28702 Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices 

the Administrator, Health Resources 

and Services Administration. The 

Bureau of Primary Health Care includes 

the following components: 

(1) Office of the Associate 

Administrator (RC); 

(2) Office of Minority and Special 

Populations (RCG); 

(3) Office of Policy and Program 

Development (RCH); 

(4) Office of Quality and Data (RCK); 

(5) Eastern Division (RCN); 

(6) Central Mid-Atlantic Division 

(RCP); 

(7) Western Division (RCQ); 

(8) Division of National Hansen’s 

Disease Programs (RC7); and 

(9) Division Immigration Health 

Service (RC9). 

Section RC–20, Functions 

(1) Delete the functional statement for 

the Office of the Associate 

Administrator (RC) and replace in its 

entirety; and (2) Delete the functional 

statement for the Office of 

Administrative Management (RCM). 

Office of the Associate Administrator 

(RC) 

Provides overall leadership, direction, 

coordination, and planning in support 

of Bureau of Primary Health Care 

programs that are designed to improve 

the health of the Nation’s underserved 

communities and vulnerable 

populations by assuring access to 

comprehensive, culturally competent, 

quality primary health care services. 

Specifically, (1) Establishes program 

goals, objectives and priorities, and 

provides oversight as to their execution; 

(2) plans, directs, coordinates and 

evaluates Bureau-wide management 

activities; (3) maintains effective 

relationships within HRSA and with 

other Department of Health and Human 

Services (HHS) organizations, other 

Federal agencies, State and local 

governments, and other public and 

private organizations concerned with 

primary health care, eliminating health 

disparities, and improving the health 

status of the Nation’s underserved and 

vulnerable populations; and (4) plans, 

directs, and coordinates Bureau-wide 

administrative management activities, 

i.e., budget, finance, personnel, 

procurements, delegations of authority, 

emergency planning, training, executive 

secretariat, and has responsibilities 

related to the awarding of BPHC grant 

and contract funds. 

Section RC–30, Delegations of Authority 

All delegations of authority and redelegations of authority made to HRSA 

officials that were in effect immediately 

prior to this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 

This reorganization is effective upon 

the date of signature. 

Dated: May 15, 2007. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E7–9786 Filed 5–21–07; 8:45 am] 

BILLING CODE 4165–15–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. 

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 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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices 28703 

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. 2006 Dec 13, Epub ahead of 

print, doi:10.1016/j.ymben.2006.12.001. 

Patent Status: U.S. Provisional 

Application No. 60/840,381 filed 24 

Aug 2006 (HHS Reference No. E–149–

2006/0–US–01). 

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. 

In Vitro Model for Hepatitis C Virion 

Production 

Description of Technology: This 

invention provides an in vitro hepatitis 

C virus (HCV) replication system that is 

capable of producing viral particles in a 

culture medium. Hepatitis C is a major 

public health problem, the development 

of therapeutics for which has been 

hampered by a lack of a robust model 

system to study the complete viral life 

cycle. This invention provides a new 

model system for the complete 

replication cycle of hepatitis C virus and 

virion production, assembly and release. 

The model is useful for screening 

antiviral agents against HCV. 

A full length HCV construct, CG1b of 

genotype 1b which is known to be 

infectious, was placed between two 

ribozymes designed to generate the 

exact 5′ and 3′ ends of HCV when 

cleaved. Using this system, HCV 

proteins and positive and negative RNA 

strands have been shown to reproduce 

intracellularly, and viral particles that 

resemble authentic HCV virions are 

produced and secreted into the culture 

medium. 

The patent application includes 

claims directed toward the following: a 

construct comprising specific nucleic 

acid sequences including HCV genotype 

1b, genotype 1a, genotype 2a or 

potentially other genotypes; a method 

for identifying a cell line that is 

permissive for infection with HCV; a 

method for propagating HCV in vitro; a 

method for screening agents capable of 

modulating HCV replication or activity; 

a method for testing the level of HCV 

replication or activity; a HCV vaccine 

comprising HCV virus particles. 

Applications: The model offers a 

novel method for investigating the 

entire HCV life cycle including 

replication and pathogenesis and is 

useful for high-throughput antiviral 

screening. This technique may also be 

useful for making infectious particles 

that are useful in the production of HCV 

vaccines. 

Advantages: This system provides a 

new, stable and efficient cell culture 

model to further study the life cycle and 

biology of HCV, and to test potential 

therapeutic targets for hepatitis C. This 

model has also been used to generate in 

cell culture HCV strains infectious for 

chimpanzees, the only experimental 

animal susceptible to infection with the 

hepatitis C virus, a critical step in the 

development of new vaccines for 

Hepatitis C. 

Market: Hepatitis C virus (HCV) 

chronically infects approximately 200 

million people worldwide and increases 

the risk of developing cirrhosis and 

hepatocellular carcinoma. This 

technology would be useful for studying 

the HCV life cycle, screening for 

therapeutic agents against multiple HCV 

strains, including Genotype 1a, 1b and 

2a, and the development of HCV 

vaccines. HCV genotypes 1 and 2 are the 

major genotypes with worldwide 

distribution; they are known to be 

associated with different clinical 

profiles and therapeutic responses. 

Hence, the model may be used to screen 

for varying levels of effectiveness of 

therapeutics against the major HCV 

genotypes. 

Development Status: This technology 

is available for use in diagnostics, drug/ 

vaccine discovery, production and 

development. Current work is directed 

toward studies into the HCV life cycle 

and replication and the pathogenesis of 

HCV screening for antiviral agents 

against multiple HCV strains. This 

model has been used to generate in cell 

culture HCV strains infectious for 

chimpanzees, the only experimental 

animal susceptible to infection with the 

hepatitis C virus, a critical step in the 

development of new vaccines for 

Hepatitis C. Future work may be 

directed toward the use of this system 

for development of vaccine candidates 

against HCV. 

Inventors: T. Jake Liang (NIDDK), 

Theo Heller (NIDDK) 

Related Publications: 

1. Z Hu et al. Altered proteolysis and 

global gene expression in hepatitis B 

virus X transgenic mouse liver. J Virol. 

2006 Feb;80(3):1405–1413. 

2. T Heller et al. An in vitro model of 

hepatitis C virion production. Proc Natl 

Acad Sci USA. 2005 Feb 

15;102(7):2579–2583. 

Patent Status: PCT Application No. 

PCT/US2005/035487 filed 30 Sep 2005 

(HHS Reference No. E–324–2004/3–

PCT–01), based on: U.S. Provisional 

Application No. 60/615,301 filed 30 Sep 

2004 (HHS Reference No. E–324–2004/ 

0–US–01), now abandoned; U.S. 

Provisional Application No. 60/642,210 

filed 06 Jan 2005 (HHS Reference No. E–

324–2004/1–US–01), now abandoned; 

and U.S. Provisional Application No. 

60/720,692 filed 26 Sep 2005 (HHS 

Reference No. E–324–2004/2–US–01), 

now abandoned. 

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, Liver 

Diseases Branch, is seeking parties 

interested in collaborative research 

directed toward molecular strategies for 

vaccine and antiviral development, and 

animal models of viral hepatitis C. 

Please contact Dr. T. Jake Liang at 301–

496–1721, jliang@nih.gov or Rochelle S. 

Blaustein at Rochelle.Blaustein@nih.gov 

for more information. 

Dated: May 14 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer,Office of Technology 

Transfer,National Institutes of Health. 

[FR Doc. E7–9845 Filed 5–21–07; 8:45 am] 

BILLING CODE 4140–01–P 


jlentini on PROD1PC65 with NOTICES