National Cancer Institute; Notice of Closed Meetings, 54582-54583 [2016-19416]
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Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
Technology Transfer on or before
August 31, 2016 will be considered.
under the Freedom of Information Act,
5 U.S.C. 552.
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated Start-Up Exclusive
Evaluation Option License Agreement
should be directed to: Surekha
Vathyam, Ph.D., Senior Licensing and
Patenting Manager, National Cancer
Institute Technology Transfer Center,
9609 Medical Center Drive, Rm 1E–530
MSC9702, Rockville, MD 20850–9702,
Email: vathyams@mail.nih.gov.
Dated: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
The
subject technology describes methods of
using derivative compositions of
hydroxylamine, including N-t-butyl
hydroxylamine (NtBuHA), for the
treatment of thioesterase deficiencies.
NtBuHA is small molecule derivative of
hydroxylamine which possesses strong
anti-oxidant properties and an ability to
cleave thioester linkages with high
specificity. These capabilities suggest
that NtBuHA may be useful as a
modulator of intracellular protein
palmitoylation dynamics when
endogenous mechanisms are
insufficient to support normal function.
The compounds disclosed in this
invention have potential therapeutic
applications for both the management of
diseases driven by excess accumulation
or malfunction of palmitoylated
proteins. Target disorders may therefore
include neuronal ceroid lipofuscinoses
(also known as Batten Disease),
amyotrophic lateral sclerosis, and Rasdriven cancers.
The prospective Start-Up Exclusive
Evaluation Option License Agreement is
being considered under the small
business initiative launched on October
1, 2011 and will comply with the terms
and conditions of 35 U.S.C. 209 and 37
CFR part 404.7. The prospective StartUp Exclusive Evaluation Option License
Agreement may be granted unless the
NIH receives written evidence and
argument that establishes that the grant
of the contemplated Start-Up Exclusive
Evaluation Option License Agreement
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.7 within fifteen (15) days
from the date of this published notice.
Complete applications for a license in
an appropriate field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Start-Up Exclusive
Evaluation Option License Agreement.
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
National Cancer Institute; Notice of
Closed Meetings
ADDRESSES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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 Cancer
Institute Special Emphasis Panel; Integrating
Biospecimen Science Approaches into
Clinical Assay Development.
Date: September 8, 2016.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Clifford W. Schweinfest,
Ph.D., Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W108,
Rockville, MD 20892–9750, 240–276–6343,
schweinfestcw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Program Project I SEP–1.
Date: September 29–30, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Blvd., Gaithersburg, MD 20878.
Contact Person: Shakeel Ahmad, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W122,
Rockville, MD 20892–9750, 240–276–6349,
ahmads@mail.nih.gov.
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Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Barrett’s Esophagus Translational Research
Network Review.
Date: October 20, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Pooks Hill, 5151
Pooks Hill Road, Bethesda, MD 20814.
Contact Person: Wlodek Lopaczynski, MD,
Ph.D., Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W608, Rockville, MD 20892–9750, 240–
276–6458, lopacw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; PAR 15–
266 Imaging.
Date: October 24, 2016.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
6W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Kenneth L. Bielat, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
Room 7W244, Rockville, MD 20892–9750,
240–276–6373, bielatk@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 SEP–3.
Date: November 3, 2016.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Byeong-Chel C. Lee, Ph.D.,
Scientific Review Officer, Review Training
and Resources Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W238, Rockville, MD 20892–9750, 240–
276–6260, byeong-chel.lee@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Pancreatic
Cancer Detection Consortium (U01).
Date: November 9, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W032, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Majed M. Hamawy, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W120,
Rockville, MD 20892–9750, 240–276–6457,
mh101v@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Biospecimen Science.
Date: December 9, 2016.
Time: 10:00 a.m. to 3:00 p.m.
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Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
Room 7W260, Rockville, MD 20892–9750,
240–276–5856, nadeem.khan@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 10, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19416 Filed 8–15–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health.
ACTION: Notice.
AGENCY:
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: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and 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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Human Monoclonal
Antibodies Targeting Glypican-2 in
Neuroblastoma.
Keywords: Glypican-2, GPC2,
Antibody, Immunotoxin, Recombinant
Immunotoxin, RIT, Chimeric Antigen
Receptor, CAR, Antibody-drug
Conjugate, ADC, bispecific antibody,
neuroblastoma.
Description of Technology:
Neuroblastoma is a rare pediatric cancer
that affects one in every hundred
thousand children under the age of
fifteen in the United States. Current
standards of care are chemotherapy and
surgery, followed by stem-cell
treatments, radiation and antiganglioside antibody therapy, which
yield an average three-year survival rate
of 10–45%. This demonstrates a need
for more effective therapies.
Glypican-2 (GPC2) is a cell surface
protein that has been shown to be
preferentially expressed on numerous
pediatric cancers, including
neuroblastoma. Due to this preferential
expression, GPC2 represents a potential
candidate for targeted therapy.
Researchers at the National Cancer
Institute’s Laboratory of Molecular
Biology (NCI LMB) have developed and
isolated several single domain
monoclonal human antibodies against
GPC2. This technology covers the naked
GPC2 antibodies as well as their use as
targeting domains in recombinant
immunotoxins (RITs) and chimeric
antigen receptors (CARs). RITs (using
clones LH1, LH4, or LH7) and CARs
(using LH7) have shown specific killing
activity against GPC2-expressing cells,
suggesting that these candidates may be
further developed as therapeutics.
