Government-Owned Inventions; Availability for Licensing, 89482 [2016-29605]

Download as PDF 89482 Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices Closed: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Terrace Level Conference Rooms, 5635 Fishers Lane, Rockville, MD 20852. Contact Person: Paul A. Sheehy, Ph.D., Director, Division of Extramural Affairs, National Eye Institute, National Institutes of Health, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301–451–2020, ps32h@ nih.gov. Information is also available on the Institute’s/Center’s home page: www.nei.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: December 6, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–29604 Filed 12–9–16; 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. 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. FOR FURTHER INFORMATION CONTACT: 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: Zika Virus Vaccines Description of Technology Zika virus (ZIKV) is a flavivirus transmitted by mosquitos that is VerDate Sep<11>2014 18:59 Dec 09, 2016 Jkt 241001 strongly linked to neurological ´ complications including Guillain-Barre syndrome, meningoencephalitis, and microcephaly. The association between active ZIKV infection during pregnancy and microcephaly and intrauterine growth retardation in the fetus has been confirmed in murine models of ZIKV infection. Scientists at NIAID have developed nucleic acid-based vaccine candidates to prevent ZIKV infection in humans. The current lead candidate vaccine is a plasmid DNA vaccine demonstrated to accord protection in preclinical models and is undergoing clinical trial evaluation. Nucleic acid-based vaccines have been developed previously for West Nile virus, another flavivirus similar to Zika (J.E. Ledgerwood, et al. J. Infect. Dis. (2011) 203 (10): 1396– 1404). Immunization with the nucleic acid ZIKV vaccine candidate results in production of noninfectious virus like particles (VLPs) made of ZIKV proteins. These ZIKV VLPs elicit an immune response which includes neutralizing antibodies to ZIKV. Other preclinical ZIKV vaccine candidates include mRNA, protein, and noninfectious VLPs. NIAID is continuing development of these vaccine candidates. The DNAbased ZIKV vaccine candidate is currently in clinical trials. Consequently, for some fields of use, NIAID will evaluate a license applicant’s capabilities and experience in advancing similar technologies through the regulatory process. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. This technology is not eligible for NIH’s start up license. Potential Commercial Applications: • Prevention of Zika virus infection Competitive Advantages: • There is currently no licensed Zika virus vaccine Development Stage: • Currently, DNA-based vaccine candidate in Phase I clinical trial • Phase II clinical trial planned for early 2017 for DNA-based vaccine candidate • Other candidates are in pre-clinical development Inventors: Barney S. Graham (NIAID), Theodore C. Pierson (NIAID), Kimberly A. Dowd (NIAID), John R. Mascola (NIAID), Wing-Pui Kong (NIAID), SungYoul Ko (NIAID), Eun Sung Yang (NIAID), Wei Shi (NIAID), Lingshu Wang (NIAID), Christina R. Demaso (NIAID), Rebecca S. Pelc (NIAID), PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Adrian Creanga (NIAID), Julie Ledgerwood (NIAID), William Schief (The Scripps Research Institute), Sebastian Ramisch (The Scripps Research Institute), Leda Castilho (Federal University of Rio de Janeiro) Publications: K.A. Dowd, et al., Science, 354, 237–240 (2016). DOI: 10.1126/science.aai9137. Intellectual Property: U.S. Patent Application No. 62/396,613 filed September 19, 2016 (HHS Reference No. E–181–2016/0–US–01). Licensing Contact: Dr. Amy Petrik, 240–627–3721; amy.petrik@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Zika virus vaccine technologies. For collaboration opportunities, please contact Dr. Amy Petrik, 240–627–3721; amy.petrik@ nih.gov. Dated: December 5, 2016. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2016–29605 Filed 12–9–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs And Border Protection Modification and Clarification of the National Customs Automation Program Tests Regarding PostSummary Corrections and Periodic Monthly Statements U.S. Customs and Border Protection, Department of Homeland Security. ACTION: General notice. AGENCY: This document announces U.S. Customs and Border Protection’s (CBP’s) plan to modify and clarify the National Customs Automation Program (NCAP) test pertaining to the processing of post-summary correction (PSC) claims to entry summaries that are filed in the Automated Commercial Environment (ACE), as well as the periodic monthly statement (PMS) test. The modifications made by this notice eliminate some requirements and liberalize certain requirements needed for the filing of a PSC making it easier for importers to file a PSC for additional entry types, and allowing for additional time to make a deposit for duties, fees and taxes owed. With regard to the PMS SUMMARY: E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Page 89482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29605]


