Prospective Grant of Exclusive Patent License: DNA-Based Vaccine for Prevention of Zika Virus Infection, 47537-47538 [2017-21986]
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47537
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total
burden
hours
Forms
Respondents
Advocate Form .................................
Advocate Annual Follow-Up Survey
End of Wave 1 Interview Script .......
End of Wave 1 Feedback Survey ....
End of Wave 2 Interview .................
End of Wave 2 Feedback Survey ....
Technical Assistance Assessment ..
Mentee Pre-Assessment ..................
Mentee Post-Assessment ................
Mentor Feedback Survey .................
Weekly Goal-Setting Guide .............
Mentee Focus Group Script .............
Parent/Guardian
Focus
Group
Script.
Site Coordinator ..............................
Site Coordinator ..............................
Site Coordinator ..............................
Site Coordinator ..............................
Site Coordinator ..............................
Site Coordinator ..............................
Site Coordinator ..............................
Mentee/Program Participant ............
Mentee/Program Participant ............
Mentor .............................................
Mentor .............................................
Mentee/Program Participant ............
Mentee’s Parent/Guardian ..............
10
10
10
10
10
10
10
700
700
700
700
60
60
1
1
1
1
1
1
1
1
1
1
10
1
1
20/60
20/60
1
45/60
1
20/60
25/60
20/60
20/60
15/60
10/60
1
1
3
3
10
8
10
3
4
233
233
175
1166
60
60
Total ..........................................
..........................................................
........................
22
........................
1968
Terry S. Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2017–21983 Filed 10–11–17; 8:45 am]
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and Alcoholism; Notice of Closed
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
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following meetings.
The meetings will be closed to the
public in accordance with the
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as amended. The grant applications and
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and personal information concerning
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Name of Committee: National Institute on
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Date: November 2, 2017.
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Agenda: To review and evaluate grant
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VerDate Sep<11>2014
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Jkt 244001
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Conflict Applications.
Date: November 14, 2017.
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National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Rockville,
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Research Service Awards for Research
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Dated: October 5, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–21989 Filed 10–11–17; 8:45 am]
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PO 00000
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Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: DNA-Based Vaccine for
Prevention of Zika Virus Infection
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Institute of
Allergy and Infectious Diseases (NIAID),
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Commercialization
Patent License to PaxVax, Inc., located
in Redwood City, California, to practice
the inventions embodied in the patent
applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before November
13, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Commercialization Patent
License should be directed to: Dr. Amy
Petrik, Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, 5601 Fishers Lane, Suite 2G,
MSC9804, Rockville, MD 20852–9804,
phone number 301–496–2644, or
petrika@mail.nih.gov.
SUMMARY:
E:\FR\FM\12OCN1.SGM
12OCN1
47538
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
The
following represents the intellectual
property is to be licensed under the
prospective agreement: HHS Ref. No. E–
181–2016/0, including provisional
patent applications 62/396,613 filed
September 19, 2016 entitled ‘‘Zika Virus
Vaccines’’, and all continuing U.S. and
foreign patents/patent applications for
the technology family, to PaxVax Inc.
All rights in these inventions have
been assigned to the Government of the
United States of America.
The prospective Exclusive Patent
License territory may be worldwide and
the field of use may be limited to:
‘‘Development and use of DNA-based
vaccines expressing virus-like particle
antigens comprising Zika virus
membrane and/or envelope proteins for
prevention of Zika virus infection in
humans.’’
Since 2015, Zika virus (ZIKV)
outbreaks have had a significant effect
on global public health. The mosquitoborne disease, which causes several
congenital abnormalities in the
developing fetus, as well as other
neurological disorders in infected
individuals has no approved vaccine to
treat or prevent infection. To address
this critical need, several approaches are
being explored for a vaccine against
ZIKV infection in priority populations
including women of child-bearing age
and their partners.
Many entities, governmental,
academic, and commercial, are actively
pursuing development of ZIKV vaccines
each using a different approach to
address this public health need. The
U.S. Government is coordinating its
vaccine development response to ZIKV
and has published this plan at https://
www.phe.gov/Preparedness/planning/
Pages/zika-white-paper.aspx.
Vaccine development approaches for
ZIKV include but are not limited to
inactivated virus (dead virus), live
attenuated virus (weakened virus),
recombinant viral vectors (weakened
virus with target genes added), and
subunit (portion of a virus) as well as
mRNA- and DNA-based (gene-targeted).
These various strategies provide
multiple redundancies, expanded
choice, and ensure short and long term
maximal benefits to the public.
