COSM_OFAS_Submissions_Help_Guide

Food and Drug Administration

CFSAN Online Submission Module
(COSM)

Offices of Food Additive Safety (OFAS)
Submissions Help Guide

COSM OFAS Submissions Help Guide
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INTRODUCTION

This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and
illustrate how to create an OFAS Regulatory submission. COSM uses a common design and
format for presenting questions to you to assist in creating submissions for OFAS. The common
elements and question types are outlined below and are presented here as an aid for first time
OFAS COSM users.

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:
•

Food Contact Notification (FCN) (Form 3480)

•

Food Master File (FMF) for a Food Contact Substance (Form 3480)

•

Pre-Notification Consultation (Form 3480)

•

Color Additive Petition (CAP) (Form 3503)

•

Color Master File (CMF) (Form 3503)

•

Food Additive Petition (FAP) (Form 3503)

•

FMF for Food Additives (Form 3503)

•

Biotechnology Final Consultation (Form 3665)

•

New Protein Consultation (Form 3666)

•

Generally Recognized as Safe Notice (Form 3667)

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COSM OFAS Submissions Help Guide
1. General Information for OFAS Submissions
The following information is common for all OFAS submissions.
a. Creating 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".

Figure 1: COSM’s Home Page
b. Summary Page Information
Upon selecting the submission type from the Home page, the system will open the
Summary page for the selected submission. Each OFAS submission type has different
sections. You may go to any section in any order you choose. The following example
illustrates the Biotechnology Final Consultation (Form 3665) summary page and
available sections.

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COSM OFAS Submissions Help Guide

Figure 2: Biotechnology Final Consultation Summary Page and Available Sections
You may enter data into sections of a submission, “leave” the submission in a draft status
and return to complete the submission later. Each section on the Summary page will
display a check mark upon its completion (Figure 2).

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COSM OFAS Submissions Help Guide

Figure 2: Biotechnology Final Consultation Summary Page and Available Sections (continued)
You should ensure that all sections are complete before attempting to download the final
submission package.
c. Tracking Numbers
The COSM will create a unique tracking number for each submission. It is important to
understand that the tracking number is not the submission number. The submission
number does not become available until after the submission has been accepted by the
FDA.

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COSM OFAS Submissions Help Guide

Figure 3: Tracking Number
d. 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.
e. Date Selection
You are prevented from entering a future date when completing a date field.
f. Contact Information
The information required in this section is identical for all OFAS submissions. The
following steps should be followed to complete the Contact Information section in the
COSM.
Step 1
Click the “Update” button next to the “Contact Information” section on the Submission
Summary page. The “Contact Information” section is displayed.

Figure 4: Submission Summary Page

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COSM OFAS Submissions Help Guide
Step 2
Click the “Auto-fill the Data” drop-down button on the right side of the Contact
Information section or manually enter the information in this section.

Figure 5: Contact Information Section
The “Auto-fill the Data” drop-down button on the right side of the Contact Information
section contains all the contacts that you entered through the Manage Contacts screen.
Select a name from the list box and the remaining contact information will be completed;
then edit the contact fields if necessary but note that if you change the data on the Contact
Information screen it does not update the data in your Manage Contacts list.
Provide the Notifier information for all mandatory fields (*) in the “Notifier Information”
section (Table 1). Provide the Agent or Attorney information in the “Agent/Attorney
Information” section if applicable (optional).

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COSM OFAS Submissions Help Guide
Table 1: Contact Information Section
Field

Description

A) Notifier

Contact Description: The person (i.e., the individual,
partnership, corporation, association or other legal entity)
who is responsible for the submission.
Contact Description: Any agent or attorney who is
authorized to act on behalf of the person who is responsible
for the submission.
Provide the contact person's name.
Enter the full name of the company.
Title of the contact person.

B) Agent/Attorney

* Name of Contact Person
* Company
* Position
Doing Business As
* Mailing Address Line 1
* Mailing Address Line 2
* Country

* Zip or Postal Code

* City
* State or Province

* Email Address
* Telephone
Fax Number

The alternate or "local" name of the company.
The street name and number or post office box number
Optional; can be used for building number, suite number,
or other information that doesn’t fit on the first line.
The country for the contact person’s mailing address.
Defaults to ‘United States of America.’ For foreign
addresses, select the appropriate country from the pulldown menu.
The zip code for the contact person’s mailing address. For
addresses outside the United States, enter the postal code, if
any.
The city for the contact person’s mailing address.
The state, province, or territory for the contact person’s
mailing address. Select a state, province, territory, or “Not
applicable” from the pull-down menu.
Provide email address.
Provide telephone number.
Provide fax number.

