National Institute of Allergy and Infectious Diseases: Licensing Opportunity and Cooperative Research and Development Agreement (“CRADA”) Opportunity; Live Attenuated Vaccine To Prevent Disease Caused by West Nile Virus, 11934-11935 [E8-4193]
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Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices
Contact Person: Janet M. Larkin, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1102,
MSC 7840, Bethesda, MD 20892, 301–435–
1026, larkinja@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Behavioral
and Social HIV/AIDS Review of SBIR
Applications.
Date: March 28, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Mark P. Rubert, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Date: April 3, 2008.
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Contact Person: George W. Chacko, PhD,
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Scientific Review, National Institutes of
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(Catalogue of Federal Domestic Assistance
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Date: March 11, 2008.
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
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Dated: February 27, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–937 Filed 3–4–08; 8:45 am]
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
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Dated: February 27, 2008.
Jennifer Spaeth,
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Committee Policy.
[FR Doc. 08–938 Filed 3–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
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DEPARTMENT OF HEALTH AND
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Dated: February 27, 2008.
Jennifer Spaeth,
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[FR Doc. 08–936 Filed 3–04–08; 8:45 am]
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Name of Committee: National Institute of
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National Institute of Allergy and
Infectious Diseases: Licensing
Opportunity and Cooperative Research
and Development Agreement
(‘‘CRADA’’) Opportunity; Live
Attenuated Vaccine To Prevent
Disease Caused by West Nile Virus
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The National Institute of
Allergy and Infectious Diseases (NIAID)
of the NIH is seeking licensees and/or
CRADA partners to further develop,
evaluate, and commercialize modified
West Nile virus (WNV) chimeras as a
live attenuated vaccine against
infections of WNV in humans. NIAID is
also seeking licensees to commercialize
modified WNV chimeras as live
attenuated veterinary vaccines against
infections of WNV in animals.
DATES: Respondents interested in
licensing the invention will be required
to submit an ‘‘Application for License to
Public Health Service Inventions’’ on or
E:\FR\FM\05MRN1.SGM
05MRN1
Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices
before June 3, 2008 for priority
consideration.
Interested CRADA collaborators must
submit a confidential proposal summary
to the NIAID (attention Percy S. Pan at
the address mentioned below) on or
before June 3, 2008 for consideration.
Guidelines for preparing full CRADA
proposals will be communicated shortly
thereafter to all respondents with whom
initial confidential discussions will
have established sufficient mutual
interest. CRADA and PHS License
Applications submitted thereafter may
be considered if a suitable CRADA
collaborator or Licensee(s) has not been
selected.
Questions about licensing
opportunities should be addressed to
Peter Soukas, J.D., Technology
Licensing Specialist, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, Maryland 20852–
3804, Telephone: (301) 435–4646 ;
Facsimile: (301) 402–0220; E-mail:
soukasp@mail.nih.gov. Information
about Patent Applications and pertinent
information not yet publicly described
can be obtained under the terms of a
Confidential Disclosure Agreement.
Respondents interested in licensing the
invention will be required to submit an
‘‘Application for License to Public
Health Service Inventions.’’
Depending upon the mutual interests
of the Licensee(s) and the NIAID, a
CRADA to collaborate to develop WNV
vaccines in humans may also be
negotiated. Proposals and questions
about this CRADA opportunity should
be addressed to Percy S. Pan,
Technology Development Associate,
Office of Technology Development,
NIAID, 6610 Rockledge Drive, Room
4071, Bethesda, MD 20892–6606,
Telephone: (301) 451–3523; E-mail:
panp@niaid.nih.gov. Respondents
interested in submitting a CRADA
Proposal should be aware that it may be
necessary to secure a license to the
above-mentioned patent rights in order
to commercialize products arising from
a CRADA.
ADDRESSES:
WNV has
recently emerged in the U.S. and is
considered a significant emerging
disease that has embedded itself over a
considerable region of the U.S. WNV
infections have been recorded in
humans as well as in different animals.
To date, WNV has killed 294 people in
the U.S. and caused severe disease in
more than 4222 others. This project is
part of NIAID’s comprehensive
emerging infectious disease program,
which supports research on bacterial,
jlentini on PROD1PC65 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
18:03 Mar 04, 2008
Jkt 214001
viral, and other types of disease-causing
microbes.
The methods and compositions of this
invention provide a means for
prevention of WNV infection by
immunization with attenuated,
immunogenic viral vaccines against
WNV. The invention involves a
chimeric virus form consisting of parts
of WNV and Dengue virus. Construction
of the hybrids and their properties are
described in detail in PNAS, Pletnev AG
et al., 2002; 99(5):3036–3041.
