48570 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Notices 

plasmid, RFP-I-SceI-GR, is a chimera 

between the ISceI endonuclease and the 

ligand binding domain of the 

glucocorticoid receptor (GR) in frame 

with red fluorescent protein (RFP). This 

GR chimera will translocate from the 

cytoplasm to the nucleus upon addition 

of triamcinolone acetonide, leading to 

rapid induction of a double-stranded 

break between the lac and tet arrays. 

Applications: 

• Tool for drug studies relating to 

DNA stability and repair. 

• Tool to probe the role of nuclear 

and DNA binding proteins in stability 

and repair. 

Inventors: Thomas A. Misteli and Evi 

Soutoglou (NCI). 

Related Publication: E Soutoglou, JF 

Dorn, K Sengupta, M Jasin, A 

Nussenzweig, T Ried, G Danuser, T 

Misteli. Positional stability of single 

double-strand breaks in mammalian 

cells. Nat Cell Biol. 2007 Jun;9(6):675– 

682. 

Patent Status: HHS Reference No. E– 

264–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: This technology is 

available as a research tool under a 

Biological Materials License. 

Licensing Contact: Steve Standley, 

PhD; 301–435–4074; sstand@od.nih.gov. 

Mouse Embryonic Stem Cell-Based 

Functional Assay To Evaluate 

Mutations in BRCA2 

Description of Technology: Mutations 

in breast cancer susceptibility genes 

BRCA1 and BRCA2 have up to an 80 

percent life time risk in developing 

breast cancer. There are no ‘‘mutation 

hot spots’’ and to date, more than 1,500 

different mutations have been identified 

in BRCA2. The absence of tumor cell 

lines expressing various mutant BRCA2 

alleles has hindered evaluations to 

determine the functional differences 

between different mutations. 

A simple, versatile and reliable mouse 

embryonic stem cell and bacterial 

artificial chromosome based assay to 

generate cell lines expressing mutant 

human BRCA2 has been developed and 

it has been used to classify 17 sequence 

variants. Available for licensing are 

wild-type and eleven mutant BRCA2 

cell lines developed from this assay that 

have either truncations or point 

mutations. These cell lines may be used 

to evaluate the effect of DNA damaging 

agents, genotoxins and 

chemotherapeutic efficacy. 

Applications: 

• Research tool to generate and study 

BRCA2 mutations. 

• Method to screen for 

chemotherapeutics. 

• Method to evaluate DNA damaging 

agents. 

Advantages: Ready to use portfolio of 

BRCA2 mutant cell lines to study 

BRCA2 mutant functional analysis. 

Market: An estimated 194,280 new 

cases of breast cancer will be diagnosed 

and may cause 40,610 deaths in the U.S. 

in 2009. 

Inventors: Shyam K. Sharan and 

Sergey Kuznetsov (NCI). 

Publication: SG Kuznetsov et al. 

Mouse embryonic stem cell-based 

functional assay to evaluate mutations 

in BRCA2. Nat Med. 2008 

Aug;14(8):875–881. 

Patent Status: HHS Reference No. E– 

261–2007/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Mouse Cancer Genetics Program, 

Center for Cancer Research, National 

Cancer Institute, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize mouse embryonic stem 

cell lines suitable for functional analysis 

of BRCA2 variants. Please contact John 

D. Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Establishment of Two Cell Lines That 

Stably Express Luciferase for In Vivo 

Tracking 

Description of Technology: Available 

for licensing are two renal carcinoma 

cell lines, 786-O(luc) and 786-O/VHL/ 

(luc) which both stably express 

luciferase. 786-O(luc) lacks von HippelLandau (VHL) protein expression and it 

has constitutively high expression of 

hypoxia-inducible transcription factor2alpha (HIF-2alpha). The second stably 

expresses VHL, a tumor suppressor, and 

has minimal HIF-2alpha expression. 

These cell lines can be tracked in vivo 

and can be used to study VHLdependent and HIF-2alpha dependent 

events such as tumorigenesis. VHL 

mutations lead to the clinical 

manifestations of von Hippel-Lindau 

disease, a rare autosomal dominant 

syndrome characterized by abnormal 

growth of blood vessels in multiple 

organs, including the brain and kidneys. 

Applications: Model to study VHL 

pathology. 

Advantages: Cell lines that stably 

express luciferase for in vivo tracking. 

Benefits: Easy, ready to use positive 

and negative VHL and HIF-2alpha cells 

that stably express luciferase for in vivo 

tests. 

