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40138 Federal Register / Vol. 71, No.

135 / Friday, July 14, 2006 / Notices

Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific for Increasing the Distribution of
Rockledge Drive, Bethesda, MD 20892, Review Special Emphasis Panel, Member Nucleic Acids;’’ Provisional, Patent
(Telephone Conference Call). Conflict: Child Psychopathology and Application 60/250,286; Provisional
Contact Person: Michael Micklin, PhD, Developmental Disabilities. Patent Application No. 60/286,308; U.S.
Chief, RPHB IRG, Center for Scientific Date: July 2, 2006.
Time: 1 p.m. to 2:30 p.m.
Patent Application No. 09/999,203; U.S.
Review, National Institutes of Health, 6701
Rockledge Drive, Room 3136, MSC 7759, Agenda: To review and evaluate grant Patent Application No. 10/132,681; and
Bethesda, MD 20892, (301) 435–2158, applications. Canadian Patent Application No.
micklinm@csr.nih.gov. Place: National Institutes of Health, 6701 2327208, to MedGenesis Therapeutix,
This notice is being published less than 15 Rockledge Drive, Bethesda, MD 20892, Inc. a Canadian company having its
days prior to the meeting due to the timing (Telephone Conference Call). headquarters in Victoria, British
limitations imposed by the review and Contact Person: Mariela Shirley, PhD, Columbia. The United States of America
funding cycle. Scientific Review Administrator, Center for is the assignee of the patent rights of the
Name of Committee: Center for Scientific Scientific Review, National Institutes of above invention. The contemplated
Review Special Emphasis Panel, Innovations Health, 6701 Rockledge Drive, Room 3186,
exclusive license may be granted in a
in BCST, Psychopathology and Sleep MSC 7848, Bethesda, MD 20892, (301) 435–
0193, shirleym@csr.nih.gov. field of use limited to the convection
Disorders. enhanced delivery and tracking of
Date: July 25, 2006. This notice is being published less than 15
days prior to the meeting due to the timing gadolinium conjugated peptides,
Time: 3 p.m. to 4 p.m.
Agenda: To review and evaluate grant limitations imposed by the review and polypeptides or lipid-based therapeutic
applications. funding cycle. agents within the central nervous
Place: National Institutes of Health, 6701 (Catalogue of Federal Domestic Assistance system of subjects with cancer,
Rockledge Drive, Bethesda, MD 20892, Program Nos. 93.306, Comparative Medicine; Parkinson’s disease, Dementia with
(Telephone Conference Call). 93.333, Clinical Research, 93.306, 93.333, Lewy bodies or Alzheimer’s disease.
Contact Person: Dana Jeffrey Plude, PhD, 93.337, 93.393–93.396, 93.837–93.844, DATES: Only written comments and/or
Scientific Review Administrator, Center for 93.846–93.878, 93.892, 93.893, National applications for a licence received by
Scientific Review, National Institutes of Institutes of Health, HHS) the NIH Office of Technology Transfer
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435– Dated: July 7, 2006. on or before September 12, 2006.
2309, pluded@csr.nih.gov. Anna Snouffer, ADDRESSES: Requests for a copy of the
This notice is being published less than 15 Acting Director, Office of Federal Advisory patent application, inquiries, comments
days prior to the meeting due to the timing Committee Policy. and other materials relating to the