The WNV chimeric vaccine does not
target the central nervous system, which
would be the case in an infection with
wild type WNV. The vaccine stimulates
strong anti-WNV immune responses,
even following a single dose of the
vaccine. When injected into mice, the
vaccine protected all of the immunized
animals from subsequent exposure to
the New York WNV strain. The vaccine
was also effective in primates.
Researchers intend to begin human
trials in late 2003.
The WNV vaccine may be used to
protect the human population,
particularly the elderly people, and
domestic animals from WNV infection
in the affected regions of the U.S. as
well as worldwide.
The invention claimed in HHS
Reference No. E–357–2001/1–US–02,
‘‘Construction of West Nile Virus and
Dengue Virus Chimeras for Use in a Live
Virus Vaccine to Prevent Disease
Caused by West Nile Virus’’ AG Pletnev
et al.), U.S. Patent Application No. 10/
871,775, filed June 18, 2004, is available
for exclusive or non-exclusive licensing
for developing a vaccine against WNV
for humans or veterinary use in
accordance with 35 U.S.C. 207 and 37
CFR Part 404. NIAID is also interested
in further development of the
technology under one or more CRADAs
in the human applications described
below.
Under the CRADA the production of
WNV vaccines for humans will be
optimized and the vaccine evaluated in
a series of clinical studies in humans as
well as initial safety testing in humans.
Positive outcomes of these studies will
indicate continued clinical development
aimed at supporting regulatory approval
of a product to be labeled for use in
humans. The Public Health Service
(PHS) has filed patent applications both
in the U.S. and internationally related to
this technology. Notice of the
availability of the patent application for
licensing was first published in the
Federal Register on May 2, 2002 (67 FR
22093).
NIAID’s principal investigator has
extensive experience with live
attenuated vaccines, their production
PO 00000
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11935
and testing, and clinical trials. The
Collaborator in this endeavor is
expected to assist NIAID in evaluating
its current system for producing the
WNV chimeras claimed in the patent
applications and to develop and
optimize an alternative production
method, if necessary, to manufacture
sufficient quantities of the vaccine for
clinical testing in humans and initial
safety studies in humans. The
Collaborator must have experience in
the manufacture of live attenuated
vaccines according to applicable FDA
guidelines and Points to Consider
documents to include Good
Manufacturing Procedures (GMP). In
addition, it is expected that the
Collaborator would provide funds to
supplement the LID’s research budget
for the project and to support the initial
human testing.
The capability statement should
include detailed descriptions of: (1)
Collaborator’s expertise in the
production of live attenuated vaccines,
(2) Collaborator’s ability to manufacture
sufficient quantities of the vaccine
according to FDA guidelines and Points
to Consider documents, (3) the technical
expertise of the Collaborator’s principal
investigator and laboratory group in
preclinical safety testing (e.g., expertise
in in vitro and in vivo toxicity and
pharmacology studies) and initial
human safety studies, and (4)
Collaborator’s ability to provide
adequate funding to support initial
human safety studies required for
marketing approval.
Dated: February 25, 2008.
Michael Mowatt,
Director, Office of Technology Development,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health.
Dated: February 26, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–4193 Filed 3–4–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of Human
Therapeutics for the Treatment of
Cancer
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
E:\FR\FM\05MRN1.SGM
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05MRN1
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[Federal Register Volume 73, Number 44 (Wednesday, March 5, 2008)]
[Notices]
[Pages 11934-11935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases: Licensing
Opportunity and Cooperative Research and Development Agreement
(``CRADA'') Opportunity; Live Attenuated Vaccine To Prevent Disease
Caused by West Nile Virus
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID) of the NIH is seeking licensees and/or CRADA partners to
further develop, evaluate, and commercialize modified West Nile virus
(WNV) chimeras as a live attenuated vaccine against infections of WNV
in humans. NIAID is also seeking licensees to commercialize modified
WNV chimeras as live attenuated veterinary vaccines against infections
of WNV in animals.
DATES: Respondents interested in licensing the invention will be
required to submit an ``Application for License to Public Health
Service Inventions'' on or
[[Page 11935]]
before June 3, 2008 for priority consideration.
Interested CRADA collaborators must submit a confidential proposal
summary to the NIAID (attention Percy S. Pan at the address mentioned
below) on or before June 3, 2008 for consideration. Guidelines for
preparing full CRADA proposals will be communicated shortly thereafter
to all respondents with whom initial confidential discussions will have
established sufficient mutual interest. CRADA and PHS License
Applications submitted thereafter may be considered if a suitable CRADA
collaborator or Licensee(s) has not been selected.
ADDRESSES: Questions about licensing opportunities should be addressed
to Peter Soukas, J.D., Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Telephone: (301)
435-4646 ; Facsimile: (301) 402-0220; E-mail: soukasp@mail.nih.gov.
