Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage Disease Type Ia, 32761-32762 [2016-12169]
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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
Corps Community Month Event Planning Form ..................
Corps Community Month Event Satisfaction .......................
300
300
1
1
300
300
.066
.033
19.8
9.9
Total ..............................................................................
* 300
........................
* 300
........................
29.7
* The same individuals complete both of the forms for a total of 300 respondents and responses.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–12146 Filed 5–23–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meetings
sradovich on DSK3TPTVN1PROD with NOTICES
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: National Human
Genome Research Institute Special Emphasis
Panel; Gabriella Miller Kids First Sequencing
Center.
Date: June 14, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NHGRI, 5635FL, Twinbrook 4th
Floor Conf. Rm., Twinbrook, Rockville, MD
20852 (Telephone Conference Call).
Contact Person: Rudy O. Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, 5635 Fishers Lane, Suite 4076, MSC
9306, Rockville, MD 20852, (301) 402–0838,
pozzattr@mail.nih.gov.
Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel; ENCODE MAPPING.
Date: June 21, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Dulles Airport Marriott,
45020, Dulles View, Aviation Drive, Dulles,
VA 20166.
VerDate Sep<11>2014
17:24 May 23, 2016
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Contact Person: Ken D. Nakamura, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 5635
Fishers Lane, Suite 4076, MSC 9306,
Rockville, MD 20852, 301–402–0838,
nakamurk@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS).
Dated: May 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12139 Filed 5–23–16; 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 of AdenoAssociated Virus Vectors for the
Treatment of Glycogen Storage
Disease Type Ia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This 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 (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:
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 61/908,861, filed
November 26, 2013, titled ‘‘AdenoAssociated Virus Vectors for the
Treatment of Glycogen Storage Disease’’
[HHS Reference No. E–552–2013/0–US–
01]; International Patent Application
No. PCT/US2014/067415 filed
November 25, 2014 titled ‘‘AdenoAssociated Virus Vectors for the
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Treatment of Glycogen Storage Disease’’
[HHS Reference No. E–552–2013/0–
PCT–02] and continuation applications,
divisional applications and foreign
counterpart applications claiming
priority to the US provisional
application No. 61/908,861.
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 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 technologies disclose novel
adeno-associated virus (AAV) vectors
expressing human glucose-6phosphatase-alpha (G6Pase-alpha or
G6PC) for the treatment of glycogen
storage disease, particularly glycogen
storage disease type Ia (GSD-Ia). GSD-Ia
is an inherited disorder of metabolism
associated with life-threatening
hypoglycemia, hepatic malignancy, and
renal failure caused by the deficiency of
G6Pase-alpha, a key enzyme in
maintaining blood glucose homeostasis
between meals. The two novel gene
therapy vectors of the invention, rAAVGPE-G6PC and rAAV-GPE-co-G6PC are
recombinant AAV vectors expressing
E:\FR\FM\24MYN1.SGM
24MYN1
32762
Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices
wild-type G6Pase-alpha and codonoptimized (co) G6Pase-alpha,
respectively. G6Pase-alpha in both
vectors is directed by nucleotides -2864
to -1 of the G6PC gene 5’-flanking
promoter/enhancer region (GPE). The
vectors also contain an intron and
stuffer sequences. The rAAV-GPE-G6PC
vector not only corrects metabolic
abnormalities in murine GSD-Ia (G6pc/- mice) but also prevents long-term risk
of hepatocellular adenoma. The results
also showed that the enhancer elements
upstream the human G6PC minimal
promoter at nucleotides -382 to -1
contained within the rAAV-GPE-G6PC
vector are responsible for the increased
efficacy in treating GSD-Ia mice.
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 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 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.
Dated: May 17, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes
of Health.
[FR Doc. 2016–12169 Filed 5–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3TPTVN1PROD 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,
VerDate Sep<11>2014
17:24 May 23, 2016
Jkt 238001
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: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Cardiac Contractility, Hypertrophy,
and Failure Study Section.
Date: June 13–14, 2016.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel O’Hare—
Rosemont, 5500 North River Road, Rosemont,
IL 60018.
Contact Person: Olga A. Tjurmina, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4030B,
MSC 7814, Bethesda, MD 20892, (301) 451–
1375, ot3d@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Nursing and
Related Clinical Sciences Overflow.
Date: June 14–15, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Martha L. Hare, Ph.D., RN,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 451–8504,
harem@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Auditory Neuroscience.
Date: June 14–15, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John Bishop, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Clinical and Integrative
Cardiovascular Sciences Study Section.
Date: June 16–17, 2016.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hotel and Corporate
Quarters, 1615 Rhode Island Avenue NW.,
Washington, DC 20036.
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Cancer Genetics Study Section.
PO 00000
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Date: June 22–23, 2016.
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: 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: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Acute Neural Injury and Epilepsy
Study Section.
Date: June 22–23, 2016.
Time: 8:30 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: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR14–022:
Juvenile Protective Factors and Aging.
Date: June 22, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.nih.gov.
(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 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12137 Filed 5–23–16; 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 of AdenoAssociated Virus Vectors for the
Treatment of Glycogen Storage
Disease Type Ia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
E:\FR\FM\24MYN1.SGM
Notice.
24MYN1
]]>Agencies
[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Pages 32761-32762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of
Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage
Disease Type Ia
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This 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 (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:
Intellectual Property
United States Provisional Patent Application No. 61/908,861, filed
November 26, 2013, titled ``Adeno-Associated Virus Vectors for the
Treatment of Glycogen Storage Disease'' [HHS Reference No. E-552-2013/
0-US-01]; International Patent Application No. PCT/US2014/067415 filed
November 25, 2014 titled ``Adeno-Associated Virus Vectors for the
Treatment of Glycogen Storage Disease'' [HHS Reference No. E-552-2013/
0-PCT-02] and continuation applications, divisional applications and
foreign counterpart applications claiming priority to the US
provisional application No. 61/908,861.
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 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 technologies disclose novel
adeno-associated virus (AAV) vectors expressing human glucose-6-
phosphatase-alpha (G6Pase-alpha or G6PC) for the treatment of glycogen
storage disease, particularly glycogen storage disease type Ia (GSD-
Ia). GSD-Ia is an inherited disorder of metabolism associated with
life-threatening hypoglycemia, hepatic malignancy, and renal failure
caused by the deficiency of G6Pase-alpha, a key enzyme in maintaining
blood glucose homeostasis between meals. The two novel gene therapy
vectors of the invention, rAAV-GPE-G6PC and rAAV-GPE-co-G6PC are
recombinant AAV vectors expressing
[[Page 32762]]
wild-type G6Pase-alpha and codon-optimized (co) G6Pase-alpha,
respectively. G6Pase-alpha in both vectors is directed by nucleotides -
2864 to -1 of the G6PC gene 5'-flanking promoter/enhancer region (GPE).
The vectors also contain an intron and stuffer sequences. The rAAV-GPE-
G6PC vector not only corrects metabolic abnormalities in murine GSD-Ia
(G6pc-/- mice) but also prevents long-term risk of hepatocellular
adenoma. The results also showed that the enhancer elements upstream
the human G6PC minimal promoter at nucleotides -382 to -1 contained
within the rAAV-GPE-G6PC vector are responsible for the increased
efficacy in treating GSD-Ia mice.
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 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 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.
Dated: May 17, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes of Health.
[FR Doc. 2016-12169 Filed 5-23-16; 8:45 am]
BILLING CODE 4140-01-P
