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  1. Animal Drug User Fee Act (ADUFA)

May 13, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Rockville Hilton
May 13, 2014
8:30 am – 12:00 pm

Purpose

To hold the first in-person meeting of the Conditional Approval Working Group consisting of members of CVM and regulated industry with the main goal of scoping the various needs for the project.

Participants

Center for Veterinary Medicine (CVM) Animal Health Institute (AHI) 
Peter Jaensch Jan Cunningham (Dechra)
Christopher Loss Paul Duquette (Phibro)
Matt Lucia - Leader Mary Hagler (Bayer), Chair
Dragan Momcilovic Beth Kee (Elanco)
John Mussman Holger Lehmann (Merck)
Jean Recta Brett McKusick (Merial)
Shannon Rutherford - Ascent Facilitator Elizabeth Norton (Novartis) - for Tamara Grisard
Stacey Shults Lesley Rausch-Derra (Aratana)
Brent Volker Aubrey Schroeder (Zoetis) - for Steve Sutherland
  Kim Swisher (Boehringer-Ingelheim)
  Kelly Klaus (AHI)
  Sam Veluvolu (AHI)

Discussion

  • The meeting opened with all the attendees introducing themselves.
  • The ground rules were discussed.
  • It was agreed that the next in person meeting between CVM and AHI would occur in September 2014. At that time, it will be decided if the next in person meeting after that will be held in November 2014 or January 2015.
  • It was agreed that virtual meetings will be held twice a month and the frequency of these meetings can be altered as necessary.
  • The main focus of the meeting was discussing each group’s perspective on the scope of the project and identifying the various potential needs regarding the expansion of the conditional approval process.
  • Next steps include AHI providing a comprehensive listing of potential needs for expansion of the conditional approval process to CVM, and at the next virtual meeting, CVM will provide feedback on AHI’s proposals.
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