Dockets Management

The FDA receives two types of submissions:

• New Submissions for FDA Action – Please use the Food and Drug Administration’s FDA Electronic Method for Specific Electronic Submissions docket for the following:
  • Citizen Petitions
  • Device Reclassification
  • Stay of Action Request
  • External Guidances
  • Food and Color Additives

While the FDA encourages submission of this information electronically, the agency continues to receive submissions via USPS, UPS, and FedEx delivery. 

• Submissions to Previously Established Dockets – The FDA’s Electronic Method for Specific Electronic Submissions cannot accept comments. Comments must be submitted directly to the topic-specific docket ID (FDA-20XX-X-XXXX) that is open for commenting via Regulations.gov, or mailed directly to the FDA’s Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. 

Some examples of submissions to previously established dockets include citizen petition amendments or withdrawals, comments to specific action, or a supplement to a reclassification.  

The FDA's Dockets Management system serves as the official repository for the administrative proceedings and rulemaking documents for the FDA, an operating division of the U.S. Department of Health and Human Services (HHS).

Dockets Management is administered by the Federal Dockets Management System (FDMS), located at Regulations.gov (see FR announcing this transition). The system allows consumers to access the FDA's administrative proceedings and rulemaking documents more readily, including Federal Register documents, petitions, supporting documents, and comments. Regulations.gov also serves as a vehicle for making your voice heard at the FDA by providing the ability to submit comments electronically.

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Related Links

• FDA Memoranda of Understanding
• Posting of Comments
• Freedom of Information
• Historical Dockets Information

Tools and Resources

• Regulations.gov
• How to Use Regulations.gov
• Electronic Code of Federal Regulations (GPO)
• Comment on Proposed Regulations and Submit Petitions