Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection, 28002-28003 [2018-12838]
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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices
Conflict: Healthcare Delivery and
Methodologies.
Date: July 16, 2018.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
MSC 7770, Bethesda, MD 20892, 301–254–
9975, helmersk@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 8, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12839 Filed 6–14–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
Commercialization License:
Streptococcus Pneumonia PSAA
Peptide for Treatment of Sepsis and
Infection
National Institutes of Health,
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, on behalf of the
Centers for Disease Control and
Prevention, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent
commercialization license to The
University of Liverpool, located in
Liverpool, UK, to practice the
inventions embodied in the patent
applications listed in the
Supplementary Information section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases on or before July 2,
2018 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:11 Jun 14, 2018
Jkt 244001
comments relating to the contemplated
exclusive patent commercialization
license should be directed to: Karen
Surabian, Licensing and Patenting
Manager, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, 5601 Fishers Lane, Suite 6D,
MSC9804, Rockville, MD 20852–9804,
phone number 301–496–2644, or
karen.surabian@nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement: United States
Provisional Patent Application Number
61/085,208, filed 07/31/2008, entitled
‘‘Methods of Enhancing
Opsonophagocytosis in Response to a
Pathogen’’ (HHS Reference No. E–329–
2013/0–US–01); PCT Patent Application
Number PCT/US2009/052384, filed 07/
31/2009, entitled ‘‘Methods of
Enhancing Opsonophagocytosis in
Response to a Pathogen’’ (HHS
Reference No. E–329–2013/0–PCT–02);
China Patent Number 200980137625.X,
issued 11/26/2014, entitled ‘‘Methods of
Enhancing Opsonophagocytosis in
Response to a Pathogen’’ (HHS
Reference No. E–329–2013/0–CN–03);
European Patent Number 2323684,
issued 05/21/2014, entitled ‘‘Use of a
Pneumococcal P4 Peptide for Enhancing
Opsonophagocytosis in Response to a
Pathogen’’ (HHS Reference No. E–329–
2013/0–EP–04), and validated in
Germany, Spain, France, the United
Kingdom, and Ireland; Hong Kong
Patent Number 1160391, issued 07/31/
2015, entitled ‘‘Methods of Enhancing
Opsonophagocytosis in Response to a
Pathogen’’ (HHS Reference No. E–329–
2013/0–HK–05); United States Patent
Number 8,431,134, issued 04/30/2013,
entitled ‘‘Use of a Pneumococcal P4
Peptide for Enhancing
Opsonophagocytosis in Response to a
Pathogen’’ (HHS Reference No. E–329–
2013/0–US–06); United States Patent
Number 9,101,582, issued 08/11/2015,
entitled ‘‘Use of a Pneumococcal P4
Peptide for Enhancing
Opsonophagocytosis in Response to a
Pathogen’’ (HHS Reference No. E–329–
2013/0–US–07); United States
Provisional Patent Application Number
60/682,495, filed 05/19/2005, entitled
‘‘Functional Epitopes of Streptococcus
Pneumonia PSAA Antigen and Uses
Thereof’’ (HHS Reference No. E–338–
2013/0–US–01); PCT Patent Application
Number PCT/US2005/027290, filed
07/29/2005, entitled ‘‘Functional
Epitopes of Streptococcus Pneumonia
PSAA Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–PCT–02);
Australia Patent Number 2005332058,
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
issued 03/15/2012, entitled ‘‘Functional
Epitopes of Streptococcus Pneumonia
PSAA Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–AU–03);
European Patent Number 1931700,
issued 07/17/2003, entitled ‘‘Functional
Epitopes of Streptococcus Pneumonia
PSAA Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–EP–04),
and validated in: Germany, Spain,
France, the United Kingdom, and
Ireland; Hong Kong Patent Number
1115144, issued 02/14/2014, entitled
‘‘Functional Epitopes of Streptococcus
Pneumonia PSAA Antigen and Uses
Thereof’’ (HHS Reference No. E–338–
2013/0–HK–05); United States Patent
Number 7,919,104, issued 04/05/2011,
entitled ‘‘Functional Epitopes of
Streptococcus Pneumonia PSAA
Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–US–06);
Canada Patent Application Number
2,631,556, filed 09/15/2014, entitled
‘‘Functional Epitopes of Streptococcus
Pneumonia PSAA Antigen and Uses
Thereof’’ (HHS Reference No. E–338–
2013/0–CA–07); Australia Patent
Number 2012201107, issued 06/06/
2013, entitled ‘‘Functional Epitopes of
Streptococcus Pneumonia PSAA
Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–AU–08);
Hong Kong Patent Number HK1163113,
issued 06/05/2015, entitled ‘‘Functional
Epitopes of Streptococcus Pneumonia
PSAA Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–HK–09);
European Patent Number 2371843,
issued 09/17/2014, entitled ‘‘Functional
Epitopes of Streptococcus Pneumonia
PSAA Antigen and Uses Thereof’’ (HHS
Reference No. E–338–2013/0–EP–10),
and validated in: Germany, France, and
the United Kingdom.
