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Day 1: October 22, 2018 Transcript: Welcome: Mitch Zeller FDA Center for Tobacco Products Opening Remarks: Jeff Walker Teton Regulatory Sciences Overview of the Meeting: Eshael Johnson Office of the Center Director (OCD) Session 1: Request for Exemption from Substantial Equivalence (Exemption Request, EX REQ): Jennifer Schmitz Office of Science (OS)/Division of Regulatory Project Management Substantial Equivalence: Cristi Stark OS/Division of Regulatory Project Management Panel Discussion: Moderator: Eshael Johnson OCD Brittani Cushman Turning Point Brands Thomas Lindegaard Scandinavian Tobacco Group Patrick Murphy RAIS Rosanna Beltre OS/Division of Regulatory Project Management Cristi Stark OS/Division of Regulatory Project Management Session 2: Premarket Tobacco Product Application (PMTA) Review Process: Nicholas Hasbrouck - OS/Division of Regulatory Project Management Modified Risk Tobacco Product (MRTP) Application Review Process: Ebony Jackson OS/Division of Regulatory Project Management Session 3: Pre-Submission Meetings with the Office of Science: Barbara Banchero OS/Division of Regulatory Project Management Tobacco Product Master Files (TPMFs): Sarah Vichensont OS/Division of Regulatory Project Management Panel Discussion: Moderator: Karin Rudolph OCD Bryan Haynes Troutman Sanders Patricia Miller Altria Russell Wolz Enthalpy Analytical Marcella Dolling - OS/Division of Regulatory Project Management Joanna Randazzo OS/Science Policy Branch Session 4: Information and Resources on Application Review Programs: Sharyn Miller OS/Division of Regulatory Project Management CTP Electronic Submissions Standards and Activities: Jeff Smith OS/Division of Regulatory Science Informatics Panel Discussion: Moderator: Karin Rudolph Leann Campbell RAIS Paisley Cameron JTI Anuschka Merson ITG Brands Sharyn Miller OS/Division of Regulatory Project Management Deborah Sholtes OS/Division of Regulatory Science Informatics Session 5 Environmental Assessments & Claims of Categorical Exclusion: Hoshing Chang OS/Division of Nonclinical Science Transfer of ownership - Renee Coneway OS/Division of Regulatory Project Management Panel Discussion: Moderator: Eshael Johnson OCD Tony Abboud Vapor Technology Association Karen Cook ITG Brands Christie Day 1 Presentation Recordings Session 1 Sessions 2 & 3 Sessions 3 & 4 & 5 Day 2: October 23, 2018 Transcript: Welcome: Karin Rudolph OCD Session 6 Content Focus: Request for Exemption from Substantial Equivalence (Exemption Requests) - Matt Walters-OS/Division of Product Science SE Report Content: Colleen Rogers OS/Division of Product Science Todd Cecil - OS/Division of Product Science Panel Discussion Moderator: Eshael Johnson - OCD Robert Buell Altria Thomas Lindegaard Scandinavian Tobacco Group Marc Scheineson Alston & Bird Todd Cecil OS/Division of Product Science Colleen Rogers OS/Division of Product Science Matt Walters OS/Division of Product Science Session 7 Premarket Tobacco Product Application Content Overview: Iilun Murphy OS/Division of Individual Health Science Tobacco Product Application Review: Modified Risk Tobacco Product Applications (MRTPAs): Ben Apelberg OS/Division of Population Health Science Panel Discussion Moderator: Karin Rudolph OCD Debbie Hayden SMNA Matt Myers Campaign for Tobacco-Free Kids Elaine Round RAIS Mohamadi Sarkar Altria Ben Apelberg OS/Division of Population Health Science Priscilla Callahan-Lyon OS/Division of Individual Health Science Session 8 Open Discussion on Newly Deemed Tobacco Products Panel Discussion Moderator: Eshael Johnson - OCD David Graham NJOY Drew Newman J.C