Information about Patent Applications and pertinent information not yet
publicly described can be obtained under the terms of a Confidential
Disclosure Agreement. Respondents interested in licensing the invention
will be required to submit an ``Application for License to Public
Health Service Inventions.''
Depending upon the mutual interests of the Licensee(s) and the
NIAID, a CRADA to collaborate to develop WNV vaccines in humans may
also be negotiated. Proposals and questions about this CRADA
opportunity should be addressed to Percy S. Pan, Technology Development
Associate, Office of Technology Development, NIAID, 6610 Rockledge
Drive, Room 4071, Bethesda, MD 20892-6606, Telephone: (301) 451-3523;
E-mail: panp@niaid.nih.gov. Respondents interested in submitting a
CRADA Proposal should be aware that it may be necessary to secure a
license to the above-mentioned patent rights in order to commercialize
products arising from a CRADA.
SUPPLEMENTARY INFORMATION: WNV has recently emerged in the U.S. and is
considered a significant emerging disease that has embedded itself over
a considerable region of the U.S. WNV infections have been recorded in
humans as well as in different animals. To date, WNV has killed 294
people in the U.S. and caused severe disease in more than 4222 others.
This project is part of NIAID's comprehensive emerging infectious
disease program, which supports research on bacterial, viral, and other
types of disease-causing microbes.
The methods and compositions of this invention provide a means for
prevention of WNV infection by immunization with attenuated,
immunogenic viral vaccines against WNV. The invention involves a
chimeric virus form consisting of parts of WNV and Dengue virus.
Construction of the hybrids and their properties are described in
detail in PNAS, Pletnev AG et al., 2002; 99(5):3036-3041.
The WNV chimeric vaccine does not target the central nervous
system, which would be the case in an infection with wild type WNV. The
vaccine stimulates strong anti-WNV immune responses, even following a
single dose of the vaccine. When injected into mice, the vaccine
protected all of the immunized animals from subsequent exposure to the
New York WNV strain. The vaccine was also effective in primates.
Researchers intend to begin human trials in late 2003.
The WNV vaccine may be used to protect the human population,
particularly the elderly people, and domestic animals from WNV
infection in the affected regions of the U.S. as well as worldwide.
The invention claimed in HHS Reference No. E-357-2001/1-US-02,
``Construction of West Nile Virus and Dengue Virus Chimeras for Use in
a Live Virus Vaccine to Prevent Disease Caused by West Nile Virus'' AG
Pletnev et al.), U.S. Patent Application No. 10/871,775, filed June 18,
2004, is available for exclusive or non-exclusive licensing for
developing a vaccine against WNV for humans or veterinary use in
accordance with 35 U.S.C. 207 and 37 CFR Part 404. NIAID is also
interested in further development of the technology under one or more
CRADAs in the human applications described below.
Under the CRADA the production of WNV vaccines for humans will be
optimized and the vaccine evaluated in a series of clinical studies in
humans as well as initial safety testing in humans. Positive outcomes
of these studies will indicate continued clinical development aimed at
supporting regulatory approval of a product to be labeled for use in
humans. The Public Health Service (PHS) has filed patent applications
both in the U.S. and internationally related to this technology. Notice
of the availability of the patent application for licensing was first
published in the Federal Register on May 2, 2002 (67 FR 22093).
NIAID's principal investigator has extensive experience with live
attenuated vaccines, their production and testing, and clinical trials.
The Collaborator in this endeavor is expected to assist NIAID in
evaluating its current system for producing the WNV chimeras claimed in
the patent applications and to develop and optimize an alternative
production method, if necessary, to manufacture sufficient quantities
of the vaccine for clinical testing in humans and initial safety
studies in humans. The Collaborator must have experience in the
manufacture of live attenuated vaccines according to applicable FDA
guidelines and Points to Consider documents to include Good
Manufacturing Procedures (GMP). In addition, it is expected that the
Collaborator would provide funds to supplement the LID's research
budget for the project and to support the initial human testing.
The capability statement should include detailed descriptions of:
(1) Collaborator's expertise in the production of live attenuated
vaccines, (2) Collaborator's ability to manufacture sufficient
quantities of the vaccine according to FDA guidelines and Points to
Consider documents, (3) the technical expertise of the Collaborator's
principal investigator and laboratory group in preclinical safety
testing (e.g., expertise in in vitro and in vivo toxicity and
pharmacology studies) and initial human safety studies, and (4)
Collaborator's ability to provide adequate funding to support initial
human safety studies required for marketing approval.
Dated: February 25, 2008.
Michael Mowatt,
Director, Office of Technology Development, National Institute of
Allergy and Infectious Diseases, National Institutes of Health.
Dated: February 26, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-4193 Filed 3-4-08; 8:45 am]
BILLING CODE 4140-01-P
