Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Notices 66177 

unique and development of 

prophylactics and/or therapeutics 

against the virus represents a significant 

contribution to agriculture and public 

health sectors throughout the world. 

Application: Novel therapeutics for 

the treatment and prevention of avian 

influenza. 

Development Status: In vitro and 

early-stage animal studies have been 

performed. 

Inventors: Barry R. O’Keefe and James 

B. McMahon (NCI). 

Patent Status: U.S. Provisional 

Application No. 60/838,712 filed 18 

Aug 2006 (HHS Reference No. E–198–

2006/0–US–01). 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Sally Hu, PhD; 

301/435–5606; HuS@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Molecular Targets 

Development Program is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize cyanovirin-N for use 

against H5N1 influenza. Please contact 

Betty Tong, PhD at 301–594–4263 or 

tongb@mail.nih.gov for more 

information. 

Methods for Treating Drug-Resistant 

HIV–1 Infection 

Description of Technology: Drugresistance is a critical factor 

contributing to the loss of clinical 

benefit of currently available human 

immunodeficiency virus-1 (HIV–1) 

therapies. Accordingly, combination 

therapies have evolved to address the 

rapidly evolving virus. However, there 

has been great concern regarding the 

growing resistance of HIV–1 strains to 

current therapies as multi-drug 

resistance to protease inhibitors is 

becoming more common. The current 

technology embodies a breakthrough 

against this immense obstacle of 

existing HIV–1 treatments. 

Compositions and methods of 

inhibiting the protease of multi-drug 

resistant retroviruses such as HIV–1 are 

available for non-exclusive licensing 

and commercial development. The 

antiviral activity of the compound 

described by the current invention has 

been established against multi-protease 

inhibitor-resistant HIV–1 variants and 

demonstrated effective in patients with 

widespread resistance to currently 

available protease inhibitors. In 

addition, commercial development of 

this composition has resulted in the 

production of a novel drug that has 

recently been granted accelerated 

approval by the U.S. Food and Drug 

Administration (FDA) for the treatment 

of HIV–1 in patients who are nonresponsive to existing antiretroviral 

therapies. 

The available composition retains the 

unique ability to inhibit drug resistant 

mutants due to its distinctive points of 

interaction with the enzyme: the agent 

tightly binds to the part of the protease 

substrate binding site, which the virus 

cannot easily change. Other 

‘‘conventional’’ protease inhibitors bind 

to other parts of the protease substrate 

binding site, which the virus can 

relatively easily change, rendering these 

drugs ineffective after repeated use. 

Therefore, the current technology 

represents a highly effective method of 

targeting drug resistant HIV–1 strains. 

Applications: (1) Novel therapeutics 

for the treatment of drug-resistant HIV; 

(2) Safe and effective methods for 

administration of anti-HIV/AIDS drugs. 

Development Status: Clinical trials 

have been performed with PrezistaTM

(darunavir), a drug resulting from 

development of the present technology, 

which has received accelerated approval 

from the FDA. 

Inventors: John W. Erickson (SAIC/ 

NCI), Sergei V. Gulnik (SAIC/NCI), 

Hiroaki C. Mitsuya (NCI), and Arun K. 

Ghosh. 

Related Publications: 

1. K Yoshimura, R Kato, MF Kavlick, 

A Nguyen, V Maroun, K Maeda, KA 

Hussain, AK Ghosh, SV Gulnik, JW 

Erickson, H Mitsuya. A potent human 

immunodeficiency virus type 1 protease 

Inhibitor, UIC–94003 (TMC 126), and 

selection of a novel (A28S) mutation in 

the protease active site. J Virol. 2002 

Feb;76(3):1349–1358. 

2. Y Koh, K Maeda, H Ogata, G Bilcer, 

T Devasamudram, JF Kincaid, P Boross, 

Y-F Wang, Y Tie, P Volarath, L Gaddis, 

JM Louis, RW Harrison, IT Weber, AK 

Ghosh, H Mitsuya. Novel bis 

tetrahydrofuranyl-urethane-containing 

nonpeptidic protease inhibitor (PI) UIC–

94017 (TMC114) potent against multiPI-resistant human immunodeficiency 

virus in vitro. Antimicrob Agents 

Chemother. 2003 Oct;47(10):3123–3129. 

