Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer, 19984-19985 [2016-07864]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
19984
Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
Technology, Ltd., a company formed
under the laws of the People’s Republic
of China and having its principle place
of business in Beijing, China.
The contemplated exclusive license
may be limited to boron neutron capture
therapy for brain tumors.
DATES: Only written comments and/or
applications for a license that are
received by NIH at the address indicated
below on or before April 21, 2016 will
be considered.
ADDRESSES: Requests for a copy of any
unpublished patent application,
inquiries, objections to this notice,
comments and other requests relating to
the contemplated license should be
directed to: Michael Shmilovich, Esq.,
CLP, Senior Licensing and Patent
Manager, 31 Center Drive Room 4A29,
MSC2479, Bethesda, MD 20892–2479,
phone number 301–435–5019, or
shmilovm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
invention pertains to boramino acid
compounds that can be used as imaging
agents for positron emission
tomography of cancer or for boron
neutron capture therapy. Mimetics
created by substituting the carboxylate
group (-COO-) of an amino acid with
trifluoroborate (-BF3-) are metabolically
stable and allow for the use of fluorine18 (18F) as the radiolabel (e.g.,
trifluoroborate phenylalanine (B-Phe)).
Using boramino acid for 18F-labeling
allows for integrating the 18F radiolabel
into the core molecular backbone rather
than the side-chains thus increasing the
agent’s target specificity. There is a
direct relationship between amino acid
uptake and cancer cell replication,
where the uptake is extensively
upregulated in most cancer cells. This
uptake increases as cancer progresses,
leading to greater uptake in high-grade
tumors and metastases. Amino acids act
as signaling molecules for proliferation
and may also reprogram metabolic
networks in the buildup of biomass.
This invention provides for an unmet
need for traceable amino acid mimics,
including those based on naturallyoccurring amino acids, which may be
non-invasively detected by imaging
technology, including for clinical
diagnosis or BNCT. Boron neutron
capture therapy (BNCT) is based on the
nuclear capture and fission reactions
that occur when non-radioactive boron10 (10B, approximately 20% of natural
elemental boron), is irradiated and thus
activated with neutrons of the
appropriate energy to yield excited
boron-11 (11B*). This isotope turn
decays into high energy alpha particles
(‘‘stripped’’ down 4He nuclei) and high
energy lithium-7 (7Li) nuclei. Both the
VerDate Sep<11>2014
17:54 Apr 05, 2016
Jkt 238001
emitted alpha particles and the lithium
ions are close proximity reactions, i.e.,
at a range of approximately 5–9 mm; the
diameter of a target cell. The energies
produced in this ionization and radiodecay is cytotoxic and thus exploited as
the basis for cancer radiotherapy. The
success of BNCT is dependent on the
selective delivery of sufficient amounts
of 10B to the tumor site with only small
amounts localized in the surrounding
normal tissues thus sparing normal
tissue from the nuclear capture and
fission reactions.
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 404.7. 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 404.7.
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: April 1, 2016.
Michael Shmilovich,
Senior Licensing and Patent Manager, Office
of Technology Transfer and Development,
National Heart, Lung, and Blood Institute.
[FR Doc. 2016–07865 Filed 4–5–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License for Commercialization:
Boron Neutron Capture Therapy for
Skin Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of a worldwide
exclusive license to practice the
inventions embodied in: HHS Ref. No.
E–135–2015/0, U.S. Provisional Patent
Application No. 62/155,085, filed April
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
30, 2015, entitled ‘‘Boron Mimics Of
Amino Acids And Uses Thereof,’’ to
Beijing Lanyears Communication
Technology, Ltd., a company formed
under the laws of the People’s Republic
of China and having its principle place
of business in Beijing, China.
The contemplated exclusive license
may be limited to boron neutron capture
therapy for skin cancer.
DATES: Only written comments and/or
applications for a license that are
received by NIH at the address indicated
below on or before April 21, 2016 will
be considered.
ADDRESSES: Requests for a copy of any
unpublished patent application,
inquiries, objections to this notice,
comments and other requests relating to
the contemplated license should be
directed to: Michael Shmilovich, Esq.,
CLP, Senior Licensing and Patent
Manager, 31 Center Drive, Room 4A29,
MSC2479, Bethesda, MD 20892–2479,
phone number 301–435–5019, or
shmilovm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
invention pertains to boramino acid
compounds that can be used as imaging
agents for positron emission
tomography of cancer or for boron
neutron capture therapy. Mimetics
created by substituting the carboxylate
group (-COO-) of an amino acid with
trifluoroborate (-BF3-) are metabolically
stable and allow for the use of fluorine18 (18F) as the radiolabel (e.g.,
trifluoroborate phenylalanine (B-Phe)).