All rights in these inventions have
been assigned to the Government of the
United States of America.
The prospective exclusive patent
commercialization license territory may
be worldwide and the field of use may
be limited to: ‘‘Development,
manufacture, and sale of a P4 peptide
therapeutic for the treatment of
infection and sepsis.’’
These inventions, developed within
the National Center for Immunization
and Respiratory Diseases (NCIRD), at the
Centers for Disease Control and
Prevention (CDC), describe methods to
bolster the human body’s own
mechanisms to fight infection by
enhancing an innate immune response,
opsonophagocytosis. The specific 24
amino acid peptide sequence (P4) acts
as a polymorphonuclear cell activator.
P4 can be administered in vivo along
with disease-specific antibodies to
enhance systemic bacterial clearance,
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices
thus leading to prolonged survival. This
technology enhances the body’s
response to a variety of bacterial
infections, including S. pneumoniae
and S. aureus.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent
commercialization license will be
royalty bearing and may be granted
unless within fifteen (15) days from the
date of this published notice, the
National Institute of Allergy and
Infectious Diseases receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. In response
to this Notice, the public may file
comments or objections. Comments and
objections, other than those in the form
of a license application, will not be
treated confidentially, and may be made
publicly available. License applications
submitted in response to this Notice
will be presumed to contain business
confidential information, and any
release of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: June 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–12838 Filed 6–14–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the joint meeting of the
National Cancer Advisory Board and
NCI Board of Scientific Advisors, June
26, 2018, 8:30 a.m. to June 27, 2018,
12:00 p.m., National Cancer Institute
Shady Grove, 9609 Medical Center
Drive, Conference Room TE 406/408,
Rockville, MD 20850 which was
published in the Federal Register on
June 05, 2018, 83 FR 26069.
This meeting notice is being amended
to update the meeting locations for the
National Cancer Advisory Board Ad Hoc
VerDate Sep<11>2014
17:11 Jun 14, 2018
Jkt 244001
Subcommittee meetings. The National
Cancer Advisory Board Ad Hoc
Subcommittee Population Science,
Epidemiology and Disparities meeting
on June 25, 2018, 5:30 p.m. to 7:30 p.m.,
will be held at the Gaithersburg Marriott
Washingtonian Center in Salons A and
B. The National Cancer Advisory Board
Ad Hoc Subcommittee on Global Cancer
Research meeting on June 25, 2018, 7:30
p.m. to 9:00 p.m., will be held at the
Gaithersburg Marriott Washingtonian
Center in Salon C.
