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  1. Animal Drug User Fee Act (ADUFA)

February 25, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Teleconference
February 25, 2014
11:30 am – 12:30 pm

Purpose

To hold an initial “kick-off” introductory meeting between members of the Conditional Approval group from CVM and regulated industry.

Participants

Center for Veterinary Medicine (CVM) Animal Health Institute (AHI)
Matthew Lucia Denni Day (VetPharm)
Andrew Beaulieu Paul Duquette (Phibro)
John Mussman Tamara Grisard (Novartis)
Christopher Loss Mary Hagler (Bayer), Chair
Shannon Rutherford Jennifer Kelley (Virbac)
Virginia Recta Brett McKusick (Merial)
Dragan Momcilovic Albert Ramudo (Boehringer-Ingelheim)
Stacey Shults Jennifer Rice (Noegen)
  Steve Sutherland (Zoetis)
  Rich Carnevale (AHI)
  Sam Veluvolu (AHI)

Discussion

  • The meeting opened with all the attendees introducing themselves
  • It was agreed that meeting in person at the AHI quarterly meetings was acceptable. The first in-person meeting of the combined group will be at the May quarterly meeting.
    • The main focus of this meeting will be to discuss each group’s perspective on the scope of the project including a discussion on any differences of opinion.
    • There will also be a discussion and agreement on how frequently between in-person meetings the two groups will meet through teleconference. There will also be a discussion and agreement on the size and composition of each group that will attend these teleconferences.
  • Similar to the capturing of the meeting minutes for the Animal Drug User Fee Act (ADUFA) negotiations, CVM will take the meeting minutes to capture the discussions when CVM and AHI meet together, distribute them for comment to all group members and then post them online for public viewing.