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Table 2. PDUFA IV Meetings – Technical Discussions with Regulated Industry Finance Subcommittee

Date Time Length	Subjects	Participants
4/7/06 1:30 to 3:30PM 2 hours	The following topics were discussed at the meeting: Future Meetings. April 21st Meeting Agenda.	FDA: Russ Abbott, FDA/CDER Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Mary McGrane, BIO Donna Peterson, BIO
4/21/06 1:30 to3:30 PM 2 Hours	The following topics were discussed at the meeting: FDA Appropriated Budget. Workload Adjuster. Industry Financial Proposals. FDA Financial Proposals.	FDA: Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Jerry Paull, FDA/CBER BIO: Mary McGrane, BIO/Genzyme (Phone) Donna Peterson, BIO/Amgen (Phone) Sara Radcliffe, BIO PhRMA: Alan Goldhammer, PhRMA Don Sauer, PhRMA/Wyeth Lynne Tracey, PhRMA/P&G
5/5/06 1:30 to 3:30 PM 2 Hours	The following topics were discussed at the meeting: FDA Technical Proposals Budget Amendment Inflation Adjuster Proposal White Oak Costs. FDA Human Drug Review Process Overhead	FDA: Jane Axelrad, FDA/CDER Nancy Boocker, FDA/CDER Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Jerry Paull, FDA/CBER BIO: Mary McGrane, BIO/Genzyme (by phone) Donna Peterson, BIO/Amgen Sara Radcliffe, BIO PhRMA: Alan Goldhammer, PhRMA Dave Keaney, PhRMA/Novartis Don Sauer, PhRMA/Wyeth Lynne Tracey, PhRMA/P&G (by phone)
5/19/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: Technical Proposals. Inflation Adjustment Proposal. FDA PDUFA III Cost Review. PDUFA III Base Resources. Unit Cost Data. Financial Baseline FTE Module.	FDA: Russ Abbott, FDA/CDER Jane Axelrad, FDA/CDER Nancy Boocker, FDA/CDER Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Theresa Mullin, FDA/OC Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen Sara Radcliffe, BIO PhRMA: Alan Goldhammer, PhRMA Don Sauer, PhRMA/Wyeth Lynne Tracey, PhRMA/P&G
6/2/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: Technical Proposals. Inflation Adjustment Proposal. Review FDA Process for Estimating FTE/Dollars. Inflation adjustment of user fee trigger for spending from appropriations	FDA: Jane Axelrad, FDA/CDER Nancy Boocker, FDA/CDER Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Theresa Mullin, FDA/OC BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen Sara Radcliffe, BIO Mary McGrane, BIO/Genzyme (by phone) PhRMA: Alan Goldhammer, PhRMA Don Sauer, PhRMA/Wyeth Lynne Tracey, PhRMA/P&G
6/16/06	The following topics were discussed at the meeting: FDA Contracts Workload Adjuster Presentation. Technical Amendments Remaining Technical Amendments. Inflation Adjustment Proposal. Financial Baseline Proposal. Future Tasks.	FDA: Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Jonathan Mathieu, FDA/OC Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen Sara Radcliffe, BIO Mary McGrane, BIO/Genzyme (by phone) PhRMA: Lynne Tracey, PhRMA/P&G
6/30/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: PDUFA IV Enhancement Proposal Cost Summary. Fees/Appropriations Relationship Models. FDA Efficiencies.	FDA: Nancy Boocker, FDA/CDER Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER Bob Linkous. FDA/CDER Martie Louviere, FDA/OC Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen Sara Radcliffe, BIO Mary McGrane, BIO/Genzyme, (by phone) PhRMA: Alan Goldhammer, PhRMA Jeff Jeffress, The Boston Consulting Group Don Sauer, PhRMA/Wyeth Lynne Tracey, PhRMA/P&G (by phone)
7/14/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: Slide Presentation. Workload Adjuster. Process Issues.	FDA: Frank Claunts, FDA/OM Martie Louviere, FDA/OC Jonathan Mathieu, FDA/OC Theresa Mullin, FDA/OC Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen PhRMA: Alan Goldhammer, PhRMA Jeff Jeffress, The Boston Consulting Group
7/21/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: FDA Revenue Estimates. Inflation Adjustment. Workload Adjuster.	FDA: Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Mike Jones, FDA/CDER (by phone) Jonathan Matheau, FDA/OP Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Mary McGrane, BIO/Genzyme (by phone) Donna Peterson, BIO/Amgen Sara Radcliffe, BIO (by phone) PhRMA: Alan Goldhammer, PhRMA Jeff Jeffress, The Boston Consulting Group Lynne Tracey, PhRMA/P&G (by phone)
7/28/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: Pending Issues. Workload Adjuster.	FDA: Frank Claunts, FDA/OM Nancy Boocker, FDA/CDER Roger Eastep, FDA/CBER Mike Jones, FDA/CDER Martie Louviere, FDA/OC Jonathan Matheau, FDA/OP Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Donna Peterson, BIO/Amgen Sara Radcliffe, BIO (by phone) PhRMA: Alan Goldhammer, PhRMA Jeff Jeffress, The Boston Consulting Group Dave Keaney, PhRMA/Novartis Don Sauer, PhRMA/Wyeth (by phone) Lynne Tracey, PhRMA/P&G (by phone)
8/25/06 1:30 to 3:30 PM 2 hours	The following topics were discussed at the meeting: Draft Proposed Statutory and Legislative History Language. Workload Adjuster. Indirect Costs/Overhead.	FDA: Frank Claunts, FDA/OM Roger Eastep, FDA/CBER Kevin Fain, FDA/OCC Bob Linkous, FDA/CDER (by phone) Martie Louviere, FDA/OC Jonathan Matheau, FDA/OP Jerry Paull, FDA/CBER BIO: Andrew Emmett, BIO Mary McGrane, BIO/Genzyme (by phone) Donna Peterson, BIO/Amgen Sara Radcliffe, BIO (by phone) PhRMA: Alan Goldhammer, PhRMA

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