Dated: June 11, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12837 Filed 6–14–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Survey of State Underage
Drinking Prevention Policies and
Practices—(OMB No. 0930–0316)—
Revision
The Sober Truth on Preventing
Underage Drinking Act (the ‘‘STOP
Act’’) (Pub. L. 109–422, reauthorized in
2016 by Pub. L. 114–255) states that the
‘‘Secretary [of Health and Human
Services] shall . . . annually issue a
report on each state’s performance in
enacting, enforcing, and creating laws,
regulations, and programs to prevent or
reduce underage drinking.’’ The
Secretary has delegated responsibility
for this report to SAMHSA. Therefore,
SAMHSA has developed a Survey of
State Underage Drinking Prevention
Policies and Practices (the ‘‘State
Survey’’) to provide input for the stateby-state report on prevention and
enforcement activities related to
underage drinking component of the
Annual Report to Congress on the
Prevention and Reduction of Underage
Drinking (‘‘Report to Congress’’).
The STOP Act also requires the
Secretary to develop ‘‘a set of measures
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
28003
to be used in preparing the report on
best practices’’ and to consider
categories including but not limited to
the following:
Category #1: Sixteen specific
underage drinking laws/regulations
enacted at the state level (e.g., laws
prohibiting sales to minors; laws related
to minors in possession of alcohol).
Note that ten additional policies have
been added to the Report to Congress
pursuant to Congressional
appropriations language or the
Secretary’s authority granted by the
STOP Act;
Category #2: Enforcement and
educational programs to promote
compliance with these laws/regulations;
Category #3: Programs targeted to
youths, parents, and caregivers to deter
underage drinking and the number of
individuals served by these programs;
Category #4: The amount that each
state invests, per youth capita, on the
prevention of underage drinking broken
into five categories: (a) Compliance
check programs in retail outlets; (b)
Checkpoints and saturation patrols that
include the goal of reducing and
deterring underage drinking; (c)
Community-based, school-based, and
higher-education-based programs to
prevent underage drinking; (d)
Underage drinking prevention programs
that target youth within the juvenile
justice and child welfare systems; and
(e) Any other state efforts or programs
that target underage drinking.
Congress’ purpose in mandating the
collection of data on state policies and
programs through the State Survey is to
provide policymakers and the public
with otherwise unavailable but much
needed information regarding state
underage drinking prevention policies
and programs. SAMHSA and other
Federal agencies that have underage
drinking prevention as part of their
mandate use the results of the State
Survey to inform federal programmatic
priorities, as do other stakeholders,
including community organizations.
The information gathered by the State
Survey has established a resource for
state agencies and the general public for
assessing policies and programs in their
own state and for becoming familiar
with the programs, policies, and
funding priorities of other states.
Because of the broad scope of data
required by the STOP Act, SAMHSA
relies on existing data sources where
possible to minimize the survey burden
on the states. SAMHSA uses data on
state underage drinking policies from
the National Institute of Alcohol Abuse
and Alcoholism’s Alcohol Policy
Information System (APIS), an
authoritative compendium of state
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 28002-28003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License:
Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and
Infection
AGENCY: National Institutes of Health, Centers for Disease Control and
Prevention, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, on behalf of the Centers for Disease Control and
Prevention, Department of Health and Human Services, is contemplating
the grant of an exclusive patent commercialization license to The
University of Liverpool, located in Liverpool, UK, to practice the
inventions embodied in the patent applications listed in the
Supplementary Information section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases on or
before July 2, 2018 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated exclusive patent
commercialization license should be directed to: Karen Surabian,
Licensing and Patenting Manager, Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone
number 301-496-2644, or [email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement: United States
Provisional Patent Application Number 61/085,208, filed 07/31/2008,
entitled ``Methods of Enhancing Opsonophagocytosis in Response to a
Pathogen'' (HHS Reference No. E-329-2013/0-US-01); PCT Patent
Application Number PCT/US2009/052384, filed 07/31/2009, entitled
``Methods of Enhancing Opsonophagocytosis in Response to a Pathogen''
(HHS Reference No. E-329-2013/0-PCT-02); China Patent Number
200980137625.X, issued 11/26/2014, entitled ``Methods of Enhancing
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-CN-03); European Patent Number 2323684, issued 05/21/2014,
entitled ``Use of a Pneumococcal P4 Peptide for Enhancing
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-EP-04), and validated in Germany, Spain, France, the United
Kingdom, and Ireland; Hong Kong Patent Number 1160391, issued 07/31/
2015, entitled ``Methods of Enhancing Opsonophagocytosis in Response to
a Pathogen'' (HHS Reference No. E-329-2013/0-HK-05); United States
Patent Number 8,431,134, issued 04/30/2013, entitled ``Use of a
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to
a Pathogen'' (HHS Reference No. E-329-2013/0-US-06); United States
Patent Number 9,101,582, issued 08/11/2015, entitled ``Use of a
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to
a Pathogen'' (HHS Reference No. E-329-2013/0-US-07); United States
Provisional Patent Application Number 60/682,495, filed 05/19/2005,
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen
and Uses Thereof'' (HHS Reference No. E-338-2013/0-US-01); PCT Patent
Application Number PCT/US2005/027290, filed 07/29/2005, entitled
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses
Thereof'' (HHS Reference No. E-338-2013/0-PCT-02); Australia Patent
Number 2005332058, issued 03/15/2012, entitled ``Functional Epitopes of
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference
No. E-338-2013/0-AU-03); European Patent Number 1931700, issued 07/17/
2003, entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA
Antigen and Uses Thereof'' (HHS Reference No. E-338-2013/0-EP-04), and
validated in: Germany, Spain, France, the United Kingdom, and Ireland;
Hong Kong Patent Number 1115144, issued 02/14/2014, entitled
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses
Thereof'' (HHS Reference No. E-338-2013/0-HK-05); United States Patent
Number 7,919,104, issued 04/05/2011, entitled ``Functional Epitopes of
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference
No. E-338-2013/0-US-06); Canada Patent Application Number 2,631,556,
filed 09/15/2014, entitled ``Functional Epitopes of Streptococcus
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-CA-07); Australia Patent Number 2012201107, issued 06/06/2013,
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen
and Uses Thereof'' (HHS Reference No. E-338-2013/0-AU-08); Hong Kong
Patent Number HK1163113, issued 06/05/2015, entitled ``Functional
Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof''
(HHS Reference No. E-338-2013/0-HK-09); European Patent Number 2371843,
issued 09/17/2014, entitled ``Functional Epitopes of Streptococcus
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-EP-10), and validated in: Germany, France, and the United
Kingdom.
All rights in these inventions have been assigned to the Government
of the United States of America.
The prospective exclusive patent commercialization license
territory may be worldwide and the field of use may be limited to:
``Development, manufacture, and sale of a P4 peptide therapeutic for
the treatment of infection and sepsis.''
These inventions, developed within the National Center for
Immunization and Respiratory Diseases (NCIRD), at the Centers for
Disease Control and Prevention (CDC), describe methods to bolster the
human body's own mechanisms to fight infection by enhancing an innate
immune response, opsonophagocytosis. The specific 24 amino acid peptide
sequence (P4) acts as a polymorphonuclear cell activator. P4 can be
administered in vivo along with disease-specific antibodies to enhance
systemic bacterial clearance,
[[Page 28003]]
thus leading to prolonged survival. This technology enhances the body's
response to a variety of bacterial infections, including S. pneumoniae
and S. aureus.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive patent commercialization license
will be royalty bearing and may be granted unless within fifteen (15)
days from the date of this published notice, the National Institute of
Allergy and Infectious Diseases receives written evidence and argument
that establishes that the grant of the license would not be consistent
with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization license. In response to this Notice, the public may
file comments or objections. Comments and objections, other than those
in the form of a license application, will not be treated
confidentially, and may be made publicly available. License
applications submitted in response to this Notice will be presumed to
contain business confidential information, and any release of
information in these license applications will be made only as required
and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
Dated: June 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-12838 Filed 6-14-18; 8:45 am]
BILLING CODE 4140-01-P