Using boramino acid for 18F-labeling
allows for integrating the 18F radiolabel
into the core molecular backbone rather
than the side-chains thus increasing the
agent’s target specificity. There is a
direct relationship between amino acid
uptake and cancer cell replication,
where the uptake is extensively
upregulated in most cancer cells. This
uptake increases as cancer progresses,
leading to greater uptake in high-grade
tumors and metastases. Amino acids act
as signaling molecules for proliferation
and may also reprogram metabolic
networks in the buildup of biomass.
This invention provides for an unmet
need for traceable amino acid mimics,
including those based on naturallyoccurring amino acids, which may be
non-invasively detected by imaging
technology, including for clinical
diagnosis or BNCT. Boron neutron
capture therapy (BNCT) is based on the
nuclear capture and fission reactions
that occur when non-radioactive boron10 (10B, approximately 20% of natural
elemental boron), is irradiated and thus
activated with neutrons of the
appropriate energy to yield excited
boron-11 (11B*). This isotope turn
E:\FR\FM\06APN1.SGM
06APN1
Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
decays into high energy alpha particles
(‘‘stripped’’ down 4He nuclei) and high
energy lithium-7 (7Li) nuclei. Both the
emitted alpha particles and the lithium
ions are close proximity reactions, i.e.,
at a range of approximately 5–9 mm; the
diameter of a target cell. The energies
produced in this ionization and radiodecay is cytotoxic and thus exploited as
the basis for cancer radiotherapy. The
success of BNCT is dependent on the
selective delivery of sufficient amounts
of 10B to the tumor site with only small
amounts localized in the surrounding
normal tissues thus sparing normal
tissue from the nuclear capture and
fission reactions.
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 404.7. 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 404.7.
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: April 1, 2016.
Michael Shmilovich,
Senior Licensing and Patent Manager, Office
of Technology Transfer and Development,
National Heart, Lung, and Blood Institute.
[FR Doc. 2016–07864 Filed 4–5–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. DHS–2016–0027]
Privacy Act of 1974; Department of
Homeland Security, U.S. Customs and
Border Protection, DHS/CBP–014
Regulatory Audit Archive System
(RAAS) System of Records
Privacy Office, Department of
Homeland Security.
ACTION: Notice of Privacy Act System of
Records.
AGENCY:
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security (DHS) proposes to
SUMMARY:
VerDate Sep<11>2014
17:54 Apr 05, 2016
Jkt 238001
update and reissue a current DHS
system of records titled, ‘‘DHS/U.S.
Customs and Border Protection (CBP)–
014 Regulatory Audit Archive System
(RAAS) System of Records’’ (73 FR
77807, December 19, 2008). This system
of records allows DHS/CBP to collect
and maintain records on individuals
subject to regulatory audits of customs
brokers, importers, and other parties
involved in international trade
activities. CBP is updating this system
of records notice to reflect changes to its
authorities, category of records, and
routine uses. Specifically, these changes
include expanding the category of
records to permit the collection of
Employer Identification Numbers (EINs)
or Social Security numbers (SSNs), also
known as a Federal Taxpayer
Identifying Number, and business
records associated with the audit from
customs brokers, importers, and other
parties via merchandise entry
documentation. CBP is clarifying the
authorities section to include updated
and more narrowly tailored authorities
to permit the collection of EIN or SSN.
CBP is making non-substantive edits to
the Routine Uses A–G to align with
previously published Departmental
Systems of Records Notices (SORNs).
Lastly, this notice includes nonsubstantive changes to simplify the
formatting and text of the previously
published notice.
Additionally, DHS is issuing a Notice
of Proposed Rulemaking to reduce the
current exemptions for this system of
records from certain provisions of the
Privacy Act elsewhere in the Federal
Register. The previously issued Final
Rule for DHS/CBP–014 RAAS (Aug. 31,
2009, 74 FR 45076) remains in effect
until a new Final Rule is issued. This
updated system will be included in the
DHS inventory of record systems.
DATES: Submit comments on or before
May 6, 2016. This updated system will
be effective May 6, 2016.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2016–0027 by one of the following
methods:
• Federal e-Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–343–4010.
• Mail: Karen L. Neuman, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received will be posted
without change to https://
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
19985
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, please visit https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
general questions, please contact: John
Connors, (202) 344–1610, Privacy
Officer, U.S. Customs and Border
Protection, Privacy and Diversity Office,
1300 Pennsylvania Ave. NW.,
Washington, DC 20229. For privacy
questions, please contact: Karen L.
