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(MVA) Virus with Continuous Cell Lines Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 30967 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- VerDate Sep<11>2014 17:15 Jun 09, 2021 Jkt 253001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1 khammond on DSKJM1Z7X2PROD with NOTICES 30968 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices Nag, M, Weisberg, AS, and Moss, B. invites other potential non-Federal will be notified when comments are Zinc-finger antiviral protein (ZAP) is a participants, who have the interest and posted or a final rule is published. restriction factor for replication of capability to bring similar contributions Do not submit detailed proposals for modified vaccinia virus Ankara (MVA) to this type of research, to submit future CRADAs to the Docket in human cells. PLoS Pathog. 2020, accepted for publication. proposals for consideration in similar Management Facility. Instead, submit CRADAs. them directly to the Coast Guard (see Intellectual Property: HHS Reference FOR FURTHER INFORMATION CONTACT). No. E–076–2019; International DATES: Comments must be submitted to Application No. PCT/US20/33788. the online docket via http:// Discussion www.regulations.gov, or reach the Licensing Contact: To license this CRADAs are authorized under 15 Docket Management Facility, on or technology, please contact Benjamin U.S.C. 3710(a).1 A CRADA promotes the before July 12, 2021. Hurley at 240–669–5092 or transfer of technology to the private [email protected], and reference Synopses of proposals regarding sector for commercial use, as well as E–076–2019. future CRADAs must reach the Coast specified research or development FOR FURTHER INFORMATION Collaborative Research Opportunity: Guard (see efforts that are consistent with the The National Institute of Allergy and CONTACT) on or before July 12, 2021. mission of the Federal parties to the Infectious Diseases is seeking statements ADDRESSES: Submit comments online at CRADA. The Federal party or parties of capability or interest from parties http://www.regulations.gov following agree with one or more non-Federal interested in collaborative research to website instructions. parties to share research resources, but further develop, evaluate or FOR FURTHER INFORMATION CONTACT: If the Federal party does not contribute commercialize this invention. For you have questions on this notice or funding. collaboration opportunities, please wish to submit proposals for future CRADAs are not procurement contact Benjamin Hurley; 240–669– CRADAs, contact Derek Meier, Project contracts. Care is taken to ensure that 5092, [email protected]. Official, Surface Branch, U.S. Coast CRADAs are not used to circumvent the Dated: June 2, 2021. Guard Research and Development contracting process. CRADAs have a Surekha Vathyam, Center, 1 Chelsea Street, New London, specific purpose and should not be Deputy Director, Technology Transfer and CT 06320, telephone 860–271–2600, confused with procurement contracts, Intellectual
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