30966 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices

Name of Committee: Center for Scientific (Catalogue of Federal Domestic Assistance as the cumbersome use of chick embryo Review Special Emphasis Panel; Member Program Nos. 93.233, National Center for fibroblast (CEF) cells), but a major Conflict: Detection and Therapy. Sleep Disorders Research; 93.837, Heart and bottleneck lies in limited host Date: July 7, 2021. Vascular Diseases Research; 93.838, Lung propagation options and a lack of viable Time: 12:00 p.m. to 5:00 p.m. Diseases Research; 93.839, Blood Diseases continuous cell lines suitable for MVA Agenda: To review and evaluate grant and Resources Research, National Institutes applications. of Health, HHS) production. To address this need, scientists at Place: National Institutes of Health, Dated: June 4, 2021. Rockledge II, 6701 Rockledge Drive, NIAID have identified a number of key Bethesda, MD 20892 (Virtual Meeting). David W. Freeman, viral factors in MVA replication in Contact Person: Laura Asnaghi, Ph.D., Program Analyst, Office of Federal Advisory mammalian cells and developed Scientific Review Officer, National Institutes Committee Policy. methods of modifying MVA in of Health, Center for Scientific Review, 6701 [FR Doc. 2021–12141 Filed 6–9–21; 8:45 am] a way that allows for the growth of MVA Rockledge Drive, Room 6200, MSC 7804, BILLING CODE 4140–01–P in cells that were previously considered Bethesda, MD 20892, (301) 443–1196, unsuitable for such purpose. For [email protected]. example, NIAID scientists observed that (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND the introduction of a serine protease Program Nos. 93.306, Comparative Medicine; HUMAN SERVICES inhibitor 1 (SPI–1) gene into the MVA 93.333, Clinical Research, 93.306, 93.333, genome led to more than a 2-log 93.337, 93.393–93.396, 93.837–93.844, National Institutes of Health 93.846–93.878, 93.892, 93.893, National enhancement of spread in human Institutes of Health, HHS) diploid MRC–5 cells, whereas deletion Government-Owned Inventions; of the gene diminished the spread of Dated: June 4, 2021. Availability for Licensing host-range extended viruses by similar David W. Freeman, AGENCY: National Institutes of Health, extents. Additionally, MRC–5 cells Program Analyst, Office of Federal Advisory HHS. stably expressing SPI–1 also enhanced Committee Policy. replication of MVA. ACTION: Notice. [FR Doc. 2021–12144 Filed 6–9–21; 8:45 am] This technology is available for BILLING CODE 4140–01–P SUMMARY: The invention listed below is licensing for commercial development owned by an agency of the U.S. in accordance with 35 U.S.C. 209 and 37 Government and is available for CFR part 404, as well as for further DEPARTMENT OF HEALTH AND licensing to achieve expeditious development and evaluation under a HUMAN SERVICES commercialization of results of research collaboration. Potential Commercial Applications: National Institutes of Health federally-funded research and • development. Foreign patent Vaccine Development: Recombinant applications are filed on selected MVA-based vaccine production in non- National Heart, Lung, and Blood CEF cell lines. inventions to extend market coverage Institute; Notice of Closed Meeting • Therapeutic oncolytic virus: for companies and may also be available Recombinant MVA constructs encoding Pursuant to section 10(d) of the for licensing. Federal Advisory Committee Act, as oncolytic tumor-suppressor proteins, FOR FURTHER INFORMATION CONTACT: amended, notice is hereby given of the pro-apoptotic proteins, cytokines, Benjamin Hurley; tel. 240–669–5092; following meeting. immunomodulatory proteins, cytotoxic [email protected]. Licensing The meeting will be closed to the peptides, suicide proteins, cytotoxins, information may be obtained by public in accordance with the pro-drugs, therapeutic RNAs, etc. communicating with the Technology provisions set forth in sections Competitive Advantages: Transfer and Intellectual Property • 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Recombinant MVA constructs for Office, National Institute of Allergy and as amended. The grant applications and use in non-avian, continual cell line- Infectious Diseases, 5601 Fishers Lane, the discussions could disclose mediated vaccine production. Rockville, MD 20852; tel. 301–496– • Efficient scale-up vaccine confidential trade secrets or commercial 2644. A signed Confidential Disclosure