Prospective Grant of A Start-Up Commercialization Exclusive License: The Development of Fenoterol Analogues for the Treatment of Brain and Hepatocellular Cancers, 20671-20672 [2013-07907]
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 29, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–07903 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
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Closed: May 14, 2013, 2:00 p.m. to 3:10
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Place: National Institutes of Health,
9000 Rockville Pike, Building 31, C Wing,
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6th Floor, Conference Room 10, Bethesda,
MD 20892.
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Dated: April, 1, 2013.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–07905 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of A Start-Up
Commercialization Exclusive License:
The Development of Fenoterol
Analogues for the Treatment of Brain
and Hepatocellular Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 to Nova
Therapeutics LLC of a start-up exclusive
commercialization license to practice
SUMMARY:
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20671
the inventions embodied in the
following US Provisional Patent
Application (and all domestic and
foreign counterparts claiming priority to
it): Serial No. 61/651,961, filed May 25,
2012, entitled, ‘‘Methods of Regulating
Cannabinoid Receptor Activity-related
Disorders and Diseases’’ [HHS Ref. E–
139–2012/0–US–01]. The patent rights
in this invention have been assigned to
the Government of the United States of
America.
The prospective start-up exclusive
commercialization license territory may
be worldwide, and the field of use may
be limited to:
A worldwide exclusive license to the
Patent Rights for research, development,
manufacture, distribution, sale, and use in
humans for the treatment of brain cancer or
hepatocellular cancer within the Licensed
Territory, exclusive of (R,R’)-4’-methoxy-1napthylfenoterol (MNF), (R,S’)-4’-methoxy-1napthylfenoterol, (R,R’)-ethylMNF, (R,R’)napthylfenoterol, (R,S’)-napthylfenoterol,
(R,R’)-ethyl-napthylfenoterol, and (R,R’)-4’amino-1-napthylfenoterol, (R,R’)-4’-hydroxy1-napthylfenoterol, (R,R’)-4-methoxyethylfenoterol, (R,R’)-methoxyfenoterol,
(R,R’)-ethylfenoterol, and (R,R’)-fenoterol,
and the respective stereoisomers of these
compounds.
Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before April
22, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive
commercialization license should be
directed to: Patrick McCue, 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–
5560; Facsimile: (301) 402–0220; Email:
mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns the discovery by the
inventors that specific fenoterol
analogues are cannabinoid receptor
activators that can inhibit one or more
signs or symptoms (such as growth)
associated with a tumor that expresses
a cannabinoid receptor. Using this
discovery, the inventors developed the
disclosed methods of treating a tumor
expressing a cannabinoid receptor.
The prospective start-up exclusive
commercialization license is being
considered under the small business
initiative launched on 1 October 2011,
and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR
404.7. The prospective start-up
exclusive commercialization license
DATES:
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
may be granted unless 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 within fifteen (15) days from
the date of this published notice.
Complete 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
evaluation option 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: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–07907 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Literature Review Approach
‘‘Identifying Research Needs for
Assessing Safe Use of High Intakes of
Folic Acid’’; Request for Information
and Comments
The National Toxicology
Program (NTP) at the National Institute
of Environmental Health Sciences
(NIEHS) in conjunction with the NIH
Office of Dietary Supplements (ODS) is
planning a workshop to identify
research needs based on consideration
of the state of the science related to the
safe use of high intakes of folic acid.
The NTP and the ODS invite comments
on an approach document, ‘‘Identifying
Research Needs for Assessing Safe Use
of High Intakes of Folic Acid,’’ for
review of the pertinent literature. The
document is available on the NTP Folic
Acid Request for Information (RFI) Web
site (https://ntp.niehs.nih.gov/go/38143).
Information gathered through this
request will be used in prioritizing
topics for the state of the science
workshop.
DATES: The deadline for receipt of
information and comments is May 28,
2013.
ADDRESSES: Comments should be
submitted at https://ntp.niehs.nih.gov/
go/38143.
FOR FURTHER INFORMATION CONTACT:
Abee L. Boyles, Ph.D., Health Scientist,
Office of Health Assessment and
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SUMMARY:
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Translation, Division of the NTP,
NIEHS, PO Box 12233, MD: K2–04,
Research Triangle Park, NC 27709;
telephone: (919) 541–7886; fax: (301)
480–3230; email: abee.boyles@nih.gov.
Courier address: NIEHS, Room 2158,
530 Davis Drive, Morrisville, NC 27560
or Regan Bailey, Ph.D., R.D., Nutritional
Epidemiologist, ODS, NIH, 6100
Executive Blvd., Room 3B01, Bethesda,
MD 20892–7517; telephone: (301) 496–
0187; fax: (301) 480–1845; email:
regan.bailey@nih.gov.
SUPPLEMENTARY INFORMATION:
Background: The NTP in conjunction
with the NIH ODS is planning a
workshop to identify research needs
based on consideration of the state of
the science related to the safe use of
high intakes of folic acid. The benefit of
supplemental folic acid for pregnant
women to prevent neural tube defects in
their children is well established; at the
same time, there is interest in
understanding potential adverse health
impacts from high intakes of folic acid.
This project aims to identify research
needs and inform the development of a
research agenda for evaluating the safe
use of high intakes of folic acid.
