Tobacco Product Ingredient Listing

eSubmitter Quick Guide: Packaging with Digital Signature
The packaging process outlined below is specific to packaging with a digital signature. This quick guide will instruct you on the basics
for using the packaging wizard.

Inside this guide:
Package Files

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Digital Signature and
User Support

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= Important Tip

After completing the submission and verifying that there is no information missing, you are ready to
package the files for submission. To proceed, the eSubmitter application should be open, and the
finished submission displayed on your computer screen.
1.
2.
3.

Click Output > Package Files for Submission from the menu bar.
If data is missing, a warning message will be displayed.
If the submission has all required data, the Packaging Files Dialog box is displayed (as shown to
the right). Within the Packaging Files Dialog box you will be prompted to move through a series of
steps detailed below.

Step 1: Overview and Package File Information
This section contains a brief overview of the
packaging process. Follow the instructions below.
1.

Specify the submission package file name.

•

2.

The Package File Name (.zip) text box
identifies the default zip file name for the
submission. (eSubmitter automatically
uses the submission name for the zip
file.) Make a note of the name for the zip
file.

Specify the submission output location.

•
•

The Package Output Location identifies
the file folder where the zip file is located.
Make a note of the output location.
To change the location click the file folder
icon, navigate to the desired location, and click

3.

Click
to proceed to Step 2: File
Attachment Verification.

Step 2: File Attachment Verification
This section lists all file attachments used in the
submission.
1.

Click Next to proceed to Step 3 and continue
packaging the submission.
OR
Click Previous to go back to Step 1.
OR
Click Cancel and exit the Package File Dialog
box.

(Continued on Next Page)

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Step 3: Digital Signature, Package Creation
This section contains the final steps for reviewing the submission report, applying a digital signature and producing the submission
package. At right is an example of what may appear in Step 3.

Review Submission Report
1.
2.
3.
4.

Click the
button.
A PDF version of the report appears.
Ensure that your submission report is accurate.
Close window to return to Packaging Files Dialog.

Applying a Digital Signature
1.
2.
3.

To attach your personal Adobe digital signature, click
Locate filename of your Adobe digital signature and click
Type in Digital Signature Password.

Produce Submission Package
1.

Click on
to initiate the packaging of the zip file and
verification of the digital signature and password.
An error message will appear if the digital signature/password is invalid.

2.

A Certification Agreement Dialog pop-up may appear as seen at right.

3.

Click
to proceed with packaging or
to return to the
previous step. Once the submission has packaged successfully, the
status bar will indicate that the packaging is complete.

4.

Click
to proceed to Step 4 to view the transmission instructions related to your submission.

Step 4: Transmit Submission Package
This section provides confirmation that the submission files have been successfully packaged. The submission is ready to be sent to FDA. Follow the
instructions below.
1.

2.

Read the instructions provided in Step 4 of the packaging wizard.
These instructions will vary depending on the program for which you are
submitting.
Click Done to close the Packaging Files Dialog box.
OR
Click Previous to return to Step 3.

Please see http://www.fda.gov/esg/ for Electronic Submissions Gateway (ESG) transmission instructions. Verify that the program for which
you are submitting accepts submissions via the ESG. Otherwise, you
will be required to mail in your submission on CD to the appropriate
address.

User Support
For technical assistance for the eSubmitter software, an email can be sent to [email protected]. In the email, please be sure
provide the company name and contact information where a response can be sent.

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