Premarket Tobacco Product Application Processes: A Public Meeting

FDA Center for Tobacco Products

FDA is hosting a public meeting providing information and guidance on premarket tobacco product application processes.

FDA White Oak Campus

<h2>A﻿bout the Meeting</h2>In the past three years, the <a href="https://www.fda.gov/tobacco-products" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">FDA Center for Tobacco Products (CTP)</a> has taken action on around 26 million tobacco product applications. The CTP Office of Science will offer insights into the FDA's requirements for Substantial Equivalence (SE) Reports and Premarket Tobacco Product Applications (PMTAs) to promote stakeholder engagement and enhance public understanding of the application process. CTP will also highlight submission and review process improvements.Goals and Objectives<ul><li>Provide information related to the premarket application processes, including SE and PMTA.</li><li>Describe how certain elements of the final SE and PMTA rules are implemented during the application review process. </li><li>Assist applicants with avoiding commonly identified problems that the Center has identified in previously submitted applications.</li><li>Encourage stakeholder involvement and improve public comprehension of the application process. </li><li>Provide answers to questions regarding SE Reports or PMTAs for those contemplating applying.</li></ul>It is important to note that the meeting will not introduce new policies or interpretations regarding product applications and their review.Dates and Times<ul><li>October 23, from 9:00 a.m. EDT to 4:30 p.m. EDT </li><li>October 24, from 8:30 a.m. EDT to 4:00 p.m. EDT</li></ul>﻿The meeting will be in-person, but with an option to participate virtually.In-person Attendance InformationThis meeting will be held at the FDA White Oak Campus in the Great Room. Address: 10903 New Hampshire Avenue Bldg. 31, Room 1503, Silver Spring, MD 20903Virtual Attendance InformationThe Zoom link will be provided to all registered attendees before the meeting. Virtual attendees can join the meetings by computer or phone.The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If a reasonable accommodation is needed, please email serina.hunter-thomas@fda.hhs.gov. Requests for sign language interpretation should be made at least 7 days before the public meeting. A request for ASL services should be sent directly to the FDA Interpreting Services Staff email account: <a href="https://mailto:interpreting.services@fda.hhs.gov" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">interpreting.services@fda.hhs.gov</a>. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.ContactFor additional details and questions contact the FDA’s CTP/OS Public Meeting Support Team at <a href="https://mailto:Workshop.CTPOS@fda.hhs.gov" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Workshop.CTPOS@fda.hhs.gov</a>.

<h2>Interested in asking a question during the meeting?</h2>Invited participants are urged to submit their questions when registering by October 6th, no later than 11:59 PM EDT. Please note questions must be about FDA’s SE and PMTA processes; questions unrelated to these topics will not be addressed during the meeting.Can’t attend the public meeting, but want to submit a question? If you are unable to attend but would like to submit a question to the CTPs Office of Science regarding the FDA's requirements for SE Reports or PMTAs, please contact <a href="https://mailto:Workshop.CTPOS@fda.hhs.gov" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Workshop.CTPOS@fda.hhs.gov</a>