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Welcome to FDA Dockets Management Federal Dockets Management System (FDMS) Info Website

In accordance with the President's eRulemaking Initiative, FDA will transition from the FDA Dockets Management System (DMS) to the Federal Dockets Management System (FDMS) located at Regulations.gov (FR Notice of Migration). