How to Submit a PMTA ?

• How to Submit a PMTA 
  1. Request an Industry Account Manager (IAM) account to establish CTP Portal account, if your company does not already have an IAM.
  2. Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
  3. Submit online via the CTP Portal. 
     Note: The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP.
     
     Applicants may request a waiver from FDA to submit a PMTA in a format other than electronically. Waivers will be granted if use of electronic means is not reasonable for the applicant.
• Amendments can also be submitted using these instructions.  Any amendment must include, among other things, the appropriate form and specify the submission tracking number(s) of the PMTA. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.   

Grouping PMTA Submissions 

• The final PMTA rule outlines how a manufacturer might submit one premarket tobacco product application for multiple products as a grouped submission such as e-liquids in varying sizes, nicotine strengths and/or flavor combinations. 
• To identify and provide information for each product contained in a grouped submission, applicants should use the Product Grouping Spreadsheet (xlsm 80 KB) [Last updated: April 28, 2022]. 
• FDA intends to consider information on each product in a grouped submission as a separate, individual application.  
• Content specific to each product in a grouped submission will need to be clearly specified.  

Importantly, each product in a grouped submission is still treated as an individual product application. FDA regulations still require individual environmental assessments to be submitted for each individual tobacco product. 

PMTA Review Process 

• Presubmission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product. For more information, see Meetings with Industry and Investigators.
  • Output
    • Meeting granted letter or
    • Meeting denial letter
    • Meeting minutes letter (if meeting is granted and held)
• Acceptance Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon Section 910 of the FD&C Act and the criteria set forth in § 1114.27(a)(1).
  • Output
    • Acceptance letter or
    • Refuse to accept (RTA) letter
• Filing Review:   A threshold determination of whether the application contains sufficient information to permit a substantive review. FDA may refuse to file a PMTA if any of the criteria in § 1114.27(b)(1) apply.
  • Output
    • Filing letter or
    • Refuse to file (RTF) letter
• Substantive Review: FDA evaluation of the scientific information and data in an application, as well as recommendations from the Tobacco Product Scientific Advisory Committee (TPSAC), if the application was referred.
  • Output
    • Deficiency letter: Additional information is needed to complete scientific review. The letter will specify the number of days an applicant has to respond.
    • Environmental information request letter: FDA made a scientific decision to issue a marketing granted order; however, the applicant is required to provide information for environmental considerations before a marketing granted order can be issued. 
• Action:
  • Output includes
    • Marketing granted order letter or
    • Marketing denial order letter
• Postmarket Requirements: Requires applicants to establish and maintain records and make reports that FDA requires as necessary to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order. Postmarket reporting requirements for all products that receive a marketing granted order are set forth in § 1114.41 and FDA may require additional reporting under the terms of a marketing granted order.                            Published by: https://www.fda.gov/