Office of the Director, National Institutes of Health, Notice of Meeting, 66177-66178 [06-9150]
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Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Notices
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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
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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.
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66177
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]
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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: https://
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
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)
Research; 93.849, Kidney Diseases, Urology
and Hematology 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]
National Institutes of Health
BILLING CODE 4140–01–M
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
cprice-sewell on PROD1PC66 with NOTICES
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
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15:22 Nov 09, 2006
Jkt 211001
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
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting.
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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Agencies
[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Notices]
[Pages 66177-66178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9150]
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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
[[Page 66178]]
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: https://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