production as a result of higher viral property such as patentable material, Agreement will be required to receive yield, enhancing epidemic/pandemic and personal information concerning copies of unpublished information preparedness. individuals associated with the grant related to the invention. Inventors: Bernard Moss, Linda Wyatt, applications, the disclosure of which Ruikang Liu, Jorge Mendez-Rios, all of would constitute a clearly unwarranted SUPPLEMENTARY INFORMATION: NIAID. invasion of personal privacy. Technology description follows: Producing Modified Ankara Publications: Name of Committee: National Heart, Lung, (MVA) Virus with Continuous Liu R, Mendez-Rios JD, Peng C, et al. SPI– and Blood Institute Special Emphasis Panel; Mammalian Cell Lines: Viral Host-range 1 is a missing host-range factor required Collaborative Research Projects (PAR–18– for replication of the attenuated modified 951). Factors for Increasing MVA Vaccine Production Yield Description of vaccinia Ankara (MVA) vaccine vector in Date: July 21, 2021. human cells.; PLoS Pathog. 2019. Time: 2:00 p.m. to 5:00 p.m. Technology: Peng C, Moss B. Repair of a previously Agenda: To review and evaluate grant Modified vaccinia Ankara (MVA) uncharacterized second host-range gene applications. based are being deployed in contributes to full replication of Place: National Institutes of Health, 6705 numerous human clinical trials for modified vaccinia virus Ankara (MVA) Rockledge Drive, Bethesda, MD 20817 indications such as , malaria, in human cells. Proc Natl Acad Sci U S (Virtual Meeting). HIV–1 and MERS to name a few. As A. 2020. Contact Person: Rajiv Kumar, Ph.D., Branch Chief, Blood and Vascular Branch, with many vaccines, scale-up and Intellectual Property: HHS Reference Office of Scientific Review/DERA, National production are significant challenges No. E–076–2019; International Heart, Lung, and Blood Institute, 6705 with the MVA platform. Not only are Application No. PCT/US20/33788. Rockledge Drive, 208–W, Bethesda, MD current large-scale MVA vaccine Licensing Contact: To license this 20892, 301–827–4612, [email protected]. production processes inefficient (such technology, please contact Benjamin

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Hurley at 240–669–5092 or Dated: June 4, 2021. Unfortunately, the production of CEF [email protected], and reference David W. Freeman, cells in bulk involves many slow and E–076–2019. Program Analyst, Office of Federal Advisory inefficient manufacturing steps both Collaborative Research Opportunity: Committee Policy. upstream and downstream. Therefore, The National Institute of Allergy and [FR Doc. 2021–12139 Filed 6–9–21; 8:45 am] especially in the context of pandemic Infectious Diseases is seeking statements BILLING CODE 4140–01–P preparedness, continuous cell lines that of capability or interest from parties allow for efficient, large-scale MVA interested in collaborative research to propagation would be beneficial. further develop, evaluate or DEPARTMENT OF HEALTH AND There is a clear need for an expanded commercialize this invention. For HUMAN SERVICES range of cell lines that are easily collaboration opportunities, please maintained in culture, and that allow contact Benjamin Hurley; (240) 669– National Institutes of Health for the production of high titers of 5092, [email protected]. infectious MVA virus. The present Government-Owned Inventions; invention provides methods of Dated: June 2, 2021. Availability for Licensing Surekha Vathyam, modifying non-permissive cell lines in a Deputy Director, Technology Transfer and AGENCY: National Institutes of Health, way that allows for production of MVA. Intellectual Property Office, National Institute HHS. Scientists at NIAID have made a of Allergy and Infectious Diseases. ACTION: Notice. breakthrough discovery by identifying [FR Doc. 2021–12182 Filed 6–9–21; 8:45 am] the mammalian Zinc finger antiviral SUMMARY BILLING CODE 4140–01–P : The invention listed below is protein (ZAP) as a restriction factor that owned by an agency of the U.S. inhibits MVA growth in mammalian Government and is available for cells. They have demonstrated that ZAP DEPARTMENT OF HEALTH AND licensing to achieve expeditious abrogation enhanced replication of the HUMAN SERVICES commercialization of results of MVA in a range of mammalian cells that federally-funded research and are normally non-permissive for MVA National Institutes of Health