83_FR_17636 83 FR 17559 - Government-Owned Inventions; Availability for Licensing

83 FR 17559 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 77 (April 20, 2018)

Page Range17559-17560
FR Document2018-08244

The invention listed below is owned by an agency of the U.S. Government and is available for licensing.

Federal Register, Volume 83 Issue 77 (Friday, April 20, 2018) 
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17559-17560]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08244]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Amy Petrik, 240-627-3721; 
[email protected]. Licensing information and copies of the U.S. patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Stabilized Influenza Hemagglutinin Stem Region Trimers and Uses Thereof

Description of Technology

    An effective universal influenza vaccine would eliminate the 
uncertain and costly process of seasonal influenza vaccine development 
each year. Researchers at the National Institute of Allergy and 
Infectious Diseases (NIAID) are developing immunogens which elicit 
neutralizing antibodies to the highly conserved stem region of the 
influenza viral protein hemagglutinin. By targeting this highly 
conserved region, which is nearly identical in various strains of 
influenza virus, these immunogens could train the immune system to 
defend against a wide variety of influenza strains including pandemic 
strains derived from animal reservoirs.
    This vaccine candidate employs a protein nanoparticle platform to 
display portions of the highly conserved stem region of the group 1 
hemagglutinin (HA) viral surface protein in its native, trimeric 
conformation. Animal studies have shown that the HA stem region trimers 
displayed on a nanoparticle are more immunogenic compared to HA stem 
region trimers alone. Immunization of mice and ferrets with an H1N1 
nanoparticle HA stem immunogen conferred protection from a lethal dose 
of H5N1 virus.
    NIAID is continuing development of these vaccine candidates through 
animal studies and moving toward clinical evaluation.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

 Universal influenza vaccine

Competitive Advantages

 Nucleic acid or recombinant protein-based vaccine
 Increased ease of production relative to current seasonal 
influenza vaccines

Development Stage

 Preclinical, animal data available

    Inventors: John R. Mascola, Jeffrey C. Boyington, Hadi M. Yassine, 
Peter D. Kwong, Barney S. Graham, Masaru Kanekiyo (all from NIAID).
    Publications: Yassine, H.M., et al. (2015) Hemagglutinin-stem 
nanoparticles generate heterosubtypic influenza protection. Nature 
Medicine 21: 1065-1070. [PMID: 26301691]
    Intellectual Property: HHS Reference Number E-066-2014 includes 
U.S. Patent Application No. 15/13,265 filed November 22, 2016 
(Pending); Canada Patent Application No. 2,950,085 filed May 27, 2015 
(Pending); China Patent Application No. 201580041202.3 filed January 
24, 2017 (Pending); Europe Patent Application No. 15727824.3 filed 
December 23, 2016 (Pending); India

[[Page 17560]]

Patent Application No. 201617042607 filed December 14, 2016 (Pending).
    Related Intellectual Property: HHS Reference Number E-293-2011.
    Licensing Contact: Dr. Amy Petrik, 240-627-3721; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize influenza monoclonal antibody 
technologies. For collaboration opportunities, please contact Dr. Amy 
Petrik, 240-627-3721; [email protected].

    Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-08244 Filed 4-19-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices 17559 agency’s estimate of the burden of the 07/31/2018, EXTENSION, National the NIH NeuroBioBank must continue proposed collection of information, Institute of Mental Health, National completing the NIH NeuroBioBank including the validity of the Institutes of Health (NIH). Tissue Access Request Form. The methodology and assumptions used; (3) Need and Use of Information primary use of the information collected Ways to enhance the quality, utility, and Collection: This request serves as notice by this instrument is to document, track, clarity of the information to be that the National Institute of Mental monitor, and evaluate the appropriate collected; and (4) Ways to minimizes Health plans to continue supporting the use of the NIH NeuroBioBank resources, the burden of the collection of research community studying as well as to notify stakeholders of information on those who are to neurological, developmental, and updates, corrections or changes to the respond, including the use of psychiatric disorders by coordinating system. appropriate automated, electronic, access to human post-mortem brain mechanical, or other technological tissue and related biospecimens stored OMB approval is requested for 3 collection techniques or other forms of by our federation of networked brain years. There are no costs to respondents’ information technology. and tissue repositories known as the other than their time. The total Proposed Collection Title: NIH NIH NeuroBioBank. To facilitate this estimated annualized burden hours are NeuroBioBank Tissue Access Request process, researchers wishing to obtain 56. Form, 0925–0723, Expiration date brain tissue and biospecimens stored by ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total annual Instrument type Type of respondents responses per respondents response burden hours respondent (in hours) NIH NeuroBioBank Tissue Access Request Form Researchers ................. 225 1 15/60 56 Total ............................................................... ....................................... 225 225 ........................ 56 Dated: April 12, 2018. SUPPLEMENTARY INFORMATION: animal studies and moving toward Melba O. Rojas, Technology description follows. clinical evaluation. Project Clearance Liaison, National Institute Stabilized Influenza Hemagglutinin This technology is available for of Mental Health, National Institutes of licensing for commercial development Health. Stem Region Trimers and Uses Thereof in accordance with 35 U.S.C. 209 and 37 [FR Doc. 2018–08243 Filed 4–19–18; 8:45 am] Description of Technology CFR part 404, as well as for further BILLING CODE 4140–01–P An effective universal influenza development and evaluation under a vaccine would eliminate the uncertain research collaboration. and costly process of seasonal influenza Potential Commercial Applications DEPARTMENT OF HEALTH AND vaccine development each year. HUMAN SERVICES Researchers at the National Institute of • Universal influenza vaccine National Institutes of Health Allergy and Infectious Diseases (NIAID) Competitive Advantages are developing immunogens which elicit neutralizing antibodies to the • Nucleic acid or recombinant protein- Government-Owned Inventions; highly conserved stem region of the based vaccine Availability for Licensing influenza viral protein hemagglutinin. • Increased ease of production relative AGENCY: National Institutes of Health, By targeting this highly conserved to current seasonal influenza vaccines HHS. region, which is nearly identical in Development Stage ACTION: Notice. various strains of influenza virus, these immunogens could train the immune • Preclinical, animal data available SUMMARY: The invention listed below is system to defend against a wide variety Inventors: John R. Mascola, Jeffrey C. owned by an agency of the U.S. of influenza strains including pandemic Boyington, Hadi M. Yassine, Peter D. Government and is available for strains derived from animal reservoirs. Kwong, Barney S. Graham, Masaru licensing. This vaccine candidate employs a Kanekiyo (all from NIAID). FOR FURTHER INFORMATION CONTACT: Dr. protein nanoparticle platform to display Publications: Yassine, H.M., et al. Amy Petrik, 240–627–3721; portions of the highly conserved stem (2015) Hemagglutinin-stem amy.petrik@nih.gov. Licensing region of the group 1 hemagglutinin nanoparticles generate heterosubtypic information and copies of the U.S. (HA) viral surface protein in its native, influenza protection. Nature Medicine patent application listed below may be trimeric conformation. Animal studies 21: 1065–1070. [PMID: 26301691] obtained by communicating with the have shown that the HA stem region Intellectual Property: HHS Reference indicated licensing contact at the trimers displayed on a nanoparticle are Number E–066–2014 includes U.S. Technology Transfer and Intellectual more immunogenic compared to HA Patent Application No. 15/13,265 filed sradovich on DSK3GMQ082PROD with NOTICES Property Office, National Institute of stem region trimers alone. November 22, 2016 (Pending); Canada Allergy and Infectious Diseases, 5601 Immunization of mice and ferrets with Patent Application No. 2,950,085 filed Fishers Lane, Rockville, MD, 20852; tel. an H1N1 nanoparticle HA stem May 27, 2015 (Pending); China Patent 301–496–2644. A signed Confidential immunogen conferred protection from a Application No. 201580041202.3 filed Disclosure Agreement will be required lethal dose of H5N1 virus. January 24, 2017 (Pending); Europe to receive copies of unpublished patent NIAID is continuing development of Patent Application No. 15727824.3 filed applications. these vaccine candidates through December 23, 2016 (Pending); India VerDate Sep<11>2014 17:44 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1

