Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines, 24318-24319 [2018-11257]
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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
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the need for childhood vaccination
products that result in fewer or no
significant adverse reactions; surveying
federal, state, and local programs and
activities related to gathering
information on injuries associated with
the administration of childhood
vaccines, including the adverse reaction
reporting requirements of section 2125
(b) of the PHS Act; advising the
Secretary on the methods of obtaining,
compiling, publishing, and using
credible data related to the frequency
and severity of adverse reactions
associated with childhood vaccines;
consulting on the development or
revision of Vaccine Information
Statements; and recommending to the
Director of the National Vaccine
Program research related to vaccine
injuries which should be conducted to
carry out the VICP.
Agenda: During the June 15, 2018,
meeting, agenda items may include
updates from DICP, Department of
Justice (DOJ), National Vaccine Program
Office (NVPO), Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health) and
Center for Biologics, Evaluation and
Research (Food and Drug
Administration). Information about the
ACCV, a roster of members, the meeting
agenda, as well as past meeting
summaries, is located on the ACCV
website: https://www.hrsa.gov/
advisorycommittees/childhoodvaccines/
index.html. Agenda items are subject to
change as priorities dictate.
Public Participation: Members of the
public will have the opportunity to
provide comments. Oral comments will
be honored in the order they are
requested and may be limited as time
allows. Requests to make oral comments
or provide written comments to the
ACCV should be sent to Annie Herzog
by June 5, 2018. Individuals who plan
to participate and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Annie
Herzog, using the address and phone
number above at least 10 days prior to
the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Clinical Center; Notice of Closed
Meeting
Prospective Grant of Exclusive
License: Production of Monovalent
Live Attenuated Zika Vaccines and
Multivalent Live Attenuated Flavivirus
Vaccines
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors of the NIH Clinical Center.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
CLINICAL CENTER, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors of the NIH Clinical Center Board
meeting.
Date: June 15, 2018.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate reports
and responses to the following Clinic
Center’s Departments: Rehabilitation
Medicine, Bioethics, Critical Care Medicine,
Imaging Sciences, Transfusion Medicine,
Laboratory Medicine, Nursing, and
Pediatrics.
Place: National Institutes of Health,
Building 10, 10 Center Drive, Bethesda, MD
20892.
Contact Person: John I. Gallin, M.D.,
Associate Director for Clinical Research,
Office of Director, NIH Clinical Center, 1
Center Drive, Room 201, Bethesda, MD
20892, 301–827–5428.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Dated: May 18, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–11212 Filed 5–24–18; 8:45 am]
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National Institute of Allergy
and Infectious Diseases, National
Institutes of Health, Public Health
Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The National Institute of
Allergy and Infectious Diseases, 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 practice the inventions
embodied in the Patents and Patent
Applications listed in the Summary
Information section of this notice to to
Fundacao Butantan, having a place of
business in Sao Paulo, Brazil.
DATES: Only written comments and/or
application for a license which are
received by the NIAID Technology
Transfer and Intellectual Property Office
on or before June 25, 2018 will be
considered.
Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated Exclusive
Commercialization Patent License
should be directed to: Peter Soukas,
Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, National Institutes of Health,
5601 Fishers Lane, Suite 6D, Rockville,
MD 20852–9804; Email: ps193c@
nih.gov; Telephone: (301) 496–2644;
Facsimile: (240) 627–3117.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
U.S. Provisional Patent Application
Number 62/307,170, filed March 11,
2016 and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ Whitehead et al., and
PCT Patent Application Number PCT/
US2017/0021989, filed March 11, 2017
and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ Whitehead et al. [HHS
Reference E–118–2016/0]; and U.S. and
foreign patent applications claiming
priority to the aforementioned
applications.
The patent rights in these inventions
have been assigned to the government of
the United States of America.
E:\FR\FM\25MYN1.SGM
25MYN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
The field of use may be limited to
monovalent live attenuated Zika
vaccines and multivalent live attenuated
flavivirus vaccines. The Licensed
Territory may be limited to the United
States of America, Canada, Mexico,
Brazil and Argentina.
