Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Autoimmune Diseases Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and Psoriasis, 59125-59126 [E6-16526]
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Federal Register / Vol. 71, No. 194 / Friday, October 6, 2006 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel, T Cell/B
Cell Mechanisms.
Date: October 17, 2006.
Time: 1 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Calbert A. Laing, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4210,
MSC 7812, Bethesda, MD 20892, 301–435–
1221, laingc@csr.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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Cognition
and Perception SRA Conflict Review.
Date: October 27, 2006.
Time: 8:30 a.m. to 10:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Helix, 1430 Rhode Island
Ave., NW., Washington, DC 20005.
Contact Person: Dana Jeffrey Plude, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Non-HIV
Microbial Vaccine Development.
Date: October 30, 2006.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Watergate, 2650 Virginia
Avenue, NW., Washington, DC 20037.
Contact Person: Jin Huang, PhD, Scientific
Review Administrator, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4095G, MSC 7812,
Bethesda, MD 20892, 301–435–1187,
jh377p@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Radiation
Therapy and Biology SBIR/STTR.
Date: October 30–31, 2006.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Bo Hong, PhD, Scientific
Review Administrator, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 6194, MSC 7804,
Bethesda, MD 20892, 301–435–5879,
hongb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, ZRG1 ONC–
P (03): Cancer Chemoprevention.
Date: October 30, 2006.
Time: 4 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
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14:52 Oct 05, 2006
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Contact Person: Zhiqiang Zou, MD, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, zouzhiq@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, NIDDK PAR
06 113.
Date: October 31–November 1, 2006.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Daniel F. McDonald, PhD,
Scientific Review Administrator, Chief, Renal
and Urological Sciences IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, (301) 435–
1215, mcdonald@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Molecular,
Cellular and Developmental Neurobiological
Small Business Applications.
Date: October 31, 2006.
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Place: Jurys Washington Hotel, 1500 New
Hampshire Avenue, NW., Washington, DC
20036.
Contact Person: Michael A. Lang, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140,
MSC 7850, Bethesda, MD 20892, (301) 435–
1265, langm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflicts in Biobehavioral Regulation and
Learning.
Date: October 31, 2006.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jane A. DoussardRoosevelt, PhD, Scientific Review
Administrator, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3184, MSC 7848, Bethesda, MD
20892, (301) 435–4445, doussarj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892,93.893, National
Institutes of Health, HHS)
Dated: September 28, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–8516 Filed 10–5–06; 8:45 am]
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59125
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Drug Discovery and
Molecular Pharmacology Study Section,
October 5, 2006, 8 a.m. to October 6,
2006, 5 p.m., Wyndham City Center
Hotel, 1143 New Hampshire Ave., NW.,
Washington, DC 20037 which was
published in the Federal Register on
September 15, 2006, 71 FR 54511–
54512.
The meeting will be held at the Red
Lion Hotel on Fifth Avenue, 1415 Fifth
Avenue, Seattle, WA 98101. The
meeting dates and time remain the
same. The meeting is closed to the
public.
Dated: September 28, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–8517 Filed 10–5–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Development and
Commercialization of Therapeutic
Products for Autoimmune Diseases
Including Rheumatoid Arthritis (RA),
Inflammatory Bowel Disease (IBD) and
Psoriasis
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), announces that the
Department of Health and Human
Services is contemplating the grant of an
exclusive license to practice the
inventions embodied in United States
Patent Application Number 60/181,909
entitled ‘‘Identification of a Novel
Domain in the Tumor Necrosis Factor
Receptor Family that Mediates Preligand Receptor Assembly and
Function’’ filed February 11, 2000 (HHS
Ref. No. E–095–2000/0–US–01); U.S.
Patent Application No. PCT/US01/
04125 entitled ‘‘Identification of a Novel
Domain in the Tumor Necrosis Factor
Receptor Family that Mediates Preligand Receptor Assembly and
Function’’ filed February 9, 2001, 2000
(HHS Ref. No. E–095–2000/0–PCT–02);
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cprice-sewell on PROD1PC66 with NOTICES
59126
Federal Register / Vol. 71, No. 194 / Friday, October 6, 2006 / Notices
U.S. Patent Application No. 10/203,495,
filed August 9, 2002, entitled
‘‘Identification of Novel Domain in the
Tumor Necrosis Factor Receptor Family
that Mediates Pre-ligand Receptor
Assembly and Function’’ (E–095–2000/
0–US–03); U.S. Patent Application No.
