Prospective Grant of Exclusive License: Convection Enhanced Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to the Central Nervous System, 78217-78218 [E6-22187]

Download as PDF Federal Register / Vol. 71, No. 249 / Thursday, December 28, 2006 / Notices Contact Person: Cheryl M. Corsaro, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD20892, (301) 435–1045, corsaroc@nih.gov. Name of Committee: Respiratory Sciences Integrated Review Group, Lung Cellular, Molecular, and Immunobiology Study Section. Date: February 15–16, 2007. Time: 8 am. to 3 pm. Agenda: To review and evaluate grant applications. Place: M Street Hotel, 1143 New Hampshire Ave., NW, Washington, DC 20037. Contact Person: George M. Barnas, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2810, MSC 7818, Bethesda, MD 20892, 301–435–0696, barnasg@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Mosquito Vectors. Date: February 15, 2007. Time: 1 pm. to 4 pm. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Fouad A. El-Zaatari, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3206, MSC 7808, Bethesda, MD 20814–9692, (301) 435–1149, elzaataf@csr.nih.gov. sroberts on PROD1PC70 with NOTICES Name of Committee: Center for Scientific Review Special Emphasis Panel, Social Science and Population Studies R03s, R15s, and R21s. Date: February 16 2007. Time: 8 am to 5 pm. Agenda: To review and evaluate grant applications. Place: Marina Del Rey Hotel, 13534 Bali Way, Marina Del Rey, CA 90292. Contact Person: Valerie Durrant, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3418, MSC 7770, Bethesda, MD 20892. (301) 435–3554, durrantv@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) VerDate Aug<31>2005 20:03 Dec 27, 2006 Jkt 211001 Dated: December 20, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9887 Filed 12–27–06; 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. AGENCY: 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 in: 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 Application 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 Medtronic Neurological, a Division of the Medtronic Corporation, having its headquarters in Minneapolis, Minnesota. 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 development and sales of a clinical grade surrogate tracer for tracking the distribution of convection enhanced delivered central nervous system therapeutics, excluding lipid based systems. Only written comments and/or applications for a license received by the NIH Office of Technology Transfer DATES: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 78217 on or before February 26, 2007 will be considered. 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)-6methyldiethylenetriamine pentaacetic acid or with iopanoic 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. Heparin-sulfate proteoglycans E:\FR\FM\28DEN1.SGM 28DEN1 78218 Federal Register / Vol. 71, No. 249 / Thursday, December 28, 2006 / Notices 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: December 20, 2006. Steven M. Ferguson Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–22187 Filed 12–27–06; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4140–01–P VerDate Aug<31>2005 20:03 Dec 27, 2006 Jkt 211001 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency transition, the Federal Emergency Management Agency will continue to support this program. Dated: December 21, 2006. Charlie Dickinson, Acting U.S. Fire Administrator. [FR Doc. E6–22301 Filed 12–27–06; 8:45 am] Open Meeting/Conference Call, Board of Visitors for the National Fire Academy U.S. Fire Administration, Federal Emergency Management Agency, DHS. ACTION: Notice of open meeting via conference call. BILLING CODE 9110–17–P AGENCY: In accordance with the Federal Advisory Committee Act, the Federal Emergency Management Agency announces the following committee meeting: SUMMARY: Name: Board of Visitors (BOV) for the National Fire Academy. Date of Meeting: January 18, 2007. Place: Building H, Room 300, National Emergency Training Center, Emmitsburg, Maryland. Time: 1:30–3:30 p.m. Proposed Agenda: Review National Fire Academy Program Activities. In accordance with section 10 (a) (2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, the Federal Emergency Management Agency announces that the committee meeting will be open to the public in the Emmitsburg commuting area with seating available on a firstcome, first-served basis. The meeting is open to the public; however, teleconference lines are limited. Members of the general public who plan to participate in the meeting should contact the Office of the Superintendent, National Fire Academy, U.S. Fire Administration, 16825 South Seton Avenue, Emmitsburg, MD 21727, (301) 447–1117, on or before January 16, 2007. Dial-in information will be provided to those wishing to participate via telephone. Minutes of the meeting will be prepared and will be available for public viewing in the Office of the U.S. Fire Administrator, U.S. Fire Administration, Federal Emergency Management Agency, Emmitsburg, Maryland 21727. Copies of the minutes will be available upon request within 60 days after the meeting. The National Fire Academy Board of Visitors is administered by the U.S. Fire Administration, which is currently part of the Preparedness Directorate of the Department of Homeland Security. In the near future, the U.S. Fire Administration will be transferred to the Federal Emergency Management Agency, also part of the Department of Homeland Security. During this SUPPLEMENTARY INFORMATION: PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5037–N–99] Notice of Submission of Proposed Information Collection to OMB; Quality Control for Rental Assistance Subsidy Determinations Office of the Chief Information Officer, HUD. ACTION: Notice. AGENCY: SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Data are collected on a sample of households receiving HUD housing assistance subsidies. These households are interviewed and their incomes verified to determine if subsidies are correctly calculated. The study identifies the costs and types of errors. The results are used to target corrective actions and measure the impact of past corrective actions. DATES: Comments Due Date: January 29, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2528–0203) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail Lillian_L._Deitzer@HUD.gov or telephone (202) 708–2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD’s Web site at https:// hlannwp031.hud.gov/po/i/icbts/ collectionsearch.cfm E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 71, Number 249 (Thursday, December 28, 2006)]
[Notices]
[Pages 78217-78218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22187]


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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 in: 
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 Application 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 Medtronic Neurological, a Division of the Medtronic 
Corporation, having its headquarters in Minneapolis, Minnesota. 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 development and sales of a clinical grade 
surrogate tracer for tracking the distribution of convection enhanced 
delivered central nervous system therapeutics, excluding lipid based 
systems.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before February 26, 2007 
will be considered.

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-methyldiethylenetriamine pentaacetic acid or 
with iopanoic 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

[[Page 78218]]

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: December 20, 2006.
Steven M. Ferguson
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-22187 Filed 12-27-06; 8:45 am]
BILLING CODE 4140-01-P
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