CFSAN Online Submission Module (COSM) Registration Help Guide
FDA US FDA
COSM RegistrationHelpGuide Food and Drug Administration
CFSAN Online Submission Module (COSM) Registration Step-by-Step Help Guide
COSM Registration Help Guide
Table of Contents
Introduction..................................................................................................................................... 2 COSM Registration Process ........................................................................................................... 3 FDA Unified Registration and Listing System (FURLS) Users..................................................... 4 Registration Step-by-Step ............................................................................................................... 4 COSM Registration Screen............................................................................................................. 5
LOGIN INFORMATION ................................................................................................................... 5 ADDRESS INFORMATION............................................................................................................... 7 SUBMISSION SELECTION............................................................................................................... 8 COMPLETE THE REGISTRATION .................................................................................................. 10 Initial Login .................................................................................................................................. 10 MANAGE PROFILE ...................................................................................................................... 11 MANAGE CONTACTS ................................................................................................................... 12 Conclusion .................................................................................................................................... 12 ABBREVIATIONS AND ACRONYMS ..................................................................................... 13
Table Table 1: Field Descriptions for Login Information (* Mandatory Information) ........................... 6
List of Figures Figure 1: COSM Login Screen ....................................................................................................... 4 Figure 2: COSM Registration Screen ............................................................................................. 5 Figure 3: Address Information Section........................................................................................... 7 Figure 4: Submission Selection screen ........................................................................................... 8 Figure 5: Submission Selection (continued) ................................................................................... 9 Figure 6: Registration Confirmation ............................................................................................. 10 Figure 7: Registration E-mail Confirmation ................................................................................. 10 Figure 8: COSM Home Screen ..................................................................................................... 11 Figure 9: Access User Profile ....................................................................................................... 11 Figure 10: Initial Manage Contact Page ....................................................................................... 12
1
COSM Registration Help Guide
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) and Dietary Supplement Programs (ODSP). 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, provide answers to all required questions, upload all requested documents and allow COSM to assemble your submission. c. Save the submission package (zip file) created by the COSM on your local device. d. Follow one of these steps to send your submission to the FDA CFSAN: (1) Log in to the FDA Electronic Submissions Gateway (ESG) and upload the file (preferred). (2) Save your submission to DVD/CD-ROM (USB drives cannot be accepted) and mail it to OFAS. (3) For sending paper submissions please consult the Guidance. e. You will receive an acknowledgement that your submission has been received by the FDA.
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, 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.
2
COSM Registration Help Guide
If you have questions regarding submissions to ODSP, please contact us by email at ODSP@fda.hhs.gov.
Note: The CFSAN Online Submission Module works best with the following browsers:
· Chrome · Firefox · Internet Explorer (version 11 or greater)
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.
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 create 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.
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)
2. ODSP Submission Types:
· New Dietary Ingredient Notification (NDIN); and
3
COSM Registration Help Guide · Structure Function Claims Notification (SFCN).
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 that 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 user name 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).
Figure 1: COSM Login Screen 4
COSM Registration Help Guide 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.
Figure 2: COSM Registration Screen
5
COSM Registration Help Guide
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)
Field
Description
User Name*
User Name must be between 8-24 characters and it must start with
an alphabet. All remaining characters can be a mixture of letters
and numbers. Only the hyphen (-) special character is allowed.
User Name is not case-sensitive.
FURLS Users: User Name will be prepopulated with the name that you created in the FURLS environment. You will be able to change your User Name at this time. Once the registration process is complete, you cannot modify your user name.
Password*
Password must be at least 8 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 casesensitive.
FURLS Users: Email address will be prepopulated. 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.
6
COSM Registration Help Guide ADDRESS INFORMATION
Figure 3: Address Information Section 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*
7
COSM Registration Help Guide · 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 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.
Figure 4: Submission Selection screen
8
COSM Registration Help Guide
Figure 5: Submission Selection (continued) 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 ODSP · New Dietary Ingredient Notification (NDIN) · Structure Function Claims Notification (SFCN) 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.
9
COSM Registration Help Guide 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.
Figure 6: Registration Confirmation
Figure 7: Registration E-mail Confirmation
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 User Name and Password and click the "Login" button. The COSM Home page is displayed (Figure 8). The Home page displays a "Menu Card" for all submissions that you selected during the registration process.
10
COSM Registration Help Guide
Figure 8: COSM Home Screen MANAGE PROFILE From the Home page you can update your profile information at any time by clicking the "Profile" menu item (Figure 9).
Figure 9: Access User Profile 11
COSM Registration Help Guide 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 in 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.
Figure 10: Initial Manage Contact Page
Conclusion
This concludes the COSM Registration Help Guide.
12
COSM Registration Help Guide
ABBREVIATIONS AND ACRONYMS
BNF
Biotechnology Final Consultation
CAP
Color Additive Petition
CFSAN
Center for Food Safety and Applied Nutrition
CMF
Color Master File
COSM
CFSAN Online Submission Module
ESG
Electronic Submission Gateway
FAP
Food Additive Petition
FCN
Food Contact Notification
FDA
Food and Drug Administration
FMF
Food Master File
FURLS
FDA Unified Registration and Listing System
GRN
Generally Recognized as Safe Notice
NDIN
New Dietary Ingredient Notification
NPC
New Protein Consultation
ODSP
Office of Dietary Supplement Programs
OFAS
Office of Food Additive Safety
PNC
Pre-Notification Consultation
SFCN
Structure Function Claims Notification
13
FDA Adobe PDF Library 15.0