80 FR 26589 - Request for Scientific Advisory Committee Nominations

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 80, Issue 89 (May 8, 2015)

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) Scientific Advisory Committee. The IMEDS Scientific Advisory Committee will provide scientific oversight and guidance of the IMEDS Program, and will report to the Reagan-Udall Foundation for the FDA's Board of Directors. Instructions on submitting nominations are listed in the ``Background'' section.

[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26589-26590]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11077]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


Request for Scientific Advisory Committee Nominations

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

DATES: All nominations must be submitted to the Reagan-Udall Foundation 
for the FDA by May 24, 2015. IMEDS Scientific Advisory Committee 
members will be selected by the IMEDS Steering Committee before July 
15, 2015; those selected will be notified by July 30, 2015 regarding 
the Steering Committee'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: Nicole Spear, Reagan-Udall Foundation 
for the FDA, 202-828-1210. Nominations should be sent to 
[email protected]. Email subject line: SAC Nomination.

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. 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 Innovation in Medical Evidence Development and Surveillance 
(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 and the Observational 
Medical Outcomes Partnership (OMOP).
    IMEDS's primary objective is to advance the science and tools 
necessary to support post-market evidence generation on regulated 
products, including safety surveillance and

[[Page 26590]]

evaluations, and to facilitate utilization of a robust electronic 
healthcare 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 Scientific Advisory Committee has oversight of all IMEDS 
projects.

II. IMEDS Scientific Advisory Committee Positions and Selection 
Criteria

    RUF is seeking nominations for four (4) voting members of the IMEDS 
Scientific Advisory Committee listed below.
    1. At Large (excluding Pharmaceutical representative): 2 members.
    2. Regulated Industry Representative: 2 members.
    The following criteria will be used to evaluate nominees for the 
IMEDS Scientific Advisory Committee.
    1. Required Criteria for Each of 4 Positions.
    a. Currently employed by/volunteering for stakeholder field (e.g., 
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 Scientific Advisory Committee (It is not a 
requirement that all nominees meet all of these criteria, but 
collectively, the Scientific Advisory Committee members should meet 
them.)
    a. Ability to complete Scientific Advisory Committee 
responsibilities (which can be accessed via the IMEDS Web site: http://imeds.reaganudall.org/governance.)
    b. Prior experience serving on a related or similar governance 
body.
    c. Understanding of post-market surveillance landscape and impact 
upon stakeholder group represented by Scientific Advisory 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.

III. Terms of Service

     The IMEDS Scientific Advisory 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 two-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

     To apply, please submit the nominee's CV and the 
nomination form that can be found on the IMEDS Web site: 
imeds.reaganudall.org, to [email protected] with ``SAC Nomination'' 
in the subject line.
     Individuals may be nominated for one or more of the 4 
voting positions, and those making nominations should specify for which 
of the 4 voting positions the nominee is being nominated.
     Individuals may nominate themselves.

    Dated: May 4, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-11077 Filed 5-7-15; 8:45 am]
 BILLING CODE 4164-04-P