Due to the vastness of the research on
folate and folic acid, screening of the
literature was undertaken to identify the
potential adverse health effects for
which further research might be
warranted. An approach document,
‘‘Identifying Research Needs for
Assessing Safe Use of High Intakes of
Folic Acid,’’ is available on the RFI Web
site (https://ntp.niehs.nih.gov/go/38143)
and should be referenced in responding
to the RFI. This document (1) outlines
the approach used to screen the
literature, (2) describes the results of the
screening effort, and (3) proposes a list
of health outcomes for discussion at the
workshop. As background for the
workshop, a literature review document
on these health outcomes will be
prepared using systematic review
methodology.
Humans require folate, a watersoluble B-complex vitamin, for the
synthesis of nucleic acids and to
provide methyl groups for biochemical
reactions within cells. These functions
are needed for everyday growth and cell
division, including during critical
periods of rapid growth and cell
division such as embryonic
development. Thus, folate is necessary
for all individuals, but is especially
important for women who may become
pregnant. Evaluating the potential for
adverse health effects associated with
high folic acid intakes has been
challenging because of the lack of
systematic studies and other sources of
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evidence on this topic. In 1998, the
Food and Nutrition Board of the
Institute of Medicine set Dietary
Reference Intakes that included the
Recommended Dietary Allowances
(RDAs) and tolerable upper intake levels
(ULs)—the highest level of daily intake
likely to pose no risk of adverse health
effects to almost all of the population—
for folic acid and other B vitamins. The
folic acid UL (1000mg) was established
with the paucity of data available to the
committee at the time; i.e., limited but
suggestive evidence that excessive folate
intake may precipitate or exacerbate
neuropathy in vitamin B12-deficient
individuals. Since this 1998 publication
that set the UL for folic acid, many
publications have reported on health
effects over a range of folic acid intakes.
Some studies have raised concerns that
high intake of folic acid may be
associated with potential adverse health
effects.
Folate is present in the diet through
its natural occurrence in food, as a food
additive, and as an ingredient in dietary
supplements. Naturally occurring folate
is unlikely to be associated with
potential adverse effects because it has
lower bioavailability than folic acid and
its consumption is also limited by the
bulk and caloric content of foods.
Therefore, the primary substance of
interest for considering the safety of
high intake is folic acid, the form of
folate commonly added to foods and
dietary supplements.
Information gathered through this RFI
will be used in prioritizing topics for the
state of the science workshop. The date
and location of the workshop have not
yet been determined, but when set, will
be announced in the Federal Register,
the NIH Guide, and on the OHAT
project Web site (https://
ntp.niehs.nih.gov/go/38144). The
overarching goals of this workshop are
to identify research needs and inform
the development of a research agenda
for evaluating the safe use of high
intakes of folic acid. The workshop will
bring together experts from multiple
disciplines including, but not limited to,
epidemiology, nutrition, medicine, and
toxicology.
Request for Comments: The NTP and
the ODS invite comments on an
approach document, ‘‘Identifying
Research Needs for Assessing Safe Use
of High Intakes of Folic Acid,’’ for
review of the pertinent literature, which
is available at https://ntp.niehs.nih.gov/
go/38143. They also request information
on issues related to evaluating potential
adverse health effects of high intakes of
folic acid. The RFI Web site contains
specific questions for the following
topics:
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[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20671-20672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of A Start-Up Commercialization Exclusive
License: The Development of Fenoterol Analogues for the Treatment of
Brain and Hepatocellular Cancers
AGENCY: National Institutes of Health, 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 to Nova
Therapeutics LLC of a start-up exclusive commercialization license to
practice the inventions embodied in the following US Provisional Patent
Application (and all domestic and foreign counterparts claiming
priority to it): Serial No. 61/651,961, filed May 25, 2012, entitled,
``Methods of Regulating Cannabinoid Receptor Activity-related Disorders
and Diseases'' [HHS Ref. E-139-2012/0-US-01]. The patent rights in this
invention have been assigned to the Government of the United States of
America.
The prospective start-up exclusive commercialization license
territory may be worldwide, and the field of use may be limited to:
A worldwide exclusive license to the Patent Rights for research,
development, manufacture, distribution, sale, and use in humans for
the treatment of brain cancer or hepatocellular cancer within the
Licensed Territory, exclusive of (R,R')-4'-methoxy-1-
napthylfenoterol (MNF), (R,S')-4'-methoxy-1-napthylfenoterol,
(R,R')-ethylMNF, (R,R')-napthylfenoterol, (R,S')-napthylfenoterol,
(R,R')-ethyl-napthylfenoterol, and (R,R')-4'-amino-1-
napthylfenoterol, (R,R')-4'-hydroxy-1-napthylfenoterol, (R,R')-4-
methoxy-ethylfenoterol, (R,R')-methoxyfenoterol, (R,R')-
ethylfenoterol, and (R,R')-fenoterol, and the respective
stereoisomers of these compounds.
DATES: Only written comments or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before April 22, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
commercialization license should be directed to: Patrick McCue, 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) 435-5560; Facsimile: (301)
402-0220; Email: mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns the discovery by the
inventors that specific fenoterol analogues are cannabinoid receptor
activators that can inhibit one or more signs or symptoms (such as
growth) associated with a tumor that expresses a cannabinoid receptor.
Using this discovery, the inventors developed the disclosed methods of
treating a tumor expressing a cannabinoid receptor.
The prospective start-up exclusive commercialization license is
being considered under the small business initiative launched on 1
October 2011, and will comply with the terms and conditions of 35
U.S.C. 209 and 37 CFR 404.7. The prospective start-up exclusive
commercialization license
[[Page 20672]]
may be granted unless 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 within fifteen
(15) days from the date of this published notice.
Complete 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 evaluation option 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: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-07907 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P