Market: 

• Incidence of VHL syndrome is 1 in 

38,951. 

• HCC is the third leading cause of 

cancer death worldwide. 

• HCC is the fifth most common 

cancer in the world. 

• Post-operative five-year survival 

rate of HCC patients is 30–40 percent. 

Inventors: Leonard M. Neckers and W. 

Marston Linehan (NCI). 

Patent Status: HHS Reference No. E– 

005–2007/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, Urologic 

Oncology Branch, is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

develop further uses for these two cell 

lines that stably express luciferase for in 

vivo tracking. Please contact John D. 

Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Dated: September 17, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–22974 Filed 9–22–09; 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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Notices 48571 

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. 

Osmogels: A New Method for 

Stabilizing Weak Molecular Complex 

Interactions 

Description of Invention: This 

invention describes a new method for 

stabilizing molecular complexes in 

polyacrylamide gels for analysis by the 

electrophoretic mobility shift assay. By 

adding specific osmolytes directly to the 

gel, investigators have found that 

weakly interacting molecular complexes 

can be sufficiently stabilized to allow 

quantitative analysis of the binding. 

Experiments with nonspecific labile 

complexes of two restriction 

endonucleases, EcoRI and BamHI, show 

that one of these added solutes is 

particularly effective at inhibiting 

complex dissociation, does not interfere 

with normal gel polymerization, and 

does not significantly slow normal gel 

migration. The results also demonstrate 

that sharp bands can be obtained for 

non-specific complexes of both enzymes 

on gels prepared with this solute while 

only smeared and distorted bands are 

observed on regular gels prepared 

without the solute. This method can be 

used for protein-protein, DNA-protein, 

and RNA-protein complexes, and can 

also be extended to include other 

techniques for separating complexes 

from free components using gel 

chromatography and capillary 

electrophoresis. 

The potential market for gels that 

allow researchers to detect and quantify 

weak molecular complex interactions is 

significant; ranging from molecular 

biologists searching for novel regulatory 

DNA-binding proteins and convenient 

ways to detect protein-protein, or 

protein-DNA/RNA complexes to 

crystallographers needing reliable 

techniques to search for optimal 

conditions of complex formation. This 

technology has the potential to 

significantly impact biomedical research 

and development across many fields. 

Application: Detection of weak 

molecular complex interactions for 

research and commercial use. 

Development Status: Late stage. 

Inventors: Nina Y. Sidorova and 

Donald C. Rau (NICHD). 

Publications: 

1. NY Sidorova, S Muradymov, DC 

Rau. Trapping DNA-protein binding 

reactions with neutral osmolytes for the 

analysis by gel mobility shift and selfcleavage assays. Nucleic Acids Res. 

2005 Sep 9;33(16):5145–5155. 

2. NY Sidorova and DC Rau. 

Differences between EcoRI nonspecific 

and ‘‘star’’ sequence complexes revealed 

by osmotic stress. Biophys J. 2004 

Oct;87(4):2564–2576. 

Patent Status: U.S. Patent Application 

No. 12/485,481 filed 16 Jun 2009 (HHS 

Reference No. E–214–2009/0–US–01); 

No foreign patent rights available. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey A. James, 

Ph.D.; 301–435–5474; 

jeffreyja@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Program in 

Physical Biology, Laboratory of Physical 

and Structural Biology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize osmogels for analysis of 

weak complexes by the electrophoretic 

mobility shift assay with potential 

extension of the technique to other 

separation methods. Please contact 

Joseph Conrad III, Ph.D. at 301–435– 

3107 or jmconrad@mail.nih.gov for 

more information. 

RNA Nanoparticles and Methods of Use 

Description of Invention: The 

invention hereby offered for licensing is 

in the field of nanoparticles and their 

usefulness in a variety of medical 

applications. More specifically the 

invention describes the design and 

synthesis of various RNA nanoparticles. 

These polyvalent nanoparticles 

comprise RNA motifs as building blocks 

that give the particles their unique 

characteristics. Moreover, the motifs can 

be pre-defined and chosen to give the 

particles desired characteristics (e.g. 

size and shape) tailored for a variety of 

applications. The polyvalent particles 

can utilize multiple unique positions to 

carry functional groups for cell 

recognition (e.g. cancer cells), therapy 

and detection. For therapeutic or 

detection applications the particles 

typically encompass at least two 

functional groups, a therapeutic or 

imaging agent and a targeting agent that 

will direct the particles to the targeted 

tissue. 

