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CITMA FDA Update
Falls Church Marriott Fairview Park
3111 Fairview Park Drive Falls Church, VA 2204
March 12, 2015
AGENDA
8:00-8:30
Continental Breakfast
8:30-8:45
Welcome and Agenda Overview
Kevin Altman, CITMA
8:45- 9:15
FDA Deeming Regulations Overview
Stacy Ehrlich, Partner - Kleinfeld Kaplan & Becker, CITMA Counsel
9:15–9:45
Pathways to a Marketing Order – SE and PMTA
Will Woodlee, Partner - Kleinfeld Kaplan & Becker, CITMA Counsel
9:45-10:15
Question & Answers on Deeming Regulations and Pathways
10:15-10:30 Morning Break
10:30-11:30 Pre-Market Tobacco Application (PMTA)– What to expect
Ann C. Tunstall Ph.D. SciLucent, LLC
Sabrina Williams, Consultant
11:30-12:15 An Insider View of the FDA regulation review process at OIRA
Andrew Perraut, Consultant, Radiant Strategies and Former Policy
Analyst in the White House Office of Information and Regulatory Affairs
(OIRA)
12:15-1:00
Lunch
1:00-1:45
How the CTP Ombudsman’s Office can assist regulated industry with
procedural and other issues
Ella Yeargin, J.D., Ombudsman, FDA Center for Tobacco Products (CTP)
1:45-2:15
Review and Questions, Benefits of Membership in CITMA
Ron Tully, TNV Ventures, LLC
Kevin Altman – Consultant, CITMA
2:15-2:30
Afternoon Break
2:30-3:15
Update on Proposed State Regulation of Vapor Products
Brittani Cushman, Director of External Affairs - National Tobacco
Company
3:15
Breakout Session on State Legislation