82_FR_49594 82 FR 49389 - Government-Owned Inventions; Availability for Licensing

82 FR 49389 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 205 (October 25, 2017)

Page Range49389-49390
FR Document2017-23177

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Federal Register, Volume 82 Issue 205 (Wednesday, October 25, 2017) 
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49389-49390]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23177]


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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 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
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unpublished patent applications.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.

Neutralizing Antibodies to Influenza HA and Their Use and 
Identification

    Description of Technology: The effectiveness of current influenza 
vaccines varies by strain and season, in part because influenza viruses 
continuously evolve to evade human immune responses. While the majority 
of seasonal influenza infections cause relatively mild symptoms, each 
year influenza virus infections result in over 500,000 hospitalizations 
in the United States and Europe. Current standard of care for 
individuals hospitalized with uncomplicated influenza infection is 
administration of neuraminidase inhibitors. However, frequent use of 
such antiviral drugs increases the risk that the virus will develop 
drug resistance, especially in high-risk populations. Thus, alternative 
strategies are required to protect or treat vulnerable populations who 
have been hospitalized with severe influenza.
    Using a combination of recombinant proteins and sophisticated flow 
cytometry, scientists at NIAID isolated families of antibodies capable 
of

[[Page 49390]]

neutralizing diverse group 1 and group 2 influenza A viruses. 
Specifically, the families of antibodies identified precisely target 
parts of the hemagglutinin (HA) protein, present on the surface of the 
influenza virus, that are least variable from season to season (Joyce, 
M.G., et al. Cell (2016) 166 (3): 609-623). Therefore, it is 
hypothesized that passive administration of members of these families 
of antibodies to individuals would represent an alternative to the 
current standard of care for severe influenza virus infection. 
Additionally, these families of antibodies could be useful for 
development of a product aimed at conferring passive immunity in 
vulnerable populations during the time of an outbreak or emergence of a 
pandemic strain of influenza.
    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.
    NIAID is continuing development of these neutralizing antibodies to 
influenza toward a clinical product for treatment and/or prevention of 
influenza virus infection. Consequently, for some fields of use, NIAID 
will evaluate a license applicant's capabilities and experience in 
advancing similar technologies through the regulatory process.
    Potential Commercial Applications:
     Prevention of influenza A virus infection
     Therapeutic intervention to treat influenza infection
    Competitive Advantages:
     Ability to potently neutralize both group 1 and group 2 
influenza A strains
    Development Stage:
     Proof of concept in animal models
    Inventors: Adrian McDermott (NIAID), Peter Kwong (NIAID), John 
Mascola (NIAID), M. Gordon Joyce (NIAID), Robert Bailer (NIAID), Sarah 
Andrews (NIAID), Paul Thomas (NIAID), Gwo-Yu Chuang (NIAID), Adam 
Wheatley (NIAID), Yi Zhang (NIAID), James Whittle (NIAID).
    Publications: Joyce, M.G., et al. Cell (2016) 166 (3): 609-623
    Intellectual Property: HHS Reference No. E-061-2016--US Patent 
