Prospective Grant of Exclusive License: The Manufacture, Use, Distribution of and Sale of Fused Azepinone Cyclin Dependent Kinase Inhibitors as Therapeutics, 23736-23737 [E9-11681]
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Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Notices
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
20, 2009 will be considered.
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4632; Facsimile: (301) 402–
0220; e-mail: lambertsond@od.nih.gov.
ADDRESSES:
The
invention concerns the use of
tetrahalogenated thalidomide
derivatives for the treatment of cancer.
Thalidomide has been shown to be a
potent inhibitor of angiogenesis (the
formation of new blood vessels). The
popular belief is that angiogenesis
enhances tumor formation by providing
tumors with increased nutrients,
allowing their sustained growth.
However, thalidomide is a natural
teratogen that can cause severe birth
defects, and has a propensity towards
causing neotropenia and deep venous
thrombosis in recipients of the drug.
This led researchers to seek out safer
derivatives of thalidomide that retain an
anti-cancer activity. The
tetrahalogenated derivatives disclosed
by this technology may represent both a
safer alternative to thalidomide and
potentially a more successful alternative
to the angiogenesis inhibitors currently
being clinically tested.
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, 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.
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
15:27 May 19, 2009
Jkt 217001
Dated: May 12, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–11680 Filed 5–19–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Manufacture, Use,
Distribution of and Sale of Fused
Azepinone Cyclin Dependent Kinase
Inhibitors as Therapeutics
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
Part 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 No. 6,610,684
entitled, ‘‘Fused Azepinone Cyclin
Dependent Kinase Inhibitors’’ and all
foreign counterparts [HHS Ref. No.
E–025–1998/0] to ShanaRx
Pharmaceuticals. 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 limited to the use
of the Cyclin Dependent Kinase
Inhibitors and their methods of use in
the Licensed Patent Rights for the
treatment of: (i) Disorders caused by
damage, injury, infection in or abnormal
function of the peripheral or central
nervous system including pain,
neuropathy, retinal degeneration,
glaucoma, Alzheimer’s disease,
Parkinson’s disease, ALS, depression,
schizophrenia, and anxiety; (ii)
disorders caused by damage, injury,
infection in or abnormal function of
cerebral vasculature and cardiac
vasculature including cardiac failure
and myocardial infections; (iii) cancer
and neoplastic disorders; (iv)
inflammatory and autoimmune diseases
including Multiple Sclerosis; and (v)
endocrine and neuroendocrine
disorders including Diabetes Mellitus.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 18, 2009 will be considered.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated co-exclusive license
should be directed to: Whitney A.
Hastings, M.S., Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804. Telephone:
(301) 451–7337; Facsimile: (301) 402–
0220; E-mail: hastingw@mail.nih.gov.
The
invention describes a class of cyclin
dependent kinase (CDK) inhibitors that
have anti-proliferative activity in human
tumor cell lines. CDKs are important in
the control of the cell cycle and
alterations in CDK expression, function,
or regulation are associated with
diseases characterized by cellular
proliferation. Increasing CDK activity
has been reported in many cancers and
observed in a wide variety of primary
human tumors and human tumorderived cell lines, including lung,
breast, brain, bone, skin, bladder,
kidney, ovary, liver, colon, pancreas as
well as in leukemia. The compounds of
this invention have also been found to
potently inhibit GSK3beta activity.
Some of compounds of this invention
have been shown to be more potent
towards the GSK3beta target than
towards CDKs. The GSK3beta enzyme, a
proline-directed serine-threonine
kinase, has been linked to a variety of
cellular processes and several disparate
areas of biology. Thus, this technology
could provide therapeutic opportunities
for a variety of indications, including
Alzheimer’s, neurological disorders, and
cardiac failure.
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 ninety (90) 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20MYN1.SGM
20MYN1
Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Notices
Dated: May 12, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–11681 Filed 5–19–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Free Admittance Under
Conditions of Emergency
AGENCY: U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day notice and request for
comments; Extension of an existing
information collection: 1651–0044.
SUMMARY: As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the Free
Admittance Under Conditions of
Emergency. This request for comment is
being made pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3505(c)(2)).
DATES: Written comments should be
received on or before July 20, 2009, to
be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Office of
Regulations and Rulings, 799 9th Street,
NW., 7th Floor, Washington, DC 20229–
1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Office of Regulations and Rulings, 799
9th Street, NW., 7th Floor, Washington,
DC 20229–1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L 104–13;
44 U.S.C. 3505(c)(2)). The comments
should address: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
VerDate Nov<24>2008
15:27 May 19, 2009
Jkt 217001
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e)
estimates of capital or start-up costs and
costs of operations, maintenance, and
purchase of services to provide
information. The comments that are
submitted will be summarized and
included in the request for Office of
Management and Budget (OMB)
approval. All comments will become a
matter of public record. In this
document the CBP is soliciting
comments concerning the following
information collection:
Title: Free Admittance Under
Conditions of Emergency.
