81_FR_7576 81 FR 7547 - Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase

81 FR 7547 - Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

Page Range7547-7548
FR Document2016-02887

The invention listed in this document is owned by an Agency of the U.S. Government and is available for licensing in accordance with Federal regulations to achieve expeditious commercialization of results of Federally funded research and development.

Federal Register, Volume 81 Issue 29 (Friday, February 12, 2016) 
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7547-7548]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0148]


Government-Owned Inventions; Availability for Licensing; 
Influenza Virus Neuramindase

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The invention listed in this document is owned by an Agency of 
the U.S. Government and is available for licensing in accordance with 
Federal regulations to achieve expeditious commercialization of results 
of Federally funded research and development.

FOR FURTHER INFORMATION CONTACT: 
    For licensing information and copies of the patent applications: 
Alice Welch, Technology Transfer Program Office, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4226, Silver 
Spring, MD 20993, 240-402-2561, FAX: 301-847-3539. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
the patent applications.
    For parties interested in licensing or collaborative research 
activities: William Ronnenberg, Technology Transfer Program Office, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4214, Silver Spring, MD 20993, 240-402-4561, 
[email protected].

SUPPLEMENTARY INFORMATION: Technology description.
    Title of Abstract: Therapeutic and prophylactic anti-Influenza 
virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that 
spans neuramindase (NA) dimers.
    Description of Technology: Influenza virus neuramindase (NA) 
protein is a surface protein that plays an essential role in virus 
replication. Drugs and antibodies that block NA function can reduce 
both the symptoms and the length of illness; however, variants of 
influenza virus are resistant to NA inhibitors. The neuramindase 1 (N1) 
subtype of NA is important because it is found in the two pandemic H1N1 
influenza virus strains (1918 Spanish flu and 2009 swine flu) and the 
H5N1 avian influenza virus. Anti-neuramindase antibody CD6 is a novel 
antibody that spans a conserved 30 amino acid epitope across the 
lateral face of a neuramindase (NA) dimer.
    The subject technology may offer an alternative to therapeutic NA 
inhibitors

[[Page 7548]]

currently available. CD6 is a potent monoclonal antibody against N1 
subtypes of NA that inhibits the enzymatic activity of the NA protein, 
including NA variants resistant to NA inhibitors. In a murine model of 
infection, a single dose of antibody was protective against lethal 
challenge with H1N1 influenza virus. The CD6 antibody can potentially 
be used in combination with other antibodies in an antibody 
``cocktail'' or in conjunction with other therapeutic agents. 
Additionally, this unique anti-NA antibody may be useful in combination 
with known neutralizing anti-hemagglutinin (HA) antibodies.

Potential Commercial Applications

     Prophylactic and therapeutic against influenza virus 
infections;
     Diagnostic tests for influenza virus infections; and
     Reagent to measure the potency of H1N1 NA in influenza 
virus vaccines.

Competitive Advantages

     Monoclonal antibody demonstrated to be effective against 
circulating H1N1 influenza viruses;
     Monoclonal antibody binds a novel, conserved epitope 
spanning NA dimers; and
     Monoclonal antibody is well-suited for an antibody 
cocktail that includes anti-HA antibodies.
    Development Stage: Early state; In vitro data available; In vivo 
data available (animal).
    Inventors: Hongquan Wan (FDA); Maryna Eichelberger (FDA); Hua Yang 
(CDC); James Stevens (CDC); David Shore (CDC); and Rebecca Garten 
(CDC).
    Publication: Wan, H., H. Yang, D. A. Shore, R. J. Garten, L. 
Couzens, J. Gao, L. Jiang, P. J. Carney, J. Villanueva, J. Stevens, and 
M. C. Eichelberger. ``Structural Characterization of a Protective 
Epitope Spanning A(H1N1)pdm09 Influenza Virus Neuraminidase Monomers.'' 
6:6114, Nature Communications, 2015.
    Intellectual Property: HHS Reference No. E-005-2015/0--U.S. 
Provisional Patent Application No. 62/088,388 filed December 5, 2014.
    Licensing and Collaborative Research Opportunity: The invention is 
owned by an Agency of the U.S. Government and is available for 
licensing in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    The Food and Drug Administration is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Parties interested in licensing or collaborative research 
activities for this technology should contact William Ronnenberg (see 
FOR FURTHER INFORMATION CONTACT).

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02887 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 7547 material on its Web site prior to the Dated: February 8, 2016. DEPARTMENT OF HEALTH AND meeting, the background material will Jill Hartzler Warner, HUMAN SERVICES be made publicly available at the Associate Commissioner for Special Medical location of the advisory committee Programs. Food and Drug Administration meeting, and the background material [FR Doc. 2016–02857 Filed 2–11–16; 8:45 am] [Docket No. FDA–2016–N–0148] will be posted on FDA’s Web site after BILLING CODE 4164–01–P the meeting. Background material is Government-Owned Inventions; available at http://www.fda.gov/ Availability for Licensing; Influenza AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND Virus Neuramindase default.htm. Scroll down to the HUMAN SERVICES AGENCY: Food and Drug Administration, appropriate advisory committee meeting Food and Drug Administration HHS. link. ACTION: Notice. Procedure: Interested persons may [Docket No. FDA–2009–D–0268] present data, information, or views, SUMMARY: The invention listed in this orally or in writing, on issues pending Agency Information Collection document is owned by an Agency of the before the committee. Written Activities; Announcement of Office of U.S. Government and is available for submissions may be made to the contact Management and Budget Approval; licensing in accordance with Federal person on or before March 24, 2016. Labeling of Certain Beers Subject to regulations to achieve expeditious Oral presentations from the public will the Labeling Jurisdiction of the Food commercialization of results of be scheduled between approximately 1 and Drug Administration Federally funded research and p.m. and 2 p.m. Those individuals development. interested in making formal oral AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: presentations should notify the contact HHS. For licensing information and copies person and submit a brief statement of ACTION: Notice. of the patent applications: Alice Welch, the general nature of the evidence or Technology Transfer Program Office, arguments they wish to present, the SUMMARY: The Food and Drug Food and Drug Administration, 10903 names and addresses of proposed Administration (FDA) is announcing New Hampshire Ave., Bldg. 1, Rm. participants, and an indication of the that a collection of information entitled 4226, Silver Spring, MD 20993, 240– approximate time requested to make ‘‘Labeling of Certain Beers Subject to the 402–2561, FAX: 301–847–3539. A their presentation on or before March Labeling Jurisdiction of the Food and signed Confidential Disclosure Drug Administration’’ has been Agreement will be required to receive 16, 2016. Time allotted for each approved by the Office of Management copies of the patent applications. presentation may be limited. If the and Budget (OMB) under the Paperwork For parties interested in licensing or number of registrants requesting to collaborative research activities: speak is greater than can be reasonably Reduction Act of 1995. William Ronnenberg, Technology accommodated during the scheduled FOR FURTHER INFORMATION CONTACT: FDA Transfer Program Office, Food and Drug open public hearing session, FDA may PRA Staff, Office of Operations, Food Administration, 10903 New Hampshire conduct a lottery to determine the and Drug Administration, 8455 Ave., Bldg. 1, Rm. 4214, Silver Spring, speakers for the scheduled open public Colesville Rd., COLE–14526, Silver MD 20993, 240–402–4561, hearing session. The contact person will Spring, MD 20993–0002, PRAStaff@ William.ronnenberg@fda.hhs.gov. notify interested persons regarding their fda.hhs.gov. SUPPLEMENTARY INFORMATION: request to speak by March 17, 2016. Technology description. SUPPLEMENTARY INFORMATION: On Persons attending FDA’s advisory December 9, 2015, the Agency Title of Abstract: Therapeutic and committee meetings are advised that the submitted a proposed collection of prophylactic anti-Influenza virus Agency is not responsible for providing information entitled ‘‘Labeling of neuraminidase 1 (N1) antibody (CD6) access to electrical outlets. Certain Beers Subject to the Labeling with a novel epitope that spans Jurisdiction of the Food and Drug neuramindase (NA) dimers. FDA welcomes the attendance of the Administration’’ to OMB for review and Description of Technology: Influenza public at its advisory committee clearance under 44 U.S.C. 3507. An virus neuramindase (NA) protein is a meetings and will make every effort to Agency may not conduct or sponsor, surface protein that plays an essential accommodate persons with disabilities. role in virus replication. Drugs and If you require accommodations due to a and a person is not required to respond to, a collection of information unless it antibodies that block NA function can disability, please contact Cindy Hong at reduce both the symptoms and the least 7 days in advance of the meeting. displays a currently valid OMB control number. OMB has now approved the length of illness; however, variants of FDA is committed to the orderly information collection and has assigned influenza virus are resistant to NA conduct of its advisory committee OMB control number 0910–0728. The inhibitors. The neuramindase 1 (N1) meetings. Please visit our Web site at approval expires on January 31, 2019. A subtype of NA is important because it is http://www.fda.gov/ copy of the supporting statement for this found in the two pandemic H1N1 asabaliauskas on DSK9F6TC42PROD with NOTICES2 AdvisoryCommittees/ information collection is available on influenza virus strains (1918 Spanish flu AboutAdvisoryCommittees/ the Internet at http://www.reginfo.gov/ and 2009 swine flu) and the H5N1 avian ucm111462.htm for procedures on public/do/PRAMain. influenza virus. Anti-neuramindase public conduct during advisory antibody CD6 is a novel antibody that Dated: February 8, 2016. spans a conserved 30 amino acid committee meetings. Leslie Kux, epitope across the lateral face of a Notice of this meeting is given under Associate Commissioner for Policy. neuramindase (NA) dimer. the Federal Advisory Committee Act (5 [FR Doc. 2016–02880 Filed 2–11–16; 8:45 am] The subject technology may offer an U.S.C. app. 2). BILLING CODE 4164–01–P alternative to therapeutic NA inhibitors VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1

