Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Brain Tumors, 19983-19984 [2016-07865]
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Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
Purpose: The purpose of the meeting
is to discuss services and issues related
to the health of migratory and seasonal
agricultural workers and their families
and to formulate recommendations for
the Secretary of the Department of
Health and Human Services.
Agenda: The agenda includes an
overview of the Council’s general
business activities. The Council will
also hear presentations from federal
officials and experts on agricultural
worker issues, including the status of
agricultural worker health at the local
and national levels. Agenda items are
subject to change as priorities indicate.
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 at
least 10 days prior to the meeting.
FOR FURTHER INFORMATION CONTACT:
Esther Paul, MBBS, MA, MPH., Office of
Policy and Program Development,
Bureau of Primary Health Care, Health
Resources and Services Administration,
5600 Fishers Lane, 16N38B, Maryland
20857; Phone number: (301) 594–4496.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–07909 Filed 4–5–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding a meeting to continue
discussions and possibly develop
recommendations regarding People
Living with HIV/AIDS. During this
meeting, PACHA members will have
discussions regarding Health System
Transformations, community
approaches to implementing the
Updated National HIV/AIDS Strategy,
and a panel making the case for food as
medicine. The meeting will be open to
the public.
DATES: The meeting will be held on May
24, 2016, from 9:00 a.m. to
approximately 5:00 p.m. (ET) and May
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:54 Apr 05, 2016
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25, 2016, from 9:00 a.m. to
approximately 12:00 p.m. (ET).
ADDRESSES: 200 Independence Avenue
SW., Washington, DC 20201 in the
Penthouse (eighth floor), Room 800.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, Public Health Analyst,
Presidential Advisory Council on HIV/
AIDS, Department of Health and Human
Services, 200 Independence Avenue
SW., Room 443H, Hubert H. Humphrey
Building, Washington, DC 20201; (202)
205–1178 or Caroline.Talev@hhs.gov.
More detailed information about
PACHA can be obtained by accessing
the Council’s page on the AIDS.gov site
at www.aids.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996. In a memorandum, dated July
13, 2010, and under Executive Order
13703, dated July 30, 2015, the
President gave certain authorities to the
PACHA for implementation of the
National HIV/AIDS Strategy for the
United States (Strategy). PACHA is
currently operating under the authority
given in Executive Order 13708, dated
September 30, 2015.
PACHA provides advice, information,
and recommendations to the Secretary
regarding programs, policies, and
research to promote effective treatment,
prevention, and cure of HIV disease and
AIDS, including considering common
co-morbidities of those infected with
HIV as needed, to promote effective HIV
prevention and treatment and quality
services to persons living with HIV
disease and AIDS.
Substantial progress has been made in
addressing the domestic HIV epidemic
since the Strategy was released in July
2010. Under Executive order 13703, the
National HIV/AIDS Strategy for the
United States: Updated to 2020
(Updated Strategy) was released.
PACHA shall contribute to the federal
effort to improve HIV prevention and
care.
The functions of the Council are
solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House
Office on National AIDS Policy. The
agenda for the upcoming meeting will
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19983
be posted on the AIDS.gov Web site at
www.aids.gov/pacha.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Caroline
Talev at Caroline.Talev@hhs.gov. Due to
space constraints, pre-registration for
public attendance is advisable and can
be accomplished by contacting Caroline
Talev at Caroline.Talev@hhs.gov by
close of business on May 17, 2016.
Members of the public will have the
opportunity to provide comments at the
meeting. Any individual who wishes to
participate in the public comment
session must register with Caroline
Talev at Caroline.Talev@hhs.gov by
close of business on May 17, 2016;
registration for public comment will not
be accepted by telephone. Individuals
are encouraged to provide a written
statement of any public comment(s) for
accurate minute taking purposes. Public
comment will be limited to two minutes
per speaker. Any members of the public
who wish to have printed material
distributed to PACHA members at the
meeting are asked to submit, at a
minimum, 1 copy of the material(s) to
Caroline Talev, no later than close of
business on May 17, 2016.
Dated: March 22, 2016.
B. Kaye Hayes,
Executive Director, Presidential Advisory
Council on HIV/AIDS.
[FR Doc. 2016–07880 Filed 4–5–16; 8:45 am]
BILLING CODE 4150–43–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
Brain Tumors
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
30, 2015, entitled ‘‘Boron Mimics Of
Amino Acids And Uses Thereof,’’ to
Beijing Lanyears Communication
SUMMARY:
E:\FR\FM\06APN1.SGM
06APN1
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
]]>Agencies
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19983-19984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License for
Commercialization: Boron Neutron Capture Therapy for Brain Tumors
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
[[Page 19984]]
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 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 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. 2016-07865 Filed 4-5-16; 8:45 am]
BILLING CODE 4140-01-P
