80 FR 44161 - Request for Steering Committee Nominations
REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION Federal Register Volume 80, Issue 142 (July 24, 2015)
Federal Register Volume 80, Issue 142 (July 24, 2015)
| Page Range | 44161-44162 | |
| FR Document | 2015-18123 |
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)] [Notices] [Pages 44161-44162] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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
![Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44161
Core Cooling Systems for Light-Water selection criteria and nomination other drug classes and/or other
Nuclear Power Reactors.’’ Specifically, instructions. toxicities.
10 CFR 50.46(a)(3) requires licensees to ADDRESSES: The Reagan-Udall
The primary objective of PredicTox is
report to the NRC each change to or Foundation for the FDA is located at to advance systems-based science and
error discovered in an acceptable 1025 Connecticut Ave. NW., Suite 1000, tools necessary to support mechanism-
emergency core cooling system (ECCS) Washington, DC 20036. based drug safety assessment and
evaluation model, or in its application, prediction. To accomplish this
FOR FURTHER INFORMATION CONTACT:
and its estimated effect on the limiting objective, the PredicTox pilot project
Questions should be sent to The Reagan-
ECCS analysis. will be conducted in an iterative,
The NRC issues a RIS to communicate Udall Foundation for the FDA, 202–
phased manner over the course of
with stakeholders on a broad range of 828–1205, PredicTox@ReaganUdall.org.
several years. The first phase will center
matters. This may include SUPPLEMENTARY INFORMATION:
on building and populating a knowledge
communicating and clarifying NRC I. Background management platform for molecular
technical or policy positions on data, preclinical in vivo pharmacologic
regulatory matters that have not been The Reagan-Udall Foundation for the
FDA (the Foundation) is an independent and toxicologic data as well as clinical
communicated to or are not broadly data from both public and private
understood by the nuclear industry. 501(c)(3) not-for-profit organization
created by Congress to advance the sources.
Proposed Action The PredicTox platform will enable
mission of FDA to modernize medical,
integration, mining, and analysis of
The NRC is requesting public veterinary, food, food ingredient, and
highly heterogeneous data not typically
comments on the draft RIS. The NRC cosmetic product development;
combined. Future phases of the project
staff will make a final determination accelerate innovation; and enhance
will focus on data mining and
regarding issuance of the RIS after it product safety. The Foundation acts as
development of analytic and
considers any public comments a neutral third party to establish novel,
visualization tools along with
received in response to this request. scientific collaborations. With the
development of multi-scale predictive
ultimate goal of improving public
Dated at Rockville, Maryland, this 14th day models capable of linking events at the
of July 2015. health, the Foundation provides a
molecular level with events at the
For the Nuclear Regulatory Commission.
unique opportunity for different sectors
clinical level (AEs) for improved safety
(FDA, patient groups, academia, other
Sheldon D. Stuchell, assessment. For additional project
government entities, and industry) to
Chief, Generic Communications Branch, information, see the Reagan-Udall
work together in a transparent way to
Division of Policy and Rulemaking, Office Foundation Web site.
of Nuclear Reactor Regulation. create exciting new research projects to
[FR Doc. 2015–18113 Filed 7–23–15; 8:45 am]
advance regulatory science. II. PredicTox Steering Committee Roles
PredicTox is a public-private and Responsibilities
BILLING CODE 7590–01–P
partnership led by the Foundation, The PredicTox Steering Committee
which brings together multiple will provide guidance on the operation
stakeholder groups to leverage collective of PredicTox, in conjunction with the
REAGAN-UDALL FOUNDATION FOR knowledge, technical expertise, data,
THE FOOD AND DRUG RUF Board, project staff, and others.
funding, and other resources to explore The Steering Committee will provide
ADMINISTRATION systems pharmacology approaches to overall programmatic oversight to
better understand and predict adverse ensure a focus on the long-term vision
Request for Steering Committee
events (AEs). Developing new tools and of the project, while the Scientific
Nominations
approaches for mechanism-based drug Advisory Committee will provide highly
ACTION: Request for nominations to the safety assessment and prediction is a specialized technical expertise.
