Government-Owned Inventions; Availability for Licensing, 18546-18547 [2021-07312]

Download as PDF 18546 Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices This technology discloses pharmaceutical compositions and methods of use to treat SLOS and diseases having a secondary NPC like cellular phenotype or wherein the disease is an inborn error in cholesterol synthesis. 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 fifteen (15) days from the date of this published notice, the National Institute of Child Health and Human Development 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 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 22, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. 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: National Advisory Council for Biomedical Imaging and Bioengineering, NACBIB, May 2021. Date: May 19, 2021. Open: 12:00 p.m. to 2:50 p.m. Agenda: Report from the Institute Director, Council members and other Institute Staff. Place: National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Closed: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David T. George, Ph.D., Associate Director, Office of Research Administration, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Room 920, Bethesda, MD 20892, georged@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib.nih.gov/about-nibib/advisorycouncil, where an agenda and any additional information for the meeting will be posted when available. Dated: April 6, 2021. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–07316 Filed 4–8–21; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2021–07341 Filed 4–8–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public by videocast as indicated below. 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, VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Elizabeth Pitts, Ph.D., 240–669–5299; elizabeth.pitts@nih.gov. Licensing information and copies of the patent applications 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 information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows. Polyvalent Influenza Virus-Like Particles (VLPs) and Use as Vaccines Description of Technology Influenza virus is a major public health concern, causing up to 500,000 deaths annually. The current strategy of reformulating vaccines annually against dominant circulating strains leads to variable protective efficacy and is unlikely to protect against novel influenza viruses with pandemic potential. Thus, there is a great need for a vaccine that provides ‘‘universal’’ protection against influenza viruses. This technology relates to a broadly protective, universal influenza vaccine candidate composed of a mixture of virus-like particles (VLPs) expressing the hemagglutinin protein or the neuraminidase protein from influenza virus strains belonging to different virus subtypes. Vaccinating animals with a mixture of VLPs expressing four or more hemagglutinin subtypes provides broad and heterosubtypic protection against lethal challenge with influenza virus strains in both mice and ferrets. This vaccine technology has great potential to provide protection against both annual epidemic and pandemicpotential influenza viruses. 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 • Vaccines against influenza virus • Universal influenza virus vaccine Competitive Advantages • Broad/universal protection against both seasonal and pandemic-potential influenza viruses • Does not require yearly reformulation as is necessary with current commercially available influenza vaccines Development Stage • In vivo data assessment (animal) E:\FR\FM\09APN1.SGM 09APN1 Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices Inventors: Jeffery Taubenberger (NIAID). Intellectual Property: HHS Reference No. E–195–2014—U.S. Provisional Application No. 62/014,814, filed June 20, 2014; PCT Application No. PCT/ US2015/029843, filed May 8, 2015; U.S. Patent No. 10,130,700, issued November 20, 2018; European Application No. #15724151.4, filed May 8, 2015 (pending); Chinese Application No. 201580037799.4, filed May 8, 2015 (pending); and Indian Application No. 201617043281, filed May 8, 2015 (pending). Licensing Contact: To license this technology, please contact Elizabeth Pitts, Ph.D., 240–669–5299; elizabeth.pitts@nih.gov. Dated: March 12, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–07312 Filed 4–8–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Webcast; Request for Public Input AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may view the presentations by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is required for both webcast viewing and oral statements. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ iccvamforum-2021. DATES: Webcast: May 27, 2021, 9:00 a.m. to approximately 3:00 p.m. EDT. Registration for Webcast: April 12, 2021, until 3:00 p.m. EDT May 27, 2021. Registration for Oral Statements: April 12, 2021, until 4:00 p.m. EDT May 14, 2021. Registration to view the webcast and present oral public statements is required. SUMMARY: VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 ADDRESSES: Webinar web page: A preliminary agenda will be posted by May 3 at https://ntp.niehs.nih.gov/go/ iccvamforum-2021. Information to connect to the webcast will be provided to those who register for viewing. FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Division of NTP, NIEHS, P.O. Box 12233, K2–17, Research Triangle Park, NC 27709. Phone: 984– 287–3150, Email: nicole.kleinstreuer@ nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2021, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background: ICCVAM, a congressionally mandated committee, promotes the development and validation of alternative testing strategies that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM’s goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships ICCVAM convenes an annual public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136). This year’s meeting will be held on May 27, 2021. Due to restrictions on inperson gatherings amid ongoing public health concerns, the public forum will be presented via webcast only. NICEATM and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States (83 FR 7487). There will be opportunities for registered participants to ask clarifying or follow-up questions of the ICCVAM members about their presentations during the meeting. Instructions for submitting these questions will be provided via email prior to the webcast. The agenda will also include time for public oral statements relevant to the ICCVAM mission and current activities from participants who have registered to do so in advance. Preliminary Agenda and Other Meeting Information: A preliminary agenda will be posted by May 3 at PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 18547 https://ntp.niehs.nih.gov/go/ iccvamforum-2021. Interested individuals are encouraged to visit this web page to stay abreast of the most current meeting information. Webcast and Registration: This webcast is open to the public. Registration for the webcast is required and is open from April 12, 2021, through 3:00 p.m. EDT on May 27, 2021 at https://ntp.niehs.nih.gov/go/ commprac-2021. Registrants will receive instructions on how to access and participate in the webcast in the email confirming their registration. Request for Oral or Written Public Statements: In addition to time for clarifying or follow-up questions following scheduled presentations, time will be allotted during the meeting for oral public statements with associated slides on topics relevant to ICCVAM’s mission. Any participant registered for the webcast may ask clarifying questions during the appropriate times in the agenda. The additional registration is only required for those who wish to give separate public statements. Written public statements on topics relevant to ICCVAM’s mission will also be accepted. Separate registration for those wishing to provide oral public statements is required and is open from April 12, 2021 through May 14, 2021 at https:// ntp.niehs.nih.gov/go/commprac-2021. The number and length of public statement presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Participants registered to present oral public statements must email their statement to ICCVAMquestions@niehs.nih.gov by May 14, 2021, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Persons presenting oral public statements will be contacted to arrange the logistics of their presentations. If participants registered to present oral public statements wish to use accompanying slides and/or submit supplementary written material, they must email these materials to ICCVAMquestions@niehs.nih.gov by May 14, 2021. This deadline is to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements on topics relevant to ICCVAM’s mission may be submitted to support an oral public statement or as standalone documents. These should be emailed to ICCVAMquestions@ niehs.nih.gov by May 14, 2021. Public statements received prior to the May 14, 2021 deadline will be distributed to E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18546-18547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

