Prospective Grant of Exclusive License: Production of Attenuated Respiratory Syncytial Virus Vaccines, 8728-8729 [2016-03486]
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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
substantial revision to the ADVERSE
REACTIONS or other labeling sections.
3. Section VI.C of the guidance states
that applicants are encouraged to
include the following statement in
promotional materials for the drug.
‘‘[DRUGNAME] reduces blood
pressure, which reduces the risk of fatal
and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions. Control of high blood
pressure should be part of
comprehensive cardiovascular risk
management, including, as appropriate,
lipid control, diabetes management,
antithrombotic therapy, smoking
cessation, exercise, and limited sodium
intake. Many patients will require more
than one drug to achieve blood pressure
goals.’’
The inclusion of this statement in the
promotional materials for the drug
would be exempt from OMB review
based on 5 CFR 1320.3(c)(2), which
states that the public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public
is not included within the definition of
collection of information.
FDA requests public comments on the
information collection provisions
described set forth in the following
table:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Hours per
response
Total hours
Submission to Docket No. FDA–2008–D–0150 ..................
Cardiovascular Outcome Claim Supplement Submission ...
1
1
1
1
1
1
10
20
10
20
Total ..............................................................................
........................
........................
........................
........................
30
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03543 Filed 2–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Production of Attenuated
Respiratory Syncytial Virus Vaccines
National Institutes of Health.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National Institute
of Allergy and Infectious Diseases
(NIAID), National Institutes of Health
(NIH), Department of Health and Human
Services (HHS), is contemplating the
grant of a an exclusive license to
practice the following invention as
embodied in the following patent
applications: (1) E–194–1999/0, Collins
et al., ‘‘Production of Attenuated
Respiratory Syncytial Virus Vaccines
Involving Modification of M2 ORF2’’,
U.S. Provisional Patent Application
Number 60/143,097, filed July 9, 1999,
PCT Patent Application Number PCT/
US2000/18534, filed July 7, 2000, U.S.
Patent Application Number 09/611,829
(now U.S. Patent Number 6,713,066),
and U.S. Patent Application Number 11/
011,502 (now U.S. Patent Number
7,485,440), (2) E–135–2010/0, Collins et
al., ‘‘Genetically Stable Live Attenuated
Vaccine for Respiratory Syncytial Virus
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:03 Feb 19, 2016
Jkt 238001
(RSV) with an Attenuation and
Temperature Sensitive Phenotype
Conferred by an Amino Acid Deletion’’,
U.S. Provisional Patent Application
Number 61/624,010, filed April 13,
2012, PCT Patent Application Number
PCT/US2013/030836, filed March 13,
2013, United States Patent Application
Number 14/394,226, filed October 13,
2014, European Patent Application
Number 13712641.3, filed March 13,
2013, (3) E–216–2014/0, Collins et al.,
‘‘Versions of Respiratory Syncytial Virus
(RSV) Vaccine Candidate LID Delta M2–
2 with Increased Attenuation’’, U.S.
Provisional Patent Application Number
62/266,199, filed December 11, 2015, (4)
E–241–2014/0, Collins et al., ‘‘Improved
RSV F Protein for Expression from a
Heterologous Vector’’, U.S. Provisional
Patent Application Number 62/105,667,
filed January 20, 2015, PCT Patent
Application Number PCT/US2016/
014154, filed January 20, 2016, and (5)
E–037–2016/0, Collins et al.,
‘‘Attenuated RSV Vaccine Strains in
which the NS1 and/or NS2 Genes have
been Shifted to Promoter-Distal
Positions’’, U.S. Provisional Patent
Application Number 62/266,206, filed
December 11, 2015, to Sanofi Pasteur,
Inc., having a place of business in
Swiftwater, Pennsylvania, U.S.A. The
patent rights in this invention have been
assigned to the United States of
America.
Only written comments and/or
application for a license which are
received by the National Institute of
Allergy and Infectious Diseases,
Technology Transfer and Intellectual
Property Office on or before March 8,
2016. will be considered.
DATES:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Peter Soukas, Senior Technology
Licensing Specialist, Technology
Transfer and Intellectual Property
Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Suite 6D, Rockville, MD 20852–9804,
Tel: (301) 594–8730 or email: ps193c@
nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Respiratory syncytial virus (RSV) is the
most important cause of viral acute
lower respiratory infection (ALRI) in
infants and children worldwide and is
responsible for over 30 million new
ALRI episodes worldwide and up to
199,000 deaths in children under five
(5) years old. In the United States, the
virus infects nearly all children at least
once by the age of two (2) and is the
most common cause of bronchiolitis and
infant pneumonia, causing up to
125,000 hospitalizations of children
each year. RSV disease burden is less
understood in the developing world, but
available data indicates that the virus
causes a significant proportion of
childhood ALRI in these parts of the
world, particularly in the first months of
life. The drug palivizumab (Synagis) can
help prevent RSV disease in high risk
infants, but it cannot treat or cure
already-serious RSV infection. No
vaccine exists today to prevent RSV due
to an incomplete understanding of the
body’s immune response to the virus,
which has challenged and delayed RSV
vaccine development efforts.
The methods and compositions of this
invention provide a means for
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
prevention of RSV and/or parainfluenza
virus (PIV) infection by immunization
with live attenuated, immunogenic viral
vaccines against RSV and/or PIV.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective exclusive license may be
granted unless, within fifteen (15) days
from the date of this published Notice,
NIH 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.
The field of use may be limited to live
attenuated vaccines against respiratory
syncytial virus (RSV) and/or
parainfluenza virus (PIV) infections in
humans.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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: February 16, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, NIAID.