The technology has been validated
with in-vitro studies (human anti-GPC2
RITs and CARs can bind to, and kill,
GPC2-positive tumor cells) and the
researchers are currently developing
mouse models to further develop GPC2targeted therapies.
Potential Commercial Applications:
—Therapeutic applications include:
Unconjugated antibodies, and use as
targeting moieties for
immunoconjugates such as CARs,
ADCs, immunotoxins, and bispecific
antibodies
—Diagnostic agent for detecting and
monitoring target-expressing
malignancies
Value Proposition:
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—First to market potential—No current
clinical trials with GPC2-targeted
therapies
—Human antibody with high specificity
and binding to targets results in less
non-specific cell killing, therefore
fewer potential side-effects for the
patient
—Small size of single domain
antibodies enhances stability,
solubility, and target recognition
Development Stage: In-vitro.
Inventor(s): Mitchell Ho (NCI), et al.
Intellectual Property: US Provisional
Application 62/369,861 (HHS Reference
No. E–211–2016/0–US–01) filed August
2, 2016, entitled ‘‘Human Monoclonal
Antibodies Targeting Glypican-2 in
Neuroblastoma.’’
Collaboration Opportunity:
Researchers at the NCI seek parties
interested in licensing or co-developing
GPC2 antibodies and/or conjugates.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 8, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–19419 Filed 8–15–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Advisory Committee for Women’s
Services; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of a meeting of
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Advisory Committee for Women’s
Services (ACWS) on August 24, 2016.
The meeting will include discussions
on child welfare and substance use
disorders among families; improving the
health of women and girls; recoveryoriented systems of care and what they
mean for women; accountable health
communities and how they relate to
behavioral health; and a conversation
with the SAMHSA Deputy of
Operations and the Chief of Staff.
The meeting is open to the public and
will be held at SAMHSA, 5600 Fishers
Lane, Rockville, MD 20857, in
Conference Room 5N76. Attendance by
the public will be limited to space
available. Interested persons may
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Agencies
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54582-54583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19416]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 Cancer Institute Special Emphasis
Panel; Integrating Biospecimen Science Approaches into Clinical
Assay Development.
Date: September 8, 2016.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Room 7W030, Rockville, MD 20850, (Telephone Conference
Call).
Contact Person: Clifford W. Schweinfest, Ph.D., Scientific
Review Officer, Special Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609 Medical Center Drive,
Room 7W108, Rockville, MD 20892-9750, 240-276-6343,
schweinfestcw@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI Program Project I SEP-1.
Date: September 29-30, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD 20878.
Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer,
Research Programs Review Branch, Division of Extramural Activities,
National Cancer Institute, 9609 Medical Center Drive, Room 7W122,
Rockville, MD 20892-9750, 240-276-6349, ahmads@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI Barrett's Esophagus Translational Research Network
Review.
Date: October 20, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Pooks Hill, 5151 Pooks Hill Road,
Bethesda, MD 20814.
Contact Person: Wlodek Lopaczynski, MD, Ph.D., Scientific Review
Officer, Research Programs Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609 Medical Center Drive,
Room 7W608, Rockville, MD 20892-9750, 240-276-6458,
lopacw@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; PAR 15-266 Imaging.
Date: October 24, 2016.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Room 6W030, Rockville, MD 20850, (Telephone Conference
Call).
Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review
Officer, Research Technology and Contract Review Branch, Division of
Extramural Activities, National Cancer Institute, 9609 Medical
Center Drive, Room 7W244, Rockville, MD 20892-9750, 240-276-6373,
bielatk@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI Omnibus R03 SEP-3.
Date: November 3, 2016.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, North Bethesda, MD 20852.
Contact Person: Byeong-Chel C. Lee, Ph.D., Scientific Review
Officer, Review Training and Resources Branch, Division of
Extramural Activities, National Cancer Institute, 9609 Medical
Center Drive, Room 7W238, Rockville, MD 20892-9750, 240-276-6260,
byeong-chel.lee@nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Pancreatic Cancer Detection Consortium (U01).
Date: November 9, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Room 7W032, Rockville, MD 20850, (Telephone Conference
Call).
Contact Person: Majed M. Hamawy, Ph.D., Scientific Review
Officer, Research Programs Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609 Medical Center Drive,
Room 7W120, Rockville, MD 20892-9750, 240-276-6457, mh101v@nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Biospecimen Science.
Date: December 9, 2016.
Time: 10:00 a.m. to 3:00 p.m.
[[Page 54583]]
Agenda: To review and evaluate grant applications.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Room 7W030, Rockville, MD 20850, (Telephone Conference
Call).
Contact Person: Nadeem Khan, Ph.D., Scientific Review Officer,
Research Technology and Contract Review Branch, Division of
Extramural Activities, National Cancer Institute, 9609 Medical
Center Drive, Room 7W260, Rockville, MD 20892-9750, 240-276-5856,
nadeem.khan@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: August 10, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-19416 Filed 8-15-16; 8:45 am]
BILLING CODE 4140-01-P