Zika virus (ZIKV) is an emerging
infectious disease that was first
identified in 1947, and that has more
recently become a major public health
threat around the world. ZIKV has
recently been shown to cause
devastating neurological damage in
infants and serious complications in
adults in some cases, and may have
other effects that have not yet been
identified or definitively linked to the
virus. There are no treatments or
vaccines for this insidious virus. While
important, current measures for
mosquito control are insufficient in
most settings to prevent the spread of
the virus. Recommendations that
women who live in or travel to endemic
areas avoid pregnancy for long periods
of time are unrealistic, particularly in
contexts where access to reproductive
services is limited, and threaten to leave
those most likely to suffer the
devastating consequences of Zika
without effective protection. There is
therefore urgent need to develop
biomedical interventions in parallel
with ongoing public health efforts
against ZIKV.
No vaccine exists today to prevent
ZIKV infections. The methods and
compositions of this invention provide
a means for prevention of ZIKV
infection by immunization with live
attenuated, immunogenic viral vaccines
against ZIKV and/or Dengue virus.
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.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
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exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, the National
Institute of Allergy and Infectious
Diseases 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 filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive
Commercialization Patent License
Agreement. 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: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–11257 Filed 5–24–18; 8:45 am]
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24319
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Boulevard,
Room 4238, MSC 9550, Bethesda, MD 20892,
301–827–5820, hiromi.ono@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIH
Pathway to Independence Award (K99/R00).
Date: June 25, 2018.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: May 21, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–11220 Filed 5–24–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 on
Drug Abuse Special Emphasis Panel;
Summer Research Education Experience
Programs (R25).
Date: June 21, 2018.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Hiromi Ono, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; SBIR
Phase II ‘‘Analytical Tools for Scholarly
Research Assessment and Decision in the
Biomedical Enterprise’’ (1214, 1217).
Date: May 31, 2018.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
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]]>Agencies
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24318-24319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Production of Monovalent
Live Attenuated Zika Vaccines and Multivalent Live Attenuated
Flavivirus Vaccines
AGENCY: National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, 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 practice the inventions embodied in
the Patents and Patent Applications listed in the Summary Information
section of this notice to to Fundacao Butantan, having a place of
business in Sao Paulo, Brazil.
DATES: Only written comments and/or application for a license which are
received by the NIAID Technology Transfer and Intellectual Property
Office on or before June 25, 2018 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated Exclusive
Commercialization Patent License should be directed to: Peter Soukas,
Technology Transfer and Patent Specialist, Technology Transfer and
Intellectual Property Office, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, 5601 Fishers Lane,
Suite 6D, Rockville, MD 20852-9804; Email: [email protected]; Telephone:
(301) 496-2644; Facsimile: (240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application Number 62/307,170, filed March
11, 2016 and entitled ``Live Attenuated Zika Virus Vaccines,''
Whitehead et al., and PCT Patent Application Number PCT/US2017/0021989,
filed March 11, 2017 and entitled ``Live Attenuated Zika Virus
Vaccines,'' Whitehead et al. [HHS Reference E-118-2016/0]; and U.S. and
foreign patent applications claiming priority to the aforementioned
applications.
The patent rights in these inventions have been assigned to the
government of the United States of America.
[[Page 24319]]
The field of use may be limited to monovalent live attenuated Zika
vaccines and multivalent live attenuated flavivirus vaccines. The
Licensed Territory may be limited to the United States of America,
Canada, Mexico, Brazil and Argentina.
Zika virus (ZIKV) is an emerging infectious disease that was first
identified in 1947, and that has more recently become a major public
health threat around the world. ZIKV has recently been shown to cause
devastating neurological damage in infants and serious complications in
adults in some cases, and may have other effects that have not yet been
identified or definitively linked to the virus. There are no treatments
or vaccines for this insidious virus. While important, current measures
for mosquito control are insufficient in most settings to prevent the
spread of the virus. Recommendations that women who live in or travel
to endemic areas avoid pregnancy for long periods of time are
unrealistic, particularly in contexts where access to reproductive
services is limited, and threaten to leave those most likely to suffer
the devastating consequences of Zika without effective protection.
There is therefore urgent need to develop biomedical interventions in
parallel with ongoing public health efforts against ZIKV.
No vaccine exists today to prevent ZIKV infections. The methods and
compositions of this invention provide a means for prevention of ZIKV
infection by immunization with live attenuated, immunogenic viral
vaccines against ZIKV and/or Dengue virus.
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.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
thirty (30) days from the date of this published notice, the National
Institute of Allergy and Infectious Diseases 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 filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Commercialization Patent
License Agreement. 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: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-11257 Filed 5-24-18; 8:45 am]
BILLING CODE 4140-01-P
