Prospective Grant of Exclusive License: Convection Enhanced Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to the Central Nervous System, 40138-40139 [06-6213]
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Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Michael Micklin, PhD,
Chief, RPHB IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 3136, MSC 7759,
Bethesda, MD 20892, (301) 435–2158,
micklinm@csr.nih.gov.
This notice is being published less than 15
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limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Innovations
in BCST, Psychopathology and Sleep
Disorders.
Date: July 25, 2006.
Time: 3 p.m. to 4 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 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
This notice is being published less than 15
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Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Bioengineering Research Partnerships—Brain
Injury and Visual Impairment.
Date: July 25, 2006.
Time: 5 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).
Contact Person: Dana Jeffrey Plude, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@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, Sleep and
Chronic Disease.
Date: July 26, 2006.
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: Michael Micklin, PhD,
Chief, RPHB IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 3136, MSC 7759,
Bethesda, MD 20892, (301) 435–2158,
micklinm@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.
VerDate Aug<31>2005
17:44 Jul 13, 2006
Jkt 208001
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Child Psychopathology and
Developmental Disabilities.
Date: July 2, 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: 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–
0193, shirleym@csr.nih.gov.
This notice is being published less than 15
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(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: July 7, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–6199 Filed 7–13–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Convection Enhanced
Delivery and Tracking of Gadolinium
Conjugated Therapeutic Agents to the
Central Nervous System
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
worldwide license to practice the
invention embodied: HHS. Ref. No. E–
202–2002 ‘‘Method for Convection
Enhanced Delivery of Therapeutic
Agents,’’ Provisional Patent
Application, 60/413,673; International
Patent Application PCT/US03/30155,
U.S. Patent Application Serial No. 10/
528,310; European Patent Applications
Serial No. 03756863.1; Australian Patent
Application No. 2003299140; Canadian
Patent Application No. 2,499,573; and
HHS Ref. No. E–206–2000/0 and/1
‘‘Method for Increasing the Distribution
of Therapeutic Agents;’’ and ‘‘Method
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
for Increasing the Distribution of
Nucleic Acids;’’ Provisional, Patent
Application 60/250,286; Provisional
Patent Application No. 60/286,308; U.S.
Patent Application No. 09/999,203; U.S.
Patent Application No. 10/132,681; and
Canadian Patent Application No.
2327208, to MedGenesis Therapeutix,
Inc. a Canadian company having its
headquarters in Victoria, British
Columbia. The United States of America
is the assignee of the patent rights of the
above invention. The contemplated
exclusive license may be granted in a
field of use limited to the convection
enhanced delivery and tracking of
gadolinium conjugated peptides,
polypeptides or lipid-based therapeutic
agents within the central nervous
system of subjects with cancer,
Parkinson’s disease, Dementia with
Lewy bodies or Alzheimer’s disease.
DATES: Only written comments and/or
applications for a licence received by
the NIH Office of Technology Transfer
on or before September 12, 2006.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael A. Shmilovich, Esq., Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5019; Facsimile: (301) 402–0220; E-mail:
shmilovm@mail.nih.gov. A signed
confidentiality nondisclosure agreement
will be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION: The patent
applications intended for licensure
disclose and/or cover the following:
E–202–2002 ‘‘Method for Convection
Enhanced Delivery of Therapeutic
Agents.’’ The invention is a method for
monitoring the spatial distribution of
therapeutic substances by MRI or CT
that have been administered to tissue
using convection enhanced delivery, a
technique that is the subject of NIHowned U.S. Patent No. 5,720,720. In one
embodiment, the tracer is a molecule,
detectable by MRI or CT, which
functions as a surrogate for the motion
of the therapeutic agent through the
solid tissue. In other particular
embodiments, the tracer is the
therapeutic agent conjugated to an
imaging moiety. The method of this
invention uses non-toxic
macromolecular MRI contrast agents
comprised of chelated Gd(III). In
particular, the surrogate tracer used in
this invention is a serum albumin
conjugated with either a gadolinium
chelate of 2-(p-isothiocyanotobenzyl)-6methyldiethylenertriamine pentaacetic
E:\FR\FM\14JYN1.SGM
14JYN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
acid or with iopanioc acid. These
macromolecular imaging agents have
clearance properties that mimic the
pharmacokinetic properties of coadministrated drugs, so as to be useful
in quantifying the range and dosage
level of therapeutic drugs using MR
imaging.