OMB Number: 1651–0044.
Form Number: None.
Abstract: This collection of
information will be used in the event of
emergency or catastrophic event to
monitor goods temporarily admitted for
the purpose of rescue or relief.
Current Actions: There are no changes
to the information collection. This
submission is being made to extend the
expiration date.
Type of Review: Extension (without
change).
Affected Public: Nonprofit Assistance
Organizations.
Estimated Number of Respondents: 1.
Estimated Time Per Respondent: 1
hour.
Estimated Total Annual Burden
Hours: 1.
Dated: May 14, 2009.
Tracey Denning,
Agency Clearance Officer, Customs and
Border Protection.
[FR Doc. E9–11754 Filed 5–19–09; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5281–N–36]
Disaster Housing Assistance ProgramIke (DHAP-Ike Grant Agreement)
AGENCY: Office of the Chief Information
Officer, HUD.
ACTION: Notice.
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.
In August and September 2008,
Hurricanes Ike and Gustave struck the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
23737
United States causing catastrophic
damage. On September 23, 2008, HUD
and FEMA executed an Interagency
Agreement under which HUD shall act
as the servicing agency of DHAP-Ike.
The paperwork involved in this action
all activities related to DHAP-Ike from
execution of the grant agreement to case
management.
DATES: Comments Due Date: June 19,
2009.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
approval Number (2577–0258) 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, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 Seventh
Street, SW., Washington, DC 20410;
e-mail Lillian Deitzer at
Lillian_L._Deitzer@HUD.gov or
telephone (202) 402–8048. This is not a
toll-free number. Copies of available
documents submitted to OMB may be
obtained from Ms. Deitzer.
SUPPLEMENTARY INFORMATION: This
notice informs the public that the
Department of Housing and Urban
Development has submitted to OMB a
request for approval of the Information
collection described below. This notice
is soliciting comments from members of
the public and affecting agencies
concerning the proposed collection of
information to: (1) 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; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
through the use of appropriate
automated collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
This notice also lists the following
information:
Title of Proposal: Disaster Housing
Assistance Program-Ike (DHAP-Ike
Grant Agreement).
OMB Approval Number: 2577–0258.
Form Numbers: None.
Description of the Need for the
Information and its Proposed Use:
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 74, Number 96 (Wednesday, May 20, 2009)]
[Notices]
[Pages 23736-23737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11681]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Manufacture, Use,
Distribution of and Sale of Fused Azepinone Cyclin Dependent Kinase
Inhibitors as Therapeutics
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 Part 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 No. 6,610,684 entitled, ``Fused Azepinone Cyclin Dependent
Kinase Inhibitors'' and all foreign counterparts [HHS Ref. No. E-025-
1998/0] to ShanaRx Pharmaceuticals. 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 limited to the use of the Cyclin Dependent
Kinase Inhibitors and their methods of use in the Licensed Patent
Rights for the treatment of: (i) Disorders caused by damage, injury,
infection in or abnormal function of the peripheral or central nervous
system including pain, neuropathy, retinal degeneration, glaucoma,
Alzheimer's disease, Parkinson's disease, ALS, depression,
schizophrenia, and anxiety; (ii) disorders caused by damage, injury,
infection in or abnormal function of cerebral vasculature and cardiac
vasculature including cardiac failure and myocardial infections; (iii)
cancer and neoplastic disorders; (iv) inflammatory and autoimmune
diseases including Multiple Sclerosis; and (v) endocrine and
neuroendocrine disorders including Diabetes Mellitus.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
August 18, 2009 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated co-exclusive
license should be directed to: Whitney A. Hastings, M.S., Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804. Telephone: (301) 451-7337; Facsimile: (301) 402-0220; E-mail:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The invention describes a class of cyclin
dependent kinase (CDK) inhibitors that have anti-proliferative activity
in human tumor cell lines. CDKs are important in the control of the
cell cycle and alterations in CDK expression, function, or regulation
are associated with diseases characterized by cellular proliferation.
Increasing CDK activity has been reported in many cancers and observed
in a wide variety of primary human tumors and human tumor-derived cell
lines, including lung, breast, brain, bone, skin, bladder, kidney,
ovary, liver, colon, pancreas as well as in leukemia. The compounds of
this invention have also been found to potently inhibit GSK3beta
activity. Some of compounds of this invention have been shown to be
more potent towards the GSK3beta target than towards CDKs. The GSK3beta
enzyme, a proline-directed serine-threonine kinase, has been linked to
a variety of cellular processes and several disparate areas of biology.
Thus, this technology could provide therapeutic opportunities for a
variety of indications, including Alzheimer's, neurological disorders,
and cardiac failure.
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 ninety
(90) 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.
[[Page 23737]]
Dated: May 12, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-11681 Filed 5-19-09; 8:45 am]
BILLING CODE 4140-01-P
