Instructions for Submitting Citizen Petitions (CPs) Electronically

FDA encourages electronic submissions to the agency.  To submit Citizen Petitions electronically, petitioners must use the submission system through www.regulations.gov. This requires adapting the "Comment" function for the electronic submission of a Citizen Petition under 21 CFR 10.30 using the docket number (FDA-2013-S-0610) FDA has established for this purpose.

To submit your Citizen Petition, please follow these instructions:

Step 1. Click on the link to FDA’s Electronic Method for Specific Electronic Submissions docket (https://www.regulations.gov/document/FDA-2013-S-0610-0003).   

Step 2. Select the live “Comment” button. Instead of a “comment” you will submit your electronic Citizen Petition and any supporting and related materials. 

Step 3. Petitioners must either type NA or provide additional details concerning the electronic Citizen Petition you will upload. Details can include first name and last name, submitting on behalf of a third party, organization name and address, category, etc. (This screen is also used for the submission of comments; therefore, it is labeled and refers to comments because of comment submission instructions.) After you fill out this section, click on the "Choose file" button to upload your Citizen Petition files. 

It is important to note large files, and voluminous files may require multiple submissions. In these instances, repeat Steps 1 through 4.

Step 4. Review submission for any changes and opt in for email confirmation which contains the tracking number associated with your submission, then click “Submit Comment”. Note the tracking number is not the docket number.  

FDA’s Dockets Management Staff will notify you when the submitted Citizen Petition is received and assigned a unique docket ID. Afterwards, information about your Citizen Petition will be publicly viewable only in the assigned docket ID and not in FDA’s Electronic Method for Specific Electronic Submissions docket. 

You can contact FDA's Dockets Management Staff at (240) 402-7500 for the status of your Citizen Petition. Please provide either the related docket ID or tracking number.