National Eye Institute; Notice of Meeting, 89481-89482 [2016-29604]
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Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
Liability immunity is afforded to
manufacturers and distributors without
regard to whether the countermeasure is
used by or administered to this
population; liability immunity is
afforded to program planners and
qualified persons when the
countermeasure is used by or
administered to this population, or the
program planner or qualified person
reasonably could have believed the
recipient was in this population.
XI. Geographic Area
42 U.S.C. 247d–6d(a)(4), 247d–
6d(b)(2)(D)
Program (CICP) to provide benefits to
certain individuals or estates of
individuals who sustain a covered
serious physical injury as the direct
result of the administration or use of the
Covered Countermeasures, and benefits
to certain survivors of individuals who
die as a direct result of the
administration or use of the Covered
Countermeasures. The causal
connection between the countermeasure
and the serious physical injury must be
supported by compelling, reliable, valid,
medical and scientific evidence in order
for the individual to be considered for
compensation. The CICP is
administered by the Health Resources
and Services Administration, within the
Department of Health and Human
Services. Information about the CICP is
available by telephone at 855–266–2427
(toll-free) or https://www.hrsa.gov/cicp/.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call)
Contact Person: Ganesan Ramesh, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Dr., Room 2182, MSC
7818, Bethesda, MD 20892, ganesan.ramesh@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
XV. Amendments
BILLING CODE 4140–01–P
42 U.S.C. 247d–6d(b)(4)
Any amendments to this Declaration
will be published in the Federal
Register.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Liability immunity is afforded for the
administration or use of a Covered
Countermeasure without geographic
limitation.
Liability immunity is afforded to
manufacturers and distributors without
regard to whether the countermeasure is
used by or administered in any
designated geographic area; liability
immunity is afforded to program
planners and qualified persons when
the countermeasure is used by or
administered in any designated
geographic area, or the program planner
or qualified person reasonably could
have believed the recipient was in that
geographic area.
Dated: December 2, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
XII. Effective Time Period
[FR Doc. 2016–29609 Filed 12–9–16; 8:45 am]
42 U.S.C. 247d–6d(b)(2)(B)
BILLING CODE 4150–28–P
Liability immunity for Covered
Countermeasures began on February 27,
2015, and extends through February 26,
2019.
XIII. Additional Time Period of
Coverage
Authority: 42 U.S.C. 247d–6d.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES
42 U.S.C. 247d–6d(b)(3)(B) and (C)
Center for Scientific Review; Notice of
Closed Meeting
I have determined that an additional
12 months of liability protection is
reasonable to allow for the
manufacturer(s) to arrange for
disposition of the Covered
Countermeasure, including return of the
Covered Countermeasures to the
manufacturer, and for Covered Persons
to take such other actions as are
appropriate to limit the administration
or use of the Covered Countermeasures.
Covered Countermeasures obtained
for the SNS during the effective period
of this Declaration are covered through
the date of administration or use
pursuant to a distribution or release
from the SNS.
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 meeting.
The meeting 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.
XIV. Countermeasures Injury
Compensation Program
42 U.S.C 247d–6e
The PREP Act authorizes the
Countermeasures Injury Compensation
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89481
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neurogastroenterology.
Date: December 14, 2016.
Time: 9:00 a.m. to 10:00 a.m.
Agenda: To review and evaluate grant
applications.
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Dated: December 6, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–29603 Filed 12–9–16; 8:45 am]
National Institutes of Health
National Eye Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Eye Council.
The meeting 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 meeting 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 Advisory
Eye Council.
Date: January 19, 2017.
Open: 8:30 a.m. to 1:00 p.m.
Agenda: Following opening remarks by the
Director, NEI, there will be presentations by
the staff of the Institute and discussions
concerning Institute programs.
Place: Terrace Level Conference Rooms,
5635 Fishers Lane, Rockville, MD 20852.
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89482
Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Terrace Level Conference Rooms,
5635 Fishers Lane, Rockville, MD 20852.
Contact Person: Paul A. Sheehy, Ph.D.,
Director, Division of Extramural Affairs,
National Eye Institute, National Institutes of
Health, 5635 Fishers Lane, Suite 1300,
Bethesda, MD 20892, 301–451–2020, ps32h@
nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nei.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: December 6, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–29604 Filed 12–9–16; 8:45 am]
BILLING CODE 4140–01–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.
FOR FURTHER INFORMATION CONTACT:
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.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Zika Virus Vaccines
Description of Technology
Zika virus (ZIKV) is a flavivirus
transmitted by mosquitos that is
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18:59 Dec 09, 2016
Jkt 241001
strongly linked to neurological
´
complications including Guillain-Barre
syndrome, meningoencephalitis, and
microcephaly. The association between
active ZIKV infection during pregnancy
and microcephaly and intrauterine
growth retardation in the fetus has been
confirmed in murine models of ZIKV
infection.
