Prospective Grant of an Exclusive Patent License: The Development and Use of a Therapeutic STAT3 Inhibitor, GLG-302, in All Proliferative Diseases, Where STAT3 Is Present, 23798-23799 [2019-10779]
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Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices
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FOR FURTHER INFORMATION CONTACT:
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helen.lamont@hhs.gov.
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the Secretary shall appoint one member
for the researcher, voluntary health
association, healthcare provider, patient
advocate, caregiver categories to replace
the five members whose terms will end
VerDate Sep<11>2014
16:40 May 22, 2019
Jkt 247001
on September 30th, 2019. After
receiving nominations, the Secretary,
with input from his staff, will make the
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will be announced soon after. Members
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taken office. Members will serve as
Special Government Employees.
Dated: May 17, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2019–10775 Filed 5–22–19; 8:45 am]
BILLING CODE 4150–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: The Development and
Use of a Therapeutic STAT3 Inhibitor,
GLG–302, in All Proliferative Diseases,
Where STAT3 Is Present
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
(U.S.) Patents and Patent Applications
listed in the SUPPLEMENTARY
INFORMATION section of this notice to
GLG Pharma LLC located in Jupiter,
Florida, USA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before June 7, 2019 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Sidra Ahsan, Licensing and
Patenting Manager, NCI Technology
Transfer Center, 9609 Medical Center
Drive, RM 1E530 MSC 9702, Bethesda,
MD 20892–9702 (for business mail),
Rockville, MD 20850–9702 Telephone:
(240) 276–5530; Facsimile: (240) 276–
5504 Email: ahsans@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 62/481,960, filed April
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
5, 2017 and entitled ‘‘Improved STAT3
Inhibitor Formulation’’ [HHS Reference
No. E–035–2017/0–US–01]; PCT Patent
Application No. PCT/US2018/026228,
filed April 5, 2018 and entitled ‘‘STAT3
Inhibitor Formulation’’ [HHS Reference
No. E–035–2017/0–PCT–02]; and U.S.
and foreign patent applications claiming
priority to the aforementioned
applications.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to: ‘‘The
development and commercialization of
a therapeutic STAT3 inhibitor, GLG–
302, in all proliferative diseases, where
STAT3 is present.’’
This technology discloses the use of
the STAT3 inhibitor GLG–302 with
Trizma salts for preclinical anti-cancer
and cancer preventive activity. GLG–
302 is a proprietary compound
developed by GLG Pharma LLC. Trizma
salts allow GLG–302 to remain in
solution for oral administration. This
formulation has been demonstrated to
be effective in the modulation of STAT3
signaling and proliferation in normal
mammary ductal epithelium, and this
formulation has demonstrated
mammary cancer preventive efficacy in
rat (ER+) and mouse (ER¥) models. The
technology provides improved sample
handing and oral bioavailability
suggesting that a therapeutic product
derived from this technology would be
applicable for the treatment of cancer
where STAT3 is present.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute 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 part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
E:\FR\FM\23MYN1.SGM
23MYN1
23799
Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices
Freedom of Information Act, 5 U.S.C.
552.
Dated: May 15, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–10779 Filed 5–22–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Hazardous Waste
Worker Training Grantee Data
Collection—42 CFR Part 65 (National
Institute of Environmental Health
Sciences)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Joseph T. Hughes, Jr., Director,
Worker Training Program (WTP),
Division of Extramural Research and
SUMMARY:
non-profit organizations that are
committed to protecting workers and
their communities by delivering highquality, peer-reviewed safety and health
curricula to target populations of
hazardous waste workers and
emergency responders has been
developed. In thirty-one years (FY
1987–2018), the NIEHS WTP has
successfully supported 20 primary
grantees that have trained more than 4.1
million workers across the country and
presented over 245,830 classroom and
hands-on training courses, which have
accounted for over 50 million contact
hours of actual training. Generally, the
grant will initially be for one year, and
subsequent continuation awards are also
for one year at a time. Grantees must
submit a separate application to have
the support continued for each
subsequent year. Grantees are to provide
information in accordance with S65.4
(a), (b), (c) and 65.6(a) on the nature,
duration, and purpose of the training,
selection criteria for trainees’
qualifications and competency of the
project director and staff, cooperative
agreements in the case of joint
applications, the adequacy of training
plans and resources, including budget
and curriculum, and response to
meeting training criteria in OSHA’s
Hazardous Waste Operations and
Emergency Response Regulations (29
CFR 1910.120). As a cooperative
agreement, there are additional
requirements for the progress report
section of the application. Grantees are
to upload their information into the
WTP Grantee Data Management System.
