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-

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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 Property Office, National Institute email [email protected]. grants, and other type of agreements. of Allergy and Infectious Diseases. SUPPLEMENTARY INFORMATION: Under the proposed CRADA, the R&D [FR Doc. 2021–12179 Filed 6–9–21; 8:45 am] Center will collaborate with one non- Public Participation and Request for BILLING CODE 4140–01–P Federal participant. Together, the R&D Comments Center and the non-Federal participant We request public comments on this will evaluate which USV characteristics notice. Although we do not plan to and parameters would be beneficial to DEPARTMENT OF HOMELAND the USCG mission set. Additionally, SECURITY respond to comments in the Federal Register, we will respond directly to both partners will evaluate how Coast Guard commenters and may modify our collision avoidance technology should proposal in light of comments. be validated on these platforms in the [Docket No. USCG–2021–0236] Comments should be marked with future. We anticipate that the Coast docket number USCG–2021–0236 and Guard’s contributions under the Cooperative Research and should provide a reason for each proposed CRADA will include the Development Agreement: Evaluating suggestion or recommendation. You following: Unmanned Surface Vessel should provide personal contact 1. Provide appropriate staff with Characteristics for Coast Guard information so that we can contact you expertise to accomplish the above Platforms if we have questions regarding your mentioned tasks. AGENCY: Coast Guard, DHS. comments; but please note that all 2. Draft test plan. 3. Provide all support resources, ACTION: comments will be posted to the online Notice of intent; request for including travel for Coast Guard staff comments. docket without change and that any personal information you include can be that support this CRADA. SUMMARY: The Coast Guard is searchable online (see the Federal 4. Obtain, transport, and provide all of announcing its intent to enter into a Register Privacy Act notice regarding the parts, tools, and equipment Cooperative Research and Development our public dockets, 73 FR 3316, Jan. 17, necessary to prepare the platform for Agreement (CRADA) with Sea Machines 2008). We also accept anonymous Sea Machines Robotics modifications. Robotics. Sea Machines Robotics will comments. 5. Provide the 29RDC and qualified work with the USCG Research and We encourage you to submit crew for the testing. Development Center (RDC) to modify comments through the Federal 6. Provide all resources required for the currently existing SM300 system eRulemaking Portal at http:// the conduct of the testing on the 29RDC. installed on the USCG RDC unmanned www.regulations.gov. If your material 7. Execute the testing IAW with the surface vessel (USV) to determine what cannot be submitted using http:// agreed upon test plan. parameters and behaviors would be www.regulations.gov, contact the Coast We anticipate that the non-Federal beneficial for USCG mission sets. Guard (see FOR FURTHER INFORMATION participants’ contributions under the Additionally, the agreement will CONTACT). Documents mentioned in this proposed CRADA will include the investigate the current state of collision notice, and all public comments, are in following: avoidance in autonomous unmanned our online docket at http:// surface vessels (USVs), to develop a www.regulations.gov and can be viewed 1 The statute confers this authority on the head of each Federal agency. The Secretary of DHS’s better understanding of how these by following that website’s instructions. authority is delegated to the Coast Guard and other capabilities should be evaluated/ Additionally, if you go to the online DHS organizational elements by DHS Delegation regulated in the future. The Coast Guard docket and sign up for email alerts, you No. 0160.1, para. II.B.34.

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