Tobacco Products

Tobacco Product Application Review - A Public Meeting

October 22-23, 2018
8:30 a.m. to 4:30 p.m. on October 22, and 8:30 to 3 p.m. on October 23

Food and Drug Administration (FDA)
Center for Tobacco Products (CTP)
Tommy Douglas Conference Center
10000 New Hampshire Avenue
Silver Spring, Maryland 20903

Meeting Objective:

This meeting is intended to improve public understanding and seek feedback on the policies and processes for the submission and review of tobacco product marketing applications, including the general scientific principles relevant to various application pathways, in order to assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act):

  • Substantial Equivalence Reports (SE Reports) – Section 905(j)
  • Exemption Requests (Ex Reqs) – Section 905(j)
  • Premarket Tobacco Product Applications (PMTAs) – Section 910
  • Modified Risk Tobacco Product Applications (MRPTAs) – Section 911

Topics to be addressed in the meeting include:

  • Overview of the tobacco product marketing applications types
  • 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 Tobacco Product Master Files, meeting requests, Grandfathered review, and Environmental Assessments

FDA will present information about the tobacco product application review programs including 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.

Register to Attend or View a Live Webcast of the Workshop:

If you wish to attend the workshop in-person or by webcast, you must register  no later than September 21, 2018. Registration is free.

Please submit registration requests online. These requests must include the prospective attendee’s name, title, affiliation, and contact information. Both in-person seating and webcast viewership are limited, so early registration is recommended. FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity.

Confirmation of registration will be emailed to you no later than September 24, 2018.

Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration in the Center for Tobacco Products Newsroom

Archived Webcast and Transcripts:

FDA will post the webcast along with complete transcripts on this website 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 submission and review, including pre-submission meetings and preparation of electronic submissions
  • Use of Tobacco Product Master Files (TPMFs)
  • Grandfathered review
  • Environmental Assessment (EA) review
  • Scientific content and evaluation of Exemption Requests and SE Reports
  • Scientific content and evaluation of PMTAs and MRTPAs

Panelists will discuss the presentations and issues listed above. If you are interested in serving as a panelist, please submit the information found in the paragraph directly below, along with the topic on which you would like to speak, to workshop.CTPOS@fda.hhs.gov by August 31, 2018.

To be considered as a panelist, please provide:

  • A one-page biosketch that describes and supports your expertise on the topic(s) being presented,
  • The nature of your experience with tobacco product marketing applications and research,
  • The position(s) you hold, and
  • Any program development activities in which you have been involved.

FDA Invites Public Comments on Tobacco Product Marketing Application Review

Docket for submitting public written comments:
FDA will announce, in the Federal Register, the establishment of a docket for submission of written comments in conjunction with the public meeting to gather information about tobacco product marketing application review. Regardless of attendance at the public meeting, interested persons are invited to submit comments and other information to the docket. The forthcoming Federal Register notice will provide detailed information on how to submit comments.

Key Dates:

  • Deadline for Requests to Serve as a Panelist: August 31, 2018
  • Registration Deadline: September 21, 2018
  • Date Successful Registrants will Receive Registration Confirmation: September 24, 2018

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 (Option 5)
e-mail: Workshop.CTPOS@fda.hhs.gov

Page Last Updated: 08/02/2018
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