Government-Owned Inventions; Availability for Licensing, 42919-42920 [2018-18397]
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Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
42919
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www.technologyadvice.com/medical/ehr-emr/smart-advisor.
www.texmed.org/EHRTool.
[FR Doc. 2018–18297 Filed 8–23–18; 8:45 am]
BILLING CODE 4150–45–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.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Vince Contreras, Ph.D., 240–669–2823;
vince.contreras@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to receive copies of unpublished patent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.
SUPPLEMENTARY INFORMATION:
Technology description follows.
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Jkt 244001
Prefusion HPIV F Immunogens and
Their Use
Description of Technology: Human
parainfluenza virus (hPIV) is an RNAbased paramyxovirus that causes
respiratory infections in children and
adults. There are four serotypes that can
result in a myriad of diseases of the
respiratory tract including croup,
bronchitis, and pneumonia (Mao et al.,
2012). hPIV is a leading cause of
respiratory tract infection and
hospitalization among children under 5,
only surpassed by the respiratory
syncytial virus (RSV). Currently, there
are limited treatment options and no
approved vaccines. Recently, studies
showed that a large proportion of
neutralizing antibodies preferentially
recognize exposed epitopes in the
prefusion conformation of the RSV F
protein, which together with other
evidence suggests that creation of
stabilized prefusion F protein
immunogens might be a universal
strategy to develop vaccine candidates
for inducing protective immune
responses in RSV and other related
viruses, such as hPIV.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases created
immunogenic PIV fusion (F)
glycoproteins for types 1,2,3 and 4
(hPIV1, hPIV2, hPIV3 and hPIV4) that
have been modified to stabilize the
prefusion conformation.
These stabilized prefusion F
immunogens, especially hPIV3, induced
high titer neutralizing responses in mice
and rhesus macaques, and should thus
serve as promising candidates for the
prevention of PIV infection in humans.
This technology is available for
licensing for commercial development
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in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• hPIV vaccines for people of all ages;
• Specific focus on the elderly and
young children.
Competitive Advantages:
• Use as a multivalent hPIV vaccine;
• Use in combination with influenza
or RSV vaccine compositions;
• hPIV3 neutralizing titers induced in
both mice and rhesus macaques were
substantially higher than the highest
PIV3 neutralizing titers observed in a
cohort of over 100 humans.
Development Stage:
• In vivo testing (primates and mice).
Inventors: Peter Kwong (NIAID), GwoYu Chuang (NIAID), Kai Xu
(NIAID),Tongqing Zhou (NIAID),
Yaroslav Tsybovsky (Leidos Biomedical
Research, Inc), Aliaksandr Druz
(NIAID), Antonio Lanzavecchia
(Institute for Research in Biomedicine),
Davide Corti (Institute for Research in
Biomedicine), Guillaume BE StewartJones (NIAID), Baoshan Zhang (NIAID),
Yongping Yang (NIAID), Paul Thomas
(NIAID), John Mascola (NIAID), Li Ou
(NIAID), Wing-pui Kong (NIAID).
Intellectual Property: HHS Reference
Number E–215–2016 includes U.S.
Provisional Patent Application Number
62/412,699 filed 10/25/2016 and PCT
Application Number PCT/US2017/
058322 filed 10/25/2017 (pending).
Related Intellectual Property: HHS
Reference Number: E–064–2016.
Licensing Contact: Vince Contreras,
Ph.D., 240–669–2823; vince.contreras@
nih.gov.
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42920
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
Dated: August 10, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–18397 Filed 8–23–18; 8:45 am]
BILLING CODE 4140–01–P
ADVISORY COUNCIL ON HISTORIC
PRESERVATION
Notice of Issuance of Program
Comment To Exempt Consideration of
Effects to Rail Properties Within Rail
Rights-of-Way
Advisory Council on Historic
Preservation.
ACTION: Program Comment issued to
exempt consideration of effects to rail
properties within rail rights-of-way.
AGENCY:
The Advisory Council on
Historic Preservation (‘‘ACHP’’) issued a
Program Comment to exempt
consideration of effects to rail properties
within rail rights-of-way at the request
of the U.S. Department of
Transportation to accelerate the review
of these undertakings under Section 106
of the National Historic Preservation Act
and to meet the requirement of Section
11504 of the Fixing America’s Surface
Transportation Act. The Program
Comment can be used by any federal
agency with responsibility to consider
the effects of undertakings within rail
rights-of-way. Federal agencies using
the Program Comment may fulfill their
Section 106 responsibilities for the
relevant undertakings by implementing
the terms of this comment, which
include identifying those activities that
meet the conditions in Appendix A and
opting into the process to identify
excluded historic rail properties and
seek further streamlining of the review
process under the property-based
approach.
