Government-Owned Invention; Availability for Licensing, 72595-72596 [2016-25343]

Download as PDF Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices and QSRS for 2016–2020 and data will be adjusted accordingly. MPSMS did not include an opioids specific measure and QSRS now allows AHRQ to now track inpatient opioids adverse drug events. Descriptions of the surveillance systems, measures, and targets can be found here: https://health.gov/hcq/ademeasures.asp. Interested persons or organizations are invited to submit written comments in response to the proposed measures and targets. Written comments should not exceed more than two pages per ADE measure. The comments should reference the specific measure or target to which feedback refers. To be considered, the person or representative from an organization must self-identify and submit the written comments by close of business on November 21, 2016. Dated: September 30, 2016. Don Wright, Deputy Assistant Secretary for Health, Director, Office of Disease Prevention and Health Promotion Office of the Assistant Secretary for Health. [FR Doc. 2016–25424 Filed 10–19–16; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on DSK3G9T082PROD with NOTICES 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 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 Conflicts: Genetics and Genomics. Date: October 25, 2016. Time: 3:30 p.m. to 6:30 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: Richard A. Currie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 Health, 6701 Rockledge Drive, Room 1108, MSC 7890, Bethesda, MD 20892, (301) 435– 1219, currieri@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Risk, Prevention, and Health Behavior. Date: October 31–November 1, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 435– 3575, faradaym@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Brain injury. Date: November 7, 2016. Time: 11:00 a.m. to 12:00 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: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435–1246, edwardss@ csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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: October 14, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–25336 Filed 10–19–16; 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; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 72595 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 of Allergy and Infectious Diseases Special Emphasis Panel Rapid Assessment of Zika Virus (ZIKV) Complications (R21). Date: November 14, 2016 Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Travis J. Taylor, Ph.D., Scientific Review Officer Scientific, Review Program, Division of Extramural Activities, Room 3G62B, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, (240) 669–5082, Travis.Taylor@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 14, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–25339 Filed 10–19–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Invention; 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 in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology E:\FR\FM\20OCN1.SGM 20OCN1 72596 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. Capsid-Free AAV Vectors for Gene Delivery and Their Use for Gene Therapy Description of Technology: The invention concerns novel capsid-free AAV vectors that can be used for gene delivery and gene therapy applications. The invention provides for a linear nucleic acid molecule comprising in this order: A first adeno-associated virus (AAV) inverted terminal repeat (ITR), a nucleotide sequence of interest, and a second AAV ITR, wherein said nucleic acid molecule is devoid of AAV capsid protein coding sequences. The said nucleic acid molecule can be applied to a host at repetition without eliciting an immune response. Methods of producing and purifying this nucleic acid molecule, as well as its use for gene transfer and gene therapy are also described. Potential Commercial Applications: The commercial applications of the technology relate to the field of gene therapy. It may offer significant advantages compared to existing methods of gene delivery and gene therapy. Competitive Advantages: • The AAV vectors described in the invention devoid the AAV capsid proteins and thus are not exposed to the adverse effects caused by immunogenicity. • In contrast to the use of plasmid DNA for gene delivery, the AAV DNA of the invention seems to confer greater stability in cell nuclei, allowing prolonged expression compared to plasmid DNA. • The vector DNA of the invention is not limited in size to the packageable size genome. • The production of the AAV DNA vector is economical, simple and provides high yields. Development Stage: Early-stage; In vitro data available Inventors: Drs. Luis Garcia, Cyriaque Beley, and Thomas Voit (INSERM Paris); Drs. Robert M. Kotin and Lina Li (NHLBI). Publication: Li L, Dimitriadis EK, Yang Y, Li J, Yuan Z, Qiao C, Beley C, Smith RH, Garcia L, Kotin RM. Production and characterization of novel recombinant adeno-associated virus replicative-form genomes: A eukaryotic source of DNA for gene VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 transfer. PLoS One. 2013 Aug 1;8(8):e69879. doi: 10.1371/ journal.pone.0069879. Intellectual Property: NIH Reference No. E–241–2010/0—US Patent Application No. 14/004,379 (Publication No. 2014–0107186 A), and its foreign counterparts in Europe (11 157986.8; 12 708035.6), Canada (2,829,518), Australia (2012228376), Brazil (BR 1 1 2013 023185 8), China (201280022523.5), Israel (228328), India (8000/DELNP/ 2013), Japan (2013–557138), and South Korea (10–2013–7026982). Licensing Contact: Uri Reichman, Ph.D., M.BA.; Phone: 301–435–4616; Email: uri.reichman@nih.gov. Dated: October 13, 2016. Uri Reichman, Senior Advisor for Licensing, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. [FR Doc. 2016–25343 Filed 10–19–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 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 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 contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16–297: Native American Research Centers for Health (NARCH). Date: November 14–16, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Tyson’s Corner, 1960 Chain Bridge Road, Mclean, VA 22102. Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Genetic Diseases. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Date: November 15, 2016. Time: 1:00 p.m. to 2:00 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: Dominique Lorang-Leins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7766, Bethesda, MD 20892, 301–326– 9721, Lorangd@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Diagnostics, Food Safety, Sterilization/Disinfection, and Bioremediation. Date: November 17–18, 2016. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, RM 3200, MSC 7808, Bethesda, MD 20892, 301–435–1167, pandyaga@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Medical Imaging. Date: November 17–18, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Mark Center, 5000 Seminary Road, Alexandria, VA 22311. Contact Person: Leonid V. Tsap, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7854, Bethesda, MD 20892, (301) 435– 2507, tsapl@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biological Chemistry and Macromolecular Biophysics. Date: November 17–18, 2016. Time: 8:00 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: Sergei Ruvinov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD 20892, 301–435– 1180, ruvinser@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Basic Research in Cancer Health Disparities/ Diversity. Date: November 17–18, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Arnold Revzin, Ph.D., Scientific Review Officer, Center for E:\FR\FM\20OCN1.SGM 20OCN1