[FR Doc. 2016–03486 Filed 2–19–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK Cooperative
Hematology Specialized Core Centers.
VerDate Sep<11>2014
19:03 Feb 19, 2016
Jkt 238001
Date: March 14–15, 2016
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Carol J. Goter-Robinson,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 748, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7791, goterrobinsonc@
extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Mouse Metabolic
Phenotyping Centers Consortium.
Date: March 14–15, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
755, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799, yangj@
extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; R24 Molecular Basis
of Diabetic Complications.
Date: March 23, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To provide concept review of
proposed grant applications.
Place: National Institutes of Health,
Building 38, 8600 Rockville Pike, Bethesda,
MD 20892.
Contact Person: Robert Wellner, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–4721,
rw175w@nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK Ancillary
Studies (R01).
Date: March 24, 2016.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
755, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799, yangj@
extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Ancillary Studies in
Liver Diseases.
Date: April 4, 2016.
Time: 4:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
8729
Contact Person: Maria E. Davila-Bloom,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 758, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7637, davila-bloomm@
extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; R24 Review.
Date: April 8, 2016.
Time: 4:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Barbara A. Woynarowska,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 754, 6707, Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
402–7172, woynarowskab@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: February 16, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–03509 Filed 2–19–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8728-8729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03486]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Production of Attenuated
Respiratory Syncytial Virus Vaccines
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH),
Department of Health and Human Services (HHS), is contemplating the
grant of a an exclusive license to practice the following invention as
embodied in the following patent applications: (1) E-194-1999/0,
Collins et al., ``Production of Attenuated Respiratory Syncytial Virus
Vaccines Involving Modification of M2 ORF2'', U.S. Provisional Patent
Application Number 60/143,097, filed July 9, 1999, PCT Patent
Application Number PCT/US2000/18534, filed July 7, 2000, U.S. Patent
Application Number 09/611,829 (now U.S. Patent Number 6,713,066), and
U.S. Patent Application Number 11/011,502 (now U.S. Patent Number
7,485,440), (2) E-135-2010/0, Collins et al., ``Genetically Stable Live
Attenuated Vaccine for Respiratory Syncytial Virus (RSV) with an
Attenuation and Temperature Sensitive Phenotype Conferred by an Amino
Acid Deletion'', U.S. Provisional Patent Application Number 61/624,010,
filed April 13, 2012, PCT Patent Application Number PCT/US2013/030836,
filed March 13, 2013, United States Patent Application Number 14/
394,226, filed October 13, 2014, European Patent Application Number
13712641.3, filed March 13, 2013, (3) E-216-2014/0, Collins et al.,
``Versions of Respiratory Syncytial Virus (RSV) Vaccine Candidate LID
Delta M2-2 with Increased Attenuation'', U.S. Provisional Patent
Application Number 62/266,199, filed December 11, 2015, (4) E-241-2014/
0, Collins et al., ``Improved RSV F Protein for Expression from a
Heterologous Vector'', U.S. Provisional Patent Application Number 62/
105,667, filed January 20, 2015, PCT Patent Application Number PCT/
US2016/014154, filed January 20, 2016, and (5) E-037-2016/0, Collins et
al., ``Attenuated RSV Vaccine Strains in which the NS1 and/or NS2 Genes
have been Shifted to Promoter-Distal Positions'', U.S. Provisional
Patent Application Number 62/266,206, filed December 11, 2015, to
Sanofi Pasteur, Inc., having a place of business in Swiftwater,
Pennsylvania, U.S.A. The patent rights in this invention have been
assigned to the United States of America.
DATES: Only written comments and/or application for a license which are
received by the National Institute of Allergy and Infectious Diseases,
Technology Transfer and Intellectual Property Office on or before March
8, 2016. will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Peter Soukas, Senior Technology Licensing
Specialist, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases, 5601 Fishers
Lane, Suite 6D, Rockville, MD 20852-9804, Tel: (301) 594-8730 or email:
ps193c@nih.gov.
SUPPLEMENTARY INFORMATION: Respiratory syncytial virus (RSV) is the
most important cause of viral acute lower respiratory infection (ALRI)
in infants and children worldwide and is responsible for over 30
million new ALRI episodes worldwide and up to 199,000 deaths in
children under five (5) years old. In the United States, the virus
infects nearly all children at least once by the age of two (2) and is
the most common cause of bronchiolitis and infant pneumonia, causing up
to 125,000 hospitalizations of children each year. RSV disease burden
is less understood in the developing world, but available data
indicates that the virus causes a significant proportion of childhood
ALRI in these parts of the world, particularly in the first months of
life. The drug palivizumab (Synagis) can help prevent RSV disease in
high risk infants, but it cannot treat or cure already-serious RSV
infection. No vaccine exists today to prevent RSV due to an incomplete
understanding of the body's immune response to the virus, which has
challenged and delayed RSV vaccine development efforts.
The methods and compositions of this invention provide a means for
[[Page 8729]]
prevention of RSV and/or parainfluenza virus (PIV) infection by
immunization with live attenuated, immunogenic viral vaccines against
RSV and/or PIV.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404. The prospective exclusive license may be granted unless, within
fifteen (15) days from the date of this published Notice, NIH 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.
The field of use may be limited to live attenuated vaccines against
respiratory syncytial virus (RSV) and/or parainfluenza virus (PIV)
infections in humans.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response 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: February 16, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
NIAID.
[FR Doc. 2016-03486 Filed 2-19-16; 8:45 am]
BILLING CODE 4140-01-P
