National Center for Advancing Translational Sciences; Notice of Meetings, 85981-85982 [2016-28625]
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
typically mice or rats that are selected
for demonstrating hallmarks of a given
disease. For cancer research, while
many mouse models exist to simulate
the response of the cancer to a particular
drug, all of the current models have
some limitations in their ability to fully
predict the concomitant physiological or
immunological response that might
result when the drug progresses to
clinical trials. This is problematic both
in models in which the cancer
spontaneously develops in the animal as
well as models in which cancerous cells
or tumors, i.e., allografts (derived from
cells of the same organism) or xenografts
(derived from cells of different
organism, usually humans), are
transplanted into an otherwise cancerfree animal.
To address these issues, researchers at
NCI developed a means of more closely
simulating in mouse models both
melanoma cancer itself and the resulting
physiological and immunological
response by creating a genetically
engineered mice (GEM)-derived allograft
(GDA). This allograft both resembles
human-like melanoma and has features
that will stimulate a normal
immunological response in the mouse.
Thus, when transplanted into a host, the
resulting tumor-containing mouse may
be used to test conventional cancer
therapies (e.g., chemotherapy and
radiotherapy), targeted drugs (e.g.,
kinase inhibitors), and
immunotherapies with an expectation
that the response in the mouse will
more closely mimic the types of
responses expected in humans if the
therapy progresses to clinical trials.
Further this melanoma-based GDA
approach may represent a new standard
for building or improving preclinical
models of other types of cancer.
Potential Commercial Applications:
• This is a novel mouse allograft
model that provides a preclinical model
of human-like advanced-stage
melanoma.
• This allograft model may be useful
for preclinical testing of conventional
therapies, targeted therapies, and
immunotherapies.
Value Proposition:
• Hgf-tg;Cdk4R24C C57BL/6 mousederived melanoma allograft with
humanized pathogenetics allows
adoption of clinically relevant
procedures and endpoints, facilitating
clinical translation.
• Features a constitutively activated
MET/MAPK pathway and disrupted
CDKN2A pathway.
• Expresses typical diagnostic
markers of human melanoma such as
DCT and TRP1.
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• Exhibits progression patterns
relevant to human disease.
Development Stage: Basic (Target ID).
Inventor(s): Chi-Ping Day, Glenn T.
Merlino, Zoe Weaver Ohler, Rajaa El
Meskini, Terry A. Van Dyke (all of NCI),
¨
and Thomas Tuting (University Hospital
Bonn).
Intellectual Property: HHS Reference
Number E–291–2015/0. This is a
Research Tool. Following the policy of
the National Institutes of Health, patent
protection will not be sought.
Publications:
1. Day CP, et al. ‘‘Glowing head’’ mice:
A genetic tool enabling reliable
preclinical image-based evaluation
of cancers in immunocompetent
allografts. PLoS One 2014;
9(11):e109956. [PMID 25369133]
2. Day CP, et al. Preclinical mouse
cancer models: A maze of
opportunities and challenges. Cell.
2015;163(1):39–53. [PMID
26406370]
Contact Information: Inquiries about
licensing, research collaborations, and
co-development opportunities should be
sent to John D. Hewes, Ph.D., email:
john.hewes@nih.gov.
Dated: November 22, 2016.
John D. Hewes,
Technology Transfer and Patenting
Specialist, Technology Transfer Center,
National Cancer Institute.
[FR Doc. 2016–28624 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PA–16–194:
Mentored Quantitative Research
Development Award.
Date: December 12, 2016.
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85981
Time: 4:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Mark P. Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Novel Strategies for Targeting HIV–CNS
Reservoirs without Reactivation.
Date: December 13, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue NW., Washington, DC
20036.
Contact Person: Dimitrios Nikolaos
Vatakis, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3190, Bethesda, MD 20892, 301–827–
7480.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(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)
Dated: November 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–28623 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Center for Advancing Translational
Sciences.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
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85982
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cures Acceleration
Network Review Board.
Date: January 12, 2017.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: January 12, 2017.
Open: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
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Dated: November 22, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–28625 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, December 14, 2016,
8:00 a.m. to December 15, 2016, 6:00
p.m., Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814
which was published in the Federal
Register on November 21, 2016, 81 FR
83253.
This meeting notice is amended to
change the start date of the meeting
from December 14, 2016 to December 9,
2016. The meeting is closed to the
public.
Dated: November 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–28643 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Development and
Commercialization of Dopamine D3
Receptor Selective Antagonists/Partial
Agonists for the Treatment of Opioid
Use Disorder, Schizophrenia Bipolar
Disorder and Tetrahydrocannabinol
Dependence
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute on
Drug Abuse, National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
Braeburn Pharmaceuticals, Inc.
(‘‘Braeburn’’) located in Princeton, New
Jersey to practice the inventions
embodied in the patent applications
listed in the SUPPLEMENTARY
INFORMATION section of this notice.
SUMMARY:
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Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before December
14, 2016 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Martha Lubet, Ph.D.,
Licensing and Patenting Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240)–276–5530;
Facsimile: (240)–276–5504; Email:
lubetm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: United
States Provisional Patent Application
No. 62/307600, filed March 14, 2016,
entitled ‘‘Dopamine D3 Receptor
Selective Antagonists/Partial Agonists;
Methods of Making and Use Thereof’’
[HHS Reference No. E–053–2016]; and
U.S. 8,748,608, Australian 2007354861,
and Canadian 2690789 (which claim
priority to PCT/US2007/71412 filed
June 15, 2007) entitled ‘‘4phenylpiperazine derivatives with
functionalized linkers as dopamine D3
selective ligands and methods of use’’
[HHS Reference No. E–128–2006] (and
U.S. and foreign patent applications or
patents claiming priority to the
aforementioned applications).
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America.
The prospective Exclusive Patent
License territory may be worldwide for
the treatment opioid use disorder
schizophrenia, bipolar disorder and
tetrahydrocannabinol dependence, as
set forth in the Licensed Patent Rights.
The present invention describes
Dopamine D3 receptor ligands and
methods of using the ligands to treat
substance use disorders, schizophrenia,
bipolar disorder and other mental
disorders.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective Exclusive Patent
License will be royalty bearing and may
be granted unless within fifteen (15)
days from the date of this published
notice, the National Institute on Drug
Abuse 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 part 404.
DATES:
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]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85981-85982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28625]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Advancing Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of meetings of the
National Center for Advancing Translational Sciences.
The meetings will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should
[[Page 85982]]
notify the Contact Person listed below in advance of the meeting.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and/or contract proposals
and the discussions could disclose confidential trade secrets or
commercial property such as patentable material, and personal
information concerning individuals associated with the grant
applications and/or contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Cures Acceleration Network Review Board.
Date: January 12, 2017.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive
Secretary, National Center for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809,
anna.ramseyewing@nih.gov.
Name of Committee: National Center for Advancing Translational
Sciences Advisory Council.
Date: January 12, 2017.
Open: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director and other staff.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive
Secretary, National Center for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809,
anna.ramseyewing@nih.gov.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance Program Nos. 93.859,
Pharmacology, Physiology, and Biological Chemistry Research; 93.350,
B--Cooperative Agreements; 93.859, Biomedical Research and Research
Training, National Institutes of Health, HHS)
Dated: November 22, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-28625 Filed 11-28-16; 8:45 am]
BILLING CODE 4140-01-P