limitations imposed by the review and [FR Doc. 06–6199 Filed 7–13–06; 8:45 am] contemplated license should be directed
funding cycle. BILLING CODE 4140–01–M to: Michael A. Shmilovich, Esq., Office
Name of Committee: Center for Scientific of Technology Transfer, National
Review Special Emphasis Panel, Institutes of Health, 6011 Executive
Bioengineering Research Partnerships—Brain DEPARTMENT OF HEALTH AND Boulevard, Suite 325, Rockville, MD
Injury and Visual Impairment.
HUMAN SERVICES 20852–3804; Telephone: (301) 435–
Date: July 25, 2006.
Time: 5 p.m. to 6 p.m. 5019; Facsimile: (301) 402–0220; E-mail:
National Institutes of Health shmilovm@mail.nih.gov. A signed
Agenda: To review and evaluate grant
applications. confidentiality nondisclosure agreement
Prospective Grant of Exclusive will be required to receive copies of the
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, License: Convection Enhanced patent applications.
(Telephone Conference Call). Delivery and Tracking of Gadolinium
SUPPLEMENTARY INFORMATION: The patent
Contact Person: Dana Jeffrey Plude, PhD, Conjugated Therapeutic Agents to the
Central Nervous System applications intended for licensure
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
disclose and/or cover the following:
Health, 6701 Rockledge Drive, Room 3176, AGENCY: National Institutes of Health, E–202–2002 ‘‘Method for Convection
MSC 7848, Bethesda, MD 20892, 301–435– Public Health Service, HHS. Enhanced Delivery of Therapeutic
2309, pluded@csr.nih.gov. ACTION: Notice. Agents.’’ The invention is a method for
This notice is being published less than 15 monitoring the spatial distribution of
days prior to the meeting due to the timing SUMMARY: This is notice, in accordance therapeutic substances by MRI or CT
limitations imposed by the review and with 35 U.S.C. 209(c)(1) and 37 CFR that have been administered to tissue
funding cycle. 404.7(a)(1)(i), that the National using convection enhanced delivery, a
Name of Committee: Center for Scientific Institutes of Health (NIH), Department technique that is the subject of NIH-
Review Special Emphasis Panel, Sleep and of Health and Human Services, is owned U.S. Patent No. 5,720,720. In one
Chronic Disease. contemplating the grant of an exclusive embodiment, the tracer is a molecule,
Date: July 26, 2006. worldwide license to practice the detectable by MRI or CT, which
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
invention embodied: HHS. Ref. No. E– functions as a surrogate for the motion
applications. 202–2002 ‘‘Method for Convection of the therapeutic agent through the
Place: National Institutes of Health, 6701 Enhanced Delivery of Therapeutic solid tissue. In other particular
Rockledge Drive, Bethesda, MD 20892, Agents,’’ Provisional Patent embodiments, the tracer is the
(Telephone Conference Call). Application, 60/413,673; International therapeutic agent conjugated to an
Contact Person: Michael Micklin, PhD, Patent Application PCT/US03/30155, imaging moiety. The method of this
Chief, RPHB IRG, Center for Scientific U.S. Patent Application Serial No. 10/ invention uses non-toxic
Review, National Institutes of Health, 6701 528,310; European Patent Applications macromolecular MRI contrast agents
Rockledge Drive, Room 3136, MSC 7759, Serial No. 03756863.1; Australian Patent comprised of chelated Gd(III). In
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Bethesda, MD 20892, (301) 435–2158,


