80 FR 45565 - Request for Steering Committee Nominations

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range		45565-45566
FR Document		2015-18637

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. This is a resubmission of FR Doc. 2015-18123, Published July 24, 2015. This resubmission includes hyperlinks that were not present in the earlier notice.

Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015)

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45565-45566]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18637]



[[Page 45565]]

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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


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. This is a resubmission of 
FR Doc. 2015-18123, Published July 24, 2015. This resubmission includes 
hyperlinks that were not present in the earlier notice.

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 (http://goo.gl/BPemhh). 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: http://goo.gl/ubXMbJ.

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
 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: http://goo.gl/00HtQL.

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 members
 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

[[Page 45566]]

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 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 at: http://goo.gl/00HtQL).

V. Nomination Instructions

     The nomination form can be accessed on the Reagan-Udall 
Foundation Web site: http://goo.gl/00HtQL.
     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 24, 2015.
Nancy Beck,
Manager, Program Development, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-18637 Filed 7-29-15; 8:45 am]
BILLING CODE 4164-04-P

Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices 45565

REAGAN-UDALL FOUNDATION FOR create exciting new research projects to Foundation Web site: http://goo.gl/
THE FOOD AND DRUG advance regulatory science. ubXMbJ.
ADMINISTRATION PredicTox is a public-private
partnership led by the Foundation, II. PredicTox Steering Committee Roles
[BAC 416404] which brings together multiple and Responsibilities
stakeholder groups to leverage collective The PredicTox Steering Committee
Request for Steering Committee will provide guidance on the operation
knowledge, technical expertise, data,
Nominations of PredicTox, in conjunction with the
funding, and other resources to explore
ACTION: Request for nominations to the systems pharmacology approaches to RUF Board, project staff, and others.
Steering Committee for the Foundation’s better understand and predict adverse The Steering Committee will provide
PredicTox project. events (AEs). Developing new tools and overall programmatic oversight to
approaches for mechanism-based drug ensure a focus on the long-term vision
SUMMARY: The Reagan-Udall Foundation safety assessment and prediction is a of the project, while the Scientific
(RUF) for the Food and Drug priority for the FDA, as highlighted in Advisory Committee will provide highly
Administration (FDA), which was the Agency’s 2011 Strategic Plan for specialized technical expertise.
created by Title VI of the Food and Drug Advancing Regulatory Science (http:// The PredicTox Steering Committee
Amendments of 2007, is requesting goo.gl/BPemhh). This project aims to will be charged with several
nominations for its PredicTox Steering harness scientific and technological responsibilities, including:
Committee. The Steering Committee knowledge, data and computational • Reviewing and approving the
will provide oversight and guidance for capacity across various sectors and PredicTox Charter
the PredicTox project, and will report to disciplines to develop and apply • Monitoring adherence to the
the Reagan-Udall Foundation for the systems-based approaches and multi- PredicTox mission and operational
FDA’s Board of Directors. This is a scales models to drug safety assessment principles in the Charter
resubmission of FR Doc. 2015–18123, in a coordinated manner. • Developing metrics and evaluating the
Published July 24, 2015. This While systems-based approaches can project at various milestones
resubmission includes hyperlinks that be applied to the development of • Reviewing and approving the
were not present in the earlier notice. predictive models for any class of drug PredicTox Research Agenda
or AE, the PredicTox pilot seeks to first • Reviewing proposals and contracts
DATES: All nominations must be
provide a proof of concept pilot by submitted to the project
submitted to the Reagan-Udall
Foundation for the FDA by August 28, focusing on large and small molecule The PredicTox Steering Committee
2015. The PredicTox Steering tyrosine kinase inhibitors (TKIs) and Chair must be able to complete
Committee members will be selected by cardiac AEs, specifically left ventricular additional responsibilities, including:
the Reagan-Udall Foundation for the dysfunction. TKIs are a rapidly growing • Defining the Steering Committee’s
FDA’s Board of Directors; those selected treatment for oncology and select other meeting agendas and facilitating those
will be notified by September 30 therapeutic areas, making them an area meetings
regarding the Board’s decision. See the of intense importance for patients, the • Recommending for termination, as
SUPPLEMENTARY INFORMATION section for FDA, and pharmaceutical necessary, any PredicTox Steering
Steering Committee responsibilities, manufacturers. Learnings from the Committee members demonstrating
selection criteria and nomination PredicTox pilot will then be applied to dereliction of duties as specified in
instructions. other drug classes and/or other the PredicTox Charter
toxicities. • Other responsibilities as required
ADDRESSES: The Reagan-Udall The primary objective of PredicTox is upon implementation of PredicTox
Foundation for the FDA is located at to advance systems-based science and A full list of Steering Committee
1025 Connecticut Ave. NW., Suite 1000, tools necessary to support mechanism- responsibilities, as well as
Washington, DC 20036. based drug safety assessment and responsibilities of the Chair, may be
FOR FURTHER INFORMATION CONTACT: prediction. To accomplish this found on the Reagan-Udall Foundation
Questions should be sent to The Reagan- objective, the PredicTox pilot project Web site: http://goo.gl/00HtQL.
Udall Foundation for the FDA, 202– will be conducted in an iterative,
828–1205, PredicTox@ReaganUdall.org. phased manner over the course of III. PredicTox Steering Committee
SUPPLEMENTARY INFORMATION: several years. The first phase will center Positions and Selection Criteria
on building and populating a knowledge RUF is seeking nominations for 7
I. Background management platform for molecular voting members of the PredicTox
The Reagan-Udall Foundation for the data, preclinical in vivo pharmacologic Steering Committee, comprised of the
FDA (the Foundation) is an independent and toxicologic data as well as clinical following 5 categories:
501(c)(3) not-for-profit organization data from both public and private • Patient Advocate: 1 member
created by Congress to advance the sources. • Pharmaceutical sector: 2 members
mission of FDA to modernize medical, The PredicTox platform will enable • Technology sector: 1 members
veterinary, food, food ingredient, and integration, mining, and analysis of • Academia/Research Institute: 2
cosmetic product development; highly heterogeneous data not typically members
accelerate innovation; and enhance combined. Future phases of the project • At Large: 1 member
product safety. The Foundation acts as will focus on data mining and The Steering Committee will also
a neutral third party to establish novel, development of analytic and have 2 members from the FDA
Lhorne on DSK7TPTVN1PROD with NOTICES

