Office of the Director, National Institutes of Health; Amended Notice of Meeting, 43149-43150 [2019-17821]

Download as PDF Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices known as FM63 and the anti-CD22 binder known as M971. CD19 and CD22 are each expressed on the surface of B cells in B cell malignancies and are hallmark examples of antigen targeting in CAR–T therapies, with CD19targeting CAR–T therapies being the first FDA approved CAR–T, and CD22targeting CAR–T showing early promise in clinical trials for ALL and NHL. This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within thirty (30) 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 license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from 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: August 6, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–17866 Filed 8–19–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. jbell on DSK3GLQ082PROD with NOTICES ACTION: Notice. SUMMARY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. VerDate Sep<11>2014 20:49 Aug 19, 2019 Jkt 247001 FOR FURTHER INFORMATION CONTACT: Vince Contreras, Ph.D., 240–669–2823; vince.contreras@nih.gov. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Recombinant Nipah F Proteins and Their Use Description of Technology Nipah virus is an emerging pathogenic paramyxovirus responsible for sporadic and isolated outbreaks of severe respiratory and neurologic disease in Southern Asia. As a zoonotic virus, disease can manifest in both animals and human with indigenous fruit bats acting as natural reservoirs of the virus. The effects of viral infection vary from acute respiratory distress to fatal encephalitis. There are currently no approved therapeutics or vaccines against the virus, and growing concerns that this highly pathogenic infection has the potential to cause larger epidemics capable of inflicting significant mortality burden. Like the RSV fusion (F) glycoprotein, the Nipah fusion glycoprotein is a target of neutralizing antibodies that mediate protection against infection. Previous studies of prefusion-stabilized F glycoproteins from pneumoviruses and other paramyxoviruses (e.g. RSV and PIVs) have shown they elicit higher titers of neutralizing antibodies in both animals and humans than post-fusion F proteins. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) designed disulfide, cavity-filling and other mutations that stabilize the Nipah F glycoprotein in the prefusion conformation and bind prefusionspecific antibodies. These mutations also increase protein expression yields up to 50-fold making the recombinant proteins easy to manufacture and amenable to the use of genetic immunization using nucleic acid or vector-based applications. The stabilized prefusion state of the Nipah F glycoprotein may be an ideal vaccine immunogen to elicit broad potent Nipah neutralizing antibodies. First and second generation prefusion PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 43149 molecules have been designed and tested in small animals and results (immunogenicity and stability) appear promising. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications • Vaccine—to elicit potent neutralizing antibodies against the Nipah Env glycoprotein. Competitive Advantages Nipah prefusion F design has the following features compared to wildtype fusion glycoprotein: • Robust stabilization. • Up to 50-fold increase in expression yields, making the recombinant proteins easy to manufacture. • Potential to link the recombinant glycoprotein to nanoparticles or oligomerization peptides. Development Stage: In vivo testing (rodents). Inventors: Barney S. Graham (NIAID), Rebecca J. Loomis (NIAID), Guillaume Stewart-Jones (NIAID), John R. Mascola (NIAID), and Jason McLellan (NIAID). Intellectual Property: HHS Reference Number E–050–2018 includes U.S. Provisional Patent Application Number 62/714,230 filed 08/03/2018. Related Intellectual Property: PCT Application No. PCT/US2008/087719 filed 19/12/2008. Licensing Contact: Vince Contreras, Ph.D., 240–669–2823; vince.contreras@ nih.gov. Dated: August 7, 2019. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2019–17867 Filed 8–19–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Amended Notice of Meeting Notice is hereby given of a time and room change in the meeting of the HEAL (Helping to End Addiction Longterm) Multi-Disciplinary Working Group, August 21, 2019, 08:30 a.m., to August 22, 2019, 03:45 p.m., Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892 which was published in the Federal Register on July 23, 2019, 84FR35402. E:\FR\FM\20AUN1.SGM 20AUN1 43150 Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices The meeting notice is amended to close the session on August 22, 2019, from 08:30 a.m. to 03:45 p.m. The meeting is partially closed to the public. DEPARTMENT OF HOMELAND SECURITY Dated: August 14, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [Docket No. USCG–2019–0347] [FR Doc. 2019–17821 Filed 8–19–19; 8:45 am] AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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. jbell on DSK3GLQ082PROD with NOTICES Name of Committee: National Institute of Mental Health Initial Review Group, Mental Health Services Research Committee SERV. Date: November 7, 2019. Time: 8:00 a.m. to 5: 00 p.m. Agenda: To review and evaluate grant applications. Place: The Dupont Hotel, 1500 New Hampshire Avenue NW, Washington, DC 20036. Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6136, MSC 9606, Bethesda, MD 20852, 301–443–1225, aschulte@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: August 14, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P VerDate Sep<11>2014 20:49 Aug 19, 2019 Jkt 247001 Merchant Mariner Medical Advisory Committee U.S. Coast Guard, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee meeting. BILLING CODE 4140–01–P [FR Doc. 2019–17820 Filed 8–19–19; 8:45 am] Coast Guard SUMMARY: The Merchant Mariner Medical Advisory Committee (Committee) and its working groups will meet to discuss matters relating to medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners’ documents, medical standards and guidelines for the physical qualifications of operators of commercial vessels, medical examiner education, and medical research. The meetings will be open to the public. DATES: Meetings: The Merchant Mariner Medical Advisory Committee and its working groups are scheduled to meet on Tuesday, September 10, 2019, and on Wednesday, September 11, 2019, from 8:00 a.m. until 5:30 p.m. each day. These meetings may adjourn early if the Committee has completed its business. Comments and supporting documentation: To ensure your comments are received by Committee members before the meetings, submit your written comments no later than September 4, 2019. ADDRESSES: The meetings will be held at Room 201, Aggie Special Events Center, Texas A & M Maritime Academy, 200 Seawolf Parkway, Galveston, TX 77554, https://www.tamug.edu/directions.html. Pre-registration Information: Preregistration is not required for access to this meeting by the public. All attendees will be required to provide a driver’s license or government-issued identification card in order to gain admittance to the building. For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Instructions: You are free to submit comments at any time, including orally at the meetings, but if you want Committee members to review your comment before the meetings, please submit your comments no later than September 4, 2018. We are particularly interested in comments on the issues in PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 the ‘‘Agenda’’ section below. You must include ‘‘Department of Homeland Security’’ and the docket number USCG–2019–0347. Written comments may also be submitted using the Federal eRulemaking Portal at https:// www.regulations.gov. If you encounter technical difficulties with comments submission, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section below. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. You may review the Privacy and Security Notice for the Federal Docket Management System at https:// www.regulations.gov/privacyNotice. Docket Search: For access to the docket, to read documents or comments related to this notice, go to https:// www.regulations.gov, type USCG–2019– 0347 in the ‘‘Search’’ box, press Enter, and then click on the item you wish to view. FOR FURTHER INFORMATION CONTACT: Mr. Davis Breyer, Alternate Designated Federal Officer of the Merchant Mariner Medical Advisory Committee, 2703 Martin Luther King Jr. Ave. SE, Stop 7509, Washington, DC 20593–7509, telephone 202–372–1445, fax 202–372– 8382 or davis.j.breyer@uscg.mil. SUPPLEMENTARY INFORMATION: Notice of this meeting is in compliance with the Federal Advisory Committee Act, 5 U.S.C. App. The Merchant Mariner Medical Advisory Committee Meeting is authorized by U.S. Code, Title 46, section 7115. The Committee advises the Secretary of the Department of Homeland Security on matters related to (a) medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners’ documents; (b) medical standards and guidelines for the physical qualifications of operators of commercial vessels; (c) medical examiner education; and (d) medical research. Agenda Day 1 The agenda for the September 10, 2019, meeting is as follows: (1) The full Committee will meet briefly to discuss the Working Groups’ business/task statements, which are listed under paragraph 2 (a)–(c) below. (2) Working Groups will separately address the following task statements, which are available at https:// homeport.uscg.mil/missions/ports-andwaterways/safety-advisory-committees/ medmac. E:\FR\FM\20AUN1.SGM 20AUN1

Agencies

[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43149-43150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17821]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Amended 
Notice of Meeting

    Notice is hereby given of a time and room change in the meeting of 
the HEAL (Helping to End Addiction Long-term) Multi-Disciplinary 
Working Group, August 21, 2019, 08:30 a.m., to August 22, 2019, 03:45 
p.m., Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892 which 
was published in the Federal Register on July 23, 2019, 84FR35402.

[[Page 43150]]

    The meeting notice is amended to close the session on August 22, 
2019, from 08:30 a.m. to 03:45 p.m. The meeting is partially closed to 
the public.

    Dated: August 14, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-17821 Filed 8-19-19; 8:45 am]
 BILLING CODE 4140-01-P
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