SUMMARY:
The Program Comment was
issued by the ACHP on August 17, 2018.
ADDRESSES: Address all questions
concerning the Program Comment to
Kelly Y. Fanizzo, Office of General
Counsel, Advisory Council on Historic
Preservation, 401 F Street NW, Suite
308, Washington, DC 20001–2637. You
may submit questions through
electronic mail to: kfanizzo@achp.gov.
FOR FURTHER INFORMATION CONTACT:
Kelly Y. Fanizzo, (202) 517–0193,
kfanizzo@achp.gov.
SUPPLEMENTARY INFORMATION: Section
106 of the National Historic
Preservation Act (‘‘NHPA’’), as
amended, 54 U.S.C. 306108 (‘‘Section
106’’), requires federal agencies to take
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DATES:
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into account the effects of undertakings
they carry out, license, permit, or fund
to historic properties and provide the
Advisory Council on Historic
Preservation (‘‘ACHP’’) a reasonable
opportunity to comment with regard to
such undertakings. The ACHP has
issued the regulations that set forth the
process through which federal agencies
comply with these responsibilities.
Those regulations are codified under 36
CFR part 800 (‘‘Section 106
regulations’’).
Under Section 800.14(e) of those
regulations, federal agencies can request
the ACHP to issue a ‘‘Program
Comment’’ on a particular category of
undertakings in lieu of conducting
reviews for each individual undertaking
in the category. An agency can meet its
Section 106 responsibilities with regard
to the effects of those undertakings by
implementing an applicable Program
Comment that has been issued by the
ACHP.
I. Background
At the request of the U.S. Department
of Transportation (‘‘USDOT’’), the
ACHP has issued a Program Comment
that provides new efficiencies in the
Section 106 review for undertakings
with the potential to affect historic rail
properties within railroad and rail
transit rights-of-way (‘‘rail ROW’’).
Section 11504 of the Fixing America’s
Surface Transportation Act (‘‘FAST
Act’’) (49 U.S.C. 24202), enacted on
December 4, 2015, mandated the
development of a Section 106
exemption for ‘‘railroad rights-of-way.’’
The FAST Act required that ‘‘the
Secretary [of the USDOT] shall submit
a proposed exemption of railroad rightsof-way from the review under section
306108 of title 54 to the [ACHP] for
consideration, consistent with the
exemption for interstate highways
approved on March 10, 2005 (70 FR
11928).’’ The FAST Act continued that,
‘‘Not later than 180 days after the date
on which the Secretary submits the
proposed exemption . . . to the
Council, the Council shall issue a final
exemption of railroad rights-of-way
from review under chapter 3061 of title
54 consistent with the exemption for
interstate highways approved on March
10, 2005 (70 FR 11928).’’ While the
Section 106 regulations provide the
process and criteria for development of
program alternatives, the FAST Act
modified the timeframe and directed
agency actions.
The ACHP worked closely with the
Federal Railroad Administration
(‘‘FRA’’), the Federal Transit
Administration (‘‘FTA’’), the Federal
Highway Administration (‘‘FHWA’’),
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Fmt 4703
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and the Office of Policy Development,
Strategic Planning, and Performance
within the Office of the Secretary,
USDOT (‘‘OST–P’’); representatives
from the railroad and rail transit
industries; and historic preservation
stakeholders to develop the final
Section 106 program alternative for rail
ROW. The ACHP communicated
extensively with the staff of the Senate
Committee on Commerce, Science, and
Transportation (‘‘Senate Committee’’) as
well in developing this program
alternative. The ACHP recommended
incorporating the originally proposed
exemption within a Program Comment
to better achieve the intent and purpose
of the FAST Act and meet the needs of
the various stakeholders.