E–206–2000 ‘‘Method for increasing
the distribution of therapeutic agents:’’
‘‘Method for increasing the distribution
of nucleic acids.’’ The invention
pertains to the reliance of therapies on
the local parenchymal delivery of
macromolecules or nucleic acids for
success. However, the volume of
distribution of many of these potential
therapeutic agents is restricted by their
interactions with the extracellular
matrix and cellular receptors. Heparinsulfate proteoglycans are cell surface
components which bind to an array of
molecules such as growth factors,
cytokines and chemokines and viruses
such as cytomegalovirus, herpes
simplex virus and HIV. The invention
provides a method of dramatically
increasing the volume of distribution
and effectiveness of certain therapeutic
agents after local delivery by the use of
facilitating agents as described in
Neuroreport. 2001 Jul 3;12(9):1961–4
entitled ‘‘Convection enhanced delivery
of AAV–2 combined with heparin
increases TK gene transfer in the rat
brain’’ and in Exp Neurol. 2001
Mar;168(1):155–61 entitled ‘‘Heparin
coinfusion during convection-enhanced
delivery (CED) increases the distribution
of the glial-derived neurotrophic factor
(GDNF) ligand family in rat striatum
and enhances the pharmacological
activity of neurturin.’’ These methods
are especially useful when used in
conjunction with technology described
and claimed in the convection enhanced
delivery technology claimed in U.S.
patent 5,720,720
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. NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
VerDate Aug<31>2005
17:44 Jul 13, 2006
Jkt 208001
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: July 5, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. 06–6213 Filed 7–13–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
Welcome to the United States Survey
Office of the Secretary, Office
of Policy, Private Sector Office, DHS.
ACTION: Emergency submission to OMB,
comment request.
AGENCY:
The Department of Homeland, Office
of the Secretary, Private Sector Office
has submitted the following (see below)
information collection request (ICR),
utilizing emergency review procedures,
to the Office of Management and Budget
(OMB) for review and clearance in
accordance with the Paperwork
Reduction Act of 1995 (Pub. L. 104–13,
44 U.S.C. chapter 35). OMB approval
has been requested by July 30, 2006. A
copy of this ICR, with applicable
supporting documentation, may be
obtained by calling the Departmental
Clearance Officer.
Comments and questions about the
ICR listed below should be forwarded to
the Office of Information and Regulatory
Affairs, Attn: OMB Desk Officer for the
Department of Homeland Security,
Office of Management and Budget,
Room 10235, Washington, DC 20503
(OMB phone number). The Office of
Management and Budget is particularly
interested in comments which: [set
asterisks]
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarify of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
PO 00000
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Fmt 4703
Sfmt 4703
40139
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses. [end asterisks]
Agency: Department of Homeland
Security, Office of the Secretary, Office
of Policy, Private Sector Office.
Title: Welcome to the United States
Survey.
OMB Number: 1601–NEW.
Frequency: One-time collection.
Affected Public: Foreign visitors into
the U.S.
Number of Respondents: 939.
Estimated Time Per Respondent: 5
minutes.
Total Burden Hours: 78.25 hours.
Total Burden Cost (capital/startup):
$0.00.
Total Burden Cost (operating/
maintaining): $0.00.
Description: The Department of
Homeland Security (DHS), Office of
Policy, Private Sector Office in
conjunction with Customs and Border
Protection (CBP) and Research Triangle
Institute, International, will interview
foreign visitors entering the United
States at four southern border ports of
entry, three northern border ports of
entry and four airport ports of entry
before the Labor Day holiday in August
2006. This survey will measure how
CBP is serving the American public
with vigilance and integrity, while
providing courteous and helpful
treatment to visitors, immigrants and
travelers. Additionally, this survey will
further the Rice-Chertoff Initiative as
has been announced by evaluating the
two model airports (Dulles International
Airport, Chantilly, VA, and Houston
International Airport, Houston, TX) for
baseline information as well as how
welcomed foreign visitors feel upon
entering the United States and
interacting with a DHS Customs and
Border Protection officer.
Scott Charbo,
Chief Information Officer.
