Electronic Submissions for Tobacco Products
On this page:
- 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 Team
The 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 Information |
|---|---|---|---|---|
| Tobacco health documents Sec. 904(a)(4) | 0910-0654 | e-Submitter tool | CTP Portal | Requires prior request of an Industry Manager Account |
| Ingredient listing (TI) Sec. 904(a)(1) | 0910-0650 | |||
| Warning plans (Cigars and Smokeless Tobacco) | 0910-0671 0910-0768 |
|||
| Quantities of harmful and potentially harmful constituents (HPHCs) Sec. 904(a)(3) | 0910-0732 | |||
|
Apply to market a new tobacco product
|
|
|||
| Modified Risk Tobacco Product (MRTP) application Sec. 911(g)(4) | N/A | |||
| Tobacco Product Master Files (TPMF) | N/A | |||
| Meeting requests | 0910-0731 | |||
| Other correspondence related to regulatory requirements | N/A | |||
| New tobacco products submitted a Premarket Tobacco Application (PMTA), 910(b) | 0910-0768 and 0910-0879 | |||
| New tobacco product submitted with a request for exemption from substantial equivalence, 905(j)(3) | 0910-0684 | |||
|
User fee information OMB Control Number 0910-0749 The burden time for this collection of information is estimated to average 4 hours per response, including the time to review instructions, search existing data sources, gather and the data needed, and complete and review the collection of information. |
0910-0749 |
FDA Form 3852 | Email TobaccoUserFees @fda.hhs.gov |
|
| Pay user fees | N/A | Invoice sent from FDA | iReceivable system; ACH Wire Transfer; check | |
| Register establishment; submit list of products and product labeling/advertising | 0910-0650 and 0910-0312 |
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 Products | Find current comment opportunities and respond. | |
|
Report a tobacco product violation OMB Control Number 0910-0716 The burden time for this collection of information is estimated to average .25 minutes per response, including the time to review instructions, search existing data sources, gather and the data needed, and complete and review the collection of information. |
0910-0291 | 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.
- Submit 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 HD 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
- If you are unable to submit online, mail submissions to CTP's Document Control Center, using FDA Form 3743 (PDF).
The burden time for this collection of information is estimated to average 50 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.
- Registration and Listing for Tobacco Products
- If you are unable to register online, please mail
Form FDA 3741 (PDF) (for cigarettes, smokeless tobacco, and roll-your-own tobacco) or
Form 3741a (PDF) (newly-regulated finished tobacco products)
OMB Control Number 0910-0650
- If you are unable to register online, please mail
The burden time for this collection of information is estimated to average 3.75 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.
- Submit tobacco product adverse experiences to the Safety Reporting Portal
- The SRP tobacco questionnaires are not available in a paper or fillable PDF format.
- If you have technical problems submitting a report, contact [email protected].
OMB Control Number 0910-0291
The burden time for this collection of information is estimated to average 36 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.
Contact 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 [email protected] 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.