Prospective Grant of Start-Up Exclusive License: Therapeutics for Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Certain Other CNS Disorders, 19213-19214 [2016-07496]
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
Dated: March 24, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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 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
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 Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Child Neurology K12
Review.
Date: April 15, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3204, MSC 9529, Bethesda, MD 20892–
9529, 301–496–0660, lbenzingw@
mail.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; P01 Review.
Date: April 29, 2016.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Administrator,
Scientific Review Branch, NINDS/NIH/
DHHS, Neuroscience Center, 6001 Executive
Blvd., Suite 3204, MSC 9529, Bethesda, MD
20892–9529, 301–402–0288,
Natalia.strunnikova@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
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[FR Doc. 2016–07497 Filed 4–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, April
13, 2016, 01:00 p.m. to April 13, 2016,
04:00 p.m., National Institutes of Health,
6701 Rockledge Drive, Bethesda, MD
20892 which was published in the
Federal Register on March 23, 2016, 81
FR 15543.
The meeting will be held on April 7,
2016 at 12:00 p.m.–4:00 p.m. The Panel
Name of the meeting will be
‘‘Neurophysiology’’. The location
remains the same. The meeting is closed
to the public.
Dated: March 25, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07480 Filed 4–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive License: Therapeutics for
Multiple Sclerosis, Amyotrophic
Lateral Sclerosis and Certain Other
CNS Disorders
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institute of
Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive license to Great Lakes
Neuroscience, Inc., which is located in
Illinois, to practice the inventions
embodied in the following patents: U.S.
Patent 8,597,660, issued December 3,
2013 (HHS reference E–144–2010/0–
US–02).
The patent rights in these inventions
have been assigned to the United States
SUMMARY:
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
19213
of America. The prospective start-up
exclusive license territory may be
worldwide and the field of use may be
limited to therapeutics for Multiple
sclerosis, Acute Disseminated
Encephalomyelitis (ADEM), Balo’s
disease, Clinically Isolated Syndrome,
HTLV–1 Associated Myelopathy (HAM),
Neuromyelitis optica and NMO
spectrum disorder, Schilder’s disease,
Traverse myelitis, amyotrophic lateral
sclerosis and other motor neuron
diseases as follows: progressive bulbar
palsy, primary lateral sclerosis,
progressive muscular atrophy, spinal
muscular atrophy, Kennedy’s disease,
and post polio syndrome.
DATES: Only written comments and/or
applications for a license which are
received by NINDS Technology Transfer
on or before April 19, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive license
should be directed to: Susan Ano, Ph.D.,
NINDS Technology Transfer, 31 Center
Drive, Suite 8A52, MS2540, Bethesda,
MD 20892; Telephone: (301) 435–5515;
Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention discloses treating
neurodegenerative diseases by
administering cyclin dependent kinase
5 (Cdk5) inhibitory peptides derived
from P35, the activator of Cdk5.
Abnormally hyperactive Cdk5 has been
shown to be associated with a variety of
neurodegenerative disorders. This
invention describes isolated peptide
fragments, pharmaceutical compositions
and methods for use of such for treating
subjects with a neurodegenerative
disease, such as Alzheimer’s disease
(AD), Amyotrophic Lateral Sclerosis
(ALS) and Parkinson’s disease (PD). An
inhibitory fragment, TFP5, disclosed in
this invention, has been shown to
ameliorate symptoms of AD in disease
animal models without any evidence of
toxicity. In particular, TFP5 treatment of
rat cortical neurons reduced
hyperactivation of Cdk5 upon neuronal
stress and insults. Following
intraperitoneal (ip) injection, TFP5 was
capable of crossing the blood-brain
barrier and localizing within the brain
where it was found to rescue memory
deficits and pathology in a double
transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive
license may be granted unless within
fifteen (15) days from the date of this
published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
E:\FR\FM\04APN1.SGM
04APN1
19214
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted 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: March 24, 2016.
Susan Ano,
Technology Development Coordinator,
NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016–07496 Filed 4–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Amended Notice of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
Notice is hereby given to clarify the
meeting times of the Sleep Disorders
Research Advisory Board, April 14–15,
2016, NHLBI/National Institutes of
Health, Two Rockledge Center, 6701
Rockledge Drive, Conference Room
9100/9104, Bethesda, MD, which was
published in the Federal Register on
March 14, 2016, 81 FR 13399.
Time: April 14 1:00 p.m. to 5:00 p.m.,
April 15 8:30 a.m. to 3:00 p.m.