[FR Doc. E6–11135 Filed 7–13–06; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2006–25312]
Meeting of the Office of Boating
Safety’s Recreational Boating Safety
Strategic Planning Panel
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
SUMMARY: The Coast Guard’s Office of
Boating Safety is sponsoring a panel of
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40138-40139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6213]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Convection Enhanced
Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to
the Central Nervous System
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive worldwide license to practice the invention embodied: HHS.
Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of
Therapeutic Agents,'' Provisional Patent Application, 60/413,673;
International Patent Application PCT/US03/30155, U.S. Patent
Application Serial No. 10/528,310; European Patent Applications Serial
No. 03756863.1; Australian Patent Application No. 2003299140; Canadian
Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and/1
``Method for Increasing the Distribution of Therapeutic Agents;'' and
``Method for Increasing the Distribution of Nucleic Acids;''
Provisional, Patent Application 60/250,286; Provisional Patent
Application No. 60/286,308; U.S. Patent Application No. 09/999,203;
U.S. Patent Application No. 10/132,681; and Canadian Patent Application
No. 2327208, to MedGenesis Therapeutix, Inc. a Canadian company having
its headquarters in Victoria, British Columbia. The United States of
America is the assignee of the patent rights of the above invention.
The contemplated exclusive license may be granted in a field of use
limited to the convection enhanced delivery and tracking of gadolinium
conjugated peptides, polypeptides or lipid-based therapeutic agents
within the central nervous system of subjects with cancer, Parkinson's
disease, Dementia with Lewy bodies or Alzheimer's disease.
DATES: Only written comments and/or applications for a licence received
by the NIH Office of Technology Transfer on or before September 12,
2006.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael A. Shmilovich, Esq., Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: shmilovm@mail.nih.gov. A
signed confidentiality nondisclosure agreement will be required to
receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent applications intended for
licensure disclose and/or cover the following:
E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic
Agents.'' The invention is a method for monitoring the spatial
distribution of therapeutic substances by MRI or CT that have been
administered to tissue using convection enhanced delivery, a technique
that is the subject of NIH-owned U.S. Patent No. 5,720,720. In one
embodiment, the tracer is a molecule, detectable by MRI or CT, which
functions as a surrogate for the motion of the therapeutic agent
through the solid tissue. In other particular embodiments, the tracer
is the therapeutic agent conjugated to an imaging moiety. The method of
this invention uses non-toxic macromolecular MRI contrast agents
comprised of chelated Gd(III). In particular, the surrogate tracer used
in this invention is a serum albumin conjugated with either a
gadolinium chelate of 2-(p-isothiocyanotobenzyl)-6-
methyldiethylenertriamine pentaacetic
[[Page 40139]]
acid or with iopanioc acid. These macromolecular imaging agents have
clearance properties that mimic the pharmacokinetic properties of co-
administrated drugs, so as to be useful in quantifying the range and
dosage level of therapeutic drugs using MR imaging.
E-206-2000 ``Method for increasing the distribution of therapeutic
agents:'' ``Method for increasing the distribution of nucleic acids.''
The invention pertains to the reliance of therapies on the local
parenchymal delivery of macromolecules or nucleic acids for success.
However, the volume of distribution of many of these potential
therapeutic agents is restricted by their interactions with the
extracellular matrix and cellular receptors. Heparin-sulfate
proteoglycans are cell surface components which bind to an array of
molecules such as growth factors, cytokines and chemokines and viruses
such as cytomegalovirus, herpes simplex virus and HIV. The invention
provides a method of dramatically increasing the volume of distribution
and effectiveness of certain therapeutic agents after local delivery by
the use of facilitating agents as described in Neuroreport. 2001 Jul
3;12(9):1961-4 entitled ``Convection enhanced delivery of AAV-2
combined with heparin increases TK gene transfer in the rat brain'' and
in Exp Neurol. 2001 Mar;168(1):155-61 entitled ``Heparin coinfusion
during convection-enhanced delivery (CED) increases the distribution of
the glial-derived neurotrophic factor (GDNF) ligand family in rat
striatum and enhances the pharmacological activity of neurturin.''
These methods are especially useful when used in conjunction with
technology described and claimed in the convection enhanced delivery
technology claimed in U.S. patent 5,720,720
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. NIH receives written
evidence and argument that establishes that the grant of the license
would not be consistent with the requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response 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: July 5, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 06-6213 Filed 7-13-06; 8:45 am]
BILLING CODE 4140-01-M