60/694,015 entitled ‘‘Amelioration of
Inflammatory Arthritis Targeting the
Pre-ligand Assembly Domain (PLAD) of
Tumor Necrosis Factor Receptors’’ filed
June 24, 2005 [E–095–2000/2–US–01];
U.S. Patent Application No. 60/717,589
entitled ‘‘Amelioration of Inflammatory
Arthritis Targeting the Pre-ligand
Assembly Domain (PLAD) of Tumor
Necrosis Factor Receptors’’ filed
September 16, 2005 [E–095–2000/3–
US–01]; U.S. PCT Application entitled
‘‘A Potential Novel Therapeutic Protein
Molecule of Inflammatory Arthritis
Targeting the Pre-ligand Assembly
Domain (PLAD) of Tumor Necrosis
Factor Receptor Type 1’’ filed February
9, 2001 [E–095–2000/4–PCT–01];
European Patent Application No.
01910476.9 entitled ‘‘Identification of
Novel Domain in the Tumor Necrosis
Factor Receptor Family that Mediates
Pre-ligand Receptor Assembly and
Function’’ filed February 9, 2001 [E–
095–2000/0–EP–06]; Australian Patent
Application No. 2001238076 entitled
‘‘Identification of Novel Domain in the
Tumor Necrosis Factor Receptor Family
that Mediates Pre-ligand Receptor
Assembly and Function’’ issued on
February 9, 2001 [E–095–2000/0–AU–
04]; and Canadian Patent Application
No. 2399388 entitled ‘‘Identification of
Novel Domain in the Tumor Necrosis
Factor Receptor Family that Mediates
Pre-ligand Receptor Assembly and
Function’’ filed February 9, 2001, [E–
095–2000/0–CA–05] to Domantis, Inc.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to
therapeutic applications for
autoimmune diseases including
rheumatoid arthritis (RA) inflammatory
bowel disease (IBD) and psoriasis as
covered under the agreement and based
upon the Patent Rights.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before December 5, 2006 will be
considered.
ADDRESSES: Requests for copies of the
patent and/or patent applications,
inquiries, comments and other materials
relating to the contemplated exclusive
license should be directed to: Mojdeh
Bahar, J.D., M.A., Technology Licensing
Specialist, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
VerDate Aug<31>2005
14:52 Oct 05, 2006
Jkt 211001
Rockville, MD. 20852–3804; Telephone:
(301) 435–2950; Facsimile: (301) 402–
0220; E-mail: BAHARM@OD.NIH.GOV.
The
invention relates to methods and
compositions that are useful for novel
treatment of arthritis and other
autoimmune diseases. This technology
discloses the identification of a
functional domain, Pre-ligand Assembly
Domain (PLAD), an essential part in
signaling involving receptors of the
Tumor Necrosis Factor superfamily and
its use in ameliorating rheumatoid
arthritis (RA). PLAD is essential for
signaling involving TFNR including
TNFR–1 (p60), TNFR–2 (p80), Fas,
TRAIL–R, LTR, CD40, CD30, CD27,
HVEM, OX40 and DR4 and can be
isolated as functional polypeptides
which can be useful in inhibiting the
first step in TNFR mediated signaling,
ligand-independent assembly of
members of the TNFR superfamily. The
ability to inhibit TNFR signaling
suggests that these PLAD polypeptides
may be useful in development of new
therapeutic molecules or as therapeutic
molecules themselves used for
modulation of immune responses,
apoptosis, and inflammation. The
inventors have discovered compounds
that interfere with PLAD and can block
the effects of TNF–a.
The prospective exclusive license will
be royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within sixty (60) days from the date of
this published notice, the NIH receives
written evidence and argument that
establish that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
Dated: September 28, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–16526 Filed 10–5–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Fogarty International Center (FIC)
2007–2011 Strategic Plan
John E. Fogarty International
Center (FIC), National Institutes of
Health. (NIH), Department of Health and
Human Services (DHHS).
ACTION: Notice with request for
comments.
AGENCY:
SUMMARY: The FIC is initiating a
strategic planning process to culminate
in the FIC Strategic Plan 2007–2011. To
anticipate and set priorities for global
health research and research training,
FIC requests input from scientists, the
general public, and interested parties.
The goal of this strategic planning
process is to identify current and future
needs and directions for global health
research. The existing FIC strategic plan
can be viewed at https://www.fic/
nih.gov/about/plan/StrategicPlan.pdf.
DATES: In order to ensure full
consideration, responses must be
submitted by November 15, 2006.
ADDRESSES: Interested persons and
organizations should submit their
responses to Strategic Plan, Fogarty
International Center, National Institutes
of Health, 16 Center Drive, Building 16,
MSC 6705, Bethesda, MD 20892–6705,
telephone 301–594–7857, Fax 301–496–
8496, E-mail: FICStratPlan@nih.gov.
Comments may be submitted
electronically via the Strategic Planning
Web site located at https://
nihfictest.cit.nih.gov/StratPlan/
index.htm. Comments may also be
submitted by mail or fax to the address
above.
