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U.S. Department of Health and Human Services

For Industry

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Center for Tobacco Products - Instructions for Registration and Submission

On June 22nd, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA). This historic legislation grants authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). Section 905 of this act sets forth statutory requirements to submit tobacco product registration and listing information to FDA.

CTP (Center for Tobacco Products) Resources
For information about the creation of Electronic Submissions refer to: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm

For Guidance, Compliance & Regulatory Information, refer to: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm

Obtaining an Electronic Submissions Gateway (ESG) account
The following checklist will provide guidance for setting up an account with the FDA Electronic Submissions Gateway (ESG) for the purpose of submitting labeling, advertising and marketing data to CTP (Center for Tobacco Products).

 

Before you Start
1. Send an email to esgprep@fda.hhs.gov requesting a WebTrader test account.  Provide the following information:  Company name, your name, phone number and submission method (WebTrader).  Note: A Corporate email account must be used for communications with FDA (public domain email accounts such as Yahoo mail, Gmail, etc are not accepted).  Click here for more information.
2. Send a Letter of Non-Repudiation to FDA.  Click here for more info.
3. Obtain a personal digital certificate.  Click here for more information on certificates.
4. Read the User Guide and tutorials on the FDA ESG website.  Review System Requirements. Note: only Internet Explorer 6, 7, 8 and Firefox 2.0.x are compatible with ESG.
Request and Set Up Your Test Account
(for technical assistance contact esgreg@gnsi.com)
Wait for email with information on how to register online for a WebTrader test account.  (reply to email from Step 1)
5. Register for a WebTrader test account.  Follow the steps outlined in the email and refer to "Registering for a web based test account" tutorial for detailed registration steps.  You will need the public key for you personal digital certificate (refer to step 3) to complete this step.  Note: The Primary Contact must be a real person; the "Company Name" is actually an account name and must be unique throughout the entire ESG test system.  We recommend appending the user's initials to your company name.
Wait for the WebTrader test account activation email. Account activation may take up to 48 hours.
6. Activation email received.  Follow the instructions outline in the email to:
     a. Install JRE (activation email will contain the specific version details)
     b. Install JCE (activation email will contain the specific version details)
     c. Configure your firewall (activation email will contain the details)
Send Test Submissions
Log in to your ESG WebTrader test account (same URL to Register for a test account) with the user ID and password you created when you registered for your test account (step 6 above).
7. Send a test submission to ‘Center for Tobacco Products’ center with submission type ‘Electronic Submission’.
Set Up a Production Account
8. Once FDA receives the test submission, you will be sent an email, with information on how to register for a production account. This may take up to two business days.
9. Register for production WebTrader account following the steps outlined in the email.  You will need the public key for your personal digital certificate to complete this step.
Wait for the WebTrader production account activation email. Account activation may take up to 48 hours.
10. Activation email received for the Production Account. Follow the instructions in the activation email.
     a. You must use the same computer that you used for testing.
     b. Make sure you have the JRE and JCE installed.
     c. Configure your firewall (activation email will contain the details)
Log in to your ESG WebTrader production account (same URL to register for a production account) with the user ID and password you created when you registered for a production account (step 9 above).
You are now ready to send electronic submissions to FDA using the ESG system.

Helpful Contact Information

For questions relating to the content of CTP submissions, contact esubmitter@fda.hhs.gov.

For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov.

For technical assistance with the registration or testing process, contact esgreg@gnsi.com. .

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