Center for Scientific Review; Notice of Closed Meeting, 7821-7822 [2016-02973]
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
Licensing Opportunity: Researchers at
the NICHD seek licensing and/or codevelopment research collaborations for
the therapeutic management of Menkes
Disease and related copper transport
disorders.
Contact Information
Requests for copies of the patent
application or inquiries about licensing,
research collaborations, and codevelopment opportunities should be
sent to John D. Hewes, Ph.D., email:
john.hewes@nih.gov.
Dated: February 8, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–02970 Filed 2–12–16; 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 and/or co-development in the
U.S. in accordance with 35 U.S.C. 209
and 37 CFR part 404 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 and/or co-development.
ADDRESSES: Information on licensing,
co-development research collaborations,
and/or copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD,
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
FOR FURTHER INFORMATION CONTACT:
Requests for copies of the patent
application or inquiries about licensing
and/or co-development should be sent
to John D. Hewes, Ph.D., email:
john.hewes@nih.gov.
SUPPLEMENTARY INFORMATION:
Technology description follows.
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SUMMARY:
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Title of invention: Modified griffithsin
tandemers for enhanced activity and
reduced viral aggregation.
Description of Technology: Griffithsin
(GRFT) is a lectin with potent antiviral
properties that is capable of preventing
and treating infections caused by a
number of enveloped viruses (including
HIV, SARS, HCV, HSV, and Japanese
encephalitis) and is currently in clinical
development as an anti-HIV
microbicide. In addition to its broad
antiviral activity, GRFT is stable at high
temperature and at a broad pH range,
displays low toxicity and
immunogenicity, and is amenable to
large-scale manufacturing. Native GRFT
is a domain-swapped homodimer that
binds to viral envelope glycoproteins
and has displayed mid-picomolar
activity in cell-based anti-HIV assays.
This invention is directed to synthetic
proteins that comprise two (or more)
obligate monomers (‘‘mGRFT’’) joined
by an amino acid linker to form
tandemers (‘‘mGRFT tandemers’’). Each
obligate monomer is generated by the
addition of Gly-Ser residues in the hinge
region of wild-type GRFT. Two or more
obligate monomers are joined by an
amino acid linker to form the mGRFT
tandamers. The properties of the
mGRFT tandemers can be modulated by
the length of the amino acid linker and
the number of obligate monomers cojoined. mGRFT tandemers exhibit gore
potent anti-viral properties when
compared against native GRFT and are
equipotent against viruses that are both
sensitive and resistant to naive GRFT.
As such, potential uses of the invention
tandemers include topical and
intravenous therapy to treat HIV
infection, particularly to treat HIV
infections that are resistant to native
GRFT.
Potential Commercial Applications
• Broad-spectrum antiviral agent
similar to wild type GRFT
• Potential activity against SARS CoV,
MERS, Ebola, HCV and influenza
Value Proposition
• Broad antiviral activity
• Stable at high temperature and at a
broad pH range
• Displays low toxicity and
immunogenicity.
Development Stage: In vivo/Lead
Validation.
Inventor(s): Barry R. O’Keefe (NCI), A.
Wlodawer (NCI), T. Moulaei (NCI).
Publication(s)
—Moulaei T. et al., Griffithsin tandemers:
flexible and potent lectin inhibitors of the
human immunodeficiency virus.
Retrovirology. 2015 Jan 23;12:6.
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7821
—A. Chatterjee et al.,Griffithsin and
Carrageenan Combination To Target
Herpes Simplex Virus 2 and Human
Papillomavirus, Antimicrob Agents
Chemother. 2015 Dec; 59(12): 7290–7298.
Intellectual Property
HHS Reference No. E–034–2013/0–
US–01.
PCT Application No. PCT/US2014/
040992 (HHS Reference No. E–034–
2013/0- US–01) filed June 5, 2013
entitled ‘‘Modified griffithsin tandemers
for enhanced activity and reduced viral
aggregation’’.
Licensing and Collaborative/CoDevelopment Research Opportunity:
Researchers at the NCI seek licensees
and/or co-development partners for the
commercialization of Griffithsin and
Griffithsin tandemers, specifically,
additional studies on stability, toxicity,
immunogenicity, and large-scale
production.
Dated: February 1, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–02971 Filed 2–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topic: Social Sciences and Population
Studies.
Date: February 23, 2016.
Time: 12:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.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)
Dated: February 9, 2016.
Sylvia Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02973 Filed 2–12–16; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[CBP Dec. No. 16–04]
Expansion of Global Entry Eligibility to
All Citizens of the Federal Republic of
Germany
U.S. Customs and Border
Protection; Department of Homeland
Security.
ACTION: General notice.
AGENCY:
U.S. Customs and Border
Protection (CBP) has established the
Global Entry international trusted
traveler program at most major U.S.
airports. Global Entry allows preapproved participants dedicated CBP
processing into the United States using
Global Entry kiosks located at
designated airports. In 2013, CBP
announced a limited pilot program
through which certain citizens of the
Federal Republic of Germany (Germany)
were eligible to apply for participation
in the Global Entry program. This
document announces that CBP is
concluding the pilot and expanding
eligibility in the Global Entry program
to include all German citizens.