7548 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices currently available. CD6 is a potent contact William Ronnenberg (see FOR DEPARTMENT OF HEALTH AND monoclonal antibody against N1 FURTHER INFORMATION CONTACT). HUMAN SERVICES subtypes of NA that inhibits the Dated: February 4, 2016. enzymatic activity of the NA protein, Food and Drug Administration Leslie Kux, including NA variants resistant to NA [Docket No. FDA–2016–N–0001] Associate Commissioner for Policy. inhibitors. In a murine model of [FR Doc. 2016–02887 Filed 2–11–16; 8:45 am] infection, a single dose of antibody was Annual Computational Science protective against lethal challenge with BILLING CODE 4164–01–P Symposium; Conference H1N1 influenza virus. The CD6 antibody can potentially be used in AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND HHS. combination with other antibodies in an HUMAN SERVICES ACTION: Notice of public conference. antibody ‘‘cocktail’’ or in conjunction with other therapeutic agents. Food and Drug Administration Additionally, this unique anti-NA SUMMARY: The Food and Drug antibody may be useful in combination Administration, in cosponsorship with with known neutralizing anti- [Docket No. FDA–2011–N–0742] the Pharmaceutical Users Software hemagglutinin (HA) antibodies. Exchange (PhUSE) is announcing a Agency Information Collection public conference entitled ‘‘The FDA/ Potential Commercial Applications Activities; Announcement of Office of PhUSE Annual Computational Science Management and Budget Approval; Symposium.’’ The purpose of the • Prophylactic and therapeutic Registration of Producers of Drugs conference is to help the broader against influenza virus infections; • Diagnostic tests for influenza virus and Listing of Drugs in Commercial community align and share experiences infections; and Distribution to advance computational science. At • Reagent to measure the potency of AGENCY: Food and Drug Administration, the conference, which will bring H1N1 NA in influenza virus vaccines. together FDA, industry, and academia, HHS. FDA will update participants on current Competitive Advantages ACTION: Notice. initiatives, and collaborative project • Monoclonal antibody demonstrated groups will address specific challenges to be effective against circulating H1N1 SUMMARY: The Food and Drug in accessing and reviewing data to influenza viruses; Administration (FDA) is announcing support product development. These • Monoclonal antibody binds a novel, that a collection of information entitled project groups will focus on solutions conserved epitope spanning NA dimers; ‘‘Registration of Producers of Drugs and and practical ways to implement them. and Listing of Drugs in Commercial DATES: The meeting will be held on • Monoclonal antibody is well-suited Distribution’’ has been approved by the March 13, 2016, from 3 p.m. to 7 p.m., for an antibody cocktail that includes Office of Management and Budget and March 14 to 15, 2016, from 9 a.m. anti-HA antibodies. (OMB) under the Paperwork Reduction to 5:30 p.m. Development Stage: Early state; In Act of 1995. ADDRESSES: The meeting will be held at vitro data available; In vivo data FOR FURTHER INFORMATION CONTACT: FDA the Silver Spring Civic Building at available (animal). PRA Staff, Office of Operations, Food Inventors: Hongquan Wan (FDA); Veterans Plaza, One Veterans Pl., Silver and Drug Administration, 8455 Spring, MD 20910, 1–240–777–5300. Maryna Eichelberger (FDA); Hua