Center for Scientific Review; Notice of Closed Meetings, 11252-11253 [05-4500]
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Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National institutes of Health
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Center for Scientific Review; Notice of
Closed Meetings
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
Environmental Health Sciences Special
Emphasis Panel, R13 Conference Grant
Review.
Date: March 29, 2005.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709, (Telephone Conference Call).
Contact Person: Linda K. Bass, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research & Training, Nat. Institute of
Environmental Hlth. Sciences, P.O. Box
12233, MD EC–30, Research Triangle Park,
NC 27709, (919) 541–1307.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National institutes of Health, HHS).
Dated: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
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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
meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, Predictive
Validity of Preschool Symptoms.
Date: March 9, 2005.
Time: 1 p.m. to 3 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: Victoria S. Levin, MSW,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3172,
MSC 7848, Bethesda, MD 20892, (301) 435–
0912; levinv@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,
Musculoskeletal Tissue Engineering.
Date: March 17–18, 2005.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Jean Dow Sipe, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106,
MSC 7814, Bethesda, MD 20892, (301) 435–
1743; sipej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflicts in Motor Function, Speech and
Rehabilitation.
Date: March 18, 2005.
Time: 3 p.m. to 5 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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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, Tumor
Biomarkers.
Date: March 22, 2005.
Time: 11 a.m. to 1 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: Eva Petrakova, PhD, MPH,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892, (301) 435–
1716, petrakoe@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, SEP Review
of Macromolecular Structure and Motion
Program Project Application.
Date: March 24, 2005.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Hotel, 1750 Rockville
Pike, Rockville, MD 20852.
Contact Person: Gopa Rakhit, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4154,
MSC 7806, Bethesda, MD 20892, (301) 435–
1721, rakhitg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Bacterial
Pathogenesis Redo.
Date: March 24, 2005.
Time: 3 p.m. to 5 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: Rolf Menzel, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3196,
MSC 7808, Bethesda, MD 20892, (301) 435–
0952, menzelro@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Functional
G Protein Pathways in Platelet Activation.
Date: March 25, 2005.
Time: 2 p.m. to 3:30 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: Robert T. Su, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4134,
MSC 7802, Bethesda, MD 20892, (301) 435–
1195, sur@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Bioinformatics Approach to Protein
Phosphorylation.
Date: March 28, 2005.
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Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Notices
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel, One
Washington Circle, Washington, DC 20037.
Contact Person: Arnold Revzin, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184,
MSC 7824, Bethesda, MD 20892, (301) 435–
1153, revzina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Stress and
Neuroendocrine Responses.
Date: March 29, 2005.
Time: 2 p.m. to 3 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: Mariela Shirley, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186,
MSC 7848, Bethesda, MD 20892, (301) 435–
0913, shirleym@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Bacterial
Pathogenesis.
Date: March 29, 2005.
Time: 2:30 p.m. to 4:30 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: Marian Wachtel, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3208,
MSC 7858, Bethesda, MD 20892, (301) 435–
1148, wachtelm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Non-Human
Visual Processing.
Date: March 29, 2005.
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: Christine L. Melchior,
PhD, Scientific Review Administrator, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176,
MSC 7844, Bethesda, MD 20892, (301) 435–
1713, melchioc@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: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–4500 Filed 3–7–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Novel Isosteric Thalidomide
Analogs With Enhanced TNF-α
Inhibitory Activity
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 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 U.S. Patent
Application No. 60/504,724 filed
September 17, 2003, entitled
‘‘Thalidomide Analogs’’ (DHHS
Reference E–189–2003/0–US–01) and
PCT Application No. PCT/US2004/
030506 filed September 17, 2004,
entitled ‘‘Thalidomide Analogs’’ (DHHS
Ref. E–189–2003/0–PCT–02) to Phase 2
Discovery, Inc. The patent rights in
these inventions have been assigned to
the United States of America.
The prospective exclusive license
territory may be United States,
Denmark, Italy, Ireland, United
Kingdom, Germany, France, Sweden,
Switzerland, Spain, Czech Republic,
Greece, Russia, Australia, Japan,
Taiwan, Singapore, China, Argentina
and Brazil, and the field of use may be
limited to development and sale of a
pharmaceutical product useful in
treating Amyotrophic Lateral Sclerosis
(ALS) and Attention Deficit
Hyperactivity Disorder (ADHD).
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before May 9, 2005 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., 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:
Inflammatory processes associated with
the over-production of cytokines,
particularly of tumor necrosis factoralpha (TNF-a), accompany numerous
neurodegenerative diseases, such as
Alzheimer’s disease and ALS, in
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addition to numerous common systemic
conditions, such as rheumatoid arthritis,
septic shock, graft-versus-host disease,
Crohn’s disease and erythema nodosum
leprosum (ENL). TNF-a has been
validated as a drug target with the
development of the inhibitors Enbril
and Remicade as prescription
medications for rheumatoid arthritis.
