Request for Steering Committee Nominations, 44161-44162 [2015-18123]
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Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
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[FR Doc. 2015–18113 Filed 7–23–15; 8:45 am]
BILLING CODE 7590–01–P
REAGAN-UDALL FOUNDATION FOR
THE FOOD AND DRUG
ADMINISTRATION
Request for Steering Committee
Nominations
Request for nominations to the
Steering Committee for the Foundation’s
PredicTox project.
ACTION:
The Reagan-Udall Foundation
(RUF) for the Food and Drug
Administration (FDA), which was
created by Title VI of the Food and Drug
Amendments of 2007, is requesting
nominations for its PredicTox Steering
Committee. The Steering Committee
will provide oversight and guidance for
the PredicTox project, and will report to
the Reagan-Udall Foundation for the
FDA’s Board of Directors.
DATES: All nominations must be
submitted to the Reagan-Udall
Foundation for the FDA by August 28,
2015. The PredicTox Steering
Committee members will be selected by
the Reagan-Udall Foundation for the
FDA’s Board of Directors; those selected
will be notified by September 30
regarding the Board’s decision. See the
SUPPLEMENTARY INFORMATION section for
Steering Committee responsibilities,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:59 Jul 23, 2015
Jkt 235001
selection criteria and nomination
instructions.
ADDRESSES: The Reagan-Udall
Foundation for the FDA is located at
1025 Connecticut Ave. NW., Suite 1000,
Washington, DC 20036.
FOR FURTHER INFORMATION CONTACT:
Questions should be sent to The ReaganUdall Foundation for the FDA, 202–
828–1205, PredicTox@ReaganUdall.org.
SUPPLEMENTARY INFORMATION:
I. Background
The Reagan-Udall Foundation for the
FDA (the Foundation) is an independent
501(c)(3) not-for-profit organization
created by Congress to advance the
mission of FDA to modernize medical,
veterinary, food, food ingredient, and
cosmetic product development;
accelerate innovation; and enhance
product safety. The Foundation acts as
a neutral third party to establish novel,
scientific collaborations. With the
ultimate goal of improving public
health, the Foundation provides a
unique opportunity for different sectors
(FDA, patient groups, academia, other
government entities, and industry) to
work together in a transparent way to
create exciting new research projects to
advance regulatory science.
PredicTox is a public-private
partnership led by the Foundation,
which brings together multiple
stakeholder groups to leverage collective
knowledge, technical expertise, data,
funding, and other resources to explore
systems pharmacology approaches to
better understand and predict adverse
events (AEs). Developing new tools and
approaches for mechanism-based drug
safety assessment and prediction is a
priority for the FDA, as highlighted in
the Agency’s 2011 Strategic Plan for
Advancing Regulatory Science. This
project aims to harness scientific and
technological knowledge, data and
computational capacity across various
sectors and disciplines to develop and
apply systems-based approaches and
multi-scales models to drug safety
assessment in a coordinated manner.
While systems-based approaches can
be applied to the development of
predictive models for any class of drug
or AE, the PredicTox pilot seeks to first
provide a proof of concept pilot by
focusing on large and small molecule
tyrosine kinase inhibitors (TKIs) and
cardiac AEs, specifically left ventricular
dysfunction. TKIs are a rapidly growing
treatment for oncology and select other
therapeutic areas, making them an area
of intense importance for patients, the
FDA, and pharmaceutical
manufacturers. Learnings from the
PredicTox pilot will then be applied to
PO 00000
Frm 00143
Fmt 4703
Sfmt 4703
44161
other drug classes and/or other
toxicities.
The primary objective of PredicTox is
to advance systems-based science and
tools necessary to support mechanismbased drug safety assessment and
prediction. To accomplish this
objective, the PredicTox pilot project
will be conducted in an iterative,
phased manner over the course of
several years. The first phase will center
on building and populating a knowledge
management platform for molecular
data, preclinical in vivo pharmacologic
and toxicologic data as well as clinical
data from both public and private
sources.
The PredicTox platform will enable
integration, mining, and analysis of
highly heterogeneous data not typically
combined. Future phases of the project
will focus on data mining and
development of analytic and
visualization tools along with
development of multi-scale predictive
models capable of linking events at the
molecular level with events at the
clinical level (AEs) for improved safety
assessment. For additional project
information, see the Reagan-Udall
Foundation Web site.
II. PredicTox Steering Committee Roles
and Responsibilities
The PredicTox Steering Committee
will provide guidance on the operation
of PredicTox, in conjunction with the
RUF Board, project staff, and others.
The Steering Committee will provide
overall programmatic oversight to
ensure a focus on the long-term vision
of the project, while the Scientific
Advisory Committee will provide highly
specialized technical expertise.
