Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Small Molecule Therapeutic Compounds Encompassed Within the Licensed Patent Rights for the Treatment of Thioesterase Deficiency Disorder, 54581-54582 [2016-19418]
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54581
Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
clearing/approving forms, processing
forms, and acknowledging data entered.
The total estimated annualized
burden hours for all respondents are
1,280. There are no costs to respondents
other than their time. CDC will seek a
three-year approval from OMB.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Initiator/C/I/O
Initiator/C/I/O
Initiator/C/I/O
Initiator/C/I/O
Number of
respondents
Form name
Number of
responses per
CIO
Average
burden per
response
(in hours)
Total burden
(in hours)
.....................................
.....................................
.....................................
.....................................
CDC 0.4601 .....................................
CDC 0.410A .....................................
CDC 0.410B .....................................
Section C of the CDC 0.1475 ..........
64
64
64
64
5
5
5
5
1
1
1
1
320
320
320
320
Totals .........................................
...........................................................
........................
........................
........................
1,280
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–19461 Filed 8–15–16; 8:45 am]
Bethesda, MD 20892–9823, (240) 669–5069,
lrust@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 10, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–19417 Filed 8–15–16; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD 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 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement
(U01).
Date: September 22, 2016.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3F100, 5601 Fishers Lane, Rockville, MD
20892 (Telephone Conference Call).
Contact Person: Lynn Rust, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G42A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
VerDate Sep<11>2014
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Jkt 238001
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation Option License
Agreement: Small Molecule
Therapeutic Compounds
Encompassed Within the Licensed
Patent Rights for the Treatment of
Thioesterase Deficiency Disorder
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of a
Start-Up Exclusive Evaluation Option
License Agreement to practice the
inventions embodied in the following
Patent Applications to Circumvent
Pharmaceuticals Inc. (‘‘Circumvent’’)
located in Pasadena, California, USA:
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 61/473,692, filed April
8, 2011, titled ‘‘Small molecule
therapeutic compounds targeting
thioesterase deficiency disorders and
methods of using the same’’ [HHS
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Reference No. E–157–2011/0–US–01],
status: Expired;
International Patent Application No.
PCT/US2012/32772 filed April 9, 2012
titled ‘‘Small molecule therapeutic
compounds targeting thioesterase
deficiency disorders and methods of
using the same’’ [HHS Reference No. E–
157–2011/0–PCT–02], status: Converted;
European Patent Application No.
12716889.6, filed November 7, 2013,
titled ‘‘Small molecule therapeutic
compounds targeting thioesterase
deficiency disorders and methods of
using the same’’ [HHS Reference No. E–
157–2011/0–EP–03], status: Pending;
and
United States Patent Application No.
14/110,393, filed October 7, 2013, titled
‘‘Small molecule therapeutic
compounds targeting thioesterase
deficiency disorders and methods of
using the same’’ [HHS Reference No. E–
157–2011/0–US–04], status: Pending.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The territory of the prospective StartUp Exclusive Evaluation Option License
Agreement may be worldwide and the
field of use may be limited to: ‘‘Small
molecule therapeutic compounds
encompassed within the Licensed
Patent Rights for the treatment of
thioesterase deficiency disorders’’
Upon the expiration or termination of
the Start-up Exclusive Evaluation
Option License Agreement, Circumvent
will have the exclusive right to execute
a Start-Up Exclusive Patent License
Agreement which will supersede and
replace the Start-up Exclusive
Evaluation Option License Agreement,
with no greater field of use and territory
than granted in the Start-up Exclusive
Evaluation Option License Agreement.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
E:\FR\FM\16AUN1.SGM
16AUN1
54582
Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
Technology Transfer on or before
August 31, 2016 will be considered.
under the Freedom of Information Act,
5 U.S.C. 552.
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated Start-Up Exclusive
Evaluation Option License Agreement
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.
Dated: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
The
subject technology describes methods of
using derivative compositions of
hydroxylamine, including N-t-butyl
hydroxylamine (NtBuHA), for the
treatment of thioesterase deficiencies.
NtBuHA is small molecule derivative of
hydroxylamine which possesses strong
anti-oxidant properties and an ability to
cleave thioester linkages with high
specificity. These capabilities suggest
that NtBuHA may be useful as a
modulator of intracellular protein
palmitoylation dynamics when
endogenous mechanisms are
insufficient to support normal function.
The compounds disclosed in this
invention have potential therapeutic
applications for both the management of
diseases driven by excess accumulation
or malfunction of palmitoylated
proteins. Target disorders may therefore
include neuronal ceroid lipofuscinoses
(also known as Batten Disease),
amyotrophic lateral sclerosis, and Rasdriven cancers.
The prospective Start-Up Exclusive
Evaluation Option License Agreement is
being considered under the small
business initiative launched on October
1, 2011 and will comply with the terms
and conditions of 35 U.S.C. 209 and 37
CFR part 404.7. The prospective StartUp Exclusive Evaluation Option License
Agreement may be granted unless the
NIH receives written evidence and
argument that establishes that the grant
of the contemplated Start-Up Exclusive
Evaluation Option License Agreement
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.7 within fifteen (15) days
from the date of this published notice.
Complete applications for a license in
an appropriate field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Start-Up Exclusive
Evaluation Option 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
National Cancer Institute; Notice of
Closed Meetings
ADDRESSES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:36 Aug 15, 2016
Jkt 238001
[FR Doc. 2016–19418 Filed 8–15–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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 Cancer
Institute Special Emphasis Panel; Integrating
Biospecimen Science Approaches into
Clinical Assay Development.
