Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase, 7547-7548 [2016-02887]
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asabaliauskas on DSK9F6TC42PROD with NOTICES2
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
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VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
Dated: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–02857 Filed 2–11–16; 8:45 am]
7547
[Docket No. FDA–2016–N–0148]
Food and Drug Administration
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Government-Owned Inventions;
Availability for Licensing; Influenza
Virus Neuramindase
AGENCY:
ACTION:
[Docket No. FDA–2009–D–0268]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
December 9, 2015, the Agency
submitted a proposed collection of
information entitled ‘‘Labeling of
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0728. The
approval expires on January 31, 2019. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02880 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
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Notice.
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.
SUMMARY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Labeling of Certain Beers Subject to
the Labeling Jurisdiction of the Food
and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
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,
William.ronnenberg@fda.hhs.gov.
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
E:\FR\FM\12FEN1.SGM
12FEN1
7548
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
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 antihemagglutinin (HA) antibodies.
asabaliauskas on DSK9F6TC42PROD with NOTICES2
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
VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Registration of Producers of Drugs
and Listing of Drugs in Commercial
Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On July 8,
2015, the Agency submitted a proposed
collection of information entitled
‘‘Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0045. The
approval expires on December 31, 2018.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02881 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Annual Computational Science
Symposium; Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration, in cosponsorship with
the Pharmaceutical Users Software
Exchange (PhUSE) is announcing a
public conference entitled ‘‘The FDA/
PhUSE Annual Computational Science
Symposium.’’ The purpose of the
conference is to help the broader
community align and share experiences
to advance computational science. At
the conference, which will bring
together FDA, industry, and academia,
FDA will update participants on current
initiatives, and collaborative project
groups will address specific challenges
in accessing and reviewing data to
support product development. These
project groups will focus on solutions
and practical ways to implement them.
DATES: The meeting will be held on
March 13, 2016, from 3 p.m. to 7 p.m.,
and March 14 to 15, 2016, from 9 a.m.
to 5:30 p.m.
ADDRESSES: The meeting will be held at
the Silver Spring Civic Building at
Veterans Plaza, One Veterans Pl., Silver
Spring, MD 20910, 1–240–777–5300.
FOR FURTHER INFORMATION CONTACT:
Chris Decker, PhUSE FDA Liaison
Director, Pharmaceutical Users Software
Exchange (PhUSE), Kent Innovation
Centre, Broadstairs, Kent CT10 2QQ,
United Kingdom; 1–609–514–5105 (US),
css@phuse.eu.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Since 2008, the Office of
Computational Science (formerly the
Computational Science Center) of FDA’s
Center for Drug Evaluation and Research
(CDER) has supported CDER’s scientific
community by offering innovative
solutions that improve the scientific
drug review process by integrating data,
tools, services, and training. Since the
first Computational Science Symposium
four years ago, FDA has played an
important part in the development and
ongoing support of the conference and
the associated PhUSE Computational
Science Working Groups. The PhUSE
Collaboration was formed to bring
together experts from industry, FDA and
other regulatory agencies, academia, and
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7547-7548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02887]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
William.ronnenberg@fda.hhs.gov.
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