The PredicTox Steering Committee
will be charged with several
responsibilities, including:
• Reviewing and approving the
PredicTox Charter
• Monitoring adherence to the
PredicTox mission and operational
principles in the Charter
• Developing metrics and evaluating
the project at various milestones
• Reviewing and approving the
PredicTox Research Agenda
• Reviewing proposals and contracts
submitted to the project
The PredicTox Steering Committee
Chair must be able to complete
additional responsibilities, including:
• Defining the Steering Committee’s
meeting agendas and facilitating those
meetings
• Recommending for termination, as
necessary, any PredicTox Steering
Committee members demonstrating
dereliction of duties as specified in the
PredicTox Charter
E:\FR\FM\24JYN1.SGM
24JYN1
44162
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
• Other responsibilities as required
upon implementation of PredicTox
A full list of Steering Committee
responsibilities, as well as
responsibilities of the Chair, may be
found on the Reagan-Udall Foundation
Web site.
III. PredicTox Steering Committee
Positions and Selection Criteria
V. Nomination Instructions
RUF is seeking nominations for 7
voting members of the PredicTox
Steering Committee, comprised of the
following 5 categories:
• Patient Advocate: 1 member
• Pharmaceutical sector: 2 members
• Technology sector: 1 member
• Academia/Research Institute: 2
members
• At Large: 1 member
The Steering Committee will also
have 2 members from the FDA
(appointed by the FDA) and 1 member
from the National Institutes of Health
(appointed by the National Institutes of
Health). These 3 individuals will be
non-voting members.
Nominees for the voting positions will
be evaluated by the RUF Board based on
the following required criteria for each
of the 7 positions:
• Ability to complete Steering
Committee responsibilities, listed above
• Currently employed by/
volunteering for stakeholder field (e.g.,
pharmaceutical, academia, patient
advocate, etc.) with several years of
relevant experience
• Leading expert in their relevant
field (based on position, publications, or
other experience)
• Working knowledge of at least one
of the following areas: Risk assessment;
drug safety profiling; pharmacology or
systems pharmacology; toxicology or
systems toxicology; biostatistics;
cardiology; oncology; bioinformatics;
ontology; multi-scale modeling;
knowledge management platforms;
software development; or data sharing
• Prior experience serving on a
related or similar governance body
• Understanding of the landscape and
the impact on the stakeholder group
they are representing with their seat
asabaliauskas on DSK5VPTVN1PROD with NOTICES
IV. Terms of Service
• The PredicTox Steering Committee
meets in-person at least twice per year,
with teleconferences in between
meetings as deemed necessary by the
Chair
• Members will serve two or three
year, staggered terms, as determined by
the RUF Board
• Members do not receive
compensation from RUF
• Members can be reimbursed by RUF
for actual and reasonable expenses
VerDate Sep<11>2014
19:59 Jul 23, 2015
Jkt 235001
incurred in support of PredicTox in
accordance with applicable law and
their specific institutional policies
• Members are subject to the
PredicTox Conflict of Interest policies
(additional information can be accessed
on the Reagan-Udall Foundation Web
site)
• The nomination form can be
accessed on the Reagan-Udall
Foundation Web site
• Individuals may be nominated for 1
or more of the 5 stakeholder categories
• Individuals may nominate
themselves or others
• The nomination deadline is August
28, 2015.
Dated: July 20, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation
for the FDA.
[FR Doc. 2015–18123 Filed 7–23–15; 8:45 am]
BILLING CODE 4164–04–P
SECURITIES AND EXCHANGE
COMMISSION
[Release No. 34–75491; File No. SR–CBOE–
2015–064]
Self-Regulatory Organizations;
Chicago Board Options Exchange,
Incorporated; Notice of Filing and
Immediate Effectiveness of a Proposed
Rule Change Relating to the Options
Regulatory Fee
July 20, 2015.
Pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934,1 and
Rule 19b–4 thereunder,2 notice is
hereby given that on July 10, 2015,
Chicago Board Options Exchange,
Incorporated filed with the Securities
and Exchange Commission (the
‘‘Commission’’) the proposed rule
change as described in Items I, II, and
III below, which Items have been
prepared by the Exchange. The
Commission is publishing this notice to
solicit comments on the proposed rule
change from interested persons.
I. Self-Regulatory Organization’s
Statement of the Terms of Substance of
the Proposed Rule Change
Chicago Board Options Exchange,
Incorporated (the ‘‘Exchange’’ or
‘‘CBOE’’) proposes to amend the
Options Regulatory Fee. The text of the
proposed rule change is available on the
Exchange’s Web site (https://
www.cboe.com/AboutCBOE/
PO 00000
U.S.C. 78s(b)(1).
