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May 15, 2014 Meeting Minutes

May 15, 2014 Meeting Minutes

Medicated Feeds Combination Working Group
Initial Meeting
May 15, 2014
1:00 pm– 3:00 pm

Purpose

Initial meeting between AHI and CVM working group (henceforth called the Medicated Feeds Combination Working Group), which agrees to explore, in concert with affected parties, potential modification of the current requirement that the use of multiple new animal drugs in the same medicated feed be subject to an approved application. The Agency also is inviting comment on potential changes to procedures and requirements related to the NADA approval process for such products that can be accomplished under the Agency’s existing statutory authority.

Attendees:

AHI CVM
Katherine Allran Jim Delaney
Keith Baker George Haibel
Paul Duquette Chad Hamel
Aubrey Schroeder Dragan Momcilovic
Rich Carnevale Karla Antonio
Kelly Klaus Susan Storey
Bruce Martin Dan Benz
Sam Veluvolu Marty Schoenemann
  Linda Wilmot
  Steve Vaughn

Discussion Points

  1. The ASCENT Process (The Path of ASCENT: The Five Principles for Mastering Change, Riboldi, Juan; 2009) was briefly discussed, including background and purpose.
  2. ADUFA III goals letter language was reviewed, which provides the reason for the formation of the group.
  3. Listening session: AHI presented their ideas on potential modifications to the current process of approving combination medicated feeds.

The Working Group agreed to meet via telecom in approximately six weeks.