Submission of original rotational plans for health warning statements for smokeless tobacco products

Steps to submit a new Warning Plan:
1. Launch eSubmitter

If a user is creating a new submission, they can click the create new submission button.
They would select the “CTP: Transmittal Form” option.

Once they select CTP: Transmittal Form, the following Create New Submission dialog will
appear. Note that anything with a blue button beside the field is mandatory. In this case, file
name and descriptive name are mandatory.

If a user wishes to continue work on an existing submission, choose the existing
submission option to see a list of draft esubmitter files.

Once a file name is entered, the introduction overview screen will appear. There is no
content to enter on this screen. The user can press an arrow to move to the next page.

The next page is Submission Type Instructions. There is no content to enter on this screen.
The user can press an arrow to move to the next page.

The next page is Submission Content. Note that this field is optional. There are multiple
options in the dropdown including but not limited to Appeals, General Correspondence,
Meeting Request, and Rotational Warning Plans. Once selected the user can move to the
next page. Note that this field is not required. A blank field will result in an XX submission
type on the CTP side.

The next page contains a PRA statement. There is no content to enter on this screen. The
user can press an arrow to move to the next page.

The Company contact screen is next. The screen contains several fields to identify the
company name, contact name, and other standard contact data entry fields. No field is
mandatory on this screen. Users have the option to leave the contact screen blank. Once
completed, users can click a button to move forward.

Company contact entry continued. Phone Fax and Reference Numbers are at the bottom of
the screen. The user can press an arrow to move to the next page. All fields are optional.

For Contact: Submitter Identification, the fields are the same as contact company. That
said, there is an optional checkbox where the user can select if the submitter name is the
same as the company name. If selected, the screen will lock and the user can press an
arrow to move to the next page. All fields are optional.

For Contact: POC Identification, the fields are the same as contact company. That said,
there are two optional checkboxes where the user can select if the POC name is the same
as the company name or the submitter name. If selected, the screen will lock and the user
can press an arrow to move to the next page. All fields are optional.

Once all three contacts are entered, the submission attachment screen will pop up. The
cover letter and submission comments fields are optional. The submission document field
requires at least one document to be uploaded. Multiple documents can be uploaded if the
user would like.

The next page is the end page for data entry. There is no content to enter on this screen. The
user will need to select the package button to start packaging the submission. Instructions
are available in the box on the screen.

If a mandatory field is missing, a missing data report will be provided. Users can click the
yes button to review the missing data report.

The missing data report will appear as follows:

If there is no missing data, the following message will display:

The package screens appear as follow. Package File Name and Output location are
mandatory. Once input, user will click the next button.

The next page contains a list of all files. There is no content to enter on this screen. The user
can press next to move to the next page.

Step 3 is the final step in eSubmitter. A submission report will be automatically generated
and can be reviewed via the submission report button. The digital signature will need to be
selected and password input to complete the submission. The digital signature can be
generated in Adobe PDF. User will select Package and Sign Submission Files button.

Once packaging is complete, the submission will be located at the output location from
Step 1 and be ready for upload into CTP Portal NG.

The next page contains information on how to submit. There is no content to enter on this
screen. The user can press next to move to the next page.

In CTP Portal, once the user logs in, the user will select Create New Submission.

User will select eSubmitter Upload.

The user will browse to and select the eSubmitter file.

Once you click the upload button, a loading screen will appear then be replaced by the
upload complete screen. At this point, if no errors are found, the submission will transmit
to CTP and the industry user has completed their submission.