Prospective Grant of Exclusive License: Development of Chitosan/IL-12 Conjugate as Immunotherapeutic Products for Human Cancers, 70308-70309 [2013-28119]
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Federal Register / Vol. 78, No. 227 / Monday, November 25, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Request
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In compliance with Section
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HRSA Telehealth Outcome Measures.
OMB No. 0915–0311—Revision.
Abstract: In order to help carry out its
mission, the Office for the Advancement
of Telehealth (OAT) created a set of
performance measures that grantees can
use to evaluate the effectiveness of their
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must develop strategic plans describing
their overall goal and objectives. The
Office of Rural Health Policy, Office for
the Advancement of Telehealth (OAT),
has worked with its grantees to develop
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hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
Burden per
Response
(in hours)
Total burden
hours
Performance improvement measurement system (PIMS) ..
700
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9,800
Dated: November 18, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–28203 Filed 11–22–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Chitosan/IL–
12 Conjugate as Immunotherapeutic
Products for Human Cancers
sroberts on DSK5SPTVN1PROD with NOTICES
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR Part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
SUMMARY:
VerDate Mar<15>2010
18:38 Nov 22, 2013
Jkt 005300
an exclusive patent license to practice
the inventions embodied in the
following U.S. Patents and Patent
Applications to Scion Cardio-vascular
(‘‘Scion’’) located in Miami, FL, USA.
Intellectual Property
1. U.S. Provisional Patent Application
No. 60/846,481; filed September 22,
2006 entitled ‘‘Methods and
Compositions for the Treatment of
Cancer’’ [HHS Ref. No. E–311–2006/0–
US–01];
2. International Patent Application
No. PCT/US2007/020540 filed
September 21, 2007 entitled
‘‘Compositions And Methods For
Chitosan Enhanced Immune Response’’
[HHS Ref. No. E–311–2006/1–PCT–01];
3. European Patent Application No.
07838692.7 filed September 21, 2007
entitled ‘‘Compositions And Methods
For Chitosan Enhanced Immune
Response’’ [HHS Ref. No. E–311–2006/
1–EP–02]; and
4. U.S. Patent Application No. 12/
442,483 filed March 23, 2009 entitled
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
‘‘Compositions And Methods For
Chitosan Enhanced Immune Response’’
[HHS Ref. No. E–311–2006/1–US–03].
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use will be limited to the use of
Licensed Patent Rights for development
of Chitosan/IL–12 conjugates as
immunotherapeutic products for human
cancers. Please note that the Field of
Use is limited to the use of Chitosan
with IL–12 only and does not include
the use of the Chitosan with any other
antigen. Additionally, the Field of Use
may be limited to certain cancer
indications.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
December 26, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
E:\FR\FM\25NON1.SGM
25NON1
sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 227 / Monday, November 25, 2013 / Notices
comments relating to the contemplated
exclusive license should be directed to:
Sabarni K. Chatterjee, Ph.D., M.B.A.
Licensing and Patenting Manager,
Cancer Branch, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5587; Facsimile: (301) 435–
4013; Email: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology describes the use of chitosan
depots with appropriate antigens and/or
cytokines for generating an immune
response in a subject. Such depots are
made by mixing one or more antigens
and/or cytokines with chitosan or a
chitosan derivative. Similar
compositions are described wherein
chitosan or a derivative forms a microor nanoparticle, which have resulted in
a more immunogenic presentation of
antigen compared to antigen in solution.
Using a representative antigen, the
inventors showed that mice vaccinated
with the subject depots had increased
humoral and cellular immune responses
compared to mice vaccinated with
antigen alone. Furthermore,
comparative mouse studies showed the
antigen-specific immune response
generated with chitosan depots of this
invention to be equipotent to
incomplete Freund’s adjuvant (IFA) and
superior to aluminum hydroxide, a
widely used adjuvant for licensed and
routinely administered vaccines. Thus,
this technology improves upon
commonly used adjuvant technology
and is widely applicable.
This technology is the first to show
that subcutaneous administrations of
chitosan and an appropriate antigen,
with no other component, can be used
for enhancing immune responses. In
additional studies, the inventors
showed that chitosan is able to maintain
a depot of recombinant cytokine. A
single subcutaneous injection of
chitosan-cytokine outperforms daily
injections of recombinant cytokine in
both the expansion of draining lymph
nodes and in the antigen presenting
ability of lymph node cells. This
technology is the first to show that
chitosan can maintain a depot of
cytokine which results in a significant
enhancement of the functional effects of
a cytokine. This technology can be used
for vaccines and immunotherapies
against various infectious agents and
cancer.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within thirty (30) days from the date of
VerDate Mar<15>2010
17:53 Nov 22, 2013
Jkt 232001
this published notice, the NIH 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 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: November 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–28119 Filed 11–22–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: December 2, 2013.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Peter Zelazowski, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6902, peter.zelazowski@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
PO 00000
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Fmt 4703
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70309
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; MicroRNAs and
Trophoblasts.
