FDA Regulation of Tobacco Washington, DC October 21, 2015 Interacting with the Agency Jeams E. Dillard III, Senior Vice President, Regulatory Affairs and Chief Innovation Officer, Altria Client Services LLC Ella Yeargin, Ombudsman, CTP, FDA Moderated by Azim Chowdhury, Partner, Keller and Heckman LLP

Ella Yeargin CTP Ombudsman FDLI, October 2015

OVERVIEW OF TODAY’S PRESENTATION Role of the Ombudsman When to Contact the CTP Ombudsman Frequent Topics: Inquiries, Complaints, Disputes Q&A 3 | FDLI | October, 2015

4 The United States Ombudsman’s Association (USOA) defines a governmental Ombudsman as “an independent, impartial public official with authority and responsibility to receive, investigate, or informally address complains about governmental actions, and, when appropriate, make findings and recommendations, and publish reports.” I receive and investigate complaints (in an informal manner) about CTP and seek to mediate, or otherwise resolve, disputes between CTP and entities outside CTP. I follow a code of ethics and operating procedures drawn from those established by the Coalition of Federal Ombudsman, the USOA, and the International Ombudsman Association. These include neutrality, impartiality, objectivity, and confidentiality. Ombudsman Principles

| FDLI | October, Am I the First Person You Should Call?

Probably Not. Start with Your Point of Contact. | FDLI | October, General Information For general inquiries, contact or (9am EST-4pm EST). All written correspondence, including regulatory correspondence, should be sent to the following address: Center for Tobacco Products Attn: Document Control Center Building 71, Room G New Hampshire Avenue Silver Spring, MD Center Addresses Tobacco Industry Questions: Small Business Industry Questions: Formal Correspondence and Speech and Meeting Requests: Also submit a proposed agenda and attendee To contact the Ombudsman with inquiries, complaints and disputes, please or call

7 When To Call Me Try, if possible, to first resolve any complaint or dispute with your POC in the CTP office involved I am here to listen to anyone who contacts my office. If I’m not the right resource, I’ll try to find it. Cannot get involved in matters that are in litigation | FDLI | October, 2015

8 What To Expect from Me To listen, ask questions (including about desired outcome), and review possible options To get involved informally at any stage in the Center’s decision-making process by request Telecon, meeting, informal s or conversations No retaliation for contacting Ombudsman May keep their identity confidential for some or all of the process (unless threats to self/others made) I’m available to provide informal advice on appeal processes Informally provide options No retaliation for filing an appeal | FDLI | October, 2015

9 Informal, efficient, saving resources Improve communications and working relationships Deep understanding of Center operations Adept at interacting with FDA staff Unbiased sounding board, recognizing that I am a CTP employee Why External Parties Contact Ombudsman

| FDLI | October, You haven’t heard back from your POC You’ve raised a concern with a CTP office, but it still has not been resolved You have an issue to discuss, but you’re not sure who to request a meeting with You have feedback to give about CTP’s processes There’s a topic you’d like to discuss anonymously Before filing a formal appeal under 21 CFR General inquiries Remember: any party may ask me to sit in at any stage of the process without retaliation What Types of Concerns Do I Hear About

11 Confidential Impartial, independent, informal, external-focused Listen, assess difficult situations, identify options Receive and investigate complaints Informally look into complaints Facilitate de-escalation of conflicts between CTP and outside parties Respond to simple inquiries Discuss informal dispute resolution options Oversee formal appeal process (21 CFR 10.75) Resolve disputes at early stage through “shuttle diplomacy” When You Call, I Listen | FDLI | October, 2015

12 How Do I Maintain Confidentiality? Communications with the CTP Ombudsman are kept confidential by request except in rare instances such as risk of injury to self or others. Keep in mind, it may be difficult to move forward with a complaint if you request that your identity be kept in confidence. In such cases, I may request permission to disclose identifying details about you. | FDLI | October, 2015

13 I’m also interested in hearing about the effectiveness of CTP’s programs and about problems that may be getting in the way of carrying out the Center’s regulatory responsibilities. I welcome this input because it helps CTP to continually assess and improve the work that it does. Part of my role is to promote good government, fairness, transparency, and accountability. What’s the Issue?

Who Contacted Me in 2014? |April, You can find my 2014 Annual Report on the CTP website by searching for Ombudsman Annual Report or clicking here.here

|April, Topics & Types of Contacts in 2014

I cannot: | FDLI | October, Become anyone’s personal advocate Violate trust (of FDA employees or external parties) Overturn a decision or action or force anyone to do so Work on a dispute when case is pending in legal process Violate the Ombudsman ethics and operating principles Become involved in cases in litigation What I Can’t Do

Stay in the Know | FDLI | October, CTP Website Sign up for regular updates Webinars, trainings, publications, tweets Warning letters, SE/NSE decisions, etc. Guidance, regulations, opportunities to comment CTP Ombudsman Website Read my annual reports Freedom of Information (FOIA) Website Familiarize yourself with what the Federal Government can/can’t share and why Read FAQs Learn how to make a FOIA request

| FDLI | October, Questions?

FDLI Tobacco Conference October 21, Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l Jim Dillard Sr. Vice President, Regulatory Affairs Chief Innovation Officer

Engagement Principles  Be the most: Informative Scientific and evidence-based Balanced Instructive and, therefore, most persuasive  Provide the best advocacy for our positions  Advocate for accurate and non- misleading product communications to adult tobacco consumers Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l20

FDA Engagements Biomarkers of Tobacco Exposure Statistics Electronic Cigarettes & the Public Health Public Workshops Scientific & Policy Organizations Regulatory Filings Site Tours Face-to-face Meetings Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l21 Third party trademarks and images are the property of their respective owners and are used for illustrative purposes only.