National Institute of General Medical Sciences; Notice of Closed Meetings, 25295-25296 [2017-11352]
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Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices
Contact Person: Shalanda A. Bynum, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, 301–755–4355,
bynumsa@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.
(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: May 26, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11349 Filed 5–31–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dehydrogenase 1 (mIDH1) inhibitors for
the Treatment of Human Cancers.
Category: Routine.
Action Needed By: There is no
specific date that this needs to be
approved by, but the sooner the
document is approved, the sooner NIH
can make a potential therapeutic
available to the public.
Summary: Administration of an
inhibitor of mIDH1 can potentially treat
cancers resulting from or characterized
by the presence of mIDH1. Industrial
partners are being sought for licensing
and to help further develop this
technology for use in humans. There are
currently few effective therapeutics to
treat resulting from aberrant activity of
mIDH1, such as acute myeloid
leukemia.
Justification: Although there is no
specific date requirement, rapid
approval is requested in order to make
a potential therapeutic available to the
public quickly.
SUPPLEMENTARY INFORMATION:
National Institutes of Health
Intellectual Property
Prospective Grant of Exclusive Patent
License: Mutant IDH1 Inhibitors Useful
for Treating Cancer
1. International Application No. PCT/US15/
067406 filed on 12/22/2015 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No: E–
243–2014/0–PCT–02), and
2. U.S. Provisional Application No. 62/
353298 filed on 06/22/2016 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
189–2016/0–US–01)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
National Center for
Advancing Translational Sciences, an
institute of 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 the
Patent Applications listed in the
Summary Information section of this
notice to GeneXion Oncology, Inc.,
located in New York, NY.
DATES: Only written comments and/or
applications for a license which are
received by the National Center for
Advancing Translational Sciences on or
before July 3, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Sury Vepa, Ph.D., J.D., Senior Licensing
and Patenting Manager, National Center
for Advancing Translational Sciences,
NIH, 9800 Medical Center Drive,
Rockville, MD 20850, Phone: 301–217–
9197, Fax: 301–217–5736, or email
sury.vepa@nih.gov. A signed
Confidential Disclosure Agreement may
be required to receive copies of the
patent applications.
Licensing Availability: The
Development of mutant Isocitrate
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SUMMARY:
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The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America and the
University of North Carolina at Chapel
Hill.
The prospective exclusive license
territory may be worldwide and the field
of use may be limited to the use of
Licensed Patent Rights for the following:
‘‘Therapeutics for cancers in humans
which result from or characterized by
the presence of mutant IDH1.’’
The inventions relate to a series of
novel compounds that potently and
selectively inhibit mIDH1. These
compounds reduce 2–HG levels in cell
lines in vitro as well as in human cancer
cells grown in mouse xenografts in vivo.
These compounds show greater than
250-fold selectivity for the mutant
enzyme over the wild-type, show
favorable in vitro stability (in mouse,
rat, dog and human hepatocyte exposure
studies), are AMES negative, and exhibit
no significant metabolic CYP liabilities.
These compounds possess very
favorable in vivo rodent
pharmacokinetics and bioavailability
and are well tolerated in rodents, even
when dosed at high levels.
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25295
Thus, the compounds of the subject
inventions can be used individually or
in combination to develop new
therapies to treat diseases which result
from mutant IDH1 activity. The diseases
caused by mutant IDH1 activity include
cancer (e.g., acute myeloid leukemia,
glioma, cholangiocarcinoma and
potentially other solid tumors) and
selected rare diseases, such as Ollier
Disease.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, the National
Center for Advancing Translational
Sciences 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.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive Patent License
Agreement. 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: May 25, 2017.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2017–11241 Filed 5–31–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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.
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25296
Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of COBRE Applications.
Date: July 19, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Robert Horowits, Ph.D.,
Scientific Review Officer, National Institute
of General Medical Sciences, National
Institutes of Health, 45 Center Drive, Room
3An.18, Bethesda, MD 20892–6200, 301–
594–6904, horowitr@mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Special Emphasis Panel.
Date: July 20, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda Downtown,
7335 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Tracy Koretsky, Ph.D.,
Scientific Review Officer, National Institute
of General Medical Sciences, National
Institutes of Health, 45 Center Drive, MSC
6200, Room 3An.12F, Bethesda, MD 20892,
301–594–2886, tracy.koretsky@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: May 26, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11352 Filed 5–31–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK30JT082PROD with NOTICES
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
VerDate Sep<11>2014
18:32 May 31, 2017
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Myocardial Ischemia and Metabolism
Study Section.
Date: June 22–23, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Kabuki, 1625 Post Street, San
Francisco, CA 94115.
Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, hamannkj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cognition and Perception.
Date: June 22, 2017.
Time: 10:00 a.m. to 1:00 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: Biao Tian, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3089B, MSC 7848, Bethesda,
MD 20892, 301–402–4411, tianbi@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Endocrinology, Metabolism,
Nutrition and Reproductive Sciences.
Date: June 26–27, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Clara M Cheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1041, chengc@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Cognition and Perception Study
Section.
Date: June 26–27, 2017.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
MSC 7770, Bethesda, MD 20892, 301–455–
1761, kellya2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Molecular and Cellular Substrates of
Complex Brain Disorders.
Date: June 26, 2017.
Time: 8:00 a.m. to 6:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Brian H. Scott, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–7490, brianscott@mail.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Somatosensory and
Chemosensory Systems Study Section.
Date: June 26–27, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle NW., Washington, DC 20005.
Contact Person: M. Catherine Bennett,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7846, Bethesda, MD 20892, 301–435–
1766, bennettc3@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Biophysical, Physiological,
Pharmacological and Bioengineering
Neuroscience.
Date: June 26–27, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The St. Regis Washington DC, 923
16th Street NW., Washington, DC 20006.
Contact Person: Paula Elyse Schauwecker,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Room 5211,
Bethesda, MD 20892, 301–760–8207,
schauweckerpe@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Health
Informatics.
Date: June 26–27, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Michael L. Bloom, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, bloomm2@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Innovative
Immunology.
Date: June 26, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Andrea Keane-Myers,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4218,
Bethesda, MD 20892, 301–435–1221,
andrea.keane-myers@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
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]]>Agencies
[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25295-25296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11352]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical Sciences; 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.
[[Page 25296]]
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Review of COBRE Applications.
Date: July 19, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center,
Montgomery County Conference Center Facility, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Robert Horowits, Ph.D., Scientific Review
Officer, National Institute of General Medical Sciences, National
Institutes of Health, 45 Center Drive, Room 3An.18, Bethesda, MD
20892-6200, 301-594-6904, horowitr@mail.nih.gov.
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Special Emphasis Panel.
Date: July 20, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Tracy Koretsky, Ph.D., Scientific Review
Officer, National Institute of General Medical Sciences, National
Institutes of Health, 45 Center Drive, MSC 6200, Room 3An.12F,
Bethesda, MD 20892, 301-594-2886, tracy.koretsky@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859, Biomedical Research and
Research Training, National Institutes of Health, HHS)
Dated: May 26, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-11352 Filed 5-31-17; 8:45 am]
BILLING CODE 4140-01-P
