FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module

INTRODUCTION

This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and illustrate how to assemble an OFAS Regulatory submission. COSM presents you with questions in a simple and consistent format to assist you in assembling OFAS submissions with ease.
Note: Prior to using this Guide, you should familiarize yourself with the COSM Registration Help Guide.

This Guide gives information relevant to the following OFAS submissions:

1. Food Contact Notification (FCN) (Form 3480)
2. Food Master File (FMF) for a Food Contact Substance (Form 3480)
3. Pre-Notification Consultation (PNC) (Form 3480)
4. Color Additive Petition (CAP) (Form 3503)
5. Color Master File (CMF) (Form 3503)
6. Food Additive Petition (FAP) (Form 3503)
7. FMF for Food Additives (FMF) (Form 3503)
8. Biotechnology Final Consultation (BNF) (Form 3665)
9. New Protein Consultation (NPC) (Form 3666)
10. Generally Recognized as Safe Notice (GRAS) (Form 3667)

Registration

Step 1. Create an Account

The first time you use the COSM you must create an account with a username, password and three security questions. In addition, the COSM registration process will require your name, address and company information.Optionally, you will be allowed to enter a list of contacts, agent or attorney information, which can be used for future submissions. These contacts will go into your personal contact list. The contact list will be available whenever you assemble a new submission. Instead of manually entering contact information for each new submission, you will have the option of selecting a contact from the list. All contact information will then be prepopulated from the selected contact. The contact list is available to you through a “Manage Contacts” link and can be updated or amended at any time after the registration process. Finally, you will be required to select the type(s) of submissions you will typically be sending to the FDA. These can also be updated or amended after the registration process.

Step 2. Complete the Login Information Tab

The registration screen has 3 separate tabs: Login Information, Address Information and Submission Selection. All required fields under each tab must be filled out correctly to complete the registration process. When you complete all the required information under a tab and click the “Continue” button, COSM automatically proceeds to the next section. Fields with an “*” are mandatory.

Step 3. Complete the Address Information Tab

The registration screen has 3 separate tabs: Login Information, Address Information and Submission Selection. All required fields under each tab must be filled out correctly to complete the registration process. When you complete all the required information under a tab and click the “Continue” button, COSM automatically proceeds to the next section. Fields with an “*” are mandatory.

• First Name*
• Middle Initial
• Last Name*
• Company*
• Title*
• Doing Business As (If applicable)
• Mailing Address*
• Mailing Address2
• City*
• Country*
• State*
• Zip Code*
• Telephone Number*
• Fax Number

Step 4. Complete the Submission Selection Tab

The Submission Selection screen allows you to select the type of submissions you will be submitting to the FDA.
When you complete all the required information under a tab and click the “Submit Registration” button, your COSM registration is complete.

Login

Step 1. Login Username and Password

Login to COSM using the Username and Password that was set up during the Registration process.

Step 2. Login Authentication
After verifying the login and password, COSM will send an email to you with a 6-digit authentication code. The authentication code will expire in 5 minutes.

Step 3. Login
You must enter the 6-digit code from the email into the space allocated on the login page. Click the Submit button and you will enter COSM.

Contacts

Step 1. Click the Manage Contacts Menu Tab
The “Manage Contacts” feature allows you to add and store one or more contacts. Some submissions require multiple contacts and if you have a list of contacts that you have previously entered, this feature will provide quick access to them when you are assembling your submission. Click the “Profile” menu button on the top right of the screen and then click “Manage Contacts”.
When the Manage Contacts screen appears, click the blue “Add New Contact” button. When you click the button, a new address form opens, and you can enter the new contact information.

Step 2. Complete the Contact Information
Complete the mandatory address fields shown on the screen and then click the “Save” button. Add as many contacts as you like by clicking the blue “Add New Contact” button. Fields with an “*” are mandatory.

• First Name*
• Middle Initial
• Last Name*
• Company*
• Title
• Doing Business As (If applicable)
• Mailing Address*
• Mailing Address2
• City*
• Country*
• State*
• Zip Code*
• Telephone Number*
• Fax Number

Step 3. Use Previously Entered Contacts when Completing Submissions
Use the Contact list whenever you begin a new application so that you don’t have to enter the address information every time you assemble a new filing. Click the “Update” button for the “Contact Information” section of the filing.

Step 4. Complete Contact Information with a Single Click
Use the Contact list whenever you begin a new application so that you don’t have to enter the address information every time you create a new filing. Click the “Update” button for the “Contact Information” section of the filing

Assemble Submission

Step 1. Select a Submission Type
The following information is common for all OFAS submissions. After logging in to the COSM you are presented with your “Home” page. Click on one of the available submission types on the Home page. The submission types were selected during the Registration process and are represented by “Menu Cards”. The following example illustrates the Biotechnology Final Consultation (Form 3665) summary page and available sections.

Summary Sections Restrictions
Mandatory Fields
All Mandatory fields/questions are designated by an asterisk symbol (*). Mandatory fields must be completed before moving on to the next screen. If any of the required fields are not completed, you will be prompted to enter the missing information before proceeding to the next section.
Date Selection
You are prevented from entering a future date when completing a date field.

Step 3. Attach Documents

Supporting documentation can be attached as questions are being answered. All documents are placed in their relevant folders as they are being uploaded. Additional documents can be attached as part of the completion process. At that time, you can upload documents not explicitly asked for within the submission. Using that option also allows you to place documents in folders that you specify.

The image below shows the folder structure for the Biotechnology Final Consultation (Form 3665) notification. Each submission type will have a different set of folders.
Note: Documents cannot be renamed once they have been uploaded to the COSM.

Stand To PDF

1. Download Final Submission Package
   Once you complete all sections, download your submission package by clicking the “Download Final Submission” button.

2. Send your documents directly to the FDA

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