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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Regulatory Information

Dockets Management

Dockets Management Staff (DMS) continues to receive USPS, UPS and FedEx delivery. And we would like to encourage the public to continue uploading submissions and any supplemental or supported materials related to a specific docket ID ( for citizen petitions, petition for reconsideration, variances, etc.) using FDA’s Electronic Method for Specific Electronic Submissions via docket ID FDA-2013-S-0610. Comments are not to be submitted on this docket ID.

ALL supplemental or supported related material (SRMs) 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).

Instructions on “how to upload”: Electronic Method for Specific Electronic Submissions to FDA's Division of Dockets Management Staff.

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.

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