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U.S. Department of Health and Human Services

Regulatory Information

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Instructions for Submitting Citizen Petitions (CPs) Electronically

In order to allow for electronic submission of Citizen Petitions, the current submission system has to be used. This requires adapting the "Comment" function on www.regulations.gov for the electronic submission of a Citizen Petition under 21 CFR 10.30 under the docket number FDA has established for this purpose. Please follow these instructions.

 
Step 1. Select the “Comment Now!” button if you are at the document details or at the search results and follow Steps 4 through 10  or go to www.regulations.gov and follow Steps 2 through 10.
 
Step 2. Type FDA-2013-S-0610 in the “SEARCH for” field.
 
Step 3. Select “Search” the blue button on the right or “Enter” key on your keyboard.
 
Step 4. Select the “Comment Now!” button. Instead of a “comment” you will be submitting your electronic Citizen Petition.
 
Step 5. 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. 
 
Step 6. 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.
 
Step 7. Select the “Continue” button to preview and make any edits to your electronic Citizen Petition submission.
 
Step 8. Read and check the disclaimer box. You must agree with the disclaimer to submit your Citizen Petition.
 
Step 9. Select the “Submit Comment” button. This action will submit your Citizen Petition to the system.
 
Step 10. You will receive a receipt with a tracking number automatically generated by www.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.