FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module

Product Information

Specifications

• Product Name: CFSAN Online Submission Module (COSM)
• Availability: 24 hours, 7 days a week
• Developed for: Transmitting submissions to FDA’s CFSAN

Product Usage Instructions

COSM Registration Process

• The COSM registration process involves creating an account with a username, password, and three security questions.
• You will also need to provide your name, address, and company information.
• During registration, you must select the type(s) of submissions you plan to send to the FDA.

OFAS Submissions

1. Register with the COSM following the registration process.
2. Log in and select the submission type, answer all questions, and upload the required documents.
3. Download the PDF file created by COSM.
4. Digitally sign the PDF as per the instructions provided.
5. Upload your submission back to COSM.
6. Click “Send to FDA” to complete the submission.

ODSP Submissions

1. Register with the COSM following the registration process.
2. Log in and select the submission type, answer all questions, and upload the required documents.
3. Submit your information by clicking “Send to FDA”.

ONFL Submissions

1. Register with the COSM following the registration process.
2. Log in and select the submission type, answer all questions, and upload the required documents.
3. Submit your information by clicking “Send to FDA”.

Frequently Asked Questions

Q: What browsers work best with COSM?

A: The CFSAN Online Submission Module works best with the following browsers.

• Browser 1
• Browser 2
• Browser 3

Introduction

The CFSAN Online Submission Module (COSM) was developed and designed to aid users wishing to transmit submissions to the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Offices of Food Additive Safety (OFAS), Dietary Supplement Programs (ODSP) and Nutrition and Food Labeling (ONFL). COSM is available 24 hours, 7 days a week.

1. OFAS Submissions: For regulatory submissions sent to the CFSAN Office of Food Additive Safety (OFAS) (food ingredients, packaging materials, new plant varieties), please read the following information:
   • a. Register with the COSM (please follow the COSM Registration Process outlined below).
   • b. Log into the COSM, select the submission type you wish to submit, provide answers to all required questions, upload all requested documents, and allow COSM to assemble your submission.
   • c. Download the PDF file created by the COSM on your local device.
   • d. Digitally sign the PDF. Instructions for how to sign the PDF file are available via a link on the final submission page.
   • e. Upload your submission back to COSM.
   • f. Click the “Send to FDA” button to complete your submission.
   • If you have any questions regarding submissions to OFAS, please contact us by phone at 240-402-1200 or by email at Premarkt@fda.hhs.gov.
2. ODSP Submissions: For submissions related to Dietary Supplements sent to the CFSAN Office of Dietary Supplement Programs (ODSP), please read the following information.
   • a. Register with the COSM (please follow the COSM Registration Process outlined below).
   • b. Log in to the COSM, select the submission type you wish to submit, provide answers to all required questions, and upload all requested documents for the submission type you are making.
   • c. Submit your information to the FDA by clicking the “Send to FDA” button.
   • If you have questions regarding submissions to ODSP, please contact us by email at ODSP@fda.hhs.gov.
3. ONFL Submissions: For submissions related to Health Claims sent to the CFSAN Office of Nutrition and Food Labeling (ONFL), please read the following information:
   • d. Register with the COSM (please follow the COSM Registration Process outlined below).
   • e. Log in to the COSM, select the submission type you wish to submit, provide answers to all required questions, and upload all requested documents for the submission type you are making.
   • f. Submit your information to the FDA by clicking the “Send to FDA” button.
   • If you have questions regarding submissions to ONFL, please contact us by email at ONFL@fda.hhs.gov.
   • Note: The CFSAN Online Submission Module works best with the following browsers:
   • Chrome
   • Firefox
   • Microsoft Edge

COSM Registration Process

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.
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.

1. OFAS Submission Types:
   • 3480 and 3480a – Food Contact Notification, Pre-Notification Consultation, Food Master File for food contact substances (FCN, PNC, FMF)
   • 3503 – Food Additive Petition, Color Additive Petition, Food Master File for food additives, Color Master File (FAP, CAP, FMF, CMF)
   • 3665 – Biotechnology Final Consultation (BNF)
   • 3666 – New Protein Consultation (NPC)
   • 3667 – Generally Recognized as Safe Notice (GRN)
   • Cell Culture Consultation (CCC)
   • Threshold of Regulation (TOR)
2. ODSP Submission Types:
   • New Dietary Ingredient Notification (NDIN); and
   • Structure Function Claims Notification (SFCN).
3. ONFL Submission Types
   • Health Claims

• Once the registration process is complete the COSM Administrator is notified. The COSM Administrator will activate your account. A confirmation email will be sent to your email address by the next business day and the account will become available for use.

FDA Unified Registration and Listing System (FURLS) Users

• NDIN and SFCN submitters who were previously using FURLS are now required to use COSM.
• Your login information (not passwords) has been migrated to a COSM account. It must, however, be activated by the COSM Administrator before it can be used.
• As a FURLS user, the first time you access the COSM, you will be required to enter the email address you last used with your FURLS login. The Registration screen will appear with the login associated with the email address. You will have the option of modifying the user name. You will be required to create a password and complete the security questions. You will then move through the remainder of the Registration process.
• Once the registration process is complete, you will log on to COSM with your username and password.

