National Cancer Institute; Amended Notice of Meeting, 133 [2016-31759]
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Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before January 18,
2017 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: Eggerton Campbell Ph.D.,
Licensing and Patenting Manager,
Technology Transfer Office (TTO)
National Human Genome Research
Institute, National Institutes of Health,
5635 Fishers Lane, Suite 3058, MSC
9307, Bethesda, MD 20892–9307.
Telephone: 301–402–1648. Fax: 301–
402–9722. email: eggerton.campbell@
nih.gov.
DATES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
sradovich on DSK3GMQ082PROD with NOTICES
1. US Provisional Patent Application
No.: 61/792,081
HHS Ref. No.: E–243–2012/0–US–01
2. PCT Patent Application No.: PCT/
2014/028045
HHS Ref. No.: E–243–2012/0–PCT–02
3. EP Patent Application 14729502.6
HHS Ref. No.: E–243–2012/0–EP–03
4. US Patent Application No.: 14/
773,885
HHS Ref. No.: E–243–2012/0–US–04
5. US Patent Application No.: 15/
070,787
HHS Ref. No.: E–243–2012/1–US–01
and all continuing applications and
foreign counterparts. The patent rights
in these inventions have been assigned
to the Government of 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 Licensed Patent Rights for the
following:
Development, manufacture and
commercialization of gene therapy products
for human gene therapy use to treat and/or
prevent Methylmalonic Acidemia (MMA)
comprised of the following: all of or
fragments of the synthetic methylmalonylCoA mutase (MUT) human polynucleotide
(synMUT) and/or recombinant synMUT
constructs, in combination with the
following:
the Anc80 vector or vectors derived from
the Anc80 vectors, wherein the derived
Anc80 vectors have capsid sequences
possessing 90% or greater sequence identity
to the Anc80 capsid sequences.
For purposes of clarity, the above
gene therapy products may be combined
with Selecta’s synthetic vaccine
particles (SVPTM) technology
encapsulating an immunomodulator.
The subject technology discloses a
synthetic codon-optimized human
VerDate Sep<11>2014
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methylmalonyl-CoA mutase (MUT)
cDNA gene (co-MUT) encoding human
MUT protein, co-MUT constructs and
uses thereof for treatment of MMA
disorders. Such uses, may include the
administration of immunomodulator(s)
in order to maximize the advantage of
the gene therapy, with fewer side
effects. MMA is an autosomal recessive
disorder caused by defects in the
mitochondria-localized enzyme
methylmalonyl-CoA mutase (MUT).
MUT deficiency, the most common
cause of MMA, is characterized by the
accumulation of methylmalonic acid.
MMA can lead to metabolic instability,
seizures, strokes, and kidney failure,
and can be lethal even when patients
are being properly managed. If
successfully developed, this invention
would be a first of its kind therapy for
MMA, by administering the disclosed
nucleic acid, vector, or recombinant
virus to a subject, optionally with an
immunomodulator.
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 Human Genome
Research Institute 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
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated Exclusive Patent
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: December 27, 2016.
Claire T. Driscoll,
Director, NHGRI Technology Transfer Office.
[FR Doc. 2016–31834 Filed 12–30–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel,
February 16, 2017, 08:00 a.m. to
February 17, 2017, 05:00 p.m., Bethesda
North Marriott Conference Hotel, 5701
PO 00000
Frm 00052
Fmt 4703
Sfmt 9990
133
Marinelli Road, Bethesda, MD 20852
which was published in the Federal
Register on December 13, 2016, 81 FR
89953.
The meeting notice is amended to
change the date of the meeting to
February 16, 2017 from 8:00 a.m. to 5:00
p.m. The meeting is closed to the
public.
Dated: December 27, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–31759 Filed 12–30–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
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 meeting.
The meeting 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: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Grant Review Neonatal Anemia.
Date: January 25, 2017.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Melissa E. Nagelin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7202, Bethesda, MD 20892, 301–435–0297,
nagelinmh2@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: December 27, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–31760 Filed 12–30–16; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Page 133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31759]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Cancer Institute Special Emphasis Panel, February 16, 2017, 08:00 a.m.
to February 17, 2017, 05:00 p.m., Bethesda North Marriott Conference
Hotel, 5701 Marinelli Road, Bethesda, MD 20852 which was published in
the Federal Register on December 13, 2016, 81 FR 89953.
The meeting notice is amended to change the date of the meeting to
February 16, 2017 from 8:00 a.m. to 5:00 p.m. The meeting is closed to
the public.
Dated: December 27, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-31759 Filed 12-30-16; 8:45 am]
BILLING CODE 4140-01-P