Date: September 8, 2016.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Clifford W. Schweinfest,
Ph.D., Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W108,
Rockville, MD 20892–9750, 240–276–6343,
schweinfestcw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Program Project I SEP–1.
Date: September 29–30, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Blvd., Gaithersburg, MD 20878.
Contact Person: Shakeel Ahmad, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W122,
Rockville, MD 20892–9750, 240–276–6349,
ahmads@mail.nih.gov.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Barrett’s Esophagus Translational Research
Network Review.
Date: October 20, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Pooks Hill, 5151
Pooks Hill Road, Bethesda, MD 20814.
Contact Person: Wlodek Lopaczynski, MD,
Ph.D., Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W608, Rockville, MD 20892–9750, 240–
276–6458, lopacw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; PAR 15–
266 Imaging.
Date: October 24, 2016.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
6W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Kenneth L. Bielat, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
Room 7W244, Rockville, MD 20892–9750,
240–276–6373, bielatk@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 SEP–3.
Date: November 3, 2016.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Byeong-Chel C. Lee, Ph.D.,
Scientific Review Officer, Review Training
and Resources Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W238, Rockville, MD 20892–9750, 240–
276–6260, byeong-chel.lee@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Pancreatic
Cancer Detection Consortium (U01).
Date: November 9, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W032, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Majed M. Hamawy, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W120,
Rockville, MD 20892–9750, 240–276–6457,
mh101v@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Biospecimen Science.
Date: December 9, 2016.
Time: 10:00 a.m. to 3:00 p.m.
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54581-54582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19418]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: Small Molecule Therapeutic Compounds Encompassed Within the
Licensed Patent Rights for the Treatment of Thioesterase Deficiency
Disorder
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part
404, that the National Institutes of Health, Department of Health and
Human Services, is contemplating the grant of a Start-Up Exclusive
Evaluation Option License Agreement to practice the inventions embodied
in the following Patent Applications to Circumvent Pharmaceuticals Inc.
(``Circumvent'') located in Pasadena, California, USA:
Intellectual Property
United States Provisional Patent Application No. 61/473,692, filed
April 8, 2011, titled ``Small molecule therapeutic compounds targeting
thioesterase deficiency disorders and methods of using the same'' [HHS
Reference No. E-157-2011/0-US-01], status: Expired;
International Patent Application No. PCT/US2012/32772 filed April
9, 2012 titled ``Small molecule therapeutic compounds targeting
thioesterase deficiency disorders and methods of using the same'' [HHS
Reference No. E-157-2011/0-PCT-02], status: Converted;
European Patent Application No. 12716889.6, filed November 7, 2013,
titled ``Small molecule therapeutic compounds targeting thioesterase
deficiency disorders and methods of using the same'' [HHS Reference No.
E-157-2011/0-EP-03], status: Pending; and
United States Patent Application No. 14/110,393, filed October 7,
2013, titled ``Small molecule therapeutic compounds targeting
thioesterase deficiency disorders and methods of using the same'' [HHS
Reference No. E-157-2011/0-US-04], status: Pending.
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of the United States of America.
The territory of the prospective Start-Up Exclusive Evaluation
Option License Agreement may be worldwide and the field of use may be
limited to: ``Small molecule therapeutic compounds encompassed within
the Licensed Patent Rights for the treatment of thioesterase deficiency
disorders''
Upon the expiration or termination of the Start-up Exclusive
Evaluation Option License Agreement, Circumvent will have the exclusive
right to execute a Start-Up Exclusive Patent License Agreement which
will supersede and replace the Start-up Exclusive Evaluation Option
License Agreement, with no greater field of use and territory than
granted in the Start-up Exclusive Evaluation Option License Agreement.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of
[[Page 54582]]
Technology Transfer on or before August 31, 2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated Start-Up
Exclusive Evaluation Option License Agreement 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 describes methods of
using derivative compositions of hydroxylamine, including N-t-butyl
hydroxylamine (NtBuHA), for the treatment of thioesterase deficiencies.
NtBuHA is small molecule derivative of hydroxylamine which possesses
strong anti-oxidant properties and an ability to cleave thioester
linkages with high specificity. These capabilities suggest that NtBuHA
may be useful as a modulator of intracellular protein palmitoylation
dynamics when endogenous mechanisms are insufficient to support normal
function.
The compounds disclosed in this invention have potential
therapeutic applications for both the management of diseases driven by
excess accumulation or malfunction of palmitoylated proteins. Target
disorders may therefore include neuronal ceroid lipofuscinoses (also
known as Batten Disease), amyotrophic lateral sclerosis, and Ras-driven
cancers.
The prospective Start-Up Exclusive Evaluation Option License
Agreement is being considered under the small business initiative
launched on October 1, 2011 and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective
Start-Up Exclusive Evaluation Option License Agreement may be granted
unless the NIH receives written evidence and argument that establishes
that the grant of the contemplated Start-Up Exclusive Evaluation Option
License Agreement would not be consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.7 within fifteen (15) days from the date
of this published notice.
Complete applications for a license in an appropriate field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Start-Up Exclusive Evaluation Option
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: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2016-19418 Filed 8-15-16; 8:45 am]
BILLING CODE 4140-01-P
