerebral 

malaria). 

• Compartmentalization of 

hemoglobin may minimize toxicities 

associated with cell-free hemoglobin, in 

contrast to currently available nitric 

oxide-based drugs which seek to 

counterbalance but not minimize these 

toxicities. 

Development Status: Pre-clinical 

stage. 

Inventors: Abdu I. Alayash (FDA) et 

al. 

Publication: FS Boretti et al. 

Sequestration of extracellular 

hemoglobin within a haptoglobin 

complex decreases its hypertensive and 

oxidative effects in dogs and guinea 

pigs. J Clin Invest. 2009 

Aug;119(8):2271–2280. [PubMed: 

19620788] 

Patent Status: U.S. Provisional 

Application No. 61/226,602 filed 17 Jul 

2009 (HHS Reference No. E–256–2009/ 

0–US–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301–435–4521; 

Fatima.Sayyid@nih.hhs.gov. 

A Biomarker and Therapeutic Target 

for Ovarian Cancer 

Description of Invention: This 

technology provides methods of 

diagnosing or treating certain ovarian 

cancers using STAMP, a steroid 

cofactor. 

According to the American Cancer 

Society, ovarian cancer is the ninth 

most common cancer in the United 

States, but is the fifth most deadly, with 

an estimated 14,600 deaths in 2009; the 

10-year survival rate for this cancer is 

less than 40 percent. The majority of 

ovarian cancer cases are diagnosed at 

late-stage disease, due to the difficulty 

in detecting this cancer in its early 

stages, when symptoms are subtle. 

There are currently no effective 

methods for early-stage diagnosis of 

ovarian cancer. Diagnosis is usually 

made through a combination of physical 

examination, ultrasound imaging, and a 

blood test for the tumor marker CA–125. 

The CA–125 test only returns a true 

positive result for about 50% of earlystage ovarian cancers, and may be 

elevated in other conditions not related 

to cancer, so it is not an adequate early 

detection tool when used alone. 

The inventors previously discovered 

STAMP, a steroid cofactor that 

modulates glucocorticoid receptormediated gene induction and 

repression. The inventors have now 

shown that STAMP mRNA levels are 

elevated in ovarian cancer samples, 

including early-stage cancers. They have 

also found that in a subset of ovarian 

cancer cell lines, introduction of 

STAMP siRNAs slows cell proliferation. 

These findings suggest that STAMP may 

be useful as a biomarker to detect early 

stage cancer in ovarian tissues, and is 

also promising as a therapeutic target for 

a subset of ovarian cancers. 

Applications: 

• Development of an early-stage 

diagnostic test for ovarian cancer. 

• Development of an siRNA-based 

therapy for ovarian cancer. 

Development Status: Discovery stage. 

Market: Ovarian cancer is the fifth 

most-deadly cancer in the United States, 

and over 21,000 new U.S. cases were 

diagnosed in 2009. 

Inventors: S. Stoney Simons et al. 

(NIDDK). 

Related Publications: In preparation. 

Patent Status: U.S. Provisional 

Application No. 61/185,503 filed 09 Jun 

2009 (HHS Reference No. E–226–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, PhD; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Disease Steroid 

Hormones Section is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize STAMP, a steroid 

cofactor. Please contact S. Stoney 

Simons at steroids@helix.nih.gov for 

more information. 

Conditional V2 Vasopressin Receptor 

Mutant Mice as a Model To Study Xlinked Nephrogenic Diabetes Insipidus 

(XNDI) 

Description of Invention: X-linked 

nephrogenic diabetes insipidus (XNDI) 

is a severe kidney disease caused by 

inactivating mutations in the V2 

vasopressin receptor (V2R) gene that 

result in the loss of renal urineconcentrating ability. At present, no 

specific pharmacological therapy has 

been developed for XNDI, primarily due 

to the lack of suitable animal models. 

This technology provides a unique and 

viable animal model of XNDI. NIH 

investigators have generated mice in 

which the V2R gene could be 

conditionally deleted during adulthood 

by administration of 4–OH-tamoxifen. 

Radioligand-binding studies confirmed 

the lack of V2R-binding sites in kidneys 

following 4–OH-tamoxifen treatment, 

and further analysis indicated that upon 

V2R deletion, adult mice displayed all 

characteristic symptoms of XNDI, 

including polyuria, polydipsia, and 

resistance to the antidiuretic actions of 

vasopressin. 

Gene expression analysis suggested 

that activation of renal EP4 PGE2 

receptors might compensate for the lack 

of renal V2R activity in XNDI mice. 

Strikingly, both acute and chronic 

treatment of the mutant mice with a 

selective EP4 receptor agonist greatly 

reduced all major manifestations of 

XNDI, including changes in renal 

morphology. These physiological 

improvements were most likely due to 

a direct action on EP4 receptors 

expressed on collecting duct cells. 

These findings illustrate the usefulness 

of V2R mutant mice for elucidating and 

testing new strategies for the potential 

treatment of humans with XNDI. 

Inventors: Ju ̈rgen Wess et al. (NIDDK) 

Publication: Li JH, Chou CL, Li B, 

Gavrilova O, Eisner C, Schnermann J, 

Anderson SA, Deng CX, Knepper MA, 

Wess J. A selective EP4 PGE2 receptor 

agonist alleviates disease in a new 

mouse model of X-linked nephrogenic 

diabetes insipidus. J Clin Invest. 2009 

Oct 1;119(10):3115–3126. [PubMed: 

19729836] 

Patent Status: HHS Reference Nos. E– 

174–2009/0 & E–175–2009/0—Research 

Tool. Patent protection is not being 

pursued for this technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Suryanarayana 

(Sury) Vepa, Ph.D., J.D.; 301–435–5020; 

vepas@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Diseases, 

Laboratory of Bioorganic Chemistry, 

Molecular Signalling Section, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Dr. Ju ̈rgen Wess at 

jwess@helix.nih.gov for more 

information. 

Dated: March 1, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–4758 Filed 3–4–10; 8:45 am] 

BILLING CODE 4140–01–P 


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