Dockets Management Staff (DMS) is now receiving USPS mail intermittently, however we would like to encourage the public to upload submissions and any supplemental or supported materials related to (citizen petitions, petition for reconsideration, variances, etc.) continue using FDA’s Electronic Method for Specific Electronic Submissions via docket ID FDA-2013-S-0610.
Instructions on “how to upload”: Electronic Method for Specific Electronic Submissions to FDA's Division of Dockets Management Staff.
ALL supplemental or supported related material must reference the previously assigned docket ID (ex. FDA-2020-X-XXXX) for DMS to process it in compliance with the Code of Federal Regulations (CFR). DMS will also alert you when we have resumed regular delivery of the maile have resumed regular delivery of the mail).
FDA's Dockets Management serves as the official repository for the administrative proceedings and rule-making documents for the Food and Drug Administration (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 FDA's administrative proceedings and rule-making documents more readily, including Federal Registers, Petitions, supporting documents and comments. Regulations.gov also serves as a vehicle for making your voice heard at FDA by providing the ability to submit comments electronically.
- FDA Memoranda of Understanding
- Posting of Comments
- Freedom of Information
- Historical Dockets Information
Tools and Resources
- How to Use Regulations.gov
- Electronic Code of Federal Regulations (GPO)
- Comment on Proposed Regulations and Submit Petitions