Both, however, are large
macromolecules that are expensive to
produce, require direct intravenous or
subcutaneous injection, and have
negligible brain access. The classical
orally active drug, thalidomide (N-aphthalimidoglutarimide), a glutamic
acid derivative, is being increasingly
used in the clinical management of a
wide spectrum of immunologicallymediated, infectious diseases, and
cancers. Its clinical value in treating
ENL derives from its TNF-a inhibitory
activity. Specifically, it inhibits TNF-a
protein expression at the posttranscriptional level by facilitating
turnover of the mRNA. More recent
research has shown similar inhibitory
action of COX2 protein expression.
These actions are mediated posttranscriptionally via AU-rich elements
found in the 3′ untranslated regions (3′–
UTRs) of each mRNA. Thalidomide’s
anti-angiogenesis activity derives from
its inhibitory actions on basic fibroblast
growth factor (bFGF) and vascular
endothelial growth factor (VEGF). The
agent, additionally, acts as an inhibitor
of the transcription factor, NFkB and a
co-stimulator of both CD8+ and CD4+ T
cells. However, the action of
thalidomide to lower TNF-a levels and
inhibit angiogenesis is not particularly
potent, and it therefore represents an
interesting lead compound for
medicinal chemistry.
Novel structural modification of
thalidomide led to the discovery of
original and potent isosteric analogues.
The present invention relates to
thalidomide analogues and, in
particular, thiothalidomides (sulfurcontaining thalidomide analogues),
methods of synthesizing the analogues,
and methods for using the analogues to
modulate TNF-a and angiogenesis
activities in a subject. Disclosed
analogues potently inhibited TNF-a
secretion, compared to thalidomide, via
post-transcriptional mechanisms that
decreased TNF-a mRNA stability via its
3′–UTR. Actions to inhibit angiogenesis
were determined in widely accepted ex
vivo assays.
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 part 404.7. The
prospective exclusive license may be
granted unless within sixty (60) days
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Agencies
[Federal Register Volume 70, Number 44 (Tuesday, March 8, 2005)]
[Notices]
[Pages 11252-11253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
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
meetings.
The meetings 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: Center for Scientific Review Special Emphasis
Panel, Predictive Validity of Preschool Symptoms.
Date: March 9, 2005.
Time: 1 p.m. to 3 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: Victoria S. Levin, MSW, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3172, MSC 7848, Bethesda, MD
20892, (301) 435-0912; levinv@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, Musculoskeletal Tissue Engineering.
Date: March 17-18, 2005.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Jean Dow Sipe, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106, MSC 7814, Bethesda, MD
20892, (301) 435-1743; sipej@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Member Conflicts in Motor Function, Speech and
Rehabilitation.
Date: March 18, 2005.
Time: 3 p.m. to 5 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: 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, Tumor Biomarkers.
Date: March 22, 2005.
Time: 11 a.m. to 1 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: Eva Petrakova, PhD, MPH, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD
20892, (301) 435-1716, petrakoe@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, SEP Review of Macromolecular Structure and Motion Program
Project Application.
Date: March 24, 2005.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Double Tree Hotel, 1750 Rockville Pike, Rockville, MD
20852.
Contact Person: Gopa Rakhit, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD
20892, (301) 435-1721, rakhitg@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Bacterial Pathogenesis Redo.
Date: March 24, 2005.
Time: 3 p.m. to 5 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: Rolf Menzel, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3196, MSC 7808, Bethesda, MD
20892, (301) 435-0952, menzelro@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Functional G Protein Pathways in Platelet Activation.
Date: March 25, 2005.
Time: 2 p.m. to 3:30 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: Robert T. Su, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4134, MSC 7802, Bethesda, MD
20892, (301) 435-1195, sur@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Bioinformatics Approach to Protein Phosphorylation.
Date: March 28, 2005.
[[Page 11253]]
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: One Washington Circle Hotel, One Washington Circle,
Washington, DC 20037.
Contact Person: Arnold Revzin, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184, MSC 7824, Bethesda, MD
20892, (301) 435-1153, revzina@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Stress and Neuroendocrine Responses.
Date: March 29, 2005.
Time: 2 p.m. to 3 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: Mariela Shirley, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186, MSC 7848, Bethesda, MD
20892, (301) 435-0913, shirleym@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Bacterial Pathogenesis.
Date: March 29, 2005.
Time: 2:30 p.m. to 4:30 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: Marian Wachtel, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3208, MSC 7858, Bethesda, MD
20892, (301) 435-1148, wachtelm@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Non-Human Visual Processing.
Date: March 29, 2005.
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: Christine L. Melchior, PhD, Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD
20892, (301) 435-1713, melchioc@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: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-4500 Filed 3-7-05; 8:45 am]
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