81 FR 54582 - National Cancer Institute; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range		54582-54583
FR Document		2016-19416
Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016)
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54582-54583]
From the Federal Register Online  [www.thefederalregister.org]
[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, 
[email protected].

    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, [email protected].

    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, 
[email protected].

    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, 
[email protected].

    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, 
[email protected].

    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, [email protected].

    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, 
[email protected].

(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
54582 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices

Technology Transfer on or before under the Freedom of Information Act, Name of Committee: National Cancer
August 31, 2016 will be considered. 5 U.S.C. 552. Institute Special Emphasis Panel; NCI
Barrett’s Esophagus Translational Research
ADDRESSES: Requests for copies of the Dated: August 8, 2016. Network Review.
patent application, inquiries, comments, Richard U. Rodriguez, Date: October 20, 2016.
and other materials relating to the Associate Director, Technology Transfer Time: 8:00 a.m. to 5:00 p.m.
contemplated Start-Up Exclusive Center, National Cancer Institute. Agenda: To review and evaluate grant
Evaluation Option License Agreement [FR Doc. 2016–19418 Filed 8–15–16; 8:45 am]
applications.
should be directed to: Surekha Place: Bethesda Marriott Pooks Hill, 5151
BILLING CODE 4140–01–P
Pooks Hill Road, Bethesda, MD 20814.
Vathyam, Ph.D., Senior Licensing and Contact Person: Wlodek Lopaczynski, MD,
Patenting Manager, National Cancer Ph.D., Scientific Review Officer, Research
Institute Technology Transfer Center, DEPARTMENT OF HEALTH AND Programs Review Branch, Division of
9609 Medical Center Drive, Rm 1E–530 HUMAN SERVICES Extramural Activities, National Cancer
MSC9702, Rockville, MD 20850–9702, Institute, 9609 Medical Center Drive, Room
Email: vathyams@mail.nih.gov. National Institutes of Health 7W608, Rockville, MD 20892–9750, 240–
276–6458, lopacw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The National Cancer Institute; Notice of Name of Committee: National Cancer
subject technology describes methods of Closed Meetings Institute Special Emphasis Panel; PAR 15–
using derivative compositions of 266 Imaging.
hydroxylamine, including N-t-butyl Pursuant to section 10(d) of the Date: October 24, 2016.
hydroxylamine (NtBuHA), for the Federal Advisory Committee Act, as Time: 11:00 a.m. to 3:00 p.m.
treatment of thioesterase deficiencies. amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant
NtBuHA is small molecule derivative of hereby given of the following meetings. applications.
hydroxylamine which possesses strong Place: National Cancer Institute Shady
The meetings will be closed to the Grove, 9609 Medical Center Drive, Room
anti-oxidant properties and an ability to
public in accordance with the 6W030, Rockville, MD 20850, (Telephone
cleave thioester linkages with high
provisions set forth in sections Conference Call).
specificity. These capabilities suggest
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: Kenneth L. Bielat, Ph.D.,
that NtBuHA may be useful as a Scientific Review Officer, Research
as amended. The grant applications and
modulator of intracellular protein Technology and Contract Review Branch,
the discussions could disclose
palmitoylation dynamics when Division of Extramural Activities, National
confidential trade secrets or commercial
endogenous mechanisms are Cancer Institute, 9609 Medical Center Drive,
property such as patentable material,
insufficient to support normal function. Room 7W244, Rockville, MD 20892–9750,
and personal information concerning 240–276–6373, bielatk@mail.nih.gov.
