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U.S. Department of Health and Human Services

For Industry

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July 10, 2012

ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
July 10, 2012
10:00 am – 3:00 pm


Purpose

To continue the discussion on ADUFA reauthorization (ADUFA III)

Participants

FDAIndustry
Steve Vaughn, FDA (via phone)Rich Carnevale, AHI
David Wardrop, FDABruce Martin, Bayer (via phone)
Roxanne Schweitzer, FDAChan Baldwin, Abbott
Elizabeth Luddy, FDAGrace Gowda, Merial
Dennis Bensley, FDAKathy Vannatta, Elanco (via phone)
Petra Garosi, FDA (via phone)Sam Veluvolu, AHI
Yanming Chae, FDATom Schriemer, Pfizer

ADUFA III Funding

  • FDA and Industry have reached tentative agreement on ADUFA III funding necessary to support the ADUFA III performance goals and enhancements.

Proposed ADUFA III Legislation and Performance Goals Letter

  • FDA and Industry reviewed the proposed ADUFA III legislation and performance goals.
  • FDA will send Industry the revised draft ADUFA III legislation and performance goals letter pertaining to the changes discussed in the meeting.
  • FDA communicated the next major steps in the reauthorization process.

Next Meeting Agenda

  • Discuss any questions that Industry may have after reviewing the revised ADUFA III legislation and performance goals letter proposal.