Registration Step-by-Step

• You can access the COSM using the following URL: https://cfsan-onlinesubmissions.fda.gov You are presented with the COSM Login screen (Figure 1).

FURLS Users:

• Enter the email address last used with your FDA FURLS login (see Figure 1(a)) and click the “Submit” button.

New and OFAS Users:

• New and OFAS users will click the “Register” button (see Figure 1(b)).

COSM Registration Screen

Login Information

• The Registration Screen (Figure 2) below, 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. You may also click on a previous tab to correct previously entered information.
• The table below shows the fields and their descriptions. Fields marked with an asterisk (*) are mandatory.

Table 1: Field Descriptions for Login Information (* Mandatory Information)

an alphabet. All remaining characters can be a mixture of letters and numbers. Only the hyphen (-) special character is allowed. The username is not case- sensitive.

FURLS Users: Username will be prepopulated with the name that you created in the FURLS environment. You will be able to change your Username at this time. Once the registration process is complete, you cannot modify your username.

Password*| Password must be at least 15 characters and contain at least one special character, one uppercase letter, and one number.

Password is case-sensitive.

New Password Confirmation| Must match the Password field
E-Mail Address| Hyphens and underscores are allowed. E-Mail is not case- sensitive.

FURLS Users: Email addresses will be pre-populated. You will not be able to change it until the Registration process is complete.

Security Questions*| Select any 3 security questions from the list and provide an answer for each selected question. Answers are not case-sensitive.

Address Information

In this section, provide the address information in the following fields:

• 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

• If the selected Country is “United States of America” or “Canada”, then the State field will display a list box to select the State or Province. The State field is not required if the country selected is not the “United States of America” or “Canada”.
• After completing the required information, click the “Continue” button and the Submission Selection screen will be presented.

Submission Selection

The Submission Selection screen allows you to select the type of submissions you will be submitting to the FDA. Use the “slide” bar icon to select the submission types that you will be submitting to the FDA. Use the “slide” bar icon to select the submission types that you will be completing through the COSM. When the slide bar is moved to the right, it will turn blue indicating that the submission type has been selected. The text will change from “Inactive” to “Active”. This information can be updated at any time after the Registration process is complete.

There are three sections for submission types:

OFAS

• Biotechnology Final Consultation (BNF)
• Color Additive Petition (CAP)
• Food Additive Petition (FAP)
• Food Contact Notification (FCN)
• Generally Recognized as Safe Notice (GRN)
• New Protein Consultation (NPC)
• Pre-Notification Consultation (PNC) for a Food Contact Substance
• Cell Culture Consultation (CCC)
• Threshold of Regulation (TOR)

ODSP

• New Dietary Ingredient Notification (NDIN)
• Structure Function Claims Notification (SFCN)

ONFL

• Health Claims

Other OFAS Submissions

• Food Master File (FMF) for food additives
• FMF for a Food Contact Substance
• Color Master File (CMF)
• You must click the “Submit Registration” button to complete your registration.

Complete the Registration

• After completing the registration process, the system will display a “Thank You” message (Figure 6). You will receive an email by the next business day, confirming that you have completed the registration process.
• Upon receipt of the email and account activation by the COSM Administrator (Figure 7), you may log in using your new credentials.

Registration

Initial Login

• After completing the registration process and receiving the activation email from the COSM Administrator, you may return to the Login screen (Figure 1, above), enter your Username and Password, and click the “Login” button.
• After the “Login” button is clicked, COSM will request that you enter a 6-digit authentication code (Figure 8). COSM sends an email (Figure 9) with the 6-digit authentication code to your registered email address immediately after your Username and Password have been verified. The authentication code will expire in 5 minutes.
• Enter the authentication code as shown in Figure 10 and click the “Submit” button.
• The COSM Home page is displayed (Figure 11). The Home page displays a “Menu Card” for all submissions that you selected during the registration process.

Manage Profile

• From the Home page, you can update your profile information at any time by clicking the “Profile” menu item (Figure 12).
• From there you may click the “Manage Profile” menu item. Then click the “Manage Contacts” menu item.
• The “Manage Profile” menu item will return you to the Profile page that you completed when first registering with the COSM. Refer to Figure 2 for those instructions.

Manage Contacts

• The “Manage Contacts” feature allows you to add and store multiple contacts. Initially, the only contact available will be the contact information that you entered during the registration process.
• This entry is known as the “Profile Contact” and will be labeled as such on the screen (Figure 10). To update address information, you click the “down” arrow (circled in red in Figure 10) and add or update any necessary information.
• Additional contacts may be entered on the Manage Contacts page by clicking the blue “Add New Contact” button. When you click the button, a new address form opens, and you can enter the new contact information.
• Some submissions require multiple contacts. When filling out a submission you may use the “Manage Contacts” feature which will provide a list of contacts or manually type each entry on the form. If you select a contact using the “Manage Contacts” feature you can modify the address information on the form. You are advised, however, that address information that is changed on the submission form does not update the information in the Manage Contacts list.

Conclusion

This concludes the COSM Registration Help Guide.

References

• HHS Accessibility & Section 508 | HHS.gov
• Online Submission

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