Neuman, (202) 343–1717, Chief Privacy
Officer, Privacy Office, Department of
Homeland Security, Washington, DC
20528.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the Privacy Act of
1974, 5 U.S.C. 552a, the Department of
Homeland Security (DHS)/U.S. Customs
and Border Protection (CBP) proposes to
update and reissue a current DHS
system of records titled, ‘‘DHS/CBP–014
Regulatory Audit Archive System
(RAAS) System of Records.’’
DHS/CBP conducts regulatory audits
in support of its oversight of customs
brokers licensed by DHS/CBP pursuant
to 19 U.S.C. 1641 to act as agents for
importers in the entry of merchandise
and payment of duties and fees. This
system of records covers records about
importers and other parties engaged in
international trade activities that are the
subject of a regulatory audit or are
identified in and related to the scope of
an audit report.
As a result of a biennial review of this
SORN, DHS/CBP is updating the
categories of records to include the
collection of EINs or SSNs, also known
as Federal Taxpayer Identifying
Number, pursuant to 19 CFR 24.5, 19
CFR 149.3, and E.O. 9397, as amended
by E.O. 13478. DHS/CBP collects this
additional data to align RAAS with
information provided by importers
through the DHS/CBP Automated
Commercial Environment System (ACE)
data-source. DHS/CBP is also clarifying
the category of records to include
business and audit records collected or
created as part of the audit process.
DHS/CBP is clarifying the authorities
section to include updated and more
narrowly tailored authorities to permit
the collection of EIN or SSN. 19 CFR
24.5 and 19 CFR 149.3 require that
DHS/CBP collect Federal Taxpayer
Identifying Numbers in association with
services resulting in issuance of a bill or
refund check upon adjustment of a cash
collection or to document entities that
are liable for payment of all duties and
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19984-19985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07864]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License for
Commercialization: Boron Neutron Capture Therapy for Skin Cancer
AGENCY: National Institutes of Health, HHS.
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 Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
a worldwide exclusive license to practice the inventions embodied in:
HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/
155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids
And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd.,
a company formed under the laws of the People's Republic of China and
having its principle place of business in Beijing, China.
The contemplated exclusive license may be limited to boron neutron
capture therapy for skin cancer.
DATES: Only written comments and/or applications for a license that are
received by NIH at the address indicated below on or before April 21,
2016 will be considered.
ADDRESSES: Requests for a copy of any unpublished patent application,
inquiries, objections to this notice, comments and other requests
relating to the contemplated license should be directed to: Michael
Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center
Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-
435-5019, or shmilovm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The invention pertains to boramino acid
compounds that can be used as imaging agents for positron emission
tomography of cancer or for boron neutron capture therapy. Mimetics
created by substituting the carboxylate group (-COO-) of an amino acid
with trifluoroborate (-BF3-) are metabolically stable and allow for the
use of fluorine-18 (\18\F) as the radiolabel (e.g., trifluoroborate
phenylalanine (B-Phe)). Using boramino acid for \18\F-labeling allows
for integrating the \18\F radiolabel into the core molecular backbone
rather than the side-chains thus increasing the agent's target
specificity. There is a direct relationship between amino acid uptake
and cancer cell replication, where the uptake is extensively
upregulated in most cancer cells. This uptake increases as cancer
progresses, leading to greater uptake in high-grade tumors and
metastases. Amino acids act as signaling molecules for proliferation
and may also reprogram metabolic networks in the buildup of biomass.
This invention provides for an unmet need for traceable amino acid
mimics, including those based on naturally-occurring amino acids, which
may be non-invasively detected by imaging technology, including for
clinical diagnosis or BNCT. Boron neutron capture therapy (BNCT) is
based on the nuclear capture and fission reactions that occur when non-
radioactive boron-10 (\10\B, approximately 20% of natural elemental
boron), is irradiated and thus activated with neutrons of the
appropriate energy to yield excited boron-11 (\11\B*). This isotope
turn
[[Page 19985]]
decays into high energy alpha particles (``stripped'' down \4\He
nuclei) and high energy lithium-7 (\7\Li) nuclei. Both the emitted
alpha particles and the lithium ions are close proximity reactions,
i.e., at a range of approximately 5-9 [micro]m; the diameter of a
target cell. The energies produced in this ionization and radio-decay
is cytotoxic and thus exploited as the basis for cancer radiotherapy.
The success of BNCT is dependent on the selective delivery of
sufficient amounts of \10\B to the tumor site with only small amounts
localized in the surrounding normal tissues thus sparing normal tissue
from the nuclear capture and fission reactions.
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 404.7.
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 404.7.
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: April 1, 2016.
Michael Shmilovich,
Senior Licensing and Patent Manager, Office of Technology Transfer and
Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-07864 Filed 4-5-16; 8:45 am]
BILLING CODE 4140-01-P