RNA nanoparticles have the potential 

to serve as excellent drug or imaging 

delivery systems due to their 

designability and versatility. 

Furthermore, the RNA nanoparticles of 

the invention are also capable of selfassembly and potentially form 

nanotubes of various shapes which offer 

potentially broad uses in medical 

implants, gene therapy, nanocircuits, 

scaffolds and medical testing. 

Applications: The technology can be 

primarily used for therapeutic and 

diagnostic applications. 

Advantages: RNA nanoparticles 

potentially offer advantages compared 

to other conventional nanoparticles: 

• They are compatible with biological 

systems and thus may be readily used 

for in vivo applications such as 

therapeutic and diagnostic. 

• They are small and have a potential 

to move efficiently through biological 

barriers to a target tissue. 

• They have multiple binding sites 

and thus can readily be conjugated with 

several functional groups (e.g. 

therapeutic molecule and targeting 

molecule). 

• They are versatile and can be 

designed in different shapes and sizes 

for different applications. 

Development Status: Early stage. 

Market: 

• According to U.S. National Science 

Foundation estimates, by 2015 the 

annual global market for nano-related 

goods and services will top $1 trillion, 

thus making it one of the fastest-growing 

industries in history. Assuming that 

these figures prove to be accurate, 

nanotechnology will emerge as a larger 

economic force than the combined 

telecommunications and information 

technology industries at the beginning 

of the technology boom of the late 

1990s. 

• The interest in nanoparticles as 

carriers of biological materials for 

medical applications has been growing 

exponentially in recent years and the 

commercial potential in the medical 

field is vast. 

• According to market research 

reports the global medical market for 

nanotechnology applications is 

expected to increase from about $1.7 

billion in 2007 to an estimated $3.8 

billion by 2013, a compound annual 

growth rate (CAGR) of 14.9%. 

• Nanoparticles have the largest share 

of the market, worth $1.6 billion in 

2007. This segment is expected to be 

worth $3.4 billion in 2013, a CAGR of 

13.4%. 

• Other nanostructured materials 

represent the second largest segment, 

generating $36.5 million in 2007 and an 

$304.7 million in 2013, for a CAGR of 

46.5%. 

• Some therapeutics and imaging 

medical products based on 

nanoparticles have recently received 

FDA approval and are ready for 

commercialization. For example, the 

Rexin G, a targeted Delivery System 

(TRS) for treatment of solid tumors is 

already used commercially in the 

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48572 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Notices 

Philippine and is currently being 

commercialized in the US by Epeius 

Biotechnologies. 

Inventor: Bruce A. Shapiro (NCI). 

Publications: 

1. E Bindewald, C Grunewald, B 

Boyle, M O’Connor, BA Shapiro. 

Computational strategies for the 

automated design of RNA nanoscale 

structures from building blocks using 

NanoTiler. J Mol Graph Model. 2008 

Oct;27(3):299–308. 

2. B Shapiro, E Bindewald, W 

Kasprzak, Y Yingling. (E Gazit, F 

Nussinov, eds.) Protocols for the In 

silico Design of RNA Nanostructures. In: 

Nanostructure Design Methods and 

Protocols. Totowa, NJ: Humana Press; 

2008. p. 93–115. 

3. HM Martinez, JV Maizel Jr, BA 

Shapiro. RNA2D3D: a program for 

generating, viewing, and comparing 3- 

dimensional models of RNA. J Biomol 

Struct Dyn. 2008 Jun;25(6):669–683. 

4. I Severcan, C Geary, L Jaeger, E 

Bindewald, W Kasprzak, B Shapiro. (G 

Alterovitz, M Ramoni, R Benson, eds.) 

Computational and Experimental RNA 

Nanoparticle Design. In: Automation in 

Genomics and Proteomics: An 

Engineering Case-Based Approach. 

Hoboken: Wiley Publishing; 2009. 

5. E Bindewald, R Hayes, YG 

Yingling, W Kasprzak, BA Shapiro. 

RNAJunction: a database of RNA 

junctions and kissing loops for threedimensional structural analysis and 

nanodesign. Nucleic Acids Res. 2008 

Jan;36:D392–397. 

6. YG Yingling and BA Shapiro. 

Computational design of an RNA 

hexagonal nanoring and an RNA 

nanotube. Nano Lett. 2007 

Aug;7(8):2328–2334. 