2 17 CFR 240.19b–4.
Fmt 4703
II. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
In its filing with the Commission, the
Exchange included statements
concerning the purpose of and basis for
the proposed rule change and discussed
any comments it received on the
proposed rule change. The text of these
statements may be examined at the
places specified in Item IV below. The
Exchange has prepared summaries, set
forth in sections A, B, and C below, of
the most significant aspects of such
statements.
A. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
1. Purpose
The Exchange proposes to decrease
the Options Regulatory Fee (‘‘ORF’’)
from $.0086 to $.0064 per contract in
order to help ensure that revenue
collected from the ORF, in combination
with other regulatory fees and fines,
does not exceed the Exchange’s total
regulatory costs. The proposed fee
change would be operative on August 1,
2015.
The ORF is assessed by the Exchange
to each Trading Permit Holder for all
options transactions executed or cleared
by the Trading Permit Holder that are
cleared by The Options Clearing
Corporation (‘‘OCC’’) in the customer
range (i.e., transactions that clear in a
customer account at OCC) regardless of
the exchange on which the transaction
occurs.3 In other words, the Exchange
imposes the ORF on all customer-range
transactions executed by a Trading
Permit Holder, even if the transactions
do not take place on the Exchange. The
ORF also is charged for transactions that
are not executed by a Trading Permit
Holder but are ultimately cleared by a
Trading Permit Holder. In the case
where a Trading Permit Holder executes
a transaction and a different Trading
Permit Holder clears the transaction, the
ORF is assessed to the Trading Permit
Holder who executed the transaction. In
the case where a non-Trading Permit
Holder executes a transaction and a
Trading Permit Holder clears the
transaction, the ORF is assessed to the
Trading Permit Holder who clears the
3 The ORF also applies to customer-range
transactions executed during Extended Trading
Hours.
1 15
Frm 00144
CBOELegalRegulatoryHome.aspx), at
the Exchange’s Office of the Secretary,
and at the Commission’s Public
Reference Room.
Sfmt 4703
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
- REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44161-44162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18123]
=======================================================================
-----------------------------------------------------------------------
REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
Request for Steering Committee Nominations
ACTION: Request for nominations to the Steering Committee for the
Foundation's PredicTox project.
-----------------------------------------------------------------------
SUMMARY: The Reagan-Udall Foundation (RUF) for the Food and Drug
Administration (FDA), which was created by Title VI of the Food and
Drug Amendments of 2007, is requesting nominations for its PredicTox
Steering Committee. The Steering Committee will provide oversight and
guidance for the PredicTox project, and will report to the Reagan-Udall
Foundation for the FDA's Board of Directors.
DATES: All nominations must be submitted to the Reagan-Udall Foundation
for the FDA by August 28, 2015. The PredicTox Steering Committee
members will be selected by the Reagan-Udall Foundation for the FDA's
Board of Directors; those selected will be notified by September 30
regarding the Board's decision. See the SUPPLEMENTARY INFORMATION
section for Steering Committee responsibilities, selection criteria and
nomination instructions.
ADDRESSES: The Reagan-Udall Foundation for the FDA is located at 1025
Connecticut Ave. NW., Suite 1000, Washington, DC 20036.
FOR FURTHER INFORMATION CONTACT: Questions should be sent to The
Reagan-Udall Foundation for the FDA, 202-828-1205,
PredicTox@ReaganUdall.org.
SUPPLEMENTARY INFORMATION:
I. Background
The Reagan-Udall Foundation for the FDA (the Foundation) is an
independent 501(c)(3) not-for-profit organization created by Congress
to advance the mission of FDA to modernize medical, veterinary, food,
food ingredient, and cosmetic product development; accelerate
innovation; and enhance product safety. The Foundation acts as a
neutral third party to establish novel, scientific collaborations. With
the ultimate goal of improving public health, the Foundation provides a
unique opportunity for different sectors (FDA, patient groups,
academia, other government entities, and industry) to work together in
a transparent way to create exciting new research projects to advance
regulatory science.
PredicTox is a public-private partnership led by the Foundation,
which brings together multiple stakeholder groups to leverage
collective knowledge, technical expertise, data, funding, and other
resources to explore systems pharmacology approaches to better
understand and predict adverse events (AEs). Developing new tools and
approaches for mechanism-based drug safety assessment and prediction is
a priority for the FDA, as highlighted in the Agency's 2011 Strategic
Plan for Advancing Regulatory Science. This project aims to harness
scientific and technological knowledge, data and computational capacity
across various sectors and disciplines to develop and apply systems-
based approaches and multi-scales models to drug safety assessment in a
coordinated manner.