SUPPLEMENTARY INFORMATION:
Background
The Fogarty International Center (FIC)
works to enhance global health by
promoting and supporting health
research and research training
worldwide. The Center uses a variety of
international research and research
training grants and fellowships to build
research capacity and human capital in
developing countries and foster
partnerships between U.S. scientists and
their foreign counterparts. The FIC is
currently developing a new strategic
plan to guide Center activities for the
next 5 years mindful of the need to set
research and research training priorities.
We welcome outside participation in
the process.
Request for Comments: To ensure the
continued relevance of its Strategic
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]]>Agencies
[Federal Register Volume 71, Number 194 (Friday, October 6, 2006)]
[Notices]
[Pages 59125-59126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Development and
Commercialization of Therapeutic Products for Autoimmune Diseases
Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD)
and Psoriasis
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), announces that the Department of Health and Human
Services is contemplating the grant of an exclusive license to practice
the inventions embodied in United States Patent Application Number 60/
181,909 entitled ``Identification of a Novel Domain in the Tumor
Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor
Assembly and Function'' filed February 11, 2000 (HHS Ref. No. E-095-
2000/0-US-01); U.S. Patent Application No. PCT/US01/04125 entitled
``Identification of a Novel Domain in the Tumor Necrosis Factor
Receptor Family that Mediates Pre-ligand Receptor Assembly and
Function'' filed February 9, 2001, 2000 (HHS Ref. No. E-095-2000/0-PCT-
02);
[[Page 59126]]
U.S. Patent Application No. 10/203,495, filed August 9, 2002, entitled
``Identification of Novel Domain in the Tumor Necrosis Factor Receptor
Family that Mediates Pre-ligand Receptor Assembly and Function'' (E-
095-2000/0-US-03); U.S. Patent Application No. 60/694,015 entitled
``Amelioration of Inflammatory Arthritis Targeting the Pre-ligand
Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors'' filed June
24, 2005 [E-095-2000/2-US-01]; U.S. Patent Application No. 60/717,589
entitled ``Amelioration of Inflammatory Arthritis Targeting the Pre-
ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors''
filed September 16, 2005 [E-095-2000/3-US-01]; U.S. PCT Application
entitled ``A Potential Novel Therapeutic Protein Molecule of
Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD)
of Tumor Necrosis Factor Receptor Type 1'' filed February 9, 2001 [E-
095-2000/4-PCT-01]; European Patent Application No. 01910476.9 entitled
``Identification of Novel Domain in the Tumor Necrosis Factor Receptor
Family that Mediates Pre-ligand Receptor Assembly and Function'' filed
February 9, 2001 [E-095-2000/0-EP-06]; Australian Patent Application
No. 2001238076 entitled ``Identification of Novel Domain in the Tumor
Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor
Assembly and Function'' issued on February 9, 2001 [E-095-2000/0-AU-
04]; and Canadian Patent Application No. 2399388 entitled
``Identification of Novel Domain in the Tumor Necrosis Factor Receptor
Family that Mediates Pre-ligand Receptor Assembly and Function'' filed
February 9, 2001, [E-095-2000/0-CA-05] to Domantis, Inc.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to therapeutic applications for
autoimmune diseases including rheumatoid arthritis (RA) inflammatory
bowel disease (IBD) and psoriasis as covered under the agreement and
based upon the Patent Rights.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before December 5,
2006 will be considered.
ADDRESSES: Requests for copies of the patent and/or patent
applications, inquiries, comments and other materials relating to the
contemplated exclusive license should be directed to: Mojdeh Bahar,
J.D., M.A., Technology Licensing Specialist, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD. 20852-3804; Telephone: (301) 435-2950;
Facsimile: (301) 402-0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The invention relates to methods and
compositions that are useful for novel treatment of arthritis and other
autoimmune diseases. This technology discloses the identification of a
functional domain, Pre-ligand Assembly Domain (PLAD), an essential part
in signaling involving receptors of the Tumor Necrosis Factor
superfamily and its use in ameliorating rheumatoid arthritis (RA). PLAD
is essential for signaling involving TFNR including TNFR-1 (p60), TNFR-
2 (p80), Fas, TRAIL-R, LTR, CD40, CD30, CD27, HVEM, OX40 and DR4 and
can be isolated as functional polypeptides which can be useful in
inhibiting the first step in TNFR mediated signaling, ligand-
independent assembly of members of the TNFR superfamily. The ability to
inhibit TNFR signaling suggests that these PLAD polypeptides may be
useful in development of new therapeutic molecules or as therapeutic
molecules themselves used for modulation of immune responses,
apoptosis, and inflammation. The inventors have discovered compounds
that interfere with PLAD and can block the effects of TNF-[alpha].
The prospective exclusive license will be royalty-bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless within sixty
(60) days from the date of this published notice, the NIH receives
written evidence and argument that establish that the grant of the
license would not be consistent with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted to
this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: September 28, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-16526 Filed 10-5-06; 8:45 am]
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