The Program Comment is the product
of consultation and careful review. The
USDOT and FRA conducted outreach
on the preliminary exemption concept
and early drafts prior to submitting a
formal request to the ACHP in July
2017. The ACHP in turn published the
draft Program Comment in the Federal
Register (82 FR 54390, November 17,
2017), and hosted additional meetings
with industry and preservation
representatives in 2018. Recognizing the
complexity of the issues to be addressed
and wanting to ensure the final product
met the statutory requirement of the
FAST Act to be consistent with the
interstate highway exemption, the staff
for the Senate Committee extended the
deadline for the final issuance of the
Program Comment. The final Program
Comment takes into account the many
significant comments and questions
raised by various stakeholders over the
course of its development and
represents the collective work of the
ACHP, USDOT (inclusive of FRA, FTA,
FHWA, and OST–P), and the Senate
Committee staff to ensure that it meets
the FAST Act requirement.
The Program Comment is comprised
of two major parts: (1) An activity-based
approach, and (2) a property-based
approach. The activity-based approach
provides a list of activities in Appendix
A for which, when the specific
conditions are met, no further Section
106 review is required. Based on the
past experience of USDOT Operating
Administrations (‘‘USDOT OAs’’),
undertakings limited to the activities
specified in Appendix A have typically
resulted in effects to historic properties
that are either minimal or not adverse.
The property-based approach
establishes a process whereby project
sponsors can opt to work with the
relevant USDOT OA and stakeholders to
develop a list of excluded historic rail
properties that would remain subject to
Section 106 review, and exempt from
E:\FR\FM\24AUN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42919-42920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18397]
-----------------------------------------------------------------------
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: Vince Contreras, Ph.D., 240-669-2823;
[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.
Prefusion HPIV F Immunogens and Their Use
Description of Technology: Human parainfluenza virus (hPIV) is an
RNA-based paramyxovirus that causes respiratory infections in children
and adults. There are four serotypes that can result in a myriad of
diseases of the respiratory tract including croup, bronchitis, and
pneumonia (Mao et al., 2012). hPIV is a leading cause of respiratory
tract infection and hospitalization among children under 5, only
surpassed by the respiratory syncytial virus (RSV). Currently, there
are limited treatment options and no approved vaccines. Recently,
studies showed that a large proportion of neutralizing antibodies
preferentially recognize exposed epitopes in the prefusion conformation
of the RSV F protein, which together with other evidence suggests that
creation of stabilized prefusion F protein immunogens might be a
universal strategy to develop vaccine candidates for inducing
protective immune responses in RSV and other related viruses, such as
hPIV.
Researchers at the Vaccine Research Center (VRC) of the National
Institute of Allergy and Infectious Diseases created immunogenic PIV
fusion (F) glycoproteins for types 1,2,3 and 4 (hPIV1, hPIV2, hPIV3 and
hPIV4) that have been modified to stabilize the prefusion conformation.
These stabilized prefusion F immunogens, especially hPIV3, induced
high titer neutralizing responses in mice and rhesus macaques, and
should thus serve as promising candidates for the prevention of PIV
infection in humans.
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:
hPIV vaccines for people of all ages;
Specific focus on the elderly and young children.
Competitive Advantages:
Use as a multivalent hPIV vaccine;
Use in combination with influenza or RSV vaccine
compositions;
hPIV3 neutralizing titers induced in both mice and rhesus
macaques were substantially higher than the highest PIV3 neutralizing
titers observed in a cohort of over 100 humans.
Development Stage:
In vivo testing (primates and mice).
Inventors: Peter Kwong (NIAID), Gwo-Yu Chuang (NIAID), Kai Xu
(NIAID),Tongqing Zhou (NIAID), Yaroslav Tsybovsky (Leidos Biomedical
Research, Inc), Aliaksandr Druz (NIAID), Antonio Lanzavecchia
(Institute for Research in Biomedicine), Davide Corti (Institute for
Research in Biomedicine), Guillaume BE Stewart-Jones (NIAID), Baoshan
Zhang (NIAID), Yongping Yang (NIAID), Paul Thomas (NIAID), John Mascola
(NIAID), Li Ou (NIAID), Wing-pui Kong (NIAID).
Intellectual Property: HHS Reference Number E-215-2016 includes
U.S. Provisional Patent Application Number 62/412,699 filed 10/25/2016
and PCT Application Number PCT/US2017/058322 filed 10/25/2017
(pending).
Related Intellectual Property: HHS Reference Number: E-064-2016.
Licensing Contact: Vince Contreras, Ph.D., 240-669-2823;
[email protected].
[[Page 42920]]
Dated: August 10, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-18397 Filed 8-23-18; 8:45 am]
BILLING CODE 4140-01-P