scientific collaborations. With the visualization tools along with (appointed by the FDA) and 1 member
ultimate goal of improving public development of multi-scale predictive from the National Institutes of Health
health, the Foundation provides a models capable of linking events at the (appointed by the National Institutes of
unique opportunity for different sectors molecular level with events at the Health). These 3 individuals will be
(FDA, patient groups, academia, other clinical level (AEs) for improved safety non-voting members.
government entities, and industry) to assessment. For additional project Nominees for the voting positions will
work together in a transparent way to information, see the Reagan-Udall be evaluated by the RUF Board based on

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45566 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices

the following required criteria for each SECURITIES AND EXCHANGE Exchange has prepared summaries, set
of the 7 positions: COMMISSION forth in sections A, B, and C below, of
• Ability to complete Steering [Release No. 34–75518; File No. SR–BATS–
the most significant parts of such
Committee responsibilities, listed statements.
2015–55
above A. Self-Regulatory Organization’s
• Currently employed by/volunteering Self-Regulatory Organizations; BATS Statement of the Purpose of, and
for stakeholder field (e.g., Exchange, Inc.; Notice of Filing and Statutory Basis for, the Proposed Rule
pharmaceutical, academia, patient Immediate Effectiveness of a Proposed Change
advocate, etc.) with several years of Rule Change To Extend the Pilot
relevant experience Period of the BATS Exchange, Inc. 1. Purpose
• Leading expert in their relevant field Supplemental Competitive Liquidity Background
(based on position, publications, or Provider Program On August 30, 2011, the Exchange
other experience)
received approval of rules applicable to
• Working knowledge of at least one of July 24, 2015.
Pursuant to section 19(b)(1) of the the qualification, listing and delisting of
the following areas: Risk assessment;
Securities Exchange Act of 1934 (the securities of issuers on the Exchange.5
drug safety profiling; pharmacology or
‘‘Act’’),1 and Rule 19b–4 thereunder,2 More recently, the Exchange received
systems pharmacology; toxicology or
notice is hereby given that on July 23, approval to operate a pilot program that
systems toxicology; biostatistics;
2015, BATS Exchange, Inc. (the is designed to incentivize certain Market
cardiology; oncology; bioinformatics;
‘‘Exchange’’ or ‘‘BATS’’) filed with the Makers 6 registered with the Exchange
ontology; multi-scale modeling; as ETP CLPs, as defined in
knowledge management platforms; Securities and Exchange Commission
(‘‘Commission’’) the proposed rule Interpretation and Policy .03 to Rule
software development; or data sharing 11.8, to enhance liquidity on the
• Prior experience serving on a related change as described in Items I and II
Exchange in certain ETPs 7 listed on the
or similar governance body below, which Items have been prepared
Exchange and thereby qualify to receive
• Understanding of the landscape and by the Exchange. The Exchange has
designated this proposal as a ‘‘non- part of a daily rebate as part of the
the impact on impact on the Program under Interpretation and Policy
stakeholder group they are controversial’’ proposed rule change
pursuant to section 19(b)(3)(A) of the .03 to Rule 11.8.8
representing with their seat The Program was approved by the
Act 3 and Rule 19b–4(f)(6)(iii)
IV. Terms of Service Commission on a pilot basis running
thereunder,4 which renders it effective
one-year from the date of
• The PredicTox Steering Committee upon filing with the Commission. The
implementation.9 The Commission