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.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pitts, Ph.D., 240-669-5299; 
[email protected]. Licensing information and copies of the patent 
applications 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 information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows.

Polyvalent Influenza Virus-Like Particles (VLPs) and Use as Vaccines 
Description of Technology

    Influenza virus is a major public health concern, causing up to 
500,000 deaths annually. The current strategy of reformulating vaccines 
annually against dominant circulating strains leads to variable 
protective efficacy and is unlikely to protect against novel influenza 
viruses with pandemic potential. Thus, there is a great need for a 
vaccine that provides ``universal'' protection against influenza 
viruses.
    This technology relates to a broadly protective, universal 
influenza vaccine candidate composed of a mixture of virus-like 
particles (VLPs) expressing the hemagglutinin protein or the 
neuraminidase protein from influenza virus strains belonging to 
different virus subtypes. Vaccinating animals with a mixture of VLPs 
expressing four or more hemagglutinin subtypes provides broad and 
heterosubtypic protection against lethal challenge with influenza virus 
strains in both mice and ferrets. This vaccine technology has great 
potential to provide protection against both annual epidemic and 
pandemic-potential influenza viruses.
    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

 Vaccines against influenza virus
 Universal influenza virus vaccine

Competitive Advantages

 Broad/universal protection against both seasonal and pandemic-
potential influenza viruses
 Does not require yearly reformulation as is necessary with 
current commercially available influenza vaccines

Development Stage

 In vivo data assessment (animal)


[[Page 18547]]


    Inventors: Jeffery Taubenberger (NIAID).
    Intellectual Property: HHS Reference No. E-195-2014--U.S. 
Provisional Application No. 62/014,814, filed June 20, 2014; PCT 
Application No. PCT/US2015/029843, filed May 8, 2015; U.S. Patent No. 
10,130,700, issued November 20, 2018; European Application No. 
#15724151.4, filed May 8, 2015 (pending); Chinese Application No. 
201580037799.4, filed May 8, 2015 (pending); and Indian Application No. 
201617043281, filed May 8, 2015 (pending).
    Licensing Contact: To license this technology, please contact 
Elizabeth Pitts, Ph.D., 240-669-5299; [email protected].

    Dated: March 12, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-07312 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P
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