The subject invention relates to the
use of nucleic acid molecules encoding
Zika virus (ZIKV) proteins that when
introduced in a cell produces
noninfectious virus-like particles (VLPs)
capable of eliciting a protective immune
response against viral infection. More
specifically, the subject vaccine is a
DNA-based candidate encoding a
polypeptide of a ZIKV membrane and
envelope proteins that when expressed
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
results in production of noninfectious
VLPs that generate protective
neutralizing antibodies against ZIKA
infection. The vaccine, which is based
on a similar vaccine developed for the
related West Nile virus, is currently
undergoing clinical trial evaluation. The
subject invention has been advertised in
the Federal Register and published on
12 December 2016.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective Exclusive Patent
License will be royalty bearing and may
be granted unless within thirty (30) days
from the date of this published notice,
the NIAID receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated Exclusive Patent
License. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: October 5, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–21986 Filed 10–11–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institute of General Medical
Sciences; Notice of 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Frm 00093
Fmt 4703
Sfmt 4703
Dated: October 5, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–21990 Filed 10–11–17; 8:45 am]
National Institutes of Health
PO 00000
Panel; Review of Support of Competitive
Research (SCORE) Award Applications.
Date: November 8, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott Chevy Chase,
5520 Wisconsin Avenue, Chevy Chase, MD
20815.
Contact Person: Manas Chattopadhyay,
Ph.D., Scientific Review Officer, Office of
Scientific Review, National Institute of
General Medical Sciences, National Institutes
of Health, Building 45, Room 3An12N, 45
Center Drive, Bethesda, MD 20892, 301–827–
5320, manasc@mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
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Date: November 16, 2017.
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Agenda: To review and evaluate grant
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Place: Hilton Garden Inn Bethesda, 7301
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Contact Person: Robert Horowits, Ph.D.,
Scientific Review Officer, National Institute
of General Medical Sciences, National
Institutes of Health, 45 Center Drive, Room
3An.18, Bethesda, MD 20892–6200, 301–
594–6904, horowitr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
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Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
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Individuals who plan to attend and
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reasonable accommodations, should
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47537-47538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: DNA-Based Vaccine
for Prevention of Zika Virus Infection
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID), an institute of the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
Exclusive Commercialization Patent License to PaxVax, Inc., located in
Redwood City, California, to practice the inventions embodied in the
patent applications listed in the Supplementary Information section of
this notice.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Allergy and Infectious
Diseases' Technology Transfer and Intellectual Property Office on or
before November 13, 2017 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Commercialization
Patent License should be directed to: Dr. Amy Petrik, Technology
Transfer and Patent Specialist, Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852-9804, phone
number 301-496-2644, or petrika@mail.nih.gov.
[[Page 47538]]
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property is to be licensed under the prospective agreement: HHS Ref.
No. E-181-2016/0, including provisional patent applications 62/396,613
filed September 19, 2016 entitled ``Zika Virus Vaccines'', and all
continuing U.S. and foreign patents/patent applications for the
technology family, to PaxVax Inc.
All rights in these inventions have been assigned to the Government
of the United States of America.
The prospective Exclusive Patent License territory may be worldwide
and the field of use may be limited to: ``Development and use of DNA-
based vaccines expressing virus-like particle antigens comprising Zika
virus membrane and/or envelope proteins for prevention of Zika virus
infection in humans.''
Since 2015, Zika virus (ZIKV) outbreaks have had a significant
effect on global public health. The mosquito-borne disease, which
causes several congenital abnormalities in the developing fetus, as
well as other neurological disorders in infected individuals has no
approved vaccine to treat or prevent infection. To address this
critical need, several approaches are being explored for a vaccine
against ZIKV infection in priority populations including women of
child-bearing age and their partners.
Many entities, governmental, academic, and commercial, are actively
pursuing development of ZIKV vaccines each using a different approach
to address this public health need. The U.S. Government is coordinating
its vaccine development response to ZIKV and has published this plan at
https://www.phe.gov/Preparedness/planning/Pages/zika-white-paper.aspx.
Vaccine development approaches for ZIKV include but are not limited
to inactivated virus (dead virus), live attenuated virus (weakened
virus), recombinant viral vectors (weakened virus with target genes
added), and subunit (portion of a virus) as well as mRNA- and DNA-based
(gene-targeted). These various strategies provide multiple
redundancies, expanded choice, and ensure short and long term maximal
benefits to the public.
The subject invention relates to the use of nucleic acid molecules
encoding Zika virus (ZIKV) proteins that when introduced in a cell
produces noninfectious virus-like particles (VLPs) capable of eliciting
a protective immune response against viral infection. More
specifically, the subject vaccine is a DNA-based candidate encoding a
polypeptide of a ZIKV membrane and envelope proteins that when
expressed results in production of noninfectious VLPs that generate
protective neutralizing antibodies against ZIKA infection. The vaccine,
which is based on a similar vaccine developed for the related West Nile
virus, is currently undergoing clinical trial evaluation. The subject
invention has been advertised in the Federal Register and published on
12 December 2016.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective Exclusive Patent License will be royalty
bearing and may be granted unless within thirty (30) days from the date
of this published notice, the NIAID receives written evidence and
argument that establishes that the grant of the license would not be
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated Exclusive Patent License.
Comments and objections submitted to this notice will not be made
available for public inspection and, to the extent permitted by law,
will not be released under the Freedom of Information Act, 5 U.S.C.
552.
Dated: October 5, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-21986 Filed 10-11-17; 8:45 am]
BILLING CODE 4140-01-P
