Prospective Grant of Exclusive License: Development of a Companion Diagnostic Kit To Detect Asparagine Synthetase Expression Levels as a Method To Screen for the Drug Efficacy in Treatments for Pancreatic Cancer, Ovarian Cancer, and Multiple Myeloma, 56857-56858 [E9-26309]
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Federal Register / Vol. 74, No. 211 / Tuesday, November 3, 2009 / Notices
first-served basis. Opportunities to
address the panel during the meeting
will occur during discussion of each
topic, and speakers will be required to
register ahead of time. If you would like
to make a formal presentation during
the open public sessions, you must
register and provide an abstract of your
presentation by 5 p.m. e.s.t. on January
15, 2010. To speak, submit your name,
title, business affiliation (if applicable),
address, telephone and fax numbers,
and e-mail address to Adele Seifried
(see FOR FURTHER INFORMATION CONTACT).
FDA has included issues for comment
in section I of the SUPPLEMENTARY
INFORMATION section. You should also
identify by letter each issue you wish to
address in your presentation and the
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should check in before the workshop. In
addition, we strongly encourage written
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electronic comments will be accepted
until February 24, 2010.
If you need special accommodations
because of disability, contact Adele
Seifried (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
workshop.
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III. Comments
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ADDRESSES). A transcript will also be
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ROM, after submission of a Freedom of
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Information request. Written requests
are to be sent to the Division of Freedom
of Information (HFI–35), Office of
Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26397 Filed 11–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): CDC Grants for
Public Health Research Dissertation
(Panel G), Funding Opportunity
Announcement (FOA) PAR07–231,
Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned SEP:
Time and Date: 12:30 p.m.–4:30 p.m.,
December 2, 2009 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘CDC Grants for Public Health
Research Dissertation, FOA PAR07–231,
Panel G.’’
Contact Person for More Information:
Maurine Goodman, MA, MPH, Scientific
Review Administrator, CDC, 1600 Clifton
Road, NE., Mailstop D72, Atlanta, GA 30333,
Telephone (404) 639–4747.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: October 23, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–26283 Filed 11–2–09; 8:45 am]
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56857
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of a Companion
Diagnostic Kit To Detect Asparagine
Synthetase Expression Levels as a
Method To Screen for the Drug
Efficacy in Treatments for Pancreatic
Cancer, Ovarian Cancer, and Multiple
Myeloma
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, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 12/281,589 and PCT Application
No. PCT/US07/05555 entitled
‘‘Materials and Methods Directed to
Asparagine Synthetase and
Asparaginase Therapies’’ (HHS Ref. No.
E–132–2006/2), to the French-based
ERYtech Pharma LLC which is located
in Lyon, France (with an additional
office in Philadelphia, Pennsylvania).
The patent rights in this invention have
been assigned to the United States of
America.
The prospective exclusive license
territory may be worldwide and the
field of use may be for to the use of the
Licensed Patent Rights limited to a
FDA-approved companion diagnostic
test predictive of L-asparaginase
therapeutic effect in the treatment of
pancreatic cancer, ovarian cancer, and
multiple myeloma as claimed in the
Licensed Patent Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
January 4, 2010 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Samuel E. Bish, Ph.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5282; Facsimile: (301) 402–0220; E-mail:
bishse@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology describes methods and
therapies involving asparagine
synthetase (ASNS) and L-asparaginase
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56858
Federal Register / Vol. 74, No. 211 / Tuesday, November 3, 2009 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
(L-asp). Included are methods to
decrease cell proliferation, most notably
in order to treat various cancers, by
administrating to a subject a
combination of an ASNS antagonist and
a formulation of L-asp. The main ASNS
antagonist utilized in these methods are
small interfering RNAs (siRNAs) that
reduce ASNS expression. Also included
are methods of screening for the efficacy
of L-asp in a subject by detecting the
expression of the ASNS gene in a
sample. The technology also describes a
kit that probes to detect ASNS gene
expression in a sample to identify the
efficacy of L-asp treatment. ASNS serves
as a key biomarker for acute
lymphoblastic leukemia (ALL) and other
malignancies because these cancer cells
express little or no ASNS compared to
normal cells. As a result, the cancerous
cells must acquire asparagine from the
bloodstream to survive and proliferate
to form tumors. Over several decades,
patients with ALL and other leukemias
have been treated with L-asparaginase
(L-asp) to break down asparagine in the
body and starve leukemia cells of
asparagine. L-asp treatment is usually
more effective when ASNS expression
in the patient is limited.
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
from the date of this published notice,
the 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.
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: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–26309 Filed 11–2–09; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Minerals Management Service
[Docket No. MMS–2009–OMM–0015]
MMS Information Collection Activity:
1010–0051, Oil and Gas Production
Measurement, Extension of a
Collection; Comment Request
AGENCY: Minerals Management Service
(MMS), Interior.
ACTION: Notice of extension of an
information collection (1010–0051).
SUMMARY: To comply with the
Paperwork Reduction Act of 1995
(PRA), MMS is inviting comments on a
collection of information that we will
submit to the Office of Management and
Budget (OMB) for review and approval.
The information collection request (ICR)
concerns the paperwork requirements in
the regulations under 30 CFR 250,
Subpart L, Oil and Gas Production
Measurement.
DATES: Submit written comments by
January 4, 2010.
FOR FURTHER INFORMATION CONTACT:
Cheryl Blundon, Regulations and
Standards Branch at (703) 787–1607.
You may also contact Cheryl Blundon to
obtain a copy, at no cost, of the
regulation that requires the subject
collection of information.
ADDRESSES: You may submit comments
by either of the following methods listed
below.