Steering Committee for the Foundation’s priority for the FDA, as highlighted in The PredicTox Steering Committee
PredicTox project. the Agency’s 2011 Strategic Plan for will be charged with several
Advancing Regulatory Science. This responsibilities, including:
SUMMARY: The Reagan-Udall Foundation project aims to harness scientific and • Reviewing and approving the
(RUF) for the Food and Drug technological knowledge, data and PredicTox Charter
Administration (FDA), which was computational capacity across various • Monitoring adherence to the
created by Title VI of the Food and Drug sectors and disciplines to develop and PredicTox mission and operational
Amendments of 2007, is requesting apply systems-based approaches and principles in the Charter
nominations for its PredicTox Steering multi-scales models to drug safety • Developing metrics and evaluating
Committee. The Steering Committee assessment in a coordinated manner. the project at various milestones
will provide oversight and guidance for While systems-based approaches can • Reviewing and approving the
the PredicTox project, and will report to be applied to the development of PredicTox Research Agenda
the Reagan-Udall Foundation for the predictive models for any class of drug • Reviewing proposals and contracts
FDA’s Board of Directors. or AE, the PredicTox pilot seeks to first submitted to the project
DATES: All nominations must be provide a proof of concept pilot by The PredicTox Steering Committee
submitted to the Reagan-Udall focusing on large and small molecule Chair must be able to complete
Foundation for the FDA by August 28, tyrosine kinase inhibitors (TKIs) and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
additional responsibilities, including:
2015. The PredicTox Steering cardiac AEs, specifically left ventricular • Defining the Steering Committee’s
Committee members will be selected by dysfunction. TKIs are a rapidly growing meeting agendas and facilitating those
the Reagan-Udall Foundation for the treatment for oncology and select other meetings
FDA’s Board of Directors; those selected therapeutic areas, making them an area • Recommending for termination, as
will be notified by September 30 of intense importance for patients, the necessary, any PredicTox Steering
regarding the Board’s decision. See the FDA, and pharmaceutical Committee members demonstrating
SUPPLEMENTARY INFORMATION section for manufacturers. Learnings from the dereliction of duties as specified in the
Steering Committee responsibilities, PredicTox pilot will then be applied to PredicTox Charter
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![44162 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
• Other responsibilities as required incurred in support of PredicTox in CBOELegalRegulatoryHome.aspx), at
upon implementation of PredicTox accordance with applicable law and the Exchange’s Office of the Secretary,
A full list of Steering Committee their specific institutional policies and at the Commission’s Public
responsibilities, as well as • Members are subject to the Reference Room.
responsibilities of the Chair, may be PredicTox Conflict of Interest policies
II. Self-Regulatory Organization’s
found on the Reagan-Udall Foundation (additional information can be accessed Statement of the Purpose of, and
Web site. on the Reagan-Udall Foundation Web Statutory Basis for, the Proposed Rule
site) Change
III. PredicTox Steering Committee
Positions and Selection Criteria V. Nomination Instructions In its filing with the Commission, the
RUF is seeking nominations for 7 • The nomination form can be Exchange included statements
voting members of the PredicTox accessed on the Reagan-Udall concerning the purpose of and basis for
Steering Committee, comprised of the Foundation Web site the proposed rule change and discussed
following 5 categories: • Individuals may be nominated for 1 any comments it received on the
• Patient Advocate: 1 member or more of the 5 stakeholder categories proposed rule change. The text of these
• Pharmaceutical sector: 2 members • Individuals may nominate statements may be examined at the
• Technology sector: 1 member themselves or others places specified in Item IV below. The
• Academia/Research Institute: 2 • The nomination deadline is August Exchange has prepared summaries, set
members 28, 2015. forth in sections A, B, and C below, of
• At Large: 1 member the most significant aspects of such
Dated: July 20, 2015.
