Prospective Grant of an Exclusive Patent License: Anti-Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of Cardiovascular Disease and Fibrotic Disease, 11762-11763 [2018-05310]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES 11762 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices guide new outcomes measurement. The Council will hear speakers in two sessions, one focuses on developing consensus about dementia care elements, and the second on models that are informing outcomes measurement. The meeting will also include updates on work from the previous meetings, a presentation on the final report from the October 2017 Care Summit, and federal workgroup updates. DATES: The meeting will be held on April 27, 2018 from 9:00 a.m. to 5:00 p.m. EDT. ADDRESSES: The meeting will be held in Room 800 in the Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Comments: Time is allocated in the afternoon on the agenda to hear public comments. The time for oral comments will be limited to two (2) minutes per individual. In lieu of oral comments, formal written comments may be submitted for the record to Rohini Khillan, OASPE, 200 Independence Avenue SW, Room 424E, Washington, DC 20201. Comments may also be sent to napa@hhs.gov. Those submitting written comments should identify themselves and any relevant organizational affiliations. FOR FURTHER INFORMATION CONTACT: Rohini Khillan (202) 690–5932, rohini.khillan@hhs.gov. Note: Seating may be limited. Those wishing to attend the meeting must send an email to napa@hhs.gov and put ‘‘April 27 Meeting Attendance’’ in the Subject line by Tuesday, April 17, so that their names may be put on a list of expected attendees and forwarded to the security officers at the Department of Health and Human Services. Any interested member of the public who is a non-U.S. citizen should include this information at the time of registration to ensure that the appropriate security procedure to gain entry to the building is carried out. Although the meeting is open to the public, procedures governing security and the entrance to Federal buildings may change without notice. If you wish to make a public comment, you must note that within your email. SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Topics of the Meeting: During the April meeting, the Clinical Care Subcommittee will be taking charge of the theme, focusing on advancing consensus on dementia care elements to guide new outcomes measurement. The Council will hear speakers in two sessions, one focuses on developing VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 consensus about dementia care elements, and the second on models that are informing outcomes measurement. The meeting will also include updates on work from the previous meetings, a presentation on the final report from the October 2017 Care Summit, and federal workgroup updates. Procedure and Agenda: This meeting is open to the public. Please allow 30 minutes to go through security and walk to the meeting room. The meeting will also be webcast at www.hhs.gov/live. Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National Alzheimer’s Project Act. The panel is governed by provisions of Public Law 92–463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: March 12, 2018. John R. Graham, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2018–05368 Filed 3–15–18; 8:45 am] BILLING CODE 4150–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Anti-Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of Cardiovascular Disease and Fibrotic Disease AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institute on Aging, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and International Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to CTS Biopharma LLC, located in Sunnyvale, CA. DATES: Only written comments and/or complete applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before April 2, 2018 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM SUMMARY: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 1E508 MSC 9702, Bethesda, MD 20892– 9702 (for business mail), Rockville, MD 20850–9702 (for overnight courier services); Telephone: (240)-276–6825; Facsimile: (240)-276–5504; Email: richard.girards@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 60/694,733 [HHS Ref No. E–092–2004/0–US–01], filed on June 27, 2005 and entitled ‘‘Antimarinobufagenin antibodies and methods for their use;’’ Patent Cooperation Treaty Patent Application No. PCT/US2006/024918 [HHS Ref No. E–092–2004/0–PCT–02], filed on June 26, 2006 and entitled ‘‘Antimarinobufagenin antibodies and methods for their use;’’ and U.S. and foreign patents and/or patent applications claiming priority to the aforementioned applications, including but not limited to United States Patent No. 8,038,997 [HHS Ref No. E–092– 2004/0–US–03] entitled ‘‘Antimarinobufagenin antibodies and methods for their use.’’ Certain rights in the patent and these applications have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights for the following: (1) The use of antimarinobufagenin antibodies for one or both of (a) the treatment of fibrotic disease and (b) the treatment of cardiovascular disease, including but not limited to preeclampsia and (2) companion diagnostics associated with the aforementioned treatments. The patents and applications potentially to be licensed disclose antibodies (mAbs) that specifically bind marinobufagenin. They also disclose use of these mAbs in the diagnosis and treatment of cardiovascular disease such as hypertension. Further, they disclose use of these mAbs in the diagnosis and treatment of fibrotic diseases. The patents and applications potentially to be licensed also disclose technologies useful with respect to companion diagnostics for both fibrotic and cardiovascular diseases. The public substantially will benefit from the clinical and commercial development of these mAbs for the treatment and of cardiovascular as well as fibrotic disorders. The public also will benefit from the clinical and commercial development of companion diagnostics relative to these conditions. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. E:\FR\FM\16MRN1.SGM 16MRN1 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: March 8, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018–05310 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health daltland on DSKBBV9HB2PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 3, 2018. Time: 1:00 p.m. to 5:00 p.m. VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Shalanda A Bynum, Ph.D., MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3206, Bethesda, MD 20892, 301–755–4355, bynumsa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 6, 2018. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301–435– 1050, freundr@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Endocrinology, Metabolism, Nutrition, and Reproductive Science. Date: April 6, 2018. Time: 10:00 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: Elaine Sierra-Rivera, Ph.D., Scientific Review Officer, EMNR IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6182 MSC 7892, Bethesda, MD 20892, 301 435– 2514, riverase@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 6, 2018. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301–451–8754, tuoj@ nei.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: March 12, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–05308 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 11763 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought and Responsible Prospective Contractors, Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director, (OD) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. SUMMARY: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. DATES: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kathy Hancock, Asst. Grants Compliance Officer, Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892 or call non-toll-free number 301–435–0949 or Email your request to FCOICompliance@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the SUPPLEMENTARY INFORMATION: E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11762-11763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Anti-
Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of 
Cardiovascular Disease and Fibrotic Disease

