Government-Owned Inventions; Availability for Licensing, 39454 [2018-17036]
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39454
Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17026 Filed 8–8–18; 8:45 am]
BILLING CODE 4164–01–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:
Amy F. Petrik, Ph.D., 240–627–3721,
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application 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to receive copies of unpublished patent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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:11 Aug 08, 2018
Jkt 244001
SUPPLEMENTARY INFORMATION:
Technology description follows.
Stabilized Group 2 Influenza
Hemagglutinin Stem Region Trimers
and Uses Thereof
Description of Technology:
Researchers at the Vaccine Research
Center of the National Institute of
Allergy and Infectious Diseases (NIAID)
have designed influenza vaccine
candidates based on group 2 influenza
hemagglutinin (HA) proteins. These
group 2 HA proteins were engineered to
remove the highly variable head region
and stabilize the remaining stem region.
The researchers then fused the
engineered group 2 HA stabilized stem
with a ferritin subunit. The resulting
fusion protein can self-assemble into
nanoparticles which display group 2 HA
stem domain trimers on their surface.
These immunogens elicit crossreactive antibodies to group 2 influenza
viruses and could be used in
combination with group 1 HA stemferritin immunogens as a universal
influenza vaccine. Interestingly, a recent
study by Andrews et al., Sci. Immunol.
2, eaan2676 (2017), suggests that crossreactive group 1/group 2 HA stem
antibodies may be more likely to be
elicited in humans by a group 2 HA
immunogen.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• Use as a broadly protective influenza
vaccine
Competitive Advantages:
• Elicits antibodies to both group 1 and
group 2 influenza A viruses
• Nucleic acid or recombinant proteinbased vaccine
• Increased ease of production
compared to current seasonal
influenza vaccines
Development Stage:
• In vivo (animal studies)
Inventors: Jeffrey C. Boyington,
Barney S. Graham, John R. Mascola,
Hadi M. Yassine, Syed M. Moin,
Lingshu Wang, Kizzmekia S. Corbett,
Masaru Kanekiyo (all from NIAID).
Intellectual Property: HHS Reference
Number E–228–2016 includes U.S.
Provisional 62/383,267 filed 2
September 2016 and PCT Patent
Application No. PCT/US2017/049894
filed 1 September 2017 (pending).
Related Intellectual Property: HHS
Reference Number E–293–2011.
Licensing Contact: Dr. Amy Petrik,
240–627–3721; amy.petrik@nih.gov.
PO 00000
Frm 00053
Fmt 4703
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Dated: July 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am]
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SUMMARY:
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Page 39454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17036]
-----------------------------------------------------------------------
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: Amy F. Petrik, Ph.D., 240-627-3721,
[email protected]. Licensing information and copies of the U.S. patent
application 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.
Stabilized Group 2 Influenza Hemagglutinin Stem Region Trimers and Uses
Thereof
Description of Technology: Researchers at the Vaccine Research
Center of the National Institute of Allergy and Infectious Diseases
(NIAID) have designed influenza vaccine candidates based on group 2
influenza hemagglutinin (HA) proteins. These group 2 HA proteins were
engineered to remove the highly variable head region and stabilize the
remaining stem region. The researchers then fused the engineered group
2 HA stabilized stem with a ferritin subunit. The resulting fusion
protein can self-assemble into nanoparticles which display group 2 HA
stem domain trimers on their surface.
These immunogens elicit cross-reactive antibodies to group 2
influenza viruses and could be used in combination with group 1 HA
stem-ferritin immunogens as a universal influenza vaccine.
Interestingly, a recent study by Andrews et al., Sci. Immunol. 2,
eaan2676 (2017), suggests that cross-reactive group 1/group 2 HA stem
antibodies may be more likely to be elicited in humans by a group 2 HA
immunogen.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
Potential Commercial Applications:
Use as a broadly protective influenza vaccine
Competitive Advantages:
Elicits antibodies to both group 1 and group 2 influenza A
viruses
Nucleic acid or recombinant protein-based vaccine
Increased ease of production compared to current seasonal
influenza vaccines
Development Stage:
In vivo (animal studies)
Inventors: Jeffrey C. Boyington, Barney S. Graham, John R. Mascola,
Hadi M. Yassine, Syed M. Moin, Lingshu Wang, Kizzmekia S. Corbett,
Masaru Kanekiyo (all from NIAID).
Intellectual Property: HHS Reference Number E-228-2016 includes
U.S. Provisional 62/383,267 filed 2 September 2016 and PCT Patent
Application No. PCT/US2017/049894 filed 1 September 2017 (pending).
Related Intellectual Property: HHS Reference Number E-293-2011.
Licensing Contact: Dr. Amy Petrik, 240-627-3721;
[email protected].
Dated: July 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-17036 Filed 8-8-18; 8:45 am]
BILLING CODE 4140-01-P