Step 3
Once the Contact Information section has been completed, click the "Save and Continue"
button to return to the Summary Page.

2. Question Types for OFAS Submissions
There are a number of different types of questions within OFAS submissions. Below is a list of
the various types.
a. Yes/No Radio Buttons
For this type of question, you select a single option from a list. Each item is chosen by
clicking the circle/radio button. Only one option can be selected. You can use the
keyboard (by pressing the "tab" key) or mouse to make your choice. A different choice
can be made by selecting a different radio button.
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COSM OFAS Submissions Help Guide

Figure 6: Yes/No Radio Button
b. Document Upload
In this type of question, you click the blue “+ Drag and Drop or Select File” button to
upload/attach any document relevant to the question or section of the submission. When
you click the blue Drag and Drop button your local pc/laptop will display a box to select
your file. Once you select the file it will be loaded into the document component as
shown below. Alternatively, if you have a file directory already open on your local
pc/laptop you can use the mouse to “drag” the file from the file directory and “drop” it
onto the document component.
(1)

The following file types/formats are accepted: pdf, xls, xlsx, mol, cdf, sdf.

(2)

Multiple documents may be added. Various options may also be available such as
"Redacted", "Confidential", "Studies", etc. You may make these selections as
necessary to specify a type or category of document.

(3)

The red trashcan button is used to delete a document.

Figure 7: Document Upload

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COSM OFAS Submissions Help Guide
c. Free Form/Multi-Line Entry
In this type of question, you can type several lines of text. The text box grows and
becomes "scrollable" to accommodate as much text as you need to enter.

Figure 8: Free Form/Multi-Line Entry
d. Expanding
In this type of question, answering “Yes” results in additional questions being displayed.
It expands so you can see additional questions below. These additional questions expand
when the answer is “Yes” and contract when the answer is “No”.

Figure 9: Expanding Entry
e. Single-line entry
In this type of question, you are able to enter no more than a single line of text.

Figure 10: Single-line Entry

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COSM OFAS Submissions Help Guide
f. Submission References
These questions often display a label such as “See Other FDA File(s)” or they will
contain specific instructions to list relevant submissions. Enter this information using
FDA assigned numbers, i.e., “PNC-099999”.

Figure 11: Questions that ask for Submission References
When you enter these submission numbers and press the “Enter” key or a comma, these
entries turn into discreet bits of data called “chips”. Please see below. Using this format
allows the system to easily distinguish one submission number from the next and helps you
to type in more accurate references. Please note that the COSM does not verify the
accuracy of the submission numbers.

Figure 12: Completed Submission References
g. Table Entries
Table entries allow you to add one or more rows of data for a single question. Each row
repeats the same types of data. You enter different values on each row. The example
below shows how these tables operate. Click the “Add…” button to create a new row in
the table; complete the data and then click the “Add…” button again for the next row.
Alternatively, you can click the “Add…” button repeatedly to enter as many rows as
necessary and then complete the data all at once. If you wish to delete a row, click the
red trashcan icon and the row is discarded.

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COSM OFAS Submissions Help Guide

Figure 13: Table Entries
h. Attachment Entries
The List of Attachments Section displays all the documents you have appended to the
submission during the completion process. These documents are placed in the folders
when you upload them during the question and answer sections throughout the
submission. In the list of attachments, you can also upload documents not explicitly
asked for within the submission. These might include References, Environmental
Studies, Confidential Environmental Information or any other documents you feel are
necessary to complete the submission.
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.

Figure 14: Attachment Entries

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COSM OFAS Submissions Help Guide
Adding Documents
Click on the "cloud" icon next to the intended folder. COSM then allows you to select a file
from your local machine. Once uploaded the document will appear in the selected folder.
Deleting Documents
1. Only documents that are uploaded from the List of Attachments page can be deleted
from the List of Attachments page. Those documents will display a red trashcan icon
next to them.
2. For documents that were added from the question and answer sections you must return
to those sections to delete them.

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COSM OFAS Submissions Help Guide

BNF
CAP
CMF
COSM
FAP
FCN
FMF
OFAS

ABBREVIATIONS AND ACRONYMS
Biotechnology Notification File
Color Additive Petition
Color Master File
CFSAN Online Submission Module
Food Additive Petition
Food Contact Notification
Food Master File
Offices of Food Additive Safety

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