• Electronically: go to https://
www.regulations.gov. In the entry titled
‘‘Enter Keyword or ID,’’ enter docket ID
MMS–2009–OMM–0015 then click
search. Under the tab ‘‘View by
Relevance’’ you can submit public
comments and view supporting and
related materials available for this
collection of information. The MMS will
post all comments.
• Mail or hand-carry comments to the
Department of the Interior; Minerals
Management Service; Attention: Cheryl
Blundon; 381 Elden Street, MS–4024;
Herndon, Virginia 20170–4817. Please
reference Information Collection 1010–
0051 in your subject line and mark your
message for return receipt. Include your
name and return address in your
message text.
SUPPLEMENTARY INFORMATION:
Title: 30 CFR Part 250, Subpart L, Oil
and Gas Production Measurement.
OMB Control Number: 1010–0051.
Abstract: The Outer Continental Shelf
(OCS) Lands Act, as amended (43 U.S.C.
1331 et seq. and 43 U.S.C. 1801 et seq.),
authorizes the Secretary of the Interior
(Secretary) to prescribe rules and
regulations to administer leasing of the
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OCS. Such rules and regulations will
apply to all operations conducted under
a lease. Operations on the OCS must
preserve, protect, and develop oil and
natural gas resources in a manner that
is consistent with the need to make such
resources available to meet the Nation’s
energy needs as rapidly as possible; to
balance orderly energy resource
development with protection of human,
marine, and coastal environments; to
ensure the public a fair and equitable
return on the resources of the OCS; and
to preserve and maintain free enterprise
competition. The Federal Oil and Gas
Royalty Management Act of 1982 (30
U.S.C. 1701, et seq.) at section
1712(b)(2) prescribes that an operator
will ‘‘develop and comply with such
minimum site security measures as the
Secretary deems appropriate, to protect
oil or gas produced or stored on a lease
site or on the Outer Continental Shelf
from theft.’’ Regulations at 30 CFR part
250, subpart L, implement these
statutory requirements. We use the
information to ensure that the volumes
of hydrocarbons produced are measured
accurately, and royalties are paid on the
proper volumes. Specifically, MMS
needs the information to:
• Determine if measurement
equipment is properly installed,
provides accurate measurement of
production on which royalty is due, and
is operating properly;
• Obtain rates of production data in
allocating the volumes of production
measured at royalty sales meters, which
can be examined during field
inspections;
• Ascertain if all removals of oil and
condensate from the lease are reported;
• Determine the amount of oil that
was shipped when measurements are
taken by gauging the tanks rather than
being measured by a meter;
• Ensure that the sales location is
secure and production cannot be
removed without the volumes being
recorded; and
• Review proving reports to verify
that data on run tickets are calculated
and reported accurately.
The MMS will protect information
from respondents considered
proprietary under the Freedom of
Information Act (5 U.S.C. 552) and its
implementing regulations (43 CFR part
2) and under regulations at 30 CFR
250.197, Data and information to be
made available to the public or for
limited inspection and 30 CFR part 252,
OCS Oil and Gas Information Program.
No items of a sensitive nature are
collected. Responses are mandatory.
Frequency: Varies by section, but
primarily monthly, or on occasion.
E:\FR\FM\03NON1.SGM
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[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56857-56858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26309]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of a
Companion Diagnostic Kit To Detect Asparagine Synthetase Expression
Levels as a Method To Screen for the Drug Efficacy in Treatments for
Pancreatic Cancer, Ovarian Cancer, and Multiple Myeloma
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, Department
of Health and Human Services, is contemplating the grant of an
exclusive patent license to practice the inventions embodied in U.S.
Patent Application No. 12/281,589 and PCT Application No. PCT/US07/
05555 entitled ``Materials and Methods Directed to Asparagine
Synthetase and Asparaginase Therapies'' (HHS Ref. No. E-132-2006/2), to
the French-based ERYtech Pharma LLC which is located in Lyon, France
(with an additional office in Philadelphia, Pennsylvania). The patent
rights in this invention have been assigned to the United States of
America.
The prospective exclusive license territory may be worldwide and
the field of use may be for to the use of the Licensed Patent Rights
limited to a FDA-approved companion diagnostic test predictive of L-
asparaginase therapeutic effect in the treatment of pancreatic cancer,
ovarian cancer, and multiple myeloma as claimed in the Licensed Patent
Rights.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
January 4, 2010 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Samuel E. Bish, Ph.D., Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5282; Facsimile: (301) 402-0220; E-mail:
bishse@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The technology describes methods and
therapies involving asparagine synthetase (ASNS) and L-asparaginase
[[Page 56858]]
(L-asp). Included are methods to decrease cell proliferation, most
notably in order to treat various cancers, by administrating to a
subject a combination of an ASNS antagonist and a formulation of L-asp.
The main ASNS antagonist utilized in these methods are small
interfering RNAs (siRNAs) that reduce ASNS expression. Also included
are methods of screening for the efficacy of L-asp in a subject by
detecting the expression of the ASNS gene in a sample. The technology
also describes a kit that probes to detect ASNS gene expression in a
sample to identify the efficacy of L-asp treatment. ASNS serves as a
key biomarker for acute lymphoblastic leukemia (ALL) and other
malignancies because these cancer cells express little or no ASNS
compared to normal cells. As a result, the cancerous cells must acquire
asparagine from the bloodstream to survive and proliferate to form
tumors. Over several decades, patients with ALL and other leukemias
have been treated with L-asparaginase (L-asp) to break down asparagine
in the body and starve leukemia cells of asparagine. L-asp treatment is
usually more effective when ASNS expression in the patient is limited.
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 from the date of this published notice, the 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.
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: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-26309 Filed 11-2-09; 8:45 am]
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