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]

Download as PDF 85982 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 Jkt 241001 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: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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: http:// 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 Jkt 241001 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 29NON1

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]


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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