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[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72595-72596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25343]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; 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 in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology

[[Page 72596]]

Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892-2479; 
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may 
be required to receive any unpublished information.

SUPPLEMENTARY INFORMATION: Technology description follows.

Capsid-Free AAV Vectors for Gene Delivery and Their Use for Gene 
Therapy

    Description of Technology: The invention concerns novel capsid-free 
AAV vectors that can be used for gene delivery and gene therapy 
applications. The invention provides for a linear nucleic acid molecule 
comprising in this order: A first adeno-associated virus (AAV) inverted 
terminal repeat (ITR), a nucleotide sequence of interest, and a second 
AAV ITR, wherein said nucleic acid molecule is devoid of AAV capsid 
protein coding sequences. The said nucleic acid molecule can be applied 
to a host at repetition without eliciting an immune response. Methods 
of producing and purifying this nucleic acid molecule, as well as its 
use for gene transfer and gene therapy are also described.
    Potential Commercial Applications: The commercial applications of 
the technology relate to the field of gene therapy. It may offer 
significant advantages compared to existing methods of gene delivery 
and gene therapy.
    Competitive Advantages:
     The AAV vectors described in the invention devoid the AAV 
capsid proteins and thus are not exposed to the adverse effects caused 
by immunogenicity.
     In contrast to the use of plasmid DNA for gene delivery, 
the AAV DNA of the invention seems to confer greater stability in cell 
nuclei, allowing prolonged expression compared to plasmid DNA.
     The vector DNA of the invention is not limited in size to 
the packageable size genome.
     The production of the AAV DNA vector is economical, simple 
and provides high yields.
    Development Stage: Early-stage; In vitro data available
    Inventors: Drs. Luis Garcia, Cyriaque Beley, and Thomas Voit 
(INSERM Paris); Drs. Robert M. Kotin and Lina Li (NHLBI).
    Publication: Li L, Dimitriadis EK, Yang Y, Li J, Yuan Z, Qiao C, 
Beley C, Smith RH, Garcia L, Kotin RM. Production and characterization 
of novel recombinant adeno-associated virus replicative-form genomes: A 
eukaryotic source of DNA for gene transfer. PLoS One. 2013 Aug 
1;8(8):e69879. doi: 10.1371/journal.pone.0069879.
    Intellectual Property: NIH Reference No. E-241-2010/0--US Patent 
Application No. 14/004,379 (Publication No. 2014-0107186 A), and its 
foreign counterparts in Europe (11 157986.8; 12 708035.6), Canada 
(2,829,518), Australia (2012228376), Brazil (BR 1 1 2013 023185 8), 
China (201280022523.5), Israel (228328), India (8000/DELNP/2013), Japan 
(2013-557138), and South Korea (10-2013-7026982).
    Licensing Contact: Uri Reichman, Ph.D., M.BA.; Phone: 301-435-4616; 
Email: uri.reichman@nih.gov.

    Dated: October 13, 2016.
Uri Reichman,
Senior Advisor for Licensing, Office of Technology Transfer and 
Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-25343 Filed 10-19-16; 8:45 am]
 BILLING CODE 4140-01-P