Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16377

technology employs protein engineering Dated: April 5, 2018. Dated: April 10, 2018. to stabilize S in its prefusion Suzanne M. Frisbie, Michelle D. Trout, conformation, preventing structural Deputy Director, Technology Transfer and Program Analyst, Office of Federal Advisory rearrangement, and exposing Intellectual Property Office, National Institute Committee Policy. antigenically preferable surfaces. The of Allergy and Infectious Diseases. [FR Doc. 2018–07820 Filed 4–13–18; 8:45 am] technology has been applied to several [FR Doc. 2018–07822 Filed 4–13–18; 8:45 am] BILLING CODE 4140–01–P CoV spikes, including those from BILLING CODE 4140–01–P human-relevant , such as HKU1- CoV, SARS-CoV, and MERS-CoV. DEPARTMENT OF HEALTH AND Particularly for MERS–COV, stabilized S DEPARTMENT OF HEALTH AND HUMAN SERVICES proteins have been shown to elicit HUMAN SERVICES superior neutralizing antibody National Institutes of Health responses up to 10-fold higher in animal National Institutes of Health models and protect mice against lethal Government-Owned Inventions; MERS-CoV infection. This technology is National Heart, Lung, and Blood Availability for Licensing applicable for delivery via other Institute; Notice of Meeting AGENCY: National Institutes of Health, platforms, such as mRNA. HHS. Pursuant to section 10(d) of the This technology is available for ACTION: Notice. licensing for commercial development Federal Advisory Committee Act, as in accordance with 35 U.S.C. 209 and 37 amended, notice is hereby given of a SUMMARY: The invention listed below is CFR part 404, as well as for further meeting of the Sleep Disorders Research owned by an agency of the U.S. development and evaluation under a Advisory Board. Government and is available for research collaboration. This meeting is open to the public but licensing to achieve expeditious Potential Commercial Applications: is being held by virtual/teleconference. commercialization of results of The stabilized prefusion coronavirus No physical meeting location is federally-funded research and spike protein can be used as a vaccine provided for any interested individuals development. Foreign patent to elicit robust neutralizing to listen to and/or participate in the applications are filed on selected antibody responses. meeting. Any individual interested in inventions to extend market coverage listening to the meeting discussions for companies and may also be available Competitive Advantages: must: access the website https:// for licensing. • Improved immunogenicity nih.webex.com/nih/onstage/ FOR FURTHER INFORMATION CONTACT: Dr. compared to other coronavirus S g.php?MTID=e9a4cbcaac003afd915c2c Amy Petrik, 240–627–3721; vaccine formulations. 94a8c787585 and enter Event Password: [email protected]. Licensing • Increased protein expression, sdrab or call-in toll number 1–650–479– information and copies of the U.S. stability, and manufacturability 3208 and enter access code: 625 446 patent application listed below may be compared to wild-type CoV S. 354, for access to the meeting. obtained by communicating with the Development Stage: Individuals require special assistance, indicated licensing contact at the • In vivo data available (animal). should notify the Contact Person listed Technology Transfer and Intellectual below in advance of the meeting. Inventors: Barney Graham (NIAID), Property Office, National Institute of Masaru Kanekiyo (NIAID), M. Gordon Name of Committee: Sleep Disorders Allergy and Infectious Diseases, 5601 Joyce (NIAID), Research Advisory Board. Fishers Lane, Rockville, MD, 20852; tel. (NIAID), Hadi Yassine (NIAID), Andrew Date: April 27, 2018. 301–496–2644. A signed Confidential Ward (Scripps), Robert Kirchdoefer Time: 2:00 p.m. to 4:00 p.m. Disclosure Agreement will be required (Scripps), Christopher Cottrell (Scripps), Agenda: Discussion of NIH Sleep Disorders to receive copies of unpublished patent Jesper Pallesen (Scripps), Hannah Research Plan Revision. applications. Turner (Scripps), Nianshuang Wang Place: National Institutes of Health, Two SUPPLEMENTARY INFORMATION: Rockledge Center, Conference Room 10167, (Dartmouth), Jason McLellan Technology description follows. 