The compounds disclosed in this individuals associated with the grant
invention have potential therapeutic Name of Committee: National Cancer
applications, the disclosure of which Institute Special Emphasis Panel; NCI
applications for both the management of would constitute a clearly unwarranted
diseases driven by excess accumulation Omnibus R03 SEP–3.
invasion of personal privacy. Date: November 3, 2016.
or malfunction of palmitoylated Time: 8:00 a.m. to 3:30 p.m.
proteins. Target disorders may therefore Name of Committee: National Cancer
Institute Special Emphasis Panel; Integrating Agenda: To review and evaluate grant
include neuronal ceroid lipofuscinoses Biospecimen Science Approaches into applications.
(also known as Batten Disease), Clinical Assay Development. Place: Bethesda North Marriott Hotel &
amyotrophic lateral sclerosis, and Ras- Date: September 8, 2016. Conference Center, 5701 Marinelli Road,
driven cancers. Time: 11:00 a.m. to 2:00 p.m. North Bethesda, MD 20852.
The prospective Start-Up Exclusive Agenda: To review and evaluate grant Contact Person: Byeong-Chel C. Lee, Ph.D.,
applications. Scientific Review Officer, Review Training
Evaluation Option License Agreement is
Place: National Cancer Institute Shady and Resources Branch, Division of
being considered under the small Extramural Activities, National Cancer
Grove, 9609 Medical Center Drive, Room
business initiative launched on October Institute, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone
1, 2011 and will comply with the terms Conference Call). 7W238, Rockville, MD 20892–9750, 240–
and conditions of 35 U.S.C. 209 and 37 Contact Person: Clifford W. Schweinfest, 276–6260, byeong-chel.lee@nih.gov.
CFR part 404.7. The prospective Start- Ph.D., Scientific Review Officer, Special Name of Committee: National Cancer
Up Exclusive Evaluation Option License Review Branch, Division of Extramural Institute Special Emphasis Panel; Pancreatic
Agreement may be granted unless the Activities, National Cancer Institute, 9609 Cancer Detection Consortium (U01).
NIH receives written evidence and Medical Center Drive, Room 7W108, Date: November 9, 2016.
argument that establishes that the grant Rockville, MD 20892–9750, 240–276–6343, Time: 9:00 a.m. to 5:00 p.m.
of the contemplated Start-Up Exclusive schweinfestcw@mail.nih.gov. Agenda: To review and evaluate grant
Name of Committee: National Cancer applications.
Evaluation Option License Agreement
Institute Special Emphasis Panel; NCI Place: National Cancer Institute Shady
would not be consistent with the Grove, 9609 Medical Center Drive, Room
Program Project I SEP–1.
requirements of 35 U.S.C. 209 and 37 7W032, Rockville, MD 20850, (Telephone
Date: September 29–30, 2016.
CFR part 404.7 within fifteen (15) days Time: 8:00 a.m. to 6:00 p.m. Conference Call).
from the date of this published notice. Agenda: To review and evaluate grant Contact Person: Majed M. Hamawy, Ph.D.,
Complete applications for a license in applications. Scientific Review Officer, Research Programs
an appropriate field of use that are filed Place: Gaithersburg Marriott Review Branch, Division of Extramural
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Washingtonian Center, 9751 Washingtonian Activities, National Cancer Institute, 9609
in response to this notice will be treated
Blvd., Gaithersburg, MD 20878. Medical Center Drive, Room 7W120,
as objections to the grant of the Rockville, MD 20892–9750, 240–276–6457,
contemplated Start-Up Exclusive Contact Person: Shakeel Ahmad, Ph.D.,
Scientific Review Officer, Research Programs mh101v@nih.gov.
Evaluation Option License Agreement. Review Branch, Division of Extramural Name of Committee: National Cancer
Comments and objections submitted to Activities, National Cancer Institute, 9609 Institute Special Emphasis Panel;
this notice will not be made available Medical Center Drive, Room 7W122, Biospecimen Science.
for public inspection and, to the extent Rockville, MD 20892–9750, 240–276–6349, Date: December 9, 2016.
permitted by law, will not be released ahmads@mail.nih.gov. 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 54583