7. BA Shapiro and YG Yingling. PCT 

Application No. PCT/US2007/13027 

filed 31 May 2007, which published as 

WO 2008/039254 on 03 Apr 2008, and 

U.S. Patent Application No. 12/227,955 

filed 02 Dec 2008; both entitled ‘‘RNA 

Hexagonal Ring and RNA Nanotube.’’ 

Patent Status: U.S. Provisional 

Application No. 61,187,495 filed 16 Jun 

2009 (HHS Reference No. E–059–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

Ph.D., MBA; 301–435–4616; 

UR7a@nih.gov; John Stansberry, Ph.D.; 

301–435–5236; js852e@nih.gov 

Collaborative Research Opportunity: 

The National Cancer Institute’s 

Nanobiology Program is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize RNA nanostructures. 

Please contact John D. Hewes, Ph.D. at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 

Bactericidal Peptides From Avian 

Leukocyte Ribonuclease A–2 

Description of Invention: These 

bactericidal polypeptides offer a novel 

alternative to conventional antibiotics 

that are used to treat and prevent 

bacterial infections. As infectioncausing bacteria continue to develop 

antibiotic resistance to first line 

antibiotics there will always be a need 

for new antibiotic alternatives. 

Additionally, a greater understanding of 

the specific cytoxic activity of RNase A 

ribonucleases, their functional domains, 

and their roles in promoting antipathogen host defense may provide 

insight into new therapeutic agents. 

This invention includes a novel 

RNase A ribonuclease from chicken 

leukocytes and polypeptides that have 

bactericidal activities against both gram 

positive and gram negative bacteria, 

including such pathogens as Escherichia 

coli, Salmonella spp., and 

Staphylococcus. 

Applications: 

• Polypeptides exhibiting 

bactericidal, bacteriostatic, and 

ribonuclease activity. 

• Pharmaceutical compositions 

comprising the bactericidal 

polypeptides. 

• Methods for treating bacterial 

infections. 

Development Status: Early stage. 

Market: With the increase in 

antibiotic and antibacterial drug 

resistance, the market for alternatives is 

growing. 

Inventors: Helene F. Rosenberg et al. 

(NIAID). 

Related Publication: T Nitto, KD Dyer, 

M Czapiga, HF Rosenberg. Evolution 

and function of leukocyte RNase A 

ribonucleases of the avian species, 

Gallus gallus. J Biol Chem. 2006 Sep 

1;281(35):25622–25634. 

Patent Status: U.S. Patent Application 

No. 12/438,700 filed 24 Feb 2009, 

claiming priority to 24 Aug 2006 (HHS 

Reference No. E–281–2006/0–US–03) 

Licensing Status: Available for 

licensing. 

Licensing Contact: RC Tang JD LLM; 

301–435–5031; tangrc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID Laboratory of Allergic 

Diseases is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact William Ronnenberg, NIAID 

Office of Technology Development, at 

301–451–3522 or 

wronnenberg@niaid.nih.gov for more 

information. 

Dated: September 17, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–22975 Filed 9–22–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0440] 

Availability of Grant Funds for the 

Support of Cooperative Agreement 

Award to Georgetown University 

Entitled: Genome Wide Methylation 

Arrays for Detecting Markers of 

Increased Susceptibility to Mammary 

Cancer Caused by In-Utero Exposures 

to Endocrine Disruptors (U01) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Veterinary Medicine (CVM), and Office 

of New Animal Drugs (ONADE) is 

announcing the availability of grant 

funds for the support of a sole source, 

cooperative agreement award to 

Georgetown University, Lombardi 

Cancer Research Center and Department 

of Oncology entitled: ‘‘Genome Wide 

Methylation Arrays for Detection 

Markers of Increased Susceptibility to 

Mammary Cancer Caused by In-Utero 

Exposures to Endocrine Disruptors 

(U01).’’ The main purpose of this study 

is to help gain an understanding of the 

extent to which exposures to endocrine 

disruptors early in life increase later 

susceptibility to developing breast 

cancer by inducing heritable epigenetic 

changes in transcription factors, which 

are linked to increased breast cancer 

risk. The study is subject to the 

requirements of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

331, et seq.) regulations issued under it 

and applicable Department of Health 

and Human Services statutes and 

regulations. 

DATES: Important dates are as follows: 

1. The application due date is 30 days 

from the publication in the Federal 

Register. 

2. The anticipated start date is 

September 2009. 

FOR FURTHER INFORMATION CONTACT: 

Peer Review/Administrative Contact: 

Michelle Fuller, Center for 

mstockstill on DSKH9S0YB1PROD with NOTICES