Prospective Grant of Exclusive Patent License: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for the Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol Dependence, 85982-85983 [2016-28698]
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
notify the Contact Person listed below
in advance of the meeting.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cures Acceleration
Network Review Board.
Date: January 12, 2017.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: January 12, 2017.
Open: 8:30 a.m. to 2:30 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
VerDate Sep<11>2014
17:48 Nov 28, 2016
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Dated: November 22, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–28625 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, December 14, 2016,
8:00 a.m. to December 15, 2016, 6:00
p.m., Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814
which was published in the Federal
Register on November 21, 2016, 81 FR
83253.
This meeting notice is amended to
change the start date of the meeting
from December 14, 2016 to December 9,
2016. The meeting is closed to the
public.
Dated: November 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–28643 Filed 11–28–16; 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 and
Commercialization of Dopamine D3
Receptor Selective Antagonists/Partial
Agonists for the Treatment of Opioid
Use Disorder, Schizophrenia Bipolar
Disorder and Tetrahydrocannabinol
Dependence
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute on
Drug Abuse, National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
Braeburn Pharmaceuticals, Inc.
(‘‘Braeburn’’) located in Princeton, New
Jersey to practice the inventions
embodied in the patent applications
listed in the SUPPLEMENTARY
INFORMATION section of this notice.
SUMMARY:
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Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before December
14, 2016 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Martha Lubet, Ph.D.,
Licensing and Patenting Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240)–276–5530;
Facsimile: (240)–276–5504; Email:
lubetm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: United
States Provisional Patent Application
No. 62/307600, filed March 14, 2016,
entitled ‘‘Dopamine D3 Receptor
Selective Antagonists/Partial Agonists;
Methods of Making and Use Thereof’’
[HHS Reference No. E–053–2016]; and
U.S. 8,748,608, Australian 2007354861,
and Canadian 2690789 (which claim
priority to PCT/US2007/71412 filed
June 15, 2007) entitled ‘‘4phenylpiperazine derivatives with
functionalized linkers as dopamine D3
selective ligands and methods of use’’
[HHS Reference No. E–128–2006] (and
U.S. and foreign patent applications or
patents claiming priority to the
aforementioned applications).
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 Patent
License territory may be worldwide for
the treatment opioid use disorder
schizophrenia, bipolar disorder and
tetrahydrocannabinol dependence, as
set forth in the Licensed Patent Rights.
The present invention describes
Dopamine D3 receptor ligands and
methods of using the ligands to treat
substance use disorders, schizophrenia,
bipolar disorder and other mental
disorders.
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 Institute on Drug
Abuse 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.
DATES:
E:\FR\FM\29NON1.SGM
29NON1
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
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: November 23, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Alcoholism, Terrace Conference Room 508,
5635 Fishers Lane, Rockville, MD 20892.
Contact Person: Richard A. Rippe, Ph.D.,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, 5635
Fishers Lane, Room 2109, Rockville, MD
20852, 301–443–8599, rippera@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
[FR Doc. 2016–28698 Filed 11–28–16; 8:45 am]
Dated: November 21, 2016.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–28626 Filed 11–28–16; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Fellowship Review.
Date: March 28, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Uniform Application for the
Community Mental Health Services
Block Grant and Substance Abuse and
Prevention Treatment Block Grant FY
2016–2017 Application Guidance and
Instructions (OMB No. 0930–0168)—
NEW
(SAMHSA) is requesting an approval
from the Office of Management and
Budget (OMB) for an amendment to the
FY 2016–2017 Uniform Application,
Section III. Behavioral Health
Assessment and Plan, C. Environmental
Factors and Plan. The intent of this
amendment is to gather information
regarding the states’ and jurisdictions’
plans to implement elements of a
syringe services program at 1 or more
community-based organizations that
receive amounts from the grant to
provide substance use disorder
treatment and recovery services to
persons who inject drugs. In response to
the emergence of prescription drug and
heroin overdoses and associated deaths
in many states and jurisdictions,
SAMHSA issued guidance on April 2,
2014, to the states and jurisdictions
regarding the use of SABG funds for
prevention education and training
regarding overdoses and the purchase of
naloxone (Narcan®) and related
materials to assemble overdose
prevention kits.
Respondents are the 50 states and the
jurisdictions (District of Columbia, the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, American Samoa,
Commonwealth of Northern Mariana
Islands, Federated States of Micronesia,
Guam, Republic of Marshall Islands,
Republic of Palau, and the Red Lake
Band of Chippewa Indians of
Minnesota).
The following reporting burden is
based on estimates developed
considering the State substance abuse
and mental health authorities
responsible for these activities and
represents the average total hours to
assemble, format, and produce the
requested information.
The Substance Abuse and Mental
Health Services Administration
Number of
respondents
Response per
respondent
Total
responses
States and Jurisdictions ............................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Respondents
60
1
60
Link for the application, Guidance,
and Amendment: https://
www.samhsa.gov/grants/block-grants/.
Written comments and
recommendations concerning the
proposed information collection should
be sent by December 29, 2016 to the
SAMHSA Desk Officer at the Office of
Information and Regulatory Affairs,
VerDate Sep<11>2014
17:48 Nov 28, 2016
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85983
Office of Management and Budget
(OMB). To ensure timely receipt of
comments, and to avoid potential delays
in OMB’s receipt and processing of mail
sent through the U.S. Postal Service,
commenters are encouraged to submit
their comments to OMB via email to:
OIRA_Submission@omb.eop.gov.
Although commenters are encouraged to
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Total burden
40 hours per State (1,500 hours).
send their comments via email,
commenters may also fax their
comments to: 202–395–7285.
Commenters may also mail them to:
Office of Management and Budget,
Office of Information and Regulatory
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85982-85983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28698]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development and
Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial
Agonists for the Treatment of Opioid Use Disorder, Schizophrenia
Bipolar Disorder and Tetrahydrocannabinol Dependence
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute on Drug Abuse, National Institutes of
Health, Department of Health and Human Services, is contemplating the
grant of an Exclusive Patent License to Braeburn Pharmaceuticals, Inc.
(``Braeburn'') located in Princeton, New Jersey to practice the
inventions embodied in the patent applications listed in the
SUPPLEMENTARY INFORMATION section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center on or before
December 14, 2016 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Martha Lubet, Ph.D., Licensing and Patenting
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville,
MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504;
Email: lubetm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: United States Provisional Patent Application
No. 62/307600, filed March 14, 2016, entitled ``Dopamine D3 Receptor
Selective Antagonists/Partial Agonists; Methods of Making and Use
Thereof'' [HHS Reference No. E-053-2016]; and U.S. 8,748,608,
Australian 2007354861, and Canadian 2690789 (which claim priority to
PCT/US2007/71412 filed June 15, 2007) entitled ``4-phenylpiperazine
derivatives with functionalized linkers as dopamine D3 selective
ligands and methods of use'' [HHS Reference No. E-128-2006] (and U.S.
and foreign patent applications or patents claiming priority to the
aforementioned applications).
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 Patent License territory may be worldwide
for the treatment opioid use disorder schizophrenia, bipolar disorder
and tetrahydrocannabinol dependence, as set forth in the Licensed
Patent Rights.
The present invention describes Dopamine D3 receptor ligands and
methods of using the ligands to treat substance use disorders,
schizophrenia, bipolar disorder and other mental disorders.
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 Institute on Drug Abuse
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.
[[Page 85983]]
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: November 23, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2016-28698 Filed 11-28-16; 8:45 am]
BILLING CODE 4140-01-P
