Government-Owned Inventions; Availability for Licensing, 17559-17560 [2018-08244]
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17559
Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
the NIH NeuroBioBank must continue
completing the NIH NeuroBioBank
Tissue Access Request Form. The
primary use of the information collected
by this instrument is to document, track,
monitor, and evaluate the appropriate
use of the NIH NeuroBioBank resources,
as well as to notify stakeholders of
updates, corrections or changes to the
system.
OMB approval is requested for 3
years. There are no costs to respondents’
other than their time. The total
estimated annualized burden hours are
56.
07/31/2018, EXTENSION, National
Institute of Mental Health, National
Institutes of Health (NIH).
Need and Use of Information
Collection: This request serves as notice
that the National Institute of Mental
Health plans to continue supporting the
research community studying
neurological, developmental, and
psychiatric disorders by coordinating
access to human post-mortem brain
tissue and related biospecimens stored
by our federation of networked brain
and tissue repositories known as the
NIH NeuroBioBank. To facilitate this
process, researchers wishing to obtain
brain tissue and biospecimens stored by
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: NIH
NeuroBioBank Tissue Access Request
Form, 0925–0723, Expiration date
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Instrument type
Type of respondents
NIH NeuroBioBank Tissue Access Request Form
Researchers .................
225
1
15/60
56
Total ...............................................................
.......................................
225
225
........................
56
Dated: April 12, 2018.
Melba O. Rojas,
Project Clearance Liaison, National Institute
of Mental Health, National Institutes of
Health.
SUPPLEMENTARY INFORMATION:
Technology description follows.
[FR Doc. 2018–08243 Filed 4–19–18; 8:45 am]
Description of Technology
BILLING CODE 4140–01–P
An effective universal influenza
vaccine would eliminate the uncertain
and costly process of seasonal influenza
vaccine development each year.
Researchers at the National Institute of
Allergy and Infectious Diseases (NIAID)
are developing immunogens which
elicit neutralizing antibodies to the
highly conserved stem region of the
influenza viral protein hemagglutinin.
By targeting this highly conserved
region, which is nearly identical in
various strains of influenza virus, these
immunogens could train the immune
system to defend against a wide variety
of influenza strains including pandemic
strains derived from animal reservoirs.
This vaccine candidate employs a
protein nanoparticle platform to display
portions of the highly conserved stem
region of the group 1 hemagglutinin
(HA) viral surface protein in its native,
trimeric conformation. Animal studies
have shown that the HA stem region
trimers displayed on a nanoparticle are
more immunogenic compared to HA
stem region trimers alone.
Immunization of mice and ferrets with
an H1N1 nanoparticle HA stem
immunogen conferred protection from a
lethal dose of H5N1 virus.
NIAID is continuing development of
these vaccine candidates through
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.
SUMMARY:
Dr.
Amy Petrik, 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
FOR FURTHER INFORMATION CONTACT:
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Stabilized Influenza Hemagglutinin
Stem Region Trimers and Uses Thereof
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animal studies and moving toward
clinical evaluation.
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
• Universal influenza vaccine
Competitive Advantages
• Nucleic acid or recombinant proteinbased vaccine
• Increased ease of production relative
to current seasonal influenza vaccines
Development Stage
• Preclinical, animal data available
Inventors: John R. Mascola, Jeffrey C.
Boyington, Hadi M. Yassine, Peter D.
Kwong, Barney S. Graham, Masaru
Kanekiyo (all from NIAID).
Publications: Yassine, H.M., et al.
(2015) Hemagglutinin-stem
nanoparticles generate heterosubtypic
influenza protection. Nature Medicine
21: 1065–1070. [PMID: 26301691]
Intellectual Property: HHS Reference
Number E–066–2014 includes U.S.
Patent Application No. 15/13,265 filed
November 22, 2016 (Pending); Canada
Patent Application No. 2,950,085 filed
May 27, 2015 (Pending); China Patent
Application No. 201580041202.3 filed
January 24, 2017 (Pending); Europe
Patent Application No. 15727824.3 filed
December 23, 2016 (Pending); India
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20APN1
17560
Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
Patent Application No. 201617042607
filed December 14, 2016 (Pending).
