[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Notices]
[Pages 47006-47007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19285]


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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 Big Data for Patients (BD4P) Program.

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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 Big Data for 
Patients (BD4P) Steering Committee. The Steering Committee will provide 
oversight and guidance for the BD4P program, 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 Friday, September 4, 2015. The BD4P 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

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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.
    Big Data for Patients (BD4P), a new program led by the Foundation, 
will bring together multiple stakeholder groups to leverage collective 
knowledge, technical expertise, funding, and other resources, to create 
a state-of-the-art patient training program and online community 
focused on the opportunities and challenges posed by Big Data.
    BD4P will empower patients and advocates with the language and 
concepts of data science, as well as critical appraisal skills, so they 
can effectively and actively participate in health research involving 
Big Data. Given the high profile of health research and initiatives 
using Big Data, combined with the growing efforts to make healthcare 
and medical research more patient-centered, it is critical that 
patients have a voice and active role in this work. It is still not 
completely understood how Big Data research will impact patient health 
care and medical decision making. BD4P presents an opportunity to 
ensure that patients are adequately informed and prepared to 
participate in this work, rather than being left out or left behind.
    Development of the program will be a fully collaborative process, 
with patients and key stakeholders involved in shaping the program 
every step of the way--from prioritizing topics for program content and 
input on program design, to actually taking the training program and 
providing feedback to evaluate the program and make improvements. We 
will ensure that the focus is not only on the impact of Big Data on 
patients, but also the impact that patients can have on Big Data 
research. For additional information on the BD4P program, visit the 
Reagan-Udall Foundation Web site: http://bit.ly/1HkhSOq.

II. BD4P Steering Committee Roles and Responsibilities

    The BD4P Steering Committee will provide guidance on the operation 
of the BD4P program, 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 program.
    The BD4P Steering Committee will be charged with several 
responsibilities, including:

 Reviewing and approving the BD4P Program Charter
 Monitoring adherence to the BD4P Program mission and 
operational principles in the Charter
 Developing metrics and evaluating the project at various 
milestones
 Reviewing and approving the BD4P Program Development Plan, 
including program curriculum, stakeholder engagement plan, and long-
term sustainability plan.
 Reviewing partnership and collaboration proposals submitted to 
the project team

    The BD4P Steering Committee Chair must be able to complete 
additional responsibilities, including:

 Defining the BD4P Steering Committee's meeting agendas and 
facilitating those meetings
 Recommending for termination, as necessary, any BD4P Steering 
Committee members demonstrating dereliction of duties as specified in 
the BD4P Charter
 Other responsibilities as required upon implementation of BD4P 
program

    A full list of BD4P Steering Committee responsibilities, as well as 
responsibilities of the Chair, may be found on the Reagan-Udall 
Foundation Web site: http://bit.ly/1KEoNTN.

III. BD4P Steering Committee Positions and Selection Criteria

    RUF is seeking nominations for 7 voting members of the BD4P 
Steering Committee, comprised of the following 5 categories:

 Patient Advocate: 3 members
 Pharmaceutical sector: 1 member
 Technology sector: 1 member
 Academia/Research Institute: 1 member
 At Large: 1 member

    The BD4P Steering Committee will also have 1 member from the FDA 
(appointed by the FDA), 1 member from the National Institutes of Health 
(appointed by the National Institutes of Health), and 1 member from the 
Patient Centered Outcomes Research Institute (appointed by PCORI). 
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: 
Adult education, data sharing, data science, health informatics, 
learning health care systems, partnerships, patient advocacy, patient 
engagement, patient-centered/patient-focused drug development, patient-
centered outcomes research, patient reported outcomes, precision 
medicine, science/health communication.
 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 BD4P 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 BD4P in accordance with applicable law 
and their specific institutional policies
 Members are subject to the BD4P Conflict of Interest policies 
(additional information can be accessed on the Reagan-Udall Foundation 
Web site at: http://bit.ly/1KEoNTN.

V. Nomination Instructions

 The nomination form can be accessed on the Reagan-Udall 
Foundation Web site: http://bit.ly/1KEoNTN
 Individuals may be nominated for 1 or more of the 5 
stakeholder categories
 Individuals may nominate themselves or others
 The nomination deadline is September 4, 2015.

    Dated: July 31, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-19285 Filed 8-5-15; 8:45 am]
BILLING CODE 4164-04-P