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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: 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.

Zika Virus Vaccines

Description of Technology

    Zika virus (ZIKV) is a flavivirus transmitted by mosquitos that is 
strongly linked to neurological complications including Guillain-
Barr[eacute] syndrome, meningoencephalitis, and microcephaly. The 
association between active ZIKV infection during pregnancy and 
microcephaly and intrauterine growth retardation in the fetus has been 
confirmed in murine models of ZIKV infection.
    Scientists at NIAID have developed nucleic acid-based vaccine 
candidates to prevent ZIKV infection in humans. The current lead 
candidate vaccine is a plasmid DNA vaccine demonstrated to accord 
protection in preclinical models and is undergoing clinical trial 
evaluation. Nucleic acid-based vaccines have been developed previously 
for West Nile virus, another flavivirus similar to Zika (J.E. 
Ledgerwood, et al. J. Infect. Dis. (2011) 203 (10): 1396-1404). 
Immunization with the nucleic acid ZIKV vaccine candidate results in 
production of noninfectious virus like particles (VLPs) made of ZIKV 
proteins. These ZIKV VLPs elicit an immune response which includes 
neutralizing antibodies to ZIKV.
    Other preclinical ZIKV vaccine candidates include mRNA, protein, 
and noninfectious VLPs.
    NIAID is continuing development of these vaccine candidates. The 
DNA-based ZIKV vaccine candidate is currently in clinical trials. 
Consequently, for some fields of use, NIAID will evaluate a license 
applicant's capabilities and experience in advancing similar 
technologies through the regulatory process.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration. This technology is not eligible for NIH's start up 
license.

Potential Commercial Applications:
     Prevention of Zika virus infection
Competitive Advantages:
     There is currently no licensed Zika virus vaccine
Development Stage:
     Currently, DNA-based vaccine candidate in Phase I clinical 
trial
     Phase II clinical trial planned for early 2017 for DNA-
based vaccine candidate
     Other candidates are in pre-clinical development

    Inventors: Barney S. Graham (NIAID), Theodore C. Pierson (NIAID), 
Kimberly A. Dowd (NIAID), John R. Mascola (NIAID), Wing-Pui Kong 
(NIAID), Sung-Youl Ko (NIAID), Eun Sung Yang (NIAID), Wei Shi (NIAID), 
Lingshu Wang (NIAID), Christina R. Demaso (NIAID), Rebecca S. Pelc 
(NIAID), Adrian Creanga (NIAID), Julie Ledgerwood (NIAID), William 
Schief (The Scripps Research Institute), Sebastian Ramisch (The Scripps 
Research Institute), Leda Castilho (Federal University of Rio de 
Janeiro)
    Publications: K.A. Dowd, et al., Science, 354, 237-240 (2016).
    DOI: 10.1126/science.aai9137.
    Intellectual Property: U.S. Patent Application No. 62/396,613 filed 
September 19, 2016 (HHS Reference No. E-181-2016/0-US-01).
    Licensing Contact: Dr. Amy Petrik, 240-627-3721; 
amy.petrik@nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize Zika virus vaccine technologies. For 
collaboration opportunities, please contact Dr. Amy Petrik, 240-627-
3721; amy.petrik@nih.gov.

    Dated: December 5, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2016-29605 Filed 12-9-16; 8:45 am]
BILLING CODE 4140-01-P

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