Application No. 62/330,837 filed May 2, 2016; Patent Cooperation Treaty 
Application No. PCT/US2017/030641 filed May 2, 2017.
    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: October 19, 2017.
Suzanne Frisbie,
Deputy Director,Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-23177 Filed 10-24-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49389 Site Studies for System-Level Name of Committee: National Institute on DEPARTMENT OF HEALTH AND Implementation of Substance Use Prevention Drug Abuse Special Emphasis Panel; NIDA HUMAN SERVICES and Treatment Services (R01; R34). Research Education Program for Clinical Date: November 7, 2017. Researchers and Clinicians (R25). National Institutes of Health Time: 1:00 p.m. to 3:00 p.m. Date: December 4, 2017. Agenda: To review and evaluate grant Government-Owned Inventions; Time: 12:00 p.m. to 3:00 p.m. applications. Place: National Institutes of Health, Agenda: To review and evaluate grant Availability for Licensing Neuroscience Center, 6001 Executive applications. AGENCY: National Institutes of Health, Boulevard, Rockville, MD 20852 (Telephone Place: National Institutes of Health, Neuroscience Center, 6001 Executive HHS. Conference Call). Contact Person: Gerald L. McLaughlin, Boulevard, Rockville, MD 20852 (Telephone ACTION: Notice. Ph.D., Scientific Review Officer, Office of Conference Call). Extramural Policy and Review, National SUMMARY: The invention listed below is Contact Person: Gerald L. McLaughlin, Institute on Drug Abuse, NIH, DHHS, 6001 owned by an agency of the U.S. Ph.D., Scientific Review Officer, Office of Executive Blvd., Room 4238, MSC 9550, Government and is available for Extramural Policy and Review, National Bethesda, MD 20892–9550, 301–827–5819, licensing to achieve expeditious Institute on Drug Abuse, NIH, DHHS, 6001 gm145a@nih.gov. commercialization of results of Executive Blvd., Room 4238, MSC 9550, Name of Committee: National Institute on federally-funded research and Bethesda, MD 20892–9550, 301–827–5819, Drug Abuse Special Emphasis Panel; Limited development. Foreign patent Competition—Cohort Studies of HIV/AIDS gm145a@nih.gov. applications are filed on selected and Substance Abuse (U01). Name of Committee: National Institute on inventions to extend market coverage Date: November 7, 2017. Drug Abuse Special Emphasis Panel; Nasal for companies and may also be available Time: 2:00 p.m. to 3:30 p.m. Delivery of CNS Therapeutics (R41, R42, R43, Agenda: To review and evaluate for licensing. R44). cooperative agreement applications. FOR FURTHER INFORMATION CONTACT: Dr. Date: December 5, 2017. Place: National Institutes of Health, Time: 1:00 p.m. to 4:30 p.m. Amy Petrik, 240–627–3721; Neuroscience Center, 6001 Executive amy.petrik@nih.gov. Licensing Agenda: To review and evaluate grant Boulevard, Rockville, MD 20852 (Telephone information and copies of the U.S. Conference Call). applications. Place: National Institutes of Health, patent application listed below may be Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of Neuroscience Center, 6001 Executive obtained by communicating with the Extramural Policy and Review, National Boulevard, Rockville, MD 20852 (Telephone indicated licensing contact at the Institute on Drug Abuse, National Institutes Conference Call). Technology Transfer and Intellectual of Health, DHHS, 6001 Executive Boulevard, Contact Person: Julia Berzhanskaya, Ph.D., Property Office, National Institute of Room 4238, MSC 9550, Bethesda, MD 20892, Scientific Review Officer, Office of Allergy and Infectious Diseases, 5601 301–827–5820, hiromi.ono@nih.gov. Extramural Policy and Review, Division of Fishers Lane, Rockville, MD, 20852; tel. Name of Committee: National Institute on Extramural Research, National