While systems-based approaches can be applied to the development of
predictive models for any class of drug or AE, the PredicTox pilot
seeks to first provide a proof of concept pilot by focusing on large
and small molecule tyrosine kinase inhibitors (TKIs) and cardiac AEs,
specifically left ventricular dysfunction. TKIs are a rapidly growing
treatment for oncology and select other therapeutic areas, making them
an area of intense importance for patients, the FDA, and pharmaceutical
manufacturers. Learnings from the PredicTox pilot will then be applied
to other drug classes and/or other toxicities.
The primary objective of PredicTox is to advance systems-based
science and tools necessary to support mechanism-based drug safety
assessment and prediction. To accomplish this objective, the PredicTox
pilot project will be conducted in an iterative, phased manner over the
course of several years. The first phase will center on building and
populating a knowledge management platform for molecular data,
preclinical in vivo pharmacologic and toxicologic data as well as
clinical data from both public and private sources.
The PredicTox platform will enable integration, mining, and
analysis of highly heterogeneous data not typically combined. Future
phases of the project will focus on data mining and development of
analytic and visualization tools along with development of multi-scale
predictive models capable of linking events at the molecular level with
events at the clinical level (AEs) for improved safety assessment. For
additional project information, see the Reagan-Udall Foundation Web
site.
II. PredicTox Steering Committee Roles and Responsibilities
The PredicTox Steering Committee will provide guidance on the
operation of PredicTox, in conjunction with the RUF Board, project
staff, and others. The Steering Committee will provide overall
programmatic oversight to ensure a focus on the long-term vision of the
project, while the Scientific Advisory Committee will provide highly
specialized technical expertise.
The PredicTox Steering Committee will be charged with several
responsibilities, including:
Reviewing and approving the PredicTox Charter
Monitoring adherence to the PredicTox mission and
operational principles in the Charter
Developing metrics and evaluating the project at various
milestones
Reviewing and approving the PredicTox Research Agenda
Reviewing proposals and contracts submitted to the project
The PredicTox Steering Committee Chair must be able to complete
additional responsibilities, including:
Defining the Steering Committee's meeting agendas and
facilitating those meetings
Recommending for termination, as necessary, any PredicTox
Steering Committee members demonstrating dereliction of duties as
specified in the PredicTox Charter
[[Page 44162]]
Other responsibilities as required upon implementation of
PredicTox
A full list of Steering Committee responsibilities, as well as
responsibilities of the Chair, may be found on the Reagan-Udall
Foundation Web site.
III. PredicTox Steering Committee Positions and Selection Criteria
RUF is seeking nominations for 7 voting members of the PredicTox
Steering Committee, comprised of the following 5 categories:
Patient Advocate: 1 member
Pharmaceutical sector: 2 members
Technology sector: 1 member
Academia/Research Institute: 2 members
At Large: 1 member
The Steering Committee will also have 2 members from the FDA
(appointed by the FDA) and 1 member from the National Institutes of
Health (appointed by the National Institutes of Health). These 3
individuals will be non-voting members.
Nominees for the voting positions will be evaluated by the RUF
Board based on the following required criteria for each of the 7
positions:
Ability to complete Steering Committee responsibilities,
listed above
Currently employed by/volunteering for stakeholder field
(e.g., pharmaceutical, academia, patient advocate, etc.) with several
years of relevant experience
Leading expert in their relevant field (based on position,
publications, or other experience)
Working knowledge of at least one of the following areas:
Risk assessment; drug safety profiling; pharmacology or systems
pharmacology; toxicology or systems toxicology; biostatistics;
cardiology; oncology; bioinformatics; ontology; multi-scale modeling;
knowledge management platforms; software development; or data sharing
Prior experience serving on a related or similar
governance body
Understanding of the landscape and the impact on the
stakeholder group they are representing with their seat
IV. Terms of Service
The PredicTox Steering Committee meets in-person at least
twice per year, with teleconferences in between meetings as deemed
necessary by the Chair
Members will serve two or three year, staggered terms, as
determined by the RUF Board
Members do not receive compensation from RUF
Members can be reimbursed by RUF for actual and reasonable
expenses incurred in support of PredicTox in accordance with applicable
law and their specific institutional policies
Members are subject to the PredicTox Conflict of Interest
policies (additional information can be accessed on the Reagan-Udall
Foundation Web site)
V. Nomination Instructions
The nomination form can be accessed on the Reagan-Udall
Foundation Web site
Individuals may be nominated for 1 or more of the 5
stakeholder categories
Individuals may nominate themselves or others
The nomination deadline is August 28, 2015.
Dated: July 20, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-18123 Filed 7-23-15; 8:45 am]
BILLING CODE 4164-04-P
