Government-Owned Inventions; Availability for Licensing, 47753-47754 [2017-22146]
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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will be held on
December 12, 2017, from 8 a.m. to 6
p.m.
ADDRESSES: Hilton Washington DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
FOR FURTHER INFORMATION CONTACT: Sara
J. Anderson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G616, Silver Spring,
MD 20993–0002, 301–796–7047,
Sara.Anderson@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On December 12, 2017, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
Barricaid Anular Closure Device by
Intrinsic Therapeutics. The proposed
Indication for Use, as stated in the PMA,
is as follows: The Barricaid is intended
to be implanted following a limited
discectomy, to prevent reherniation and
the recurrence of pain or dysfunction.
The Barricaid is indicated for patients
with radiculopathy (with or without
back pain), a posterior or posterolateral
herniation, characterized by
radiographic confirmation of neural
compression using magnetic resonance
imaging, and a large anular defect (e.g.,
between 4–6 mm tall and between 6–12
mm wide) post discectomy, at one level
between L4 and S1.
FDA intends to make background
material available to the public no later
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SUMMARY:
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than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before December 1, 2017.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 3, 2017. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 9, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov or 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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47753
Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22174 Filed 10–12–17; 8:45 am]
BILLING CODE 4164–01–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 inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed below may be
obtained by emailing the indicated
licensing contact at the National Heart,
Lung, and Blood, Office of Technology
Transfer and Development Office of
Technology Transfer, 31 Center Drive
Room 4A29, MSC2479, Bethesda, MD
20892–2479; telephone: 301–402–5579.
A signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: This
notice is 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. A description of the
technology follows.
SUMMARY:
Derivatives of
Docosahexaenoylethanolamide (DEA)
for Neurogenesis
The invention pertains to derivatives
of docosahexaenoylethanolamide
(synaptamide or DEA) and their use in
inducing neurogenesis, neurite growth,
and/or synaptogenesis. As such, these
DEA derivatives can be used as
therapeutics for neurodegenerative
diseases such as traumatic brain injury,
spinal cord injury, peripheral nerve
injury, stroke, multiple sclerosis,
autism, Alzheimer’s disease,
Huntington’s disease, Parkinson’s
disease, amyotrophic lateral sclerosis.
The DEA derivatives of the invention
have increased potency and hydrolysis
resistance as compared to native DEA.
Docosahexaenoic acid (DHA), an n-3
E:\FR\FM\13OCN1.SGM
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47754
Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
polyunsaturated fatty acid accumulates
in the brain during development, and
has been implicated in learning and
memory development. DEA, a
metabolite derived from DHA, also has
been shown to accelerate neuronal
growth and development. In vitro
studies in which neural progenitor cells
were treated with DEA derivatives
showed an increase in the number of
somatic neurons produced after
differentiation.
Potential Commercial Applications
• Neurogenesis,
• Neurite growth,
• Synaptogenesis,
• Therapeutics for traumatic brain
injury, spinal cord injury, peripheral
nerve injury, stroke, multiple sclerosis,
autism, Alzheimer’s disease,
Huntington’s disease, Parkinson’s
disease, and amyotrophic lateral
sclerosis.
Inventors: Erika Englund (NCATS),
Juan Marugan (NCATS), Samarjit
Patnaik (NCATS), Hee-Yong Kim
(NIAAA).
Intellectual Property: HHS Reference
No. E–070–2012/0, U.S. Provisional
Patent Application 61/624,741 filed
April 16, 2012 (expired), International
Patent Application PCT/US2013/032333
filed March 15, 2013 (expired), U.S.
Patent 9,422,308; German Patent
602013016154.2, French Patent
2847178, and UK Patent 2847178.
Licensing Contact: Michael
Shmilovich, Esq, CLP; 301–435–5019;
shmilovm@nih.gov.
Dated: October 5, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development .
[FR Doc. 2017–22146 Filed 10–12–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
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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; Immune
System Plasticity in Dental, Oral, and
Craniofacial Diseases.
Date: November 1, 2017.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–435–
1781, liuyh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–17–
263: Innovation for HIV Vaccine Discovery.
