[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45565-45566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18637]



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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.

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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, 
[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 (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

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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