6701 Rockledge Drive, Bethesda, MD 20892 (Dartmouth), (Virtual Meeting). Novel Multivalent Nanoparticle Intellectual Property: HHS Reference Contact Person: Michael J. Twery, Ph.D., Vaccines No. E–234–2016/0, U.S. Provisional Director, National Center on Sleep Disorders Description of Technology: Current Patent Application Number 62/412,703, Research Division of Lung Diseases, National seasonal vaccines are filed October 25, 2016, PCT Patent Heart, Lung, and Blood Institute, National designed to elicit immunity to Institutes of Health, 6701 Rockledge Drive, Application PCT/US2017/058370 filed circulating strains of influenza each October 25, 2017. Suite 10042, Bethesda, MD 20892–7952, 301– 435–0199, [email protected]. year. The targeted strains are selected Licensing Contact: Amy Petrik, Ph.D., based on predictions of which strains 240–627–3721; [email protected]. This notice is being published less than 15 days prior to the meeting due to the timing are likely to be predominant in the Collaborative Research Opportunity: limitations of receiving input from committee human population for a given year. This The National Institute of Allergy and members prior to presenting the plan to other prediction must be made well ahead of Infectious Diseases is seeking statements audiences for comment and meeting a the influenza season to allow time for of capability or interest from parties legislative reporting deadline. vaccine production and can be interested in collaborative research to (Catalogue of Federal Domestic Assistance inaccurate. further develop, evaluate or Program Nos. 93.233, National Center for Scientists at NIAID’s Vaccine commercialize norovirus diagnostics or Sleep Disorders Research; 93.837, Heart and Research Center are developing an vaccines. For collaboration Vascular Diseases Research; 93.838, Lung alternative approach for design and opportunities, please contact Amy Diseases Research; 93.839, Blood Diseases production of seasonal influenza Petrik, Ph.D., 240–627–3721; and Resources Research, National Institutes vaccines. The design includes [email protected]. of Health, HHS) recombinant fusion proteins that self-

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assemble into nanoparticles with BR112017014219–8 filed June 29, 2017; fax to 202–395–6974, Attention: Desk influenza antigenic proteins displayed Israel Patent Application No. 253187 Officer for NIH. on the nanoparticle surface ( 499, filed December 31, 2015; Japan Patent FOR FURTHER INFORMATION CONTACT: To 102–106 (2013)). Further engineering Application No. 2017–534796 filed June request more information on the these recombinant fusion proteins, the 28, 2017; South Korean Patent proposed project or to obtain a copy of scientists have developed nanoparticles Application No. 10–2017–7021112 filed the data collection plans and that simultaneously display multiple July 27, 2017; Singapore Patent instruments, contact: Melba Rojas, strains of influenza viral protein Application No. 11201705264W filed NIMH Project Clearance Liaison, (the receptor-binding domain June 23, 2017. Science Policy and Evaluation Branch, of hemagglutinin) on their surface. Due Related Intellectual Property: HHS Office of Science Policy, Planning and to the heterogeneity of the antigenic Reference Number E–293–2011 Communications, NIMH, Neuroscience protein derived from multiple strains, Licensing Contact: Dr. Amy Petrik, Center, 6001 Executive Boulevard, MSC these nanoparticles are referred to as 240–627–3721; [email protected]. 9667, Bethesda, 20892, call mosaic nanoparticles. Collaborative Research Opportunity: 301–443–4335, or email your request, Upon immunization of mice with The National Institute of Allergy and including your mailing address, to mosaic nanoparticles displaying Infectious Diseases is seeking statements [email protected]. antigens from eight different H1N1 of capability or interest from parties SUPPLEMENTARY INFORMATION: This strains, the elicited antibodies interested in collaborative research to proposed information collection was neutralized a panel of H1N1 strains further develop, evaluate or previously published in the Federal from 1918 through 2009 including the commercialize influenza monoclonal Register on January 29, 2018, pages strains that had not been displayed on antibody technologies. For collaboration 4062–4063 (83 FR 4062) and allowed 60 the mosaic nanoparticle. However, mice opportunities, please contact Dr. Amy days for public comment. No public immunized with a mixture of the eight Petrik, 240–627–3721; amy.petrik@ comments were received. The purpose types of nanoparticles, each displaying nih.gov. of this notice is to allow an additional a single antigenic protein, did not elicit Dated: April 5, 2018. 