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  4. Deemed Tobacco Product Applications - A Public Meeting - 10/28/2019 - 10/29/2019
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Meeting

Event Title
Deemed Tobacco Product Applications - A Public Meeting
October 28-29, 2019

Scheduled

Date:
October 28-29, 2019
Time:
08:30 AM - 04:30 PM EDT
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Organized By:
Please note that we have reached maximum capacity for in-person attendance. You may still register to watch the free webcast through Sept. 30.
Center Date Time Location
CTP October 28, 2019 8:30 a.m. to 4:30 p.m. Food and Drug Administration (FDA)
Center for Tobacco Products (CTP)
White Oak Conference Center
Building 31, Room 1503, Section A
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
CTP October 29, 2019 8:30 a.m. to 4:30 p.m. Food and Drug Administration (FDA)
Center for Tobacco Products (CTP)
White Oak Conference Center
Building 31, Room 1503, Section A
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Meeting Objective: 

This meeting is intended to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles. The information will improve public understanding and assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act):

Topics to be addressed in the meeting include: 

  • Overview of the tobacco product marketing application pathways
  • Information that should be included in a tobacco product marketing application
  • Administrative processes involved in the submission and review of a tobacco product marketing application
  • Other topics relevant to the submission of tobacco product marketing applications, including communications between FDA and industry during an application review process, use of Tobacco Product Master Files, as well as electronic submission resources and tools

FDA will present information about the tobacco product application review programs including lessons learned, process improvements, and observations that may inform further improvements in submissions and the review process.  FDA will seek feedback from the public and have panels of FDA and regulated industry representatives to discuss the topics.

The meeting is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.


Who Should Attend this Meeting?

Tobacco product manufacturers, including small business tobacco manufacturers, importers, distributors, wholesalers, and retailers; scientific and medical experts;  federal, state, and local government agencies; and other interested stakeholders, such as academic researchers and public health organizations.  

Registration to Attend or View a Live Webcast of the Meeting: 

If you wish to attend the workshop by webcast, you must register by submitting an electronic request no later than September 30, 2019; registration is free.

Please submit electronic requests to register at https://www.surveymonkey.com/r/YPXTFJN. Requests for registration must include the prospective attendee’s name, title, affiliation, and contact information. We have reached maximum capacity for in-person attendance.  

Onsite registration may be allowed if space is available. 

Archived Webcast and Transcripts: 

FDA will post the webcast and complete transcripts as soon as they are available.

Panelists:

FDA is interested in gathering information and perspectives from stakeholders on the topics to be discussed.  We are inviting nominations for panelists to address information pertaining to the following topics related to tobacco product marketing application review: 

  • Application development and submission, including pre-submission meetings and use of Tobacco Product Master Files.
  • Scientific content and evaluation of PMTAs 
  • Scientific content and evaluation of Exemption Requests and SE Reports 
  • Preparation of electronic submissions including FDA resources and tools available to support application submission

Panelists will discuss the presentations and issues listed above. If you are interested in serving as a panelist, please submit the information requested below to Workshop.CTPOS@fda.hhs.gov by September 13, 2019.

To be considered as a panelist, please provide:

  • Identify the topic which you would like to discuss;
  • A one-page biosketch, including the position(s) you hold, that describes and supports your expertise on the topic(s) being presented 

Key Dates:

  • Deadline for Requests to Serve as a Panelist: September 13, 2019
  • Registration Deadline: September 30, 2019

Special Accommodations:

If you need special accommodations because of disability, please email Workshop.CTPOS@fda.hhs.gov, or call 1-877-287-1373 (Option 5) at least seven days before the meeting. 

Contact for Questions:

Telephone: 1-877-287-1373
e-mail:  Workshop.CTPOS@fda.hhs.gov