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U.S. Department of Health and Human Services

For Industry

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February 7, 2012

AGDUFA II Negotiations

Center for Veterinary Medicine (CVM)
Metro Park North, Rockville, MD 20855

February 7, 2012
9:00 am – 3:00 pm

Purpose

  • To discuss FDA and Industry perspectives on AGDUFA II reauthorization, the negotiating process going forward, financial proposal, and planning for future discussions.


Participants

 FDA  Industry 
 Steve Vaughn, CVM Stephanie Batliner, GADA
 David Wardrop, CVM Jennifer Johansson, GADA
 Roxanne Schweitzer, CVM Herschel Gaddy, GADA
 Ken Harshman, CVM Gerald Macedo, GADA
 Dennis Bensley, CVM Ed Allera, GADA
 Petra Garosi, CVM 
 Julie Bailey, CVM 
 Yanming Chae, CVM 
 Sharon Tarbell, CVM 
 Alexis Nazario-Negron, OFM 
 Frank Claunts, Consultant 

Recognition of Negotiation Leads and Ratifiers

  • David Wardrop and Steve Vaughn are the co-leads representing FDA.
  • Stephanie Batliner and Jennifer Johansson are co-leads representing Industry.
  • Generic Animal Drug Alliance (GADA) will provide a letter certifying they represent the majority of Industry.

Negotiation Ground Rules

  • The ground rules that will govern AGDUFA II negotiations were discussed and agreed by both FDA and Industry.

Industry Perspective on AGDUFA II

  • Industry briefly discussed their areas of concern including reducing review time, master file reviews, scheduling of inspections, reduced fees for certain submission types, phased review, and incentives for electronic submissions.

FDA Perspectives on AGDUFA II

  • FDA’s presentation discussed a sound financial footing for the program, such as the inflation adjuster, the appropriation shortfall, and stabilizing the fee revenue stream.
  • In addition, FDA discussed the expected baseline resources for the first year of AGDUFA II – FY 2014. This is the level of resources required to continue the current program into AGDUFA II without any performance change. FDA’s current estimate for FY2014 starting base cost is $6.031 million. FDA also discussed the estimated cost per FTE in FY2014 that would be used to determine additional resources for AGDUFA II. The projected cost of a FTE in FY 2014 is approximately $281,000. This figure includes costs such as salary, benefits, contracts, IT, GSA rent, and other rent-related expenditures.

Establishment of Future Agendas

  • FDA and Industry agreed to the topics for the next meeting on February 28, 2012.