development. Foreign patent replication. In particular, CRISPR/Cas9 applications are filed on selected inactivation of ZAP was shown to National Heart, Lung, and Blood inventions to extend market coverage produce stable cell lines capable of Institute; Notice of Closed Meeting for companies and may also be available supporting MVA replication. Pursuant to section 10(d) of the for licensing. Additionally, recombinant host cells Federal Advisory Committee Act, as FOR FURTHER INFORMATION CONTACT: engineered to produce vaccinia virus amended, notice is hereby given of the Benjamin Hurley at 240–669–5092; proteins C12L and C16L have been following meeting. [email protected]. Licensing shown to overcome the host range The meeting will be closed to the information may be obtained by inhibition of the MVA. public in accordance with the communicating with the Technology This technology is available for provisions set forth in sections Transfer and Intellectual Property licensing for commercial development 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Office, National Institute of Allergy and in accordance with 35 U.S.C. 209 and 37 as amended. The grant applications and Infectious Diseases, 5601 Fishers Lane, CFR part 404, as well as for further the discussions could disclose Rockville, MD 20852; tel. 301–496– development and evaluation under a confidential trade secrets or commercial 2644. A signed Confidential Disclosure research collaboration. property such as patentable material, Agreement will be required to receive Potential Commercial Applications: • and personal information concerning copies of unpublished information Vaccine Development: individuals associated with the grant related to the invention. Recombinant continuous cell lines applications, the disclosure of which SUPPLEMENTARY INFORMATION: useful for efficient, large-scale would constitute a clearly unwarranted production of MVA. Technology description follows: • invasion of personal privacy. May offer improved vaccine Producing Modified Vaccinia Ankara production scaling-response times, Name of Committee: National Heart, Lung, (MVA) Virus With Continuous Cell enhancing epidemic/pandemic and Blood Institute Special Emphasis Panel; Lines: Modifications of Mammalian NHLBI Career Development Awards—K99. preparedness. Date: July 14, 2021. Host Cells for Increasing MVA Vaccine Competitive Advantages: Time: 11:30 a.m. to 1:00 p.m. Production Yield • Overcomes inefficiencies associated Agenda: To review and evaluate grant Description of Technology: Modified with CEF production of MVA-based applications. vaccinia Ankara (MVA) is a well-known vaccines. Place: National Institutes of Health, 6705 and important platform for vaccine Inventors: Bernard Moss, Linda Wyatt, Rockledge Drive, Bethesda, MD 20817 Chen Peng, Gilad Sivan, Shira (Virtual Meeting). development, and many MVA-based Contact Person: Lindsay M. Garvin, Ph.D., vaccine trials are currently underway to Glushakow-Smith, all of NIAID. Scientific Review Officer, Office of Scientific prevent a variety of microbial diseases. Publications: Review/DERA, National Heart, Lung, and While MVA shows promise as a vaccine Liu R, Mendez-Rios JD, Peng C, et al. SPI– Blood Institute, National Institutes of Health, platform, wide-scale industry use of 1 is a missing host-range factor required 6705 Rockledge Drive, Suite 208–Y, MVA may be currently held back due to for replication of the attenuated modified Bethesda, MD 20892, (301) 827–7911, MVA’s severe host-restriction, and the vaccinia Ankara (MVA) vaccine vector in [email protected]. fact that large bulks of culture cells are human cells.; PLoS Pathog. 2019. (Catalogue of Federal Domestic Assistance presently required to produce enough Peng C, Moss B. Repair of a previously Program Nos. 93.233, National Center for uncharacterized second host-range gene Sleep Disorders Research; 93.837, Heart and product for mass commercial use. At contributes to full replication of Vascular Diseases Research; 93.838, Lung present, the range of commonly-used modified vaccinia virus Ankara (MVA) Diseases Research; 93.839, Blood Diseases culture cells that can support high-titer in human cells. Proc Natl Acad Sci U S and Resources Research, National Institutes production of MVA is limited to chick A. 2020. of Health, HHS) embryo fibroblast (CEF) cells. Peng, C, Wyatt, L, Glushakow-Smith, SG, Lal-

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