17560 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices Patent Application No. 201617042607 ADDRESSES: Submit comments online at sector for commercial use, as well as filed December 14, 2016 (Pending). http://www.regulations.gov following specified research or development Related Intellectual Property: HHS website instructions. efforts that are consistent with the Reference Number E–293–2011. FOR FURTHER INFORMATION CONTACT: If mission of the Federal parties to the Licensing Contact: Dr. Amy Petrik, you have questions on this notice or CRADA. The Federal party or parties 240–627–3721; amy.petrik@nih.gov. wish to submit proposals for future agree with one or more non-Federal Collaborative Research Opportunity: CRADAs, contact LT Ryan Huebner, parties to share research resources, but The National Institute of Allergy and the Federal party does not contribute Project Official, Surface Branch, U.S. Infectious Diseases is seeking statements funding. Coast Guard Research and Development of capability or interest from parties CRADAs are not procurement Center, 1 Chelsea Street, New London, interested in collaborative research to contracts. Care is taken to ensure that CT 06320, telephone 860–271–2815, further develop, evaluate or CRADAs are not used to circumvent the email Ryan.P.Huebner@uscg.mil. commercialize influenza monoclonal contracting process. CRADAs have a antibody technologies. For collaboration SUPPLEMENTARY INFORMATION: specific purpose and should not be opportunities, please contact Dr. Amy Public Participation and Request for confused with procurement contracts, Petrik, 240–627–3721; amy.petrik@ Comments grants, and other type of agreements. nih.gov. Under the proposed CRADA, the R&D We request public comments on this Dated: April 5, 2018. Center will collaborate with one non- notice. Although we do not plan to Suzanne M. Frisbie, Federal participant. Together, the R&D respond to comments in the Federal Center and the non-Federal participant Deputy Director, Technology Transfer and Register we will respond directly to Intellectual Property Office, National Institute will conduct thermo conductive tests on commenters and may modify our the Coast Guard’s MWCSS in various of Allergy and Infectious Diseases. proposal in light of comments. [FR Doc. 2018–08244 Filed 4–19–18; 8:45 am] environmental scenarios to determine Comments should be marked with the system’s insulation properties to be BILLING CODE 4140–01–P docket number USCG–2018–0185 and used to create safe parameters for should provide a reason for each personnel wearing the MWCSS during suggestion or recommendation. You Ice Rescue missions. DEPARTMENT OF HOMELAND should provide personal contact We anticipate that the Coast Guard’s SECURITY information so that we can contact you contributions under the proposed if we have questions regarding your CRADA will include the following: Coast Guard comments; but please note that all (1) Provide appropriate staff with [Docket No. USCG–2018–0185] comments will be posted to the online pertinent expertise to take the lead in docket without change and that any accomplishing the required tasks; Cooperative Research and personal information you include can be (2) Provide information regarding the Development Agreement: Safe searchable online (see the Federal ensemble items and parameters needed Parameters for Ice Operations Register Privacy Act notice regarding for creating the test plan; Coast Guard, DHS. AGENCY: our public dockets, 73 FR 3316, Jan. 17, (3) Provide all support resources, 2008). We also accept anonymous including travel, for Coast Guard staff Notice of intent; request for ACTION: comments. that supports this CRADA; comments. (4) Obtain, transport and provide all We encourage you to submit SUMMARY: The Coast Guard is comments through the Federal of the ensemble items to be used during announcing its intent to enter into a eRulemaking Portal at http:// the testing; Cooperative Research and Development www.regulations.gov. If your material (5) Provide personnel support to non- Agreement (CRADA) with W.L. GORE cannot be submitted using http:// Federal participant to assist with setting and Associates Inc. (GORE) to conduct www.regulations.gov, contact the Coast up and execute testing in accordance insulation value testing for the Coast Guard (see FOR FURTHER INFORMATION with the agreed upon test plan; Guard’s Maritime Cold Weather Suit CONTACT). Documents mentioned in this (6) Work with non-Federal participant System (MCWSS) in the air instead of notice, and all public comments, are in to develop a Final Report, which will the water, which the system was our online docket at http:// document the methodologies, findings, designed for. While the Coast Guard is www.regulations.gov and can be viewed conclusions, and recommendations of currently considering partnering with by following that website’s instructions. this CRADA work. GORE, we are soliciting public comment Additionally, if you go to the online We anticipate that the non-Federal on the possible nature of and docket and sign up for email alerts, you participants’ contributions under the participation of other parties in the will be notified when comments are proposed CRADA will include the proposed CRADA. In addition, the Coast posted or a final rule is published. following: (1) Provide appropriate staff with Guard also invites other potential non- If desired, submit detailed proposals pertinent expertise to support the above Federal participants, who have the for future CRADAs directly to the Coast mentioned tasks; interest and capability to bring similar Guard (see FOR FURTHER INFORMATION (2) Provide all necessary facility contributions to this type of research, to CONTACT). resources needed to conduct insulation consider submitting proposals for value testing; Discussion consideration in similar CRADAs. (3) Provide technical approach for the CRADAs are authorized under 15 sradovich on DSK3GMQ082PROD with NOTICES DATES: Comments must be submitted to test plan; the online docket via http:// U.S.C. 3710(a).1 A CRADA promotes the (4) Lead the testing runs of the Coast www.regulations.gov on or before May transfer of technology to the private Guard’s MWCSS in accordance with the 21, 2018. agreed upon test plan; 1 The statute confers this authority on the head of Synopses of proposals regarding (5) Provide test data upon completion each Federal agency. The Secretary of DHS’s future CRADAs must reach the Coast authority is delegated to the Coast Guard and other of testing. Guard (see FOR FURTHER INFORMATION DHS organizational elements by DHS Delegation The Coast Guard reserves the right to CONTACT) on or before May 21, 2018. No. 0160.1, para. II.B.34. select for CRADA participants all, some, VerDate Sep<11>2014 17:44 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1


Document Created: 2018-04-20 00:03:00
Document Modified: 2018-04-20 00:03:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. Amy Petrik, 240-627-3721; [email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation83 FR 17559 
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