meets in-person at least twice per year, Commission is publishing this notice to
approved the Program on July 28,
with teleconferences in between solicit comments on the proposed rule
2014.10 The Exchange implemented the
meetings as deemed necessary by the change from interested persons.
Program on July 28, 2014 and the pilot
Chair.
I. Self-Regulatory Organization’s period for the Program is scheduled to
• Members will serve two or three
Statement of the Terms of Substance of end on July 28, 2015.
year, staggered terms, as determined by
the Proposed Rule Change Proposal To Extend the Operation of the
the RUF Board.
• Members do not receive The Exchange is proposing to extend Program
compensation from RUF. the pilot period for the Exchange’s The Exchange established the
• Members can be reimbursed by RUF Supplemental Competitive Liquidity Program in order to enhance liquidity
for actual and reasonable expenses Provider Program (the ‘‘Program’’), on the Exchange in certain ETPs listed
incurred in support of PredicTox in which is currently set to expire on July on the Exchange (and thereby enhance
accordance with applicable law and 28, 2015, for 3 months, to expire on the Exchange’s ability to compete as a
their specific institutional policies. October 28, 2015. listing venue) by providing a
• Members are subject to the The text of the proposed rule change
mechanism by which ETP CLPs
PredicTox Conflict of Interest policies is available at the Exchange’s Web site
compete for part of a daily quoting
(additional information can be accessed at www.batstrading.com, at the
incentive on the basis of providing the
on the Reagan-Udall Foundation Web principal office of the Exchange, and at
most aggressive quotes with the greatest
site at: http://goo.gl/00HtQL). the Commission’s Public Reference
amount of size. Such competition has
Room.
V. Nomination Instructions the ability to reduce spreads, facilitate
II. Self-Regulatory Organization’s the price discovery process, and reduce
• The nomination form can be
Statement of the Purpose of, and costs for investors trading in such
accessed on the Reagan-Udall
Statutory Basis for, the Proposed Rule securities, thereby promoting capital
Foundation Web site: http://goo.gl/
Change formation and helping the Exchange to
00HtQL.
compete as a listing venue. The
• Individuals may be nominated for 1 In its filing with the Commission, the
or more of the 5 stakeholder categories. Exchange included statements 5 See Securities Exchange Act Release No. 65225
• Individuals may nominate concerning the purpose of and basis for (August 30, 2011), 76 FR 55148 (September 6, 2011)
themselves or others. the proposed rule change and discussed (SR–BATS–2011–018).
• The nomination deadline is August any comments it received on the 6 As defined in BATS Rules, the term ‘‘Market

28, 2015. proposed rule change. The text of these Maker’’ means a Member that acts a as a market
Lhorne on DSK7TPTVN1PROD with NOTICES

maker pursuant to chapter XI of BATS Rules.
Dated: July 24, 2015. statements may be examined at the 7 ETP is defined in Interpretation and Policy
places specified in Item IV below. The .03(b)(4) to Rule 11.8.
Nancy Beck,
8 See Securities Exchange Act Release No. 72692
Manager, Program Development, Reagan- 1 15 U.S.C. 78s(b)(1). (July 28, 2014), 79 FR 44908 (August 1, 2014) (SR–
Udall Foundation for the FDA. 2 17 CFR 240.19b–4. BATS–2014–022) (‘‘CLP Approval Order’’).
[FR Doc. 2015–18637 Filed 7–29–15; 8:45 am] 3 15 U.S.C. 78s(b)(3)(A). 9 See id at 44909.

BILLING CODE 4164–04–P 4 17 CFR 240.19b–4(f)(6)(iii). 10 Id.

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Document Created: 2018-02-23 09:30:10
Document Modified: 2018-02-23 09:30:10

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 45565