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                Manufacturing

Manufacturing

                        Electronic Submissions for Tobacco Products
          Submit Tobacco Product Applications for Deemed Tobacco Products
          Tobacco User Fees
          Submit Documents via the CTP Portal
          Submit Ingredient Listing for Tobacco Products
          Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions Home
          Tobacco Products
          Compliance, Enforcement & Training
          Manufacturing
          Electronic Submissions for Tobacco ProductsManufacturing Electronic Submissions for Tobacco Products
  
  	
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Electronic Submission Types
	Process for electronically submitting information to CTP via the CTP Portal
	Resources for Submitting Electronic Submissions to CTP
	Contact CTP Electronic Submissions TeamThe FDA’s Center for Tobacco Products has several processes in place for manufacturers and other industry to submit regulatory information and correspondence about tobacco products using electronic methods. For most submissions to CTP, including meeting requests and correspondence, manufacturers may use the FDA e-Submitter tool to package files and information, and then transmit those files via the CTP Portal.* Submission types that do not use the CTP Portal, but can still be submitted electronically, include user fees, establishment registration, product listing, and safety reporting.**

Filing submissions electronically assists FDA with the receipt, processing, review and archiving process for tobacco products.

*The CTP Portal provides more functionality than the existing FDA Electronic Submissions Gateway, or ESG, WebTrader tool. CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you can still use it to submit documents to CTP.
**The Safety Reporting Portal (SRP) is a secure web-based system that streamlines the submission of individual adverse experiences (health problems) and product problems involving tobacco products. The SRP does not accept submissions formatted in any computer language (such as xml or html).

Electronic Submission Types



Submission Type
			OMB Control Number(s)
			Prepare Via
			Submit Via
			Additional InformationTobacco health documents Sec. 904(a)(4)
			0910-0654
			e-Submitter tool
			CTP Portal
			Requires prior request of an Industry Manager AccountIngredient listing (TI) Sec. 904(a)(1)
			0910-0650Warning plans (Smokeless Tobacco and Cigars)
			0910-0671
			0910-0768Quantities of harmful and potentially harmful constituents (HPHCs) Sec. 904(a)(3)
			0910-0732Apply to market a new tobacco product

			SE Reports Sec. 905(j),  EX REQ
				Sec. 905(j)(3),
				PMTA
			0910-0673

			0910-0684

			0910-0768
			0910-0879Modified Risk Tobacco Product (MRTP) application Sec. 911(g)(4)
			N/ATobacco Product Master Files (TPMF)
			N/AMeeting requests
			0910-0731Other correspondence related to regulatory requirements
			N/ANew tobacco products submitted a Premarket Tobacco Application (PMTA), Sec. 910(b)
			0910-0768
			0910-0879New tobacco product submitted with a request for exemption from substantial equivalence, Sec. 905(j)(3)
			0910-0684Pre-Existing Tobacco Products
			0910-0775User fee information
			0910-0749
			FDA Form 3852
			Email: TobaccoUserFees
			@fda.hhs.govPay user fees
			N/A
			Invoice sent from FDA
			iReceivable system; ACH Wire Transfer; checkRegister establishment; submit list of products and product labeling/advertising
			0910-0312
			0910-0650
			
			Tobacco Registration and Product Listing Module - Next Generation (TRLM NG)

			If you are unable to submit online using TRLM NG, please mail the appropriate Registration & Listing PDF form (FDA Form 3741 or, for deemed establishments, FDA Form 3741a)documents to CTP's Document Control Center.Report a tobacco product adverse experience or product problem
			0910-0291
			
			Safety Reporting Portal
			Learn about the types of  problems that should be reported to FDA.Comment on tobacco product rules, regulations, and guidance
			N/A
			
			Submit Comments on Tobacco Regulatory Activities
			Find current comment opportunities and respond.Report a tobacco product violation
			0910-0716
			Electronic form
			Report Potential Tobacco Product Violation
			If unable to submit online, mail the paper form.See all timelines and guidance for regulatory submissions made by manufacturers, distributors and importers.

Process for electronically submitting information to CTP via the CTP Portal

Prepare submission electronically using FDA’s eSubmitter tool.
	Work with CTP to plan and submit a test or practice submission to CTP to identify any challenges or issues prior to full submission.
	See CTP’s eSubmitter Submission Checklist and Technical Working Instructions for help preparing your electronic submission. Persons with disabilities having problems accessing the PDF may call 1-877-CTP-1373 for assistance.
	Submit final files via the CTP Portal (Request for an Industry Account Manager (IAM) account.)Resources for Submitting Electronic Submissions to CTP

**General resources for using e-Submitter and the CTP Portal:**

Overview of the Electronic Submissions Process for Industry: Contains basic information about the documents and data needed to successfully create an electronic submission.
	Electronic Submission File Formats and Specifications: Provides greater detail about file types and electronic submission standards available for tobacco product submissions.
	FAQs and Common Errors and Questions that Delay Submission Processing: Contains more information about electronic submissions to CTP, including confidentiality and trade secret policies as well as links to additional relevant FDA guidance documents.
	Using FDA eSubmitter to Prepare your Tobacco Product Submissions: Details the process for using the downloadable eSubmitter software to package files together in preparation for submitting to FDA.
	Submitting documents via the CTP Portal**More information about specific submission types:**

Ingredient Listings for Tobacco Products
	Premarket Tobacco Product Applications
	Substantial Equivalence Reports
	Exemption from Substantial Equivalence
	Tobacco Health Document Sec 904(a)(4) Submission, Technical Working Specifications
	If you are unable to submit online, mail submissions to CTP's Document Control Center, using FDA Form 3743 (PDF).
		OMB Control Number 0910-0654
	Registration and Listing for Tobacco Products
	If you are unable to register online, please mailForm FDA 3741 (PDF) (for cigarettes, smokeless tobacco, and roll-your-own tobacco) orForm 3741a (PDF) (newly-regulated finished tobacco products)
		OMB Control Number 0910-0650
	Submit tobacco product adverse experiences to the Safety Reporting Portal (SRP)
	The SRP tobacco questionnaires are not available in a paper or fillable PDF format.
		If you have technical problems submitting a report, contact SRPSupport@fda.hhs.gov. 
		OMB Control Number 0910-0291
	Pre-Existing Tobacco ProductsContact CTP Electronic Submissions Team

Contact the CTP electronic submissions team with any additional questions regarding electronic submissions.

The Electronic Submissions Help Desk can assist with technical questions prior to submission of an application.  Once an application has been submitted, it will follow the regulatory process and receive an appropriate determination following our policies. We encourage applicants to know the various electronic requirements and to contact the help desk with questions prior to submission. If you have any questions regarding your submitted application, you may email AskCTP@fda.hhs.gov or call 1-877-287-1373.

For questions other than electronic submissions, contact the product's manufacturer or contact us.

If you are unable to submit online, mail submissions to CTP's Document Control Center.

                                                                                  Content current as of:
      09/15/2022
              
              
Regulated Product(s)
		 TobaccoManufacturing

          
                        Electronic Submissions for Tobacco Products
          Submit Tobacco Product Applications for Deemed Tobacco Products
          Tobacco User Fees
          Submit Documents via the CTP Portal
          Submit Ingredient Listing for Tobacco Products
          Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions
 
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