Date: December 2, 2013.
Time: 4:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Sherry L. Dupere, Ph.D.,
Chief, Scientific Review Branch, Scientific
Review Branch, National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20892, 301–451–3415, duperes@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Assessing Placental
Development and Function SBIR.
Date: December 3, 2013.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: David Weinberg, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive
Boulevard, Room 5B01, Bethesda, MD
20892–7510, 301–435–6973,
David.Weinberg@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Pediatric Orthotics
SBIR.
Date: December 4, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: David Weinberg, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive
Boulevard, Room 5B01, Bethesda, MD
20892–7510, 301–435–6973,
David.Weinberg@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: December 4, 2013.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\25NON1.SGM
25NON1
]]>Agencies
[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Notices]
[Pages 70308-70309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28119]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Chitosan/
IL-12 Conjugate as Immunotherapeutic Products for Human Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
Part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an exclusive patent
license to practice the inventions embodied in the following U.S.
Patents and Patent Applications to Scion Cardio-vascular (``Scion'')
located in Miami, FL, USA.
Intellectual Property
1. U.S. Provisional Patent Application No. 60/846,481; filed
September 22, 2006 entitled ``Methods and Compositions for the
Treatment of Cancer'' [HHS Ref. No. E-311-2006/0-US-01];
2. International Patent Application No. PCT/US2007/020540 filed
September 21, 2007 entitled ``Compositions And Methods For Chitosan
Enhanced Immune Response'' [HHS Ref. No. E-311-2006/1-PCT-01];
3. European Patent Application No. 07838692.7 filed September 21,
2007 entitled ``Compositions And Methods For Chitosan Enhanced Immune
Response'' [HHS Ref. No. E-311-2006/1-EP-02]; and
4. U.S. Patent Application No. 12/442,483 filed March 23, 2009
entitled ``Compositions And Methods For Chitosan Enhanced Immune
Response'' [HHS Ref. No. E-311-2006/1-US-03].
The patent rights in these inventions have been assigned to the
government of the United States of America.
The prospective exclusive license territory may be worldwide and
the field of use will be limited to the use of Licensed Patent Rights
for development of Chitosan/IL-12 conjugates as immunotherapeutic
products for human cancers. Please note that the Field of Use is
limited to the use of Chitosan with IL-12 only and does not include the
use of the Chitosan with any other antigen. Additionally, the Field of
Use may be limited to certain cancer indications.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
December 26, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and
[[Page 70309]]
comments relating to the contemplated exclusive license should be
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Licensing and
Patenting Manager, Cancer Branch, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-5587; Facsimile: (301)
435-4013; Email: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: The technology describes the use of chitosan
depots with appropriate antigens and/or cytokines for generating an
immune response in a subject. Such depots are made by mixing one or
more antigens and/or cytokines with chitosan or a chitosan derivative.
Similar compositions are described wherein chitosan or a derivative
forms a micro- or nanoparticle, which have resulted in a more
immunogenic presentation of antigen compared to antigen in solution.
Using a representative antigen, the inventors showed that mice
vaccinated with the subject depots had increased humoral and cellular
immune responses compared to mice vaccinated with antigen alone.
Furthermore, comparative mouse studies showed the antigen-specific
immune response generated with chitosan depots of this invention to be
equipotent to incomplete Freund's adjuvant (IFA) and superior to
aluminum hydroxide, a widely used adjuvant for licensed and routinely
administered vaccines. Thus, this technology improves upon commonly
used adjuvant technology and is widely applicable.
This technology is the first to show that subcutaneous
administrations of chitosan and an appropriate antigen, with no other
component, can be used for enhancing immune responses. In additional
studies, the inventors showed that chitosan is able to maintain a depot
of recombinant cytokine. A single subcutaneous injection of chitosan-
cytokine outperforms daily injections of recombinant cytokine in both
the expansion of draining lymph nodes and in the antigen presenting
ability of lymph node cells. This technology is the first to show that
chitosan can maintain a depot of cytokine which results in a
significant enhancement of the functional effects of a cytokine. This
technology can be used for vaccines and immunotherapies against various
infectious agents and cancer.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless within thirty
(30) days from the date of this published notice, the NIH 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 404.7.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted to
this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: November 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28119 Filed 11-22-13; 8:45 am]
BILLING CODE 4140-01-P