Agenda: To review and evaluate grant Email ncitechtransfer@mail.nih.gov. A —First to market potential—No current
applications. signed Confidential Disclosure clinical trials with GPC2-targeted
Place: National Cancer Institute Shady Agreement may be required to receive therapies
Grove, 9609 Medical Center Drive, Room —Human antibody with high specificity
copies of the patent applications.
7W030, Rockville, MD 20850, (Telephone
Conference Call). SUPPLEMENTARY INFORMATION: and binding to targets results in less
Contact Person: Nadeem Khan, Ph.D., Technology description follows. non-specific cell killing, therefore
Scientific Review Officer, Research Title of invention: Human Monoclonal fewer potential side-effects for the
Technology and Contract Review Branch, Antibodies Targeting Glypican-2 in patient
Division of Extramural Activities, National Neuroblastoma. —Small size of single domain
Cancer Institute, 9609 Medical Center Drive, antibodies enhances stability,
Room 7W260, Rockville, MD 20892–9750, Keywords: Glypican-2, GPC2,
solubility, and target recognition
240–276–5856, nadeem.khan@nih.gov. Antibody, Immunotoxin, Recombinant
Immunotoxin, RIT, Chimeric Antigen Development Stage: In-vitro.
(Catalogue of Federal Domestic Assistance Inventor(s): Mitchell Ho (NCI), et al.
Program Nos. 93.392, Cancer Construction; Receptor, CAR, Antibody-drug
Intellectual Property: US Provisional
93.393, Cancer Cause and Prevention Conjugate, ADC, bispecific antibody,
Application 62/369,861 (HHS Reference
Research; 93.394, Cancer Detection and neuroblastoma.
Diagnosis Research; 93.395, Cancer
No. E–211–2016/0–US–01) filed August
Description of Technology: 2, 2016, entitled ‘‘Human Monoclonal
Treatment Research; 93.396, Cancer Biology Neuroblastoma is a rare pediatric cancer
Research; 93.397, Cancer Centers Support; Antibodies Targeting Glypican-2 in
that affects one in every hundred Neuroblastoma.’’
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
thousand children under the age of Collaboration Opportunity:
HHS) fifteen in the United States. Current Researchers at the NCI seek parties
standards of care are chemotherapy and interested in licensing or co-developing
Dated: August 10, 2016. surgery, followed by stem-cell
Melanie J. Gray, GPC2 antibodies and/or conjugates.
treatments, radiation and anti- Contact Information: Requests for
Program Analyst, Office of Federal Advisory ganglioside antibody therapy, which
Committee Policy.
copies of the patent application or
yield an average three-year survival rate inquiries about licensing, research
[FR Doc. 2016–19416 Filed 8–15–16; 8:45 am] of 10–45%. This demonstrates a need collaborations, and co-development
BILLING CODE 4140–01–P for more effective therapies. opportunities should be sent to John D.
Glypican-2 (GPC2) is a cell surface Hewes, Ph.D., email: john.hewes@
protein that has been shown to be nih.gov.
DEPARTMENT OF HEALTH AND preferentially expressed on numerous
HUMAN SERVICES Dated: August 8, 2016.
pediatric cancers, including
neuroblastoma. Due to this preferential John D. Hewes,
National Institutes of Health Technology Transfer Specialist, Technology
expression, GPC2 represents a potential
candidate for targeted therapy. Transfer Center, National Cancer Institute.
Government-Owned Inventions; [FR Doc. 2016–19419 Filed 8–15–16; 8:45 am]
Availability for Licensing Researchers at the National Cancer
Institute’s Laboratory of Molecular BILLING CODE 4140–01–P
AGENCY: National Institutes of Health. Biology (NCI LMB) have developed and
ACTION: Notice. isolated several single domain
monoclonal human antibodies against DEPARTMENT OF HEALTH AND
SUMMARY: The invention listed below is GPC2. This technology covers the naked HUMAN SERVICES
owned by an agency of the U.S. GPC2 antibodies as well as their use as
Government and is available for Substance Abuse and Mental Health
targeting domains in recombinant Services Administration
licensing and/or co-development in the immunotoxins (RITs) and chimeric
U.S. in accordance with 35 U.S.C. 209 antigen receptors (CARs). RITs (using
and 37 CFR part 404 to achieve Advisory Committee for Women’s
clones LH1, LH4, or LH7) and CARs Services; Notice of Meeting
expeditious commercialization of (using LH7) have shown specific killing
results of federally-funded research and activity against GPC2-expressing cells, Pursuant to Public Law 92–463,
development. Foreign patent suggesting that these candidates may be notice is hereby given of a meeting of
applications are filed on selected further developed as therapeutics. the Substance Abuse and Mental Health
inventions to extend market coverage Services Administration’s (SAMHSA)
The technology has been validated
for companies and may also be available Advisory Committee for Women’s
with in-vitro studies (human anti-GPC2
for licensing and/or co-development. Services (ACWS) on August 24, 2016.
RITs and CARs can bind to, and kill,
ADDRESSES: Invention Development and GPC2-positive tumor cells) and the The meeting will include discussions
Marketing Unit, Technology Transfer researchers are currently developing on child welfare and substance use
Center, National Cancer Institute, 9609 mouse models to further develop GPC2- disorders among families; improving the
Medical Center Drive, Mail Stop 9702, targeted therapies. health of women and girls; recovery-
Rockville, MD 20850–9702. Potential Commercial Applications: oriented systems of care and what they
FOR FURTHER INFORMATION CONTACT: mean for women; accountable health
—Therapeutic applications include:
Information on licensing and co- communities and how they relate to
Unconjugated antibodies, and use as
development research collaborations, behavioral health; and a conversation
asabaliauskas on DSK3SPTVN1PROD with NOTICES

targeting moieties for
and copies of the U.S. patent with the SAMHSA Deputy of
immunoconjugates such as CARs,
applications listed below may be Operations and the Chief of Staff.
ADCs, immunotoxins, and bispecific
obtained by contacting: Attn. Invention The meeting is open to the public and
antibodies
Development and Marketing Unit, will be held at SAMHSA, 5600 Fishers
Technology Transfer Center, National —Diagnostic agent for detecting and Lane, Rockville, MD 20857, in
Cancer Institute, 9609 Medical Center monitoring target-expressing Conference Room 5N76. Attendance by
Drive, Mail Stop 9702, Rockville, MD malignancies the public will be limited to space
20850–9702, Tel. 240–276–5515 or Value Proposition: available. Interested persons may

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Document Created: 2016-08-16 03:20:14
Document Modified: 2016-08-16 03:20:14
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		September 8, 2016.
FR Citation		81 FR 54582