Government-Owned Inventions; Availability for Licensing, 53886 [2018-23311]
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53886
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Category of respondent
Average time
per response
(in hours)
Total annual
burden hours
Individuals (DARF-Oral) ...................................................................................
711
16
4/60
758
Total ..........................................................................................................
2,844
45,504
........................
3,033
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–23313 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Peter Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Recombinant Respiratory Syncytial
Virus Challenge Strain
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
Description of Technology
RSV is the most important viral agent
of severe respiratory tract disease
worldwide, especially in infants and
young children, and it also causes
severe disease in the elderly and in
immunocompromised individuals.
There are no licensed vaccines or
antivirals suitable for routine use.
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
This invention relates to a reverse
genetics system and cDNA-derived virus
for a contemporary wild-type clinical
isolate of RSV of antigenic subgroup A,
termed RSV strain A/Maryland/001/11,
that was isolated in 2011 from an adult
with respiratory illness. The genomic
sequence was determined. A reverse
genetics system was created encoding a
recombinant, replication competent
RSV that contains a codon-optimized G
ORF, which was done to stabilize the
cDNA for replication in bacteria.
Because this virus was generated by
reverse genetics, it is a ‘‘clean’’ virus
with a well-defined passage history.
Clinical study material of this challenge
virus has been manufactured and is
available for use as an U.S. Food and
Drug Administration (FDA) regulated
Investigational New Drug (IND) in
clinical studies in adult volunteers
within and outside of the United States.
Preliminary clinical data confirmed that
this virus efficiently infects and
replicates in 95% of study participants
pre-selected for pre-existing RSV
antibody titers in the bottom 50% of the
range. The challenge virus causes mild
upper respiratory illness in the majority
of infected participants, typical for RSV
illness in otherwise healthy adults. This
provides a suitable challenge system for
evaluating antivirals, as well as vaccines
for older children and adults. This also
could be used for developing liveattenuated RSV vaccine candidates
based on this contemporary strain, using
the stabilized point mutations,
stabilized codon-deletions, and genedeletions that were previously used in
RSV strain A2.
This invention relates to a reverse
genetics system and the encoded RSV
vaccine challenge strain that infects and
causes disease in RSV-experienced
adults and is available for antiviral and
vaccine research.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications
PO 00000
• Vaccine development
• Viral diagnostics
Frm 00040
Fmt 4703
Sfmt 4703
• Vaccine research
Competitive Advantages
• Ease of manufacture
• Clinical trial material
• Low-cost vaccines
• Intranasal administration/needlefree delivery
Development Stage
• In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–235–2018–0.
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov.
Dated: October 12, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–23311 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
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HUMAN SERVICES
National Institutes of Health
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Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The invention listed below is owned by an agency of the U.S.
Government and is available for licensing to achieve expeditious
commercialization of results of federally-funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301-594-8730;
[email protected]. Licensing information and copies of the patent
applications listed below may be obtained by communicating with the
indicated licensing contact at the Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
Recombinant Respiratory Syncytial Virus Challenge Strain
Description of Technology
RSV is the most important viral agent of severe respiratory tract
disease worldwide, especially in infants and young children, and it
also causes severe disease in the elderly and in immunocompromised
individuals. There are no licensed vaccines or antivirals suitable for
routine use.
This invention relates to a reverse genetics system and cDNA-
derived virus for a contemporary wild-type clinical isolate of RSV of
antigenic subgroup A, termed RSV strain A/Maryland/001/11, that was
isolated in 2011 from an adult with respiratory illness. The genomic
sequence was determined. A reverse genetics system was created encoding
a recombinant, replication competent RSV that contains a codon-
optimized G ORF, which was done to stabilize the cDNA for replication
in bacteria. Because this virus was generated by reverse genetics, it
is a ``clean'' virus with a well-defined passage history. Clinical
study material of this challenge virus has been manufactured and is
available for use as an U.S. Food and Drug Administration (FDA)
regulated Investigational New Drug (IND) in clinical studies in adult
volunteers within and outside of the United States. Preliminary
clinical data confirmed that this virus efficiently infects and
replicates in 95% of study participants pre-selected for pre-existing
RSV antibody titers in the bottom 50% of the range. The challenge virus
causes mild upper respiratory illness in the majority of infected
participants, typical for RSV illness in otherwise healthy adults. This
provides a suitable challenge system for evaluating antivirals, as well
as vaccines for older children and adults. This also could be used for
developing live-attenuated RSV vaccine candidates based on this
contemporary strain, using the stabilized point mutations, stabilized
codon-deletions, and gene-deletions that were previously used in RSV
strain A2.
This invention relates to a reverse genetics system and the encoded
RSV vaccine challenge strain that infects and causes disease in RSV-
experienced adults and is available for antiviral and vaccine research.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as
well as for further development and evaluation under a research
collaboration.
Potential Commercial Applications
Vaccine development
Viral diagnostics
Vaccine research
Competitive Advantages
Ease of manufacture
Clinical trial material
Low-cost vaccines
Intranasal administration/needle-free delivery
Development Stage
In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference No. E-235-2018-0.
Licensing Contact: Peter Soukas, J.D., 301-594-8730;
[email protected].
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize for development of a vaccine for
respiratory or other infections. For collaboration opportunities,
please contact Peter Soukas, J.D., 301-594-8730; [email protected].
Dated: October 12, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-23311 Filed 10-24-18; 8:45 am]
BILLING CODE 4140-01-P