Related Intellectual Property: HHS
Reference Number E–293–2011.
Licensing Contact: Dr. Amy Petrik,
240–627–3721; amy.petrik@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 influenza monoclonal
antibody technologies. For collaboration
opportunities, please contact Dr. Amy
Petrik, 240–627–3721; amy.petrik@
nih.gov.
Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–08244 Filed 4–19–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0185]
Cooperative Research and
Development Agreement: Safe
Parameters for Ice Operations
Coast Guard, DHS.
Notice of intent; request for
comments.
AGENCY:
ACTION:
The Coast Guard is
announcing its intent to enter into a
Cooperative Research and Development
Agreement (CRADA) with W.L. GORE
and Associates Inc. (GORE) to conduct
insulation value testing for the Coast
Guard’s Maritime Cold Weather Suit
System (MCWSS) in the air instead of
the water, which the system was
designed for. While the Coast Guard is
currently considering partnering with
GORE, we are soliciting public comment
on the possible nature of and
participation of other parties in the
proposed CRADA. In addition, the Coast
Guard also invites other potential nonFederal participants, who have the
interest and capability to bring similar
contributions to this type of research, to
consider submitting proposals for
consideration in similar CRADAs.
DATES: Comments must be submitted to
the online docket via https://
www.regulations.gov on or before May
21, 2018.
Synopses of proposals regarding
future CRADAs must reach the Coast
Guard (see FOR FURTHER INFORMATION
CONTACT) on or before May 21, 2018.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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17:44 Apr 19, 2018
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Submit comments online at
https://www.regulations.gov following
website instructions.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice or
wish to submit proposals for future
CRADAs, contact LT Ryan Huebner,
Project Official, Surface Branch, U.S.
Coast Guard Research and Development
Center, 1 Chelsea Street, New London,
CT 06320, telephone 860–271–2815,
email Ryan.P.Huebner@uscg.mil.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Public Participation and Request for
Comments
We request public comments on this
notice. Although we do not plan to
respond to comments in the Federal
Register we will respond directly to
commenters and may modify our
proposal in light of comments.
Comments should be marked with
docket number USCG–2018–0185 and
should provide a reason for each
suggestion or recommendation. You
should provide personal contact
information so that we can contact you
if we have questions regarding your
comments; but please note that all
comments will be posted to the online
docket without change and that any
personal information you include can be
searchable online (see the Federal
Register Privacy Act notice regarding
our public dockets, 73 FR 3316, Jan. 17,
2008). We also accept anonymous
comments.
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the Coast
Guard (see FOR FURTHER INFORMATION
CONTACT). Documents mentioned in this
notice, and all public comments, are in
our online docket at https://
www.regulations.gov and can be viewed
by following that website’s instructions.
Additionally, if you go to the online
docket and sign up for email alerts, you
will be notified when comments are
posted or a final rule is published.
If desired, submit detailed proposals
for future CRADAs directly to the Coast
Guard (see FOR FURTHER INFORMATION
CONTACT).
Discussion
CRADAs are authorized under 15
U.S.C. 3710(a).1 A CRADA promotes the
transfer of technology to the private
1 The statute confers this authority on the head of
each Federal agency. The Secretary of DHS’s
authority is delegated to the Coast Guard and other
DHS organizational elements by DHS Delegation
No. 0160.1, para. II.B.34.
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Sfmt 4703
sector for commercial use, as well as
specified research or development
efforts that are consistent with the
mission of the Federal parties to the
CRADA. The Federal party or parties
agree with one or more non-Federal
parties to share research resources, but
the Federal party does not contribute
funding.
CRADAs are not procurement
contracts. Care is taken to ensure that
CRADAs are not used to circumvent the
contracting process. CRADAs have a
specific purpose and should not be
confused with procurement contracts,
grants, and other type of agreements.
Under the proposed CRADA, the R&D
Center will collaborate with one nonFederal participant. Together, the R&D
Center and the non-Federal participant
will conduct thermo conductive tests on
the Coast Guard’s MWCSS in various
environmental scenarios to determine
the system’s insulation properties to be
used to create safe parameters for
personnel wearing the MWCSS during
Ice Rescue missions.