micklinm@csr.nih.gov.
Application No. 2003299140; Canadian particular, the surrogate tracer used in
This notice is being published less than 15 Patent Application No. 2,499,573; and this invention is a serum albumin
days prior to the meeting due to the timing HHS Ref. No. E–206–2000/0 and/1 conjugated with either a gadolinium
limitations imposed by the review and ‘‘Method for Increasing the Distribution chelate of 2-(p-isothiocyanotobenzyl)-6-
funding cycle. of Therapeutic Agents;’’ and ‘‘Method methyldiethylenertriamine pentaacetic

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Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices 40139

acid or with iopanioc acid. These under the Freedom of Information Act, technological collection techniques or
macromolecular imaging agents have 5 U.S.C. 552. other forms of information technology,
clearance properties that mimic the Dated: July 5, 2006. e.g., permitting electronic submissions
pharmacokinetic properties of co- David R. Sadowski,
of responses. [end asterisks]
administrated drugs, so as to be useful Agency: Department of Homeland
Acting Director, Division of Technology
in quantifying the range and dosage Security, Office of the Secretary, Office
Development and Transfer, Office of
level of therapeutic drugs using MR Technology Transfer, National Institutes of of Policy, Private Sector Office.
imaging. Health. Title: Welcome to the United States
E–206–2000 ‘‘Method for increasing Survey.
[FR Doc. 06–6213 Filed 7–13–06; 8:45 am]
the distribution of therapeutic agents:’’ OMB Number: 1601–NEW.
BILLING CODE 4140–01–M Frequency: One-time collection.
‘‘Method for increasing the distribution
of nucleic acids.’’ The invention Affected Public: Foreign visitors into
pertains to the reliance of therapies on the U.S.
DEPARTMENT OF HOMELAND Number of Respondents: 939.
the local parenchymal delivery of SECURITY Estimated Time Per Respondent: 5
macromolecules or nucleic acids for minutes.
success. However, the volume of Office of the Secretary Total Burden Hours: 78.25 hours.
distribution of many of these potential Total Burden Cost (capital/startup):
therapeutic agents is restricted by their Welcome to the United States Survey $0.00.
interactions with the extracellular Total Burden Cost (operating/
matrix and cellular receptors. Heparin- AGENCY: Office of the Secretary, Office
of Policy, Private Sector Office, DHS. maintaining): $0.00.
sulfate proteoglycans are cell surface Description: The Department of
components which bind to an array of ACTION: Emergency submission to OMB,
Homeland Security (DHS), Office of
molecules such as growth factors, comment request. Policy, Private Sector Office in
cytokines and chemokines and viruses The Department of Homeland, Office conjunction with Customs and Border
such as cytomegalovirus, herpes of the Secretary, Private Sector Office Protection (CBP) and Research Triangle
simplex virus and HIV. The invention has submitted the following (see below) Institute, International, will interview
provides a method of dramatically information collection request (ICR), foreign visitors entering the United
increasing the volume of distribution utilizing emergency review procedures, States at four southern border ports of
and effectiveness of certain therapeutic to the Office of Management and Budget entry, three northern border ports of
agents after local delivery by the use of (OMB) for review and clearance in entry and four airport ports of entry
facilitating agents as described in accordance with the Paperwork before the Labor Day holiday in August
Neuroreport. 2001 Jul 3;12(9):1961–4 Reduction Act of 1995 (Pub. L. 104–13, 2006. This survey will measure how
entitled ‘‘Convection enhanced delivery 44 U.S.C. chapter 35). OMB approval CBP is serving the American public
of AAV–2 combined with heparin has been requested by July 30, 2006. A with vigilance and integrity, while
increases TK gene transfer in the rat copy of this ICR, with applicable providing courteous and helpful
brain’’ and in Exp Neurol. 2001 supporting documentation, may be treatment to visitors, immigrants and
Mar;168(1):155–61 entitled ‘‘Heparin obtained by calling the Departmental travelers. Additionally, this survey will
coinfusion during convection-enhanced Clearance Officer. further the Rice-Chertoff Initiative as
delivery (CED) increases the distribution Comments and questions about the has been announced by evaluating the
of the glial-derived neurotrophic factor ICR listed below should be forwarded to two model airports (Dulles International
(GDNF) ligand family in rat striatum the Office of Information and Regulatory Airport, Chantilly, VA, and Houston
and enhances the pharmacological Affairs, Attn: OMB Desk Officer for the International Airport, Houston, TX) for
activity of neurturin.’’ These methods Department of Homeland Security, baseline information as well as how
are especially useful when used in Office of Management and Budget, welcomed foreign visitors feel upon
conjunction with technology described Room 10235, Washington, DC 20503 entering the United States and
and claimed in the convection enhanced (OMB phone number). The Office of interacting with a DHS Customs and
delivery technology claimed in U.S. Management and Budget is particularly Border Protection officer.
patent 5,720,720 interested in comments which: [set Scott Charbo,
The prospective exclusive license will asterisks]
be royalty bearing and will comply with Chief Information Officer.
• Evaluate whether the proposed
the terms and conditions of 35 U.S.C. [FR Doc. E6–11135 Filed 7–13–06; 8:45 am]
collection of information is necessary
209 and 37 CFR 404.7. The prospective for the proper performance of the BILLING CODE 4410–10–P
exclusive license may be granted unless, functions of the agency, including
within sixty (60) days from the date of whether the information will have
this published notice. NIH receives DEPARTMENT OF HOMELAND
practical utility;
SECURITY
written evidence and argument that • Evaluate the accuracy of the
establishes that the grant of the license agency’s estimate of the burden of the Coast Guard
would not be consistent with the proposed collection of information,
requirements of 35 U.S.C. 209 and 37 including the validity of the [USCG–2006–25312]
CFR 404.7. methodology and assumptions used;
Properly filed competing applications • Enhance the quality, utility, and Meeting of the Office of Boating
for a license filed in response to this clarify of the information to be Safety’s Recreational Boating Safety
notice will be treated as objections to collected; and Strategic Planning Panel
jlentini on PROD1PC65 with NOTICES

the contemplated license. Comments • Minimize the burden of the AGENCY: Coast Guard, DHS.
and objections submitted in response to collection of information on those who ACTION: Notice of meeting.
this notice will not be made available are to respond, including through the
for public inspection, and, to the extent use of appropriate automated, SUMMARY: The Coast Guard’s Office of
permitted by law, will not be released electronic, mechanical, or other Boating Safety is sponsoring a panel of

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