30 days for public comment. The a similar breadth of neutralizing Suzanne M. Frisbie, National Institute of Mental Health antibody response. (NIMH), National Institutes of Health, NIAID is continuing development of Deputy Director, Technology Transfer and may not conduct or sponsor, and the these vaccine candidates through Intellectual Property Office, National Institute of Allergy and Infectious Diseases. respondent is not required to respond animal studies and moving toward to, an information collection that has clinical evaluation. [FR Doc. 2018–07821 Filed 4–13–18; 8:45 am] been extended, revised, or implemented This technology is available for BILLING CODE 4140–01–P on or after October 1, 1995, unless it licensing for commercial development displays a currently valid OMB control in accordance with 35 U.S.C. 209 and 37 DEPARTMENT OF HEALTH AND number. CFR part 404, as well as for further HUMAN SERVICES In compliance with Section development and evaluation under a 3507(a)(1)(D) of the Paperwork research collaboration. National Institutes of Health Reduction Act of 1995, the National Potential Commercial Applications: • Institutes of Health (NIH) has submitted Vaccine platform for seasonal Submission for OMB Review; 30-Day influenza with broader protection to the Office of Management and Budget Comment Request; Generic Clearance (OMB) a request for review and coverage for the Research Domain Criteria Competitive Advantages: approval of the information collection • (RDoC) Initiative (National Institute of listed below. Nucleic acid or recombinant Mental Health) protein-based vaccine Proposed Collection: Generic • Increased ease of production AGENCY: National Institutes of Health, Clearance for the Research Domain compared to current seasonal influenza HHS. Criteria (RDoC) Initiative, 0925–NEW, National Institute of Mental Health vaccines ACTION: Notice. Development Stage: (NIMH), National Institutes of Health • In vivo (animal studies) SUMMARY: In compliance with the (NIH). Inventors: Barney S. Graham, Hadi Paperwork Reduction Act of 1995, the Need and Use of Information Yassine, Masaru Kanekiyo (all from National Institutes of Health (NIH) has Collection: This request serves as notice NIAID). submitted to the Office of Management that the National Institute of Mental Publications: Kanekiyo, M, et al. and Budget (OMB) a request for review Health (NIMH) is seeking OMB approval Manuscript under revision. and approval of the information of a generic plan to conduct information Intellectual Property: HHS Reference collection listed below. collections to interface with the Number E–060–2015 includes U.S. scientific community and promote the DATES: Patent Application No. 15/540,898 filed Comments regarding this RDoC Initiative. As the lead Federal June 29, 2017 (Pending); Canada Patent information collection are best assured agency for research on mental illnesses, Application No. 2,974,346 filed of having their full effect if received NIMH’s mission is to transform the December 31, 2015 (Pending); China within 30 days of the date of this understanding and treatment of mental Patent Application No. 201580076324.6 publication. illnesses through basic and clinical filed December 31, 2015 (Pending); ADDRESSES: Written comments and/or research, paving the way for prevention, Europe Patent Application No. suggestions regarding the item(s) recovery, and cure. To this end, NIMH 15825772.5 filed July 7, 2017 (Pending); contained in this notice, especially launched the RDoC Initiative in 2009 to India Patent Application No regarding the estimated public burden implement Strategy 1.4 of the 2008 201717026077 filed July 21, 2017 and associated response time, should be NIMH Strategic Plan: ‘‘Develop new (Pending); Australia Patent Application directed to the: Office of Management ways of classifying disorders based on No. 2015373928 filed July 21, 2017; and Budget, Office of Regulatory Affairs, dimensions of observable behaviors and Brazil Patent Application No. [email protected] or by brain functions.’’ The aim of RDoC is to

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