National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 32763 [2016-12140]
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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices
This 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 (HHS), is
contemplating the grant of an exclusive
license to practice the inventions
embodied in the following Patent
Applications to Dimension
Therapeutics, Inc. (‘‘Dimension’’)
located in Cambridge, Massachusetts,
USA:
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 62/096,400, filed
December 23, 2014, titled ‘‘AdenoAssociated Virus Vectors Encoding
G6PC and Uses Thereof’’ [HHS
Reference No. E–039–2015/0–US–01];
International Patent Application No.
PCT/US2015/067338 filed December 22,
2015 titled ‘‘Adeno-Associated Virus
Vectors Encoding G6PC and Uses
Thereof’’ [HHS Reference No. E–039–
2015/0–PCT–02]; and all continuation
applications, divisional applications
and foreign counterpart applications
claiming priority to the U.S. provisional
application No. 62/096,400.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the Government of the
United States of America.
The prospective exclusive licensed
territory may be worldwide and the
field of use may be limited to:
‘‘Development and commercialization of
gene therapy using adeno-associated
viral vectors for the treatment of
Glycogen Storage Disease Type Ia.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before June
8, 2016 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: Surekha Vathyam, Ph.D.,
Senior Licensing and Patenting
Manager, National Cancer Institute
Technology Transfer Center, 9609
Medical Center Drive, Rm 1E–530
MSC9702, Rockville, MD 20850–9702,
Email: vathyams@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
subject technology discloses novel
adeno-associated virus (AAV) vectors
expressing human G6Pase-alpha (or
G6PC) for the treatment of glycogen
storage disease, particularly GSD-Ia.
GSD-Ia is an inherited disorder of
metabolism associated with lifethreatening hypoglycemia, hepatic
malignancy, and renal failure caused by
the deficiency of G6Pase-alpha, a key
VerDate Sep<11>2014
17:24 May 23, 2016
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enzyme in maintaining blood glucose
homeostasis between meals. These new
recombinant AAV vectors that express
human G6Pase-alpha directed by the
tissue-specific human G6PC promoter/
enhancer at nucleotides -2864 to -1
incorporate the following
improvements: (1) One expresses a
variant of G6Pase-alpha with enhanced
enzymatic activity; (2) the other
expresses a codon-optimized variant of
G6Pase-alpha with higher enzyme
expression levels and enhanced
enzymatic activity.
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 part 404.7. The
prospective exclusive license may be
granted unless within fifteen (15) 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 part 404.7.
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.
Date: May 19, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes
of Health.
[FR Doc. 2016–12168 Filed 5–23–16; 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
PO 00000
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32763
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Stem Cell-Derived Blood Products (SBIR).
Date: June 16, 2016.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7180, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Tony L. Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435–
0725, creazzotl@mail.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: May 18, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12140 Filed 5–23–16; 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: Heart, Lung, and
Blood Initial Review Group; Heart, Lung, and
Blood Program Project Review Committee.
Date: June 17, 2016.
Time: 8:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Jeffrey H. Hurst, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
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24MYN1
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[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Page 32763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12140]
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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; Stem Cell-Derived Blood Products (SBIR).
Date: June 16, 2016.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Tony L. Creazzo, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD
20892-7924, 301-435-0725, creazzotl@mail.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: May 18, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-12140 Filed 5-23-16; 8:45 am]
BILLING CODE 4140-01-P