The information collected is used by the
Director through officers, employees,
experts, and consultants to evaluate
applications based on technical merit to
determine whether to make awards and
whether appropriate training is being
conducted to support continuation of
the grant into subsequent years.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
616.
Training (DERT), NIEHS, P.O. Box
12233 MD: K3–14, Research Triangle
Park, NC 27709 or call non-toll-free
number (984) 287–3271 or Email your
request, including your address to:
hughes3@niehs.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on March 12, 2019, Vol. 84, No.
48 page 8883 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Hazardous
Waste Worker Training Grantee Data
Collection—42 CFR part 65 (NIEHS),
0925–0348, Expiration Date 03/31/2019
REINSTATEMENT WITHOUT
CHANGE, National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This request for OMB review
and approval of the information
collection is required by regulation 42
CFR part 65(a)(6). The National Institute
of Environmental Health Sciences
(NIEHS) was given major responsibility
for initiating a worker safety and health
training program under Section 126 of
the Superfund Amendments and
Reauthorization Act of 1986 (SARA) for
hazardous waste workers and
emergency responders. A network of
khammond on DSKBBV9HB2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Type of
respondent
Information Collection Questionnaire (Data Management
System).
Grantee ..........
22
2
14
616
Total ..............................................................................
........................
22
44
........................
616
VerDate Sep<11>2014
16:40 May 22, 2019
Jkt 247001
PO 00000
Frm 00046
Fmt 4703
Number of
respondents
Number of
responses per
respondent
Form name
Sfmt 4703
E:\FR\FM\23MYN1.SGM
23MYN1
Total annual
burden hour
]]>Agencies
[Federal Register Volume 84, Number 100 (Thursday, May 23, 2019)]
[Notices]
[Pages 23798-23799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: The Development
and Use of a Therapeutic STAT3 Inhibitor, GLG-302, in All Proliferative
Diseases, Where STAT3 Is Present
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, an institute of the National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an Exclusive Patent License to practice the
inventions embodied in the (U.S.) Patents and Patent Applications
listed in the Supplementary Information section of this notice to GLG
Pharma LLC located in Jupiter, Florida, USA.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before June 7, 2019 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an Exclusive Patent License
should be directed to: Sidra Ahsan, Licensing and Patenting Manager,
NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-
9702 Telephone: (240) 276-5530; Facsimile: (240) 276-5504 Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent Application No. 62/481,960, filed
April 5, 2017 and entitled ``Improved STAT3 Inhibitor Formulation''
[HHS Reference No. E-035-2017/0-US-01]; PCT Patent Application No. PCT/
US2018/026228, filed April 5, 2018 and entitled ``STAT3 Inhibitor
Formulation'' [HHS Reference No. E-035-2017/0-PCT-02]; and U.S. and
foreign patent applications claiming priority to the aforementioned
applications.
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to: ``The development and
commercialization of a therapeutic STAT3 inhibitor, GLG-302, in all
proliferative diseases, where STAT3 is present.''
This technology discloses the use of the STAT3 inhibitor GLG-302
with Trizma salts for preclinical anti-cancer and cancer preventive
activity. GLG-302 is a proprietary compound developed by GLG Pharma
LLC. Trizma salts allow GLG-302 to remain in solution for oral
administration. This formulation has been demonstrated to be effective
in the modulation of STAT3 signaling and proliferation in normal
mammary ductal epithelium, and this formulation has demonstrated
mammary cancer preventive efficacy in rat (ER+) and mouse (ER-) models.
The technology provides improved sample handing and oral
bioavailability suggesting that a therapeutic product derived from this
technology would be applicable for the treatment of cancer where STAT3
is present.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the National
Cancer Institute 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 part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in these license applications will be made only as
required and upon a request under the
[[Page 23799]]
Freedom of Information Act, 5 U.S.C. 552.
Dated: May 15, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-10779 Filed 5-22-19; 8:45 am]
BILLING CODE 4140-01-P