3. AK Ghosh, PR Sridhar, S 

Leshchenko, AK Hussain, J Li, AY 

Kovalevsky, DE Walters, JE Wedekind, 

V Grum-Tokars, D Das, H Mitsuya. 

Structure-based design of novel HIV–1 

protease inhibitors to combat drug 

resistance. J Med Chem. 2006 Aug 24; 

49(17):5252–5261. 

4. AK Ghosh, P Ramu Sridhar, N 

Kumaragurubaran, Y Koh, IT Weber, H 

Mitsuya. Bis-tetrahydrofuran: a 

privileged ligand for darunavir and a 

new generation of HIV protease 

inhibitors that combat drug resistance. 

ChemMedChem. 2006 Sep;1(9):939–950. 

Patent Status: U.S. Patent Application 

No. 09/720,276 filed 07 Mar 2001 (HHS 

Reference No. E–200–1998/0–US–02); 

European Patent Application No. 

99931861.1 filed 23 Jun 1999 (HHS 

Reference No. E–200–1998/0–EP 08). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Sally Hu, PhD; 

301/435–5606; HuS@mail.nih.gov. 

Dated: November 3, 2006. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E6–19050 Filed 11–9–06; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health, Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Advisory Committee to the Director, 

NIH. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Advisory Committee 

to the Director, NIH. 

Date: December 1, 2006. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: Among the topics proposed for 

discussion are: (1) NIH Director’s Report; (2) 

NIH Director’s Council of Public 

Representatives Liaison Report; (3) Institute 

Director’s Report; and (4) Work Group on 

Outside Awards for NIH Employees. 

Place: National Institutes of Health, 

Building 31, C Wing, Conference Room 6, 

9000 Rockville Pike, Bethesda, MD 20892. 

Contact Person: Shelly Pollard, ACD 

Coordinator, National Institutes of Health, 

9000 Rockville Pike, Building 31, Room 

5B64, Bethesda, MD 20892. (301) 496–0959. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 


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66178 Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Notices 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nih.gov/about/director/acd.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: November 3, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9150 Filed 11–19–06; 8:45 am] 

BILLING CODE 4140–01–M 

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 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. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Research Support Services. 

Date: November 17, 2006. 

Time: 8:30 a.m. to 1 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Crystal City Marriott, 1999 Jefferson 

Davis Highway, Arlington, VA 22202. 

Contact Person: Holly Patton, PhD, 

Scientific Review Administrator, Review 

Branch/Division of Extramural Affairs, 

National Heart, Lung, and Blood Institute, 

Two Rockledge Center, 6701 Rockledge Drive 

Room 7188, Bethesda, MD 20892, (301) 435–

0280, pattonh@nhibi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

(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: November 2, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9155 Filed 11–9–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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 section 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. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Economic Analysis 

of Urinary Incontinence Treatment. 

Date: November 29, 2006. 

Time: 4:30 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Boulevard, Bethesda, MD 20982 

(Telephone Conference Call). 

Contact Person: Michele L. Barnard, PhD, 

Scientific Review Administrator, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 753, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452. (301) 

594–8898. barnardm@extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: November 3, 2006 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9151 Filed 11–9–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; ZEB1 OSR–A(J2) 

Training Meeting. 

Date: December 11, 2006. 

Time: 1 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Suite 200, small conference room, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: David George, PhD, 

Director, Office of Scientific Review, 

National Institute of Biomedical Imaging and 

Bioengineering, 6707 Democracy Blvd., Suite 

920, Bethesda, MD 20892, 301–496–8633, 

georged1@mail.nih.gov. 

Dated: November 2, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9153 Filed 11–9–06; 8:45 am] 

BILLING CODE 4140–01–M 


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