We anticipate that the Coast Guard’s
contributions under the proposed
CRADA will include the following:
(1) Provide appropriate staff with
pertinent expertise to take the lead in
accomplishing the required tasks;
(2) Provide information regarding the
ensemble items and parameters needed
for creating the test plan;
(3) Provide all support resources,
including travel, for Coast Guard staff
that supports this CRADA;
(4) Obtain, transport and provide all
of the ensemble items to be used during
the testing;
(5) Provide personnel support to nonFederal participant to assist with setting
up and execute testing in accordance
with the agreed upon test plan;
(6) Work with non-Federal participant
to develop a Final Report, which will
document the methodologies, findings,
conclusions, and recommendations of
this CRADA work.
We anticipate that the non-Federal
participants’ contributions under the
proposed CRADA will include the
following:
(1) Provide appropriate staff with
pertinent expertise to support the above
mentioned tasks;
(2) Provide all necessary facility
resources needed to conduct insulation
value testing;
(3) Provide technical approach for the
test plan;
(4) Lead the testing runs of the Coast
Guard’s MWCSS in accordance with the
agreed upon test plan;
(5) Provide test data upon completion
of testing.
The Coast Guard reserves the right to
select for CRADA participants all, some,
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17559-17560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08244]
-----------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: Dr. Amy Petrik, 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 Influenza Hemagglutinin Stem Region Trimers and Uses Thereof
Description of Technology
An effective universal influenza vaccine would eliminate the
uncertain and costly process of seasonal influenza vaccine development
each year. Researchers at the National Institute of Allergy and
Infectious Diseases (NIAID) are developing immunogens which elicit
neutralizing antibodies to the highly conserved stem region of the
influenza viral protein hemagglutinin. By targeting this highly
conserved region, which is nearly identical in various strains of
influenza virus, these immunogens could train the immune system to
defend against a wide variety of influenza strains including pandemic
strains derived from animal reservoirs.
This vaccine candidate employs a protein nanoparticle platform to
display portions of the highly conserved stem region of the group 1
hemagglutinin (HA) viral surface protein in its native, trimeric
conformation. Animal studies have shown that the HA stem region trimers
displayed on a nanoparticle are more immunogenic compared to HA stem
region trimers alone. Immunization of mice and ferrets with an H1N1
nanoparticle HA stem immunogen conferred protection from a lethal dose
of H5N1 virus.
NIAID is continuing development of these vaccine candidates through
animal studies and moving toward clinical evaluation.
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
Universal influenza vaccine
Competitive Advantages
Nucleic acid or recombinant protein-based vaccine
Increased ease of production relative to current seasonal
influenza vaccines
Development Stage
Preclinical, animal data available
Inventors: John R. Mascola, Jeffrey C. Boyington, Hadi M. Yassine,
Peter D. Kwong, Barney S. Graham, Masaru Kanekiyo (all from NIAID).
Publications: Yassine, H.M., et al. (2015) Hemagglutinin-stem
nanoparticles generate heterosubtypic influenza protection. Nature
Medicine 21: 1065-1070. [PMID: 26301691]
Intellectual Property: HHS Reference Number E-066-2014 includes
U.S. Patent Application No. 15/13,265 filed November 22, 2016
(Pending); Canada Patent Application No. 2,950,085 filed May 27, 2015
(Pending); China Patent Application No. 201580041202.3 filed January
24, 2017 (Pending); Europe Patent Application No. 15727824.3 filed
December 23, 2016 (Pending); India
[[Page 17560]]
Patent Application No. 201617042607 filed December 14, 2016 (Pending).
Related Intellectual Property: HHS Reference Number E-293-2011.
Licensing Contact: Dr. Amy Petrik, 240-627-3721;
[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 influenza monoclonal antibody
technologies. For collaboration opportunities, please contact Dr. Amy
Petrik, 240-627-3721; [email protected].
Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-08244 Filed 4-19-18; 8:45 am]
BILLING CODE 4140-01-P