Institute on 301–496–2644. A signed Confidential Drug Abuse Special Emphasis Panel; Disclosure Agreement will be required Drug Abuse, NIH, DHHS, 6001 Executive Advancing Exceptional Research on HIV/ Boulevard, Room 4234, MSC 9550, Bethesda, to receive copies of unpublished patent AIDS and Substance Abuse (R01). Date: November 10, 2017. MD 20892, 301–827–5840, applications. Time: 12:00 p.m. to 3:00 p.m. julia.berzhanskaya@nih.gov. SUPPLEMENTARY INFORMATION: Agenda: To review and evaluate grant Name of Committee: National Institute on Technology description follows. applications. Drug Abuse Special Emphasis Panel; Place: National Institutes of Health, Neutralizing Antibodies to Influenza Conference Grant Review (R13). Neuroscience Center, 6001 Executive HA and Their Use and Identification Date: December 6, 2017. Boulevard, Rockville, MD 20852 (Telephone Description of Technology: The Conference Call). Time: 1:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant effectiveness of current influenza Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of applications. vaccines varies by strain and season, in Extramural Policy and Review, National Place: National Institutes of Health, part because influenza viruses Institute on Drug Abuse, National Institutes Neuroscience Center, 6001 Executive continuously evolve to evade human of Health, DHHS, 6001 Executive Boulevard, Boulevard, Rockville, MD 20852 (Telephone immune responses. While the majority Room 4238, MSC 9550, Bethesda, MD 20892, Conference Call). of seasonal influenza infections cause 301–827–5820, hiromi.ono@nih.gov. Contact Person: Shang-Yi Anne Tsai, relatively mild symptoms, each year Name of Committee: National Institute on Ph.D., Scientific Review Officer, Office of influenza virus infections result in over Drug Abuse Special Emphasis Panel; Extramural Policy and Review, Division of 500,000 hospitalizations in the United Wearable to Track Recovery and Relapse Extramural Research, National Institute on States and Europe. Current standard of Factors for People w/Addiction (R43, R44). Date: November 21, 2017. Drug Abuse, NIH, DHHS, 6001 Executive care for individuals hospitalized with Time: 1:00 p.m. to 4:30 p.m. Boulevard, Room 4228, MSC 9550, Bethesda, uncomplicated influenza infection is Agenda: To review and evaluate grant MD 20892, 301–827–5842, shangyi.tsai@ administration of neuraminidase applications. nih.gov. inhibitors. However, frequent use of Place: National Institutes of Health, (Catalogue of Federal Domestic Assistance such antiviral drugs increases the risk Neuroscience Center, 6001 Executive Program Nos.: 93.279, Drug Abuse and that the virus will develop drug Boulevard, Rockville, MD 20852 (Telephone Addiction Research Programs, National resistance, especially in high-risk Conference Call). sradovich on DSK3GMQ082PROD with NOTICES Institutes of Health, HHS) populations. Thus, alternative strategies Contact Person: Julia Berzhanskaya, Ph.D., are required to protect or treat Scientific Review Officer, Office of Dated: October 19, 2017. Extramural Policy and Review, Division of vulnerable populations who have been Natasha M. Copeland, Extramural Research, National Institute on hospitalized with severe influenza. Program Analyst, Office of Federal Advisory Using a combination of recombinant Drug Abuse, NIH, DHHS, 6001 Executive Committee Policy. proteins and sophisticated flow Boulevard, Room 4234, MSC 9550, Bethesda, MD 20892, 301–827–5840, [FR Doc. 2017–23128 Filed 10–24–17; 8:45 am] cytometry, scientists at NIAID isolated julia.berzhanskaya@nih.gov. BILLING CODE 4140–01–P families of antibodies capable of VerDate Sep<11>2014 22:06 Oct 24, 2017 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1