Additionally, this document announces
that certain U.S. citizens may apply for
membership in EasyPASS, Germany’s
registered traveler program.
DATES: Global Entry eligibility will be
expanded to German citizens on
February 16, 2016. Applications will be
accepted beginning February 16, 2016.
FOR FURTHER INFORMATION CONTACT:
Larry Panetta, Office of Field
Operations, (202) 344–1253,
Larry.A.Panetta@cbp.dhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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Background
Global Entry Program
Global Entry is a voluntary program
that allows for dedicated CBP
processing of pre-approved travelers
arriving in the United States at Global
Entry kiosks located at designated
airports. On February 6, 2012, CBP
issued the final rule that promulgated
the regulation (8 CFR 235.12) to
establish Global Entry as an ongoing
voluntary regulatory program in the
Federal Register (77 FR 5681). The final
rule contains a detailed description of
the program, the eligibility criteria, the
application and selection process, and
the initial airport locations. Travelers
who wish to participate in Global Entry
must apply via the Global On-Line
Enrollment System (GOES) Web site,
https://goes-app.cbp.dhs.gov, and pay
the applicable fee. Applications for
Global Entry must be completed and
submitted electronically.
Eligibility for participation in Global
Entry is limited to U.S. citizens, U.S.
nationals, U.S. lawful permanent
residents, and certain nonimmigrant
aliens from countries that have entered
into arrangements with CBP regarding
international trusted traveler programs.
Specifically, the regulation provides
that certain nonimmigrant aliens from
countries that have entered into
arrangements with CBP concerning
international trusted traveler programs
may be eligible to apply for
participation in Global Entry after CBP
announces the arrangement by
publication of a notice in the Federal
Register. The notice will include the
country, the scope of eligibility of
nonimmigrant aliens from that country
(e.g., whether only citizens of the
foreign country or citizens and noncitizens are eligible) and other
conditions that may apply based on the
terms of the arrangement. See 8 CFR
235.12(b)(1)(ii). In the preamble of the
Global Entry final rule, CBP recognized
the existence of previous arrangements
it had with Mexico and the Netherlands
regarding the international trusted
traveler programs and announced that
Mexican nationals and certain citizens
of the Netherlands were eligible to
apply for the Global Entry program. CBP
further specified that Mexican nationals
and citizens of the Netherlands who
were existing participants in the Global
Entry pilot would be automatically
enrolled in the ongoing Global Entry
program. CBP also stated that pursuant
to a previous Federal Register notice,1
1 See
the Utilization of Global Entry Kiosks by
NEXUS and SENTRI Participants Federal Register
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participants in NEXUS and certain
participants in SENTRI would still be
allowed to use the Global Entry kiosks.
In a notice published in the Federal
Register (78 FR 48706) on August 9,
2013, CBP expanded Global Entry
eligibility to include citizens of the
Republic of Korea who are participants
in the Smart Entry System (SES), a
trusted traveler program for preapproved, low-risk travelers at
designated airports in the Republic of
Korea via the use of e-gates; a limited
number of citizens of the State of Qatar;
and a limited number of citizens of the
United Kingdom who frequently travel
to the United States.
In a notice published in the Federal
Register (80 FR 1509) on January 12,
2015, CBP expanded Global Entry
eligibility to include citizens of the
Republic of Panama. Additionally, this
document announced that U.S. citizens
who participate in Global Entry or U.S.
citizens who can utilize Global Entry
kiosks as NEXUS or SENTRI
participants have the option to apply for
membership in Panama Global Pass, the
Republic of Panama’s trusted traveler
program.
Limited Global Entry Pilot for Certain
German Citizens
In the August 9, 2013 notice
referenced in the previous section, CBP
also announced a limited Global Entry
pilot program allowing certain German
citizens to apply for Global Entry. This
pilot program allowed certain German
citizens who participated in ABG Plus,
Germany’s former trusted traveler
program, to apply for participation in
Global Entry.2 During this limited pilot,
German citizens who were identified as
potentially being eligible for
participation in the pilot program
received a promotional code and
information about the program from the
German government. The United States
and Germany limited the number of
citizens who could apply for Global
Entry to allow for the development of
the program’s infrastructure. The notice
stated that CBP expected to be able to
expand eligiblility to include all
German citizens in the near future and
that such an expansion would be
announced by notice in the Federal
Register and on https://
www.globalentry.gov.
Expansion of Global Entry Program to
Include All Citizens of Germany
This document announces that
pursuant to the Joint Declaration signed
notice, December 29, 2010 (75 FR 82202) for further
information.
2 ABG Plus has since been discontinued.
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Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7821-7822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Special Topic: Social Sciences and Population Studies.
Date: February 23, 2016.
Time: 12:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of
[[Page 7822]]
Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD
20892, (301) 435-1712, ryansj@csr.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)
Dated: February 9, 2016.
Sylvia Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-02973 Filed 2-12-16; 8:45 am]
BILLING CODE 4140-01-P