Agenda: Information will be
presented on the status of selected NIH
sleep research programs and interagency coordination activities. The
Sleep Disorders Research Advisory
Board will discuss a potential
framework for a revision of the NIH
Sleep Disorders Research Plan. The
Board will also hear brief presentations
from organizations and individuals
interested in NIH sleep research
programs and planning.
Dated: March 29, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07502 Filed 4–1–16; 8:45 am]
BILLING CODE 4140–01–P
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19:03 Apr 01, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
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 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
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 Institute on
Aging Special Emphasis Panel; Integrative
Perspectives in Early Life.
Date: May 4, 2016.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2C212, 7201 Wisconsin
Avenue, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Carmen Moten, MPH,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7703
cmoten@mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Nutrient
Signaling and Bone Loss.
Date: May 4, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ramesh Vemuri, Ph.D.,
Chief, Scientific Review Branch, Scientific
Review Branch, National Institue On Aging,
National Institites Of Health, 7201 Wisconsin
Avenue, Suite 2C–212, Bethesda, MD 20892,
301–402–7700, rv23r@nih.gov
Name of Committee: National Institute on
Aging Special Emphasis Panel; Alzheimer’s
Disease Drug Development.
Date: May 17, 2016.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging, The
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute On Aging, Gateway Building 2C/
212, 7201 Wisconsin Avenue, BETHESDA,
PO 00000
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MD 20892 301–496–9666
parsadanian@commat;nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Integrative
Approach to Delirium and Dementia.
Date: May 18, 2016.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Isis S. Mikhail, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C12, Bethesda,
MD 20892301–402–7704 mikhaili@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 29, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07547 Filed 4–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19213-19214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive License: Therapeutics for
Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Certain Other CNS
Disorders
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institute of Neurological Disorders and
Stroke (NINDS), National Institutes of Health (NIH), Department of
Health and Human Services, is contemplating the grant of a start-up
exclusive license to Great Lakes Neuroscience, Inc., which is located
in Illinois, to practice the inventions embodied in the following
patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference
E-144-2010/0-US-02).
The patent rights in these inventions have been assigned to the
United States of America. The prospective start-up exclusive license
territory may be worldwide and the field of use may be limited to
therapeutics for Multiple sclerosis, Acute Disseminated
Encephalomyelitis (ADEM), Balo's disease, Clinically Isolated Syndrome,
HTLV-1 Associated Myelopathy (HAM), Neuromyelitis optica and NMO
spectrum disorder, Schilder's disease, Traverse myelitis, amyotrophic
lateral sclerosis and other motor neuron diseases as follows:
progressive bulbar palsy, primary lateral sclerosis, progressive
muscular atrophy, spinal muscular atrophy, Kennedy's disease, and post
polio syndrome.
DATES: Only written comments and/or applications for a license which
are received by NINDS Technology Transfer on or before April 19, 2016
will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated start-up
exclusive license should be directed to: Susan Ano, Ph.D., NINDS
Technology Transfer, 31 Center Drive, Suite 8A52, MS2540, Bethesda, MD
20892; Telephone: (301) 435-5515; Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention discloses treating
neurodegenerative diseases by administering cyclin dependent kinase 5
(Cdk5) inhibitory peptides derived from P35, the activator of Cdk5.
Abnormally hyperactive Cdk5 has been shown to be associated with a
variety of neurodegenerative disorders. This invention describes
isolated peptide fragments, pharmaceutical compositions and methods for
use of such for treating subjects with a neurodegenerative disease,
such as Alzheimer's disease (AD), Amyotrophic Lateral Sclerosis (ALS)
and Parkinson's disease (PD). An inhibitory fragment, TFP5, disclosed
in this invention, has been shown to ameliorate symptoms of AD in
disease animal models without any evidence of toxicity. In particular,
TFP5 treatment of rat cortical neurons reduced hyperactivation of Cdk5
upon neuronal stress and insults. Following intraperitoneal (ip)
injection, TFP5 was capable of crossing the blood-brain barrier and
localizing within the brain where it was found to rescue memory
deficits and pathology in a double transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive license may be granted unless
within fifteen (15) days from the date of this published notice, the
NIH receives written evidence and argument that establishes that the
grant of the license would not be consistent with the
[[Page 19214]]
requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated start-up exclusive license. Comments and objections
submitted 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: March 24, 2016.
Susan Ano,
Technology Development Coordinator, NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016-07496 Filed 4-1-16; 8:45 am]
BILLING CODE 4140-01-P