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute on Aging, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the U.S. and International Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to CTS Biopharma LLC, located in Sunnyvale, CA.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before April 2, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior 
Technology Transfer Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E508 MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702 (for overnight courier 
services); Telephone: (240)-276-6825; Facsimile: (240)-276-5504; Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 60/694,733 [HHS 
Ref No. E-092-2004/0-US-01], filed on June 27, 2005 and entitled 
``Anti-marinobufagenin antibodies and methods for their use;'' Patent 
Cooperation Treaty Patent Application No. PCT/US2006/024918 [HHS Ref 
No. E-092-2004/0-PCT-02], filed on June 26, 2006 and entitled ``Anti-
marinobufagenin antibodies and methods for their use;'' and U.S. and 
foreign patents and/or patent applications claiming priority to the 
aforementioned applications, including but not limited to United States 
Patent No. 8,038,997 [HHS Ref No. E-092-2004/0-US-03] entitled ``Anti-
marinobufagenin antibodies and methods for their use.''
    Certain rights in the patent and these applications have been 
assigned to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of the Licensed Patent 
Rights for the following: (1) The use of anti-marinobufagenin 
antibodies for one or both of (a) the treatment of fibrotic disease and 
(b) the treatment of cardiovascular disease, including but not limited 
to preeclampsia and (2) companion diagnostics associated with the 
aforementioned treatments.
    The patents and applications potentially to be licensed disclose 
antibodies (mAbs) that specifically bind marinobufagenin. They also 
disclose use of these mAbs in the diagnosis and treatment of 
cardiovascular disease such as hypertension. Further, they disclose use 
of these mAbs in the diagnosis and treatment of fibrotic diseases. The 
patents and applications potentially to be licensed also disclose 
technologies useful with respect to companion diagnostics for both 
fibrotic and cardiovascular diseases. The public substantially will 
benefit from the clinical and commercial development of these mAbs for 
the treatment and of cardiovascular as well as fibrotic disorders. The 
public also will benefit from the clinical and commercial development 
of companion diagnostics relative to these conditions.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404.

[[Page 11763]]

The prospective exclusive license will be royalty bearing, and the 
prospective exclusive license may be granted unless within fifteen (15) 
days from the date of this published notice, the National Cancer 
Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice must be 
complete and in acceptable form by the expiration date of this Notice 
to be considered for a license. License applications submitted in 
response to this Notice will be presumed to contain business 
confidential information and any release of information in these 
license applications will be made only as required and upon a request 
under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: March 8, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-05310 Filed 3-15-18; 8:45 am]
 BILLING CODE 4140-01-P

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