The Steering Committee will also statements.
have 2 members from the FDA Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation A. Self-Regulatory Organization’s
(appointed by the FDA) and 1 member
for the FDA. Statement of the Purpose of, and
from the National Institutes of Health
[FR Doc. 2015–18123 Filed 7–23–15; 8:45 am] Statutory Basis for, the Proposed Rule
(appointed by the National Institutes of Change
Health). These 3 individuals will be BILLING CODE 4164–04–P
non-voting members. 1. Purpose
Nominees for the voting positions will The Exchange proposes to decrease
be evaluated by the RUF Board based on SECURITIES AND EXCHANGE the Options Regulatory Fee (‘‘ORF’’)
the following required criteria for each COMMISSION from $.0086 to $.0064 per contract in
of the 7 positions: [Release No. 34–75491; File No. SR–CBOE– order to help ensure that revenue
• Ability to complete Steering 2015–064] collected from the ORF, in combination
Committee responsibilities, listed above with other regulatory fees and fines,
• Currently employed by/ Self-Regulatory Organizations; does not exceed the Exchange’s total
volunteering for stakeholder field (e.g., Chicago Board Options Exchange, regulatory costs. The proposed fee
pharmaceutical, academia, patient Incorporated; Notice of Filing and change would be operative on August 1,
advocate, etc.) with several years of Immediate Effectiveness of a Proposed 2015.
relevant experience Rule Change Relating to the Options The ORF is assessed by the Exchange
• Leading expert in their relevant Regulatory Fee to each Trading Permit Holder for all
field (based on position, publications, or options transactions executed or cleared
other experience) July 20, 2015. by the Trading Permit Holder that are
• Working knowledge of at least one Pursuant to Section 19(b)(1) of the cleared by The Options Clearing
of the following areas: Risk assessment; Securities Exchange Act of 1934,1 and Corporation (‘‘OCC’’) in the customer
drug safety profiling; pharmacology or Rule 19b–4 thereunder,2 notice is range (i.e., transactions that clear in a
systems pharmacology; toxicology or hereby given that on July 10, 2015, customer account at OCC) regardless of
systems toxicology; biostatistics; Chicago Board Options Exchange, the exchange on which the transaction
cardiology; oncology; bioinformatics; Incorporated filed with the Securities occurs.3 In other words, the Exchange
ontology; multi-scale modeling; and Exchange Commission (the imposes the ORF on all customer-range
knowledge management platforms; ‘‘Commission’’) the proposed rule transactions executed by a Trading
software development; or data sharing change as described in Items I, II, and Permit Holder, even if the transactions
• Prior experience serving on a III below, which Items have been do not take place on the Exchange. The
related or similar governance body prepared by the Exchange. The ORF also is charged for transactions that
• Understanding of the landscape and Commission is publishing this notice to are not executed by a Trading Permit
the impact on the stakeholder group solicit comments on the proposed rule Holder but are ultimately cleared by a
they are representing with their seat change from interested persons. Trading Permit Holder. In the case
IV. Terms of Service I. Self-Regulatory Organization’s where a Trading Permit Holder executes
Statement of the Terms of Substance of a transaction and a different Trading
• The PredicTox Steering Committee Permit Holder clears the transaction, the
meets in-person at least twice per year, the Proposed Rule Change
ORF is assessed to the Trading Permit
with teleconferences in between Chicago Board Options Exchange, Holder who executed the transaction. In
asabaliauskas on DSK5VPTVN1PROD with NOTICES
meetings as deemed necessary by the Incorporated (the ‘‘Exchange’’ or the case where a non-Trading Permit
Chair ‘‘CBOE’’) proposes to amend the Holder executes a transaction and a
• Members will serve two or three Options Regulatory Fee. The text of the Trading Permit Holder clears the
year, staggered terms, as determined by proposed rule change is available on the transaction, the ORF is assessed to the
the RUF Board Exchange’s Web site (http:// Trading Permit Holder who clears the
• Members do not receive www.cboe.com/AboutCBOE/
compensation from RUF 3 The ORF also applies to customer-range
• Members can be reimbursed by RUF 1 15 U.S.C. 78s(b)(1). transactions executed during Extended Trading
for actual and reasonable expenses 2 17 CFR 240.19b–4. Hours.
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Document Created: 2018-02-23 09:24:43
Document Modified: 2018-02-23 09:24:43
| 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 | |
| Action | Request for nominations to the Steering Committee for the Foundation's PredicTox project. | |
| 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. | |
| Contact | Questions should be sent to The Reagan-Udall Foundation for the FDA, 202-828-1205, [email protected] | |
| FR Citation | 80 FR 44161 |
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