Date: November 3, 2017.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Barna Dey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
Bethesda, MD 20892, 301–451–2796, bdey@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Epidemiology, Ethical and
Population Sciences.
Date: November 3, 2017.
Time: 2:30 p.m. to 4:30 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: Gniesha Yvonne
Dinwiddie, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3137, Bethesda, MD 20892,
dinwiddiegy@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Systems Science and Health in the
Behavioral and Social Science.
Date: November 7, 2017.
Time: 1:00 p.m. to 5:00 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: Ping Wu, Ph.D., Scientific
Review Officer, HDM IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
Bethesda, MD 20892, 301–451–8428, wup4@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
PO 00000
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Improving Smoking Cessation in
Socioeconomically Disadvantaged
Populations via Scalable Interventions.
Date: November 7, 2017.
Time: 1:00 p.m. to 5:00 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: Kristen Prentice, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3112,
MSC 7808, Bethesda, MD 20892, 301–496–
0726, prenticekj@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Digestive Sciences.
Date: November 8–9, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Martha Garcia, Ph.D.,
Scientific Reviewer Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186,
MSC 7818, Bethesda, MD 20892, 301–435–
1243, garciamc@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Computational, Modeling, and
Biodata Management.
Date: November 8, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Allen Richon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7892, Bethesda, MD 20892, 301–379–
9351, allen.richon@nih.hhs.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Pathophysiology of
Neurodevelopmental Disorders.
Date: November 8, 2017.
Time: 11:00 a.m. to 2:00 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: Boris P Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–17–
171: Cancer Tissue Engineering Collaborative
Research.
Date: November 8, 2017.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
E:\FR\FM\13OCN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47753-47754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22146]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the patent applications listed below may be obtained by emailing the
indicated licensing contact at the National Heart, Lung, and Blood,
Office of Technology Transfer and Development Office of Technology
Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479;
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may
be required to receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: This notice is 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. A description of
the technology follows.
Derivatives of Docosahexaenoylethanolamide (DEA) for Neurogenesis
The invention pertains to derivatives of
docosahexaenoylethanolamide (synaptamide or DEA) and their use in
inducing neurogenesis, neurite growth, and/or synaptogenesis. As such,
these DEA derivatives can be used as therapeutics for neurodegenerative
diseases such as traumatic brain injury, spinal cord injury, peripheral
nerve injury, stroke, multiple sclerosis, autism, Alzheimer's disease,
Huntington's disease, Parkinson's disease, amyotrophic lateral
sclerosis. The DEA derivatives of the invention have increased potency
and hydrolysis resistance as compared to native DEA. Docosahexaenoic
acid (DHA), an n-3
[[Page 47754]]
polyunsaturated fatty acid accumulates in the brain during development,
and has been implicated in learning and memory development. DEA, a
metabolite derived from DHA, also has been shown to accelerate neuronal
growth and development. In vitro studies in which neural progenitor
cells were treated with DEA derivatives showed an increase in the
number of somatic neurons produced after differentiation.
Potential Commercial Applications
Neurogenesis,
Neurite growth,
Synaptogenesis,
Therapeutics for traumatic brain injury, spinal cord
injury, peripheral nerve injury, stroke, multiple sclerosis, autism,
Alzheimer's disease, Huntington's disease, Parkinson's disease, and
amyotrophic lateral sclerosis.
Inventors: Erika Englund (NCATS), Juan Marugan (NCATS), Samarjit
Patnaik (NCATS), Hee-Yong Kim (NIAAA).
Intellectual Property: HHS Reference No. E-070-2012/0, U.S.
Provisional Patent Application 61/624,741 filed April 16, 2012
(expired), International Patent Application PCT/US2013/032333 filed
March 15, 2013 (expired), U.S. Patent 9,422,308; German Patent
602013016154.2, French Patent 2847178, and UK Patent 2847178.
Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019;
shmilovm@nih.gov.
Dated: October 5, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and Development .
[FR Doc. 2017-22146 Filed 10-12-17; 8:45 am]
BILLING CODE 4140-01-P
