File a Citizen Petition

by Amanda Dykeman
Head Research Coordinator and Administrator of Essure Problems/Vice President of ASHES Nonprofit

An FDA Citizen Petition is a process provided by the United States Food and Drug Administration for individuals and community organizations to make requests to the FDA for changes to health policy. When filing a petition, be specific about the action you would like the FDA to take and provide as much evidence as possible as to why the FDA should take that action.

How to file a citizens petition electronically:

Go to regulations.gov. (If you are already at the document details, skip to step 4.)

Type FDA-2013-S-0610 in the "SEARCH for" field.

Select "Search" the blue button on the right or "Enter" key on your keyboard.

Select the "Comment Now!" button. Instead of a "comment" you will be submitting your electronic Citizen Petition.

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. 

Your uploaded Citizen Petition files will be listed and your information filled out. When the submitted Citizen Petition is assigned to another unique docket you will be notified in writing of its receipt. Information about your Citizen Petition will be publicly viewable only in that docket not in this electronic submission docket. It is important to note large files and multiple files may require that you submit multiple times. In these instances repeat Steps 1 through 10.

Select the "Continue" button to preview and make any edits to your electronic Citizen Petition submission.

Read and check the disclaimer box. You must agree with the disclaimer to submit your Citizen Petition.

Select the "Submit Comment" button. This action will submit your Citizen Petition to the system.

You will receive a receipt with a tracking number automatically generated by regulations.gov. This tracking number is used to check the status of your Citizen Petition in the FDA's Federal Dockets Management System. You can contact FDA's Division of Dockets Management at 301-827-6860 for the status of your Citizen Petition in this system.