49390 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices neutralizing diverse group 1 and group interested in collaborative research to copies are available from: Commandant 2 influenza A viruses. Specifically, the further develop, evaluate or (CG–612), Attn: Paperwork Reduction families of antibodies identified commercialize influenza monoclonal Act Manager, U.S. Coast Guard, 2703 precisely target parts of the antibody technologies. For collaboration Martin Luther King Jr. Ave. SE., Stop hemagglutinin (HA) protein, present on opportunities, please contact Dr. Amy 7710, Washington, DC 20593–7710. the surface of the influenza virus, that Petrik, 240–627–3721; amy.petrik@ FOR FURTHER INFORMATION: Contact Mr. are least variable from season to season nih.gov. Anthony Smith, Office of Information (Joyce, M.G., et al. Cell (2016) 166 (3): Dated: October 19, 2017. Management, telephone 202–475–3532, 609–623). Therefore, it is hypothesized Suzanne Frisbie, or fax 202–372–8405, for questions on that passive administration of members these documents. Deputy Director,Technology Transfer and of these families of antibodies to Intellectual Property Office, National Institute SUPPLEMENTARY INFORMATION: individuals would represent an of Allergy and Infectious Diseases. alternative to the current standard of Public Participation and Request for [FR Doc. 2017–23177 Filed 10–24–17; 8:45 am] care for severe influenza virus infection. Comments BILLING CODE 4140–01–P Additionally, these families of This Notice relies on the authority of antibodies could be useful for the Paperwork Reduction Act of 1995; development of a product aimed at 44 U.S.C. Chapter 35, as amended. An conferring passive immunity in DEPARTMENT OF HOMELAND SECURITY ICR is an application to OIRA seeking vulnerable populations during the time the approval, extension, or renewal of a of an outbreak or emergence of a Coast Guard Coast Guard collection of information pandemic strain of influenza. (Collection). The ICR contains This technology is available for [Docket No. USCG–2017–0124] information describing the Collection’s licensing for commercial development purpose, the Collection’s likely burden in accordance with 35 U.S.C. 209 and 37 Collection of Information Under Review by Office of Management and on the affected public, an explanation of CFR part 404, as well as for further the necessity of the Collection, and development and evaluation under a Budget; OMB Control Number: 1625– 0057 other important information describing research collaboration. the Collection. There is one ICR for each NIAID is continuing development of AGENCY:Coast Guard, DHS. Collection. these neutralizing antibodies to The Coast Guard invites comments on Thirty-day notice requesting ACTION: influenza toward a clinical product for whether this ICR should be granted comments. treatment and/or prevention of based on the Collection being necessary influenza virus infection. Consequently, SUMMARY: In compliance with the for the proper performance of for some fields of use, NIAID will Paperwork Reduction Act of 1995 the Departmental functions. In particular, evaluate a license applicant’s U.S. Coast Guard is forwarding an the Coast Guard would appreciate capabilities and experience in Information Collection Request (ICR), comments addressing: (1) The practical advancing similar technologies through abstracted below, to the Office of utility of the Collection; (2) the accuracy the regulatory process. Management and Budget (OMB), Office of the estimated burden of the Potential Commercial Applications: of Information and Regulatory Affairs Collection; (3) ways to enhance the • Prevention of influenza A virus (OIRA), requesting approval for quality, utility, and clarity of infection reinstatement, without change, of the • Therapeutic intervention to treat information subject to the Collection; following collection of information: and (4) ways to minimize the burden of influenza infection 1625–0057, Small Passenger Vessels— Competitive Advantages: the Collection on respondents, Title 46 Subchapters K and T. Our ICR including the use of automated • Ability to potently neutralize both describes the information we seek to group 1 and group 2 influenza A strains collection techniques or other forms of collect from the public. Review and information technology. These Development Stage: • Proof of concept in animal models comments by OIRA ensure we only comments will help OIRA determine Inventors: Adrian McDermott (NIAID), impose paperwork burdens whether to approve the ICR referred to Peter Kwong (NIAID), John Mascola commensurate with our performance of in this Notice. (NIAID), M. Gordon Joyce (NIAID), duties. We encourage you to respond to this Robert Bailer (NIAID), Sarah Andrews DATES: Comments must reach the Coast request by submitting comments and (NIAID), Paul Thomas (NIAID), Gwo-Yu Guard and OIRA on or before November related materials. Comments to Coast Chuang (NIAID), Adam Wheatley 24, 2017. Guard or OIRA must contain the OMB (NIAID), Yi Zhang (NIAID), James ADDRESSES: You may submit comments Control Number of the ICR. They must Whittle (NIAID). identified by Coast Guard docket also contain the docket number of this Publications: Joyce, M.G., et al. Cell number [USCG–2017–0124] to the Coast request, [USCG–2017–0124], and must (2016) 166 (3): 609–623 Guard using the Federal eRulemaking be received by November 24, 2017. Intellectual Property: HHS Reference Portal at http://www.regulations.gov. Submitting Comments No. E–061–2016—US Patent Alternatively, you may submit Application No. 62/330,837 filed May 2, comments to OIRA using one of the We encourage you to submit 2016; Patent Cooperation Treaty following means: comments through the Federal eRulemaking Portal at http:// sradovich on DSK3GMQ082PROD with NOTICES Application No. PCT/US2017/030641 (1) Email: dhsdeskofficer@ filed May 2, 2017. omb.eop.gov. www.regulations.gov. If your material Licensing Contact: Dr. Amy Petrik, (2) Mail: OIRA, 725 17th Street NW., cannot be submitted using http:// 240–627–3721; amy.petrik@nih.gov. Washington, DC 20503, attention Desk www.regulations.gov, contact the person Collaborative Research Opportunity: Officer for the Coast Guard. in the FOR FURTHER INFORMATION The National Institute of Allergy and A copy of the ICR is available through CONTACT section of this document for Infectious Diseases is seeking statements the docket on the Internet at http:// alternate instructions. Documents of capability or interest from parties www.regulations.gov. Additionally, mentioned in this notice, and all public VerDate Sep<11>2014 22:06 Oct 24, 2017 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1


Document Created: 2017-10-25 01:18:01
Document Modified: 2017-10-25 01:18:01
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 Citation82 FR 49389 
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