[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23961-23962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09448]


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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 Innovation in Medical Evidence Development and 
Surveillance program.

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SUMMARY: The Reagan-Udall Foundation 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 Innovation 
in Medical Evidence Development and Surveillance (IMEDS) Steering 
Committee. The IMEDS Steering Committee will provide oversight and 
guidance of the IMEDS Program, and will report to the Reagan-Udall 
Foundation for the FDA's Board of Directors. Instructions on making 
nominations are listed in the ``Background'' section.

DATES: All nominations must be submitted to the Reagan-Udall Foundation 
for the FDA by April 30, 2013. IMEDS Steering Committee members will be 
selected by the Reagan-Udall Foundation for the FDA's Board of 
Directors on May 23, 2013; those selected will be notified by May 30 
regarding the Board's decision.
    Location: The Reagan-Udall Foundation for the FDA is located at 
1025 Connecticut Ave. NW., Suite 1000, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Jane Reese-Coulbourne, Reagan-Udall 
Foundation for the FDA, 202-828-1206. Nominations should be sent to 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The Reagan-Udall Foundation for the FDA (the Foundation or RUF) 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. 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.
    The Foundation acts as a neutral third party to establish novel, 
scientific collaborations. Much like any other independently developed 
information, FDA evaluates the scientific information from these 
collaborations to determine how Reagan-Udall Foundation projects can 
help the Agency to fulfill its mission.
    The IMEDS program is offered by the Foundation. IMEDS is a public-
private partnership created to build upon the significant progress made 
on research methodology by the Sentinel Initiative, including its Mini-
Sentinel pilot and the Observational Medical Outcomes Partnership 
(OMOP).
    IMEDS's primary objective is to advance the science and tools 
necessary to support postmarket evidence generation on regulated 
products, including safety surveillance and evaluations, and to 
facilitate utilization of a robust electronic health care data platform 
for generating better evidence on regulated products in the post-market 
settings. To accomplish this objective, the IMEDS program includes 
three projects:
    1. IMEDS-Methods: Supports the development of a methods research 
agenda and coordination of methods research in support of using 
electronic health data for safety surveillance conducted by FDA as well 
as the broader community of researchers.
    2. IMEDS-Education: Offers educational opportunities in areas 
related to medical product safety surveillance, and methods research 
and application for scientific professionals.
    3. IMEDS-Evaluation: Applies Methods and Education lessons learned 
for medical product assessments to facilitate leveraging Sentinel tools 
and capabilities toward a national resource for evidence generation.
    The IMEDS Steering Committee will have oversight of all IMEDS 
projects.

II. IMEDS Steering Committee Positions and Selection Criteria

    RUF is seeking nominations for seven voting members of the IMEDS 
Steering

[[Page 23962]]

Committee listed in this document. (The IMEDS Steering Committee will 
also have two members of FDA appointed by FDA, and a liaison from the 
Reagan-Udall Foundation Board of Directors who will be appointed by the 
Reagan-Udall Foundation Board of Directors; these three individuals 
will be nonvoting members).

1. Pharmaceutical Industry: Two members
2. Academia/Research Institute: One member
3. Provider (i.e., Clinician): One member
4. Data Partner: One member
5. Patient Advocate: One member
6. Consumer Advocate: One member

    The following criteria will be used to evaluate nominees for the 
IMEDS Steering Committee.
    1. Required Criteria for Each of Seven Positions
    a. Currently employed by/volunteering for stakeholder field (e.g., 
pharmaceutical, academia, patient advocate, provider, etc.) with 
several years of relevant experience.
    b. Leading expert in their relevant field (based on position/title, 
publications, or other experience).
    2. Criteria across Steering Committee (It is not a requirement that 
all nominees meet all of these criteria, but collectively, the Steering 
Committee members should meet them.)
    a. Ability to complete Steering Committee responsibilities (which 
can be accessed via the Reagan-Udall Foundation Web site: http://www.reaganudall.org/.)
    b. Prior experience serving on a related or similar governance 
body.
    c. Understanding of postmarket surveillance landscape and impact 
upon stakeholder group represented by Steering Committee seat, or 
understanding of issues around use of electronic health data for 
observational purposes.
    d. Individuals both with and without past experience in Mini-
Sentinel, OMOP, and similar research/regulatory science initiatives to 
ensure a diversity of perspectives.
    e. Individuals from both U.S.- and international-based 
institutions.
    3. The IMEDS Steering Committee Chair must be able to complete the 
additional responsibilities listed for this position in the IMEDS 
Charter (section 2.3.6.2).

III. Terms of Service

     The IMEDS Steering Committee meets in-person at least 
twice per year, with bimonthly teleconferences in between meetings (or 
monthly teleconferences as deemed necessary by the Chair).
     Members serve 2-year terms, and a maximum of two terms 
(based on IMEDS fiscal calendar).
     Members do not receive compensation from RUF.
     Members can be reimbursed by RUF for actual and reasonable 
expenses incurred in support of IMEDS in accordance with applicable law 
and their specific institutional policies.
     Members are subject to the IMEDS Conflict of Interest 
policies.

IV. Nomination Instructions

     In 200 words or less, please describe the relevant 
expertise and experience the nominee would bring while serving as the 
IMEDS Steering Committee Chair and/or a Member and to what extent they 
would meet the criteria.
     Individuals may be nominated for one or more of the seven 
voting positions, and those making nominations should specify for which 
of the seven voting positions the nominee is being nominated.
     Individuals may nominate themselves.

    Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2013-09448 Filed 4-22-13; 8:45 am]
BILLING CODE 4164-04-P