Yang Colesville Rd., COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: (CDC); James Stevens (CDC); David Spring, MD 20993–0002, PRAStaff@ Chris Decker, PhUSE FDA Liaison Shore (CDC); and Rebecca Garten (CDC). fda.hhs.gov. Director, Pharmaceutical Users Software Publication: Wan, H., H. Yang, D. A. Shore, R. J. Garten, L. Couzens, J. Gao, SUPPLEMENTARY INFORMATION: On July 8, Exchange (PhUSE), Kent Innovation L. Jiang, P. J. Carney, J. Villanueva, J. 2015, the Agency submitted a proposed Centre, Broadstairs, Kent CT10 2QQ, Stevens, and M. C. Eichelberger. collection of information entitled United Kingdom; 1–609–514–5105 (US), ‘‘Structural Characterization of a ‘‘Registration of Producers of Drugs and css@phuse.eu. Protective Epitope Spanning Listing of Drugs in Commercial SUPPLEMENTARY INFORMATION: A(H1N1)pdm09 Influenza Virus Distribution’’ to OMB for review and I. Background Neuraminidase Monomers.’’ 6:6114, clearance under 44 U.S.C. 3507. An Nature Communications, 2015. Agency may not conduct or sponsor, Since 2008, the Office of Intellectual Property: HHS Reference and a person is not required to respond Computational Science (formerly the No. E–005–2015/0—U.S. Provisional to, a collection of information unless it Computational Science Center) of FDA’s Patent Application No. 62/088,388 filed displays a currently valid OMB control Center for Drug Evaluation and Research December 5, 2014. number. OMB has now approved the (CDER) has supported CDER’s scientific Licensing and Collaborative Research information collection and has assigned community by offering innovative Opportunity: The invention is owned by OMB control number 0910–0045. The solutions that improve the scientific an Agency of the U.S. Government and approval expires on December 31, 2018. drug review process by integrating data, is available for licensing in accordance A copy of the supporting statement for tools, services, and training. Since the asabaliauskas on DSK9F6TC42PROD with NOTICES2 with 35 U.S.C. 209 and 37 CFR part 404. this information collection is available first Computational Science Symposium The Food and Drug Administration is on the Internet at http:// four years ago, FDA has played an seeking statements of capability or www.reginfo.gov/public/do/PRAMain. important part in the development and interest from parties interested in ongoing support of the conference and collaborative research to further Dated: February 8, 2016. the associated PhUSE Computational develop, evaluate, or commercialize this Leslie Kux, Science Working Groups. The PhUSE technology. Parties interested in Associate Commissioner for Policy. Collaboration was formed to bring licensing or collaborative research [FR Doc. 2016–02881 Filed 2–11–16; 8:45 am] together experts from industry, FDA and activities for this technology should BILLING CODE 4164–01–P other regulatory agencies, academia, and VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1


Document Created: 2016-02-12 01:24:26
Document Modified: 2016-02-12 01:24:26
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.
ContactFor licensing information and copies of the patent applications: Alice Welch, Technology Transfer Program Office, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4226, Silver Spring, MD 20993, 240-402-2561, FAX: 301-847-3539. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
FR Citation81 FR 7547 
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