Scientists at NIAID have developed
nucleic acid-based vaccine candidates
to prevent ZIKV infection in humans.
The current lead candidate vaccine is a
plasmid DNA vaccine demonstrated to
accord protection in preclinical models
and is undergoing clinical trial
evaluation. Nucleic acid-based vaccines
have been developed previously for
West Nile virus, another flavivirus
similar to Zika (J.E. Ledgerwood, et al.
J. Infect. Dis. (2011) 203 (10): 1396–
1404). Immunization with the nucleic
acid ZIKV vaccine candidate results in
production of noninfectious virus like
particles (VLPs) made of ZIKV proteins.
These ZIKV VLPs elicit an immune
response which includes neutralizing
antibodies to ZIKV.
Other preclinical ZIKV vaccine
candidates include mRNA, protein, and
noninfectious VLPs.
NIAID is continuing development of
these vaccine candidates. The DNAbased ZIKV vaccine candidate is
currently in clinical trials.
Consequently, for some fields of use,
NIAID will evaluate a license
applicant’s capabilities and experience
in advancing similar technologies
through the regulatory process.
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. This technology
is not eligible for NIH’s start up license.
Potential Commercial Applications:
• Prevention of Zika virus infection
Competitive Advantages:
• There is currently no licensed Zika
virus vaccine
Development Stage:
• Currently, DNA-based vaccine
candidate in Phase I clinical trial
• Phase II clinical trial planned for
early 2017 for DNA-based vaccine
candidate
• Other candidates are in pre-clinical
development
Inventors: Barney S. Graham (NIAID),
Theodore C. Pierson (NIAID), Kimberly
A. Dowd (NIAID), John R. Mascola
(NIAID), Wing-Pui Kong (NIAID), SungYoul Ko (NIAID), Eun Sung Yang
(NIAID), Wei Shi (NIAID), Lingshu
Wang (NIAID), Christina R. Demaso
(NIAID), Rebecca S. Pelc (NIAID),
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Adrian Creanga (NIAID), Julie
Ledgerwood (NIAID), William Schief
(The Scripps Research Institute),
Sebastian Ramisch (The Scripps
Research Institute), Leda Castilho
(Federal University of Rio de Janeiro)
Publications: K.A. Dowd, et al.,
Science, 354, 237–240 (2016).
DOI: 10.1126/science.aai9137.
Intellectual Property: U.S. Patent
Application No. 62/396,613 filed
September 19, 2016 (HHS Reference No.
E–181–2016/0–US–01).
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 Zika virus vaccine
technologies. For collaboration
opportunities, please contact Dr. Amy
Petrik, 240–627–3721; amy.petrik@
nih.gov.
Dated: December 5, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2016–29605 Filed 12–9–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs And Border Protection
Modification and Clarification of the
National Customs Automation
Program Tests Regarding PostSummary Corrections and Periodic
Monthly Statements
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: General notice.
AGENCY:
This document announces
U.S. Customs and Border Protection’s
(CBP’s) plan to modify and clarify the
National Customs Automation Program
(NCAP) test pertaining to the processing
of post-summary correction (PSC)
claims to entry summaries that are filed
in the Automated Commercial
Environment (ACE), as well as the
periodic monthly statement (PMS) test.
The modifications made by this notice
eliminate some requirements and
liberalize certain requirements needed
for the filing of a PSC making it easier
for importers to file a PSC for additional
entry types, and allowing for additional
time to make a deposit for duties, fees
and taxes owed. With regard to the PMS
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89481-89482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29604]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Advisory Eye Council.
The meeting 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 meeting 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 Advisory Eye Council.
Date: January 19, 2017.
Open: 8:30 a.m. to 1:00 p.m.
Agenda: Following opening remarks by the Director, NEI, there
will be presentations by the staff of the Institute and discussions
concerning Institute programs.
Place: Terrace Level Conference Rooms, 5635 Fishers Lane,
Rockville, MD 20852.
[[Page 89482]]
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Terrace Level Conference Rooms, 5635 Fishers Lane,
Rockville, MD 20852.
Contact Person: Paul A. Sheehy, Ph.D., Director, Division of
Extramural Affairs, National Eye Institute, National Institutes of
Health, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301-451-
2020, ps32h@nih.gov.
Information is also available on the Institute's/Center's home
page: www.nei.nih.gov, where an agenda and any additional
information for the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.867,
Vision Research, National Institutes of Health, HHS)
Dated: December 6, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-29604 Filed 12-9-16; 8:45 am]
BILLING CODE 4140-01-P