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                FDA eSubmitter

FDA eSubmitter

                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
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          eSubmitter Tutorial Videos
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          FDA eSubmitter
          Using eSubmitter to Prepare Tobacco Product SubmissionsFDA eSubmitter Using eSubmitter to Prepare Tobacco Product Submissions
  
  	
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Update to Latest eSubmitter Version for Tobacco Product Submissions
	Prepare Tobacco Product Submissions to Submit Online
	Format and Electronic Submissions via eSubmitter
	Submit Online
	Additional AssistanceStay up to date on product news, announcements, and other important information by signing up for our email lists.

Update to Latest eSubmitter Version for Tobacco Product Submissions

FDA updates eSubmitter submission templates monthly, usually in the first or second week of the month. Using updated templates for your submission helps ensure the latest fields are used and the structure of each submission can be received and processed by the FDA.

For new submissions, eSubmitter will automatically provide the newest template.
	To update a previous submission, use the “Save As” option, and eSubmitter will load the newer template.**Can’t see the newest eSubmitter updates?**

Check to make sure eSubmitter updates aren’t being blocked by your IT infrastructure.
	If blocked, manually reinstall critical CTP templates as needed, by accessing “application history” on the FDA’s main eSubmitter webpage.Since November 2017, when CTP extended the ingredient listing deadline, FDA has updated eSubmitter to address feedback from industry, including allowing:

alpha numeric tobacco product (TP) numbers
	attachment of.xlsx format Excel filesPrepare Tobacco Product Submissions to Submit Online:

Download the eSubmitter software to package regulatory documents into an electronic submission package to send to the Center for Tobacco Products (CTP), including:

Listing of Ingredients in Tobacco Products (Sections 904(a)(1) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
	Tobacco Health Documents (Sections 904(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
	Reporting Harmful and Potentially Harmful Constituents (Sections 904(a)(3) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
	Product Applications (Premarket Tobacco Applications (PMTA), Substantial Equivalence (SE), Exemption from Substantial Equivalence, Tobacco Product Master Files (TPMF), Modified Risk Tobacco Products (MRTP))Format Electronic Submissions via eSubmitter

**Follow the character limits for the file path and file name. The character limits are:**

	File path: 200 characters with spaces maximum, including folder and subfolder names, such as: C:\FredsFiles\SubmissionFolder987\AmendmentFolder5\ToxSection\ToxData\toxdatefile678.xpt|
		**Avoid subfolders when possible. Fewer folders within your submission will help keep all related files together and in one place*.
		File name: 50 characters maximum, such as toxdatefile123.xpt.**Assign unique file names to ALL files throughout the submission so no filenames are repeated twice.*
	**Avoid special characters, including spaces, or foreign language characters in file paths or file names.**
	Examples of non-accepted filename characters:
		Spaces. Use an underscore “_” or hyphen “-” instead of spaces in file names.
			/, \, @, %, <,>, “, ?, |, :, ;
			Non-English characters, such as ä,é,î,ð,ñ,ü,æ
	**Save files as standard file types**. FDA accepts many different file types or file formats, including many common file types for ingredient listing, such as *.xpt, xls, xlsx, , csv, txt, , html, xml, , rtf, and others.
	*Data sets*: FDA recommends SAS Transport file format (*.xpt) or Comma Separated Values file format (*.csv) for data sets when possible even if such data are displayed as tables in the narrative PDF documents.
		*Text*: FDA recommends PDF format.
		*Proprietary software:* If a proprietary software is used and FDA does not have the software, the files can’t be opened.
	**Break up submissions of more than 2GB in size and cross-reference**. Additionally, for files larger than 2GB:
	Provide a table of contents before packaging multiple files to ensure FDA is aware of all anticipated files.
		Identify the filename of the main application document within the table of contents.
		Submit a table of contents and the main application document separately from the remainder of the files.
		Refer to the Electronic Common Technical Document (eCTD) model, which is an FDA - supported electronic submissions standard found in Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (May 2015)
	**Create a Cover Letter (optional) to attach to your main application document that**outlines the organizational structure and includes the number of eSubmitter packages and files you  will transmit. 
	**Send it to your CTP point of contact** (regulatory health project manager) in advance of your submission so FDA knows how many files or eSubmitter packages to expect.
		***Consider using “open file” hyperlinks**in table-of-contents-style list within the cover letter referencing additional documents within the submission. Where possible, bookmark across files and folders to referenced points wherever possible.
	**Read additional materials to assist with electronic submissions.** FDA’s Center for Tobacco Products has created several reference documents to assist users with the electronic submissions process:
	Overview of the Electronic Submissions Process for Industry. Contains basic information about the documents and data needed to successfully create and submit an eSubmitter package.
		Electronic Submission File Formats and Specifications. Provides greater detail about file types and electronic submission standards for tobacco product submissions.
		FAQs and Common Errors and Questions that Delay Submission Processing. Contains additional references related to electronic submissions to CTP, including confidentiality and trade secret policies as well as links to relevant FDA guidance documents.
		Electronic Submissions for Tobacco Products. Contains information for industry about how to electronically submit information to CTP.Submit online

Upload your eSubmitter package through the CTP Portal.
	Read more about how to Submit Documents via the CTP Portal.Additional Assistance

Read the eSubmitter User Guide.
	Contact CTP
	For eSubmitter technical support, email esubmitter@fda.hhs.gov or call 1-877-CTP-1373
		For support submitting electronically via the CTP Portal, email CTPeSub@fda.hhs.gov.
	Work with CTP to submit a “test submission” 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.
		Watch video tutorials using eSubmitter.
	For regulatory questions, email TobaccoIndustryQuestions@fda.hhs.gov.
	Family Smoking Prevention and Tobacco Control Act (Public Law 111-31)
	Manufacturers

                                                                                  Content current as of:
      10/12/2023
              
              
Regulated Product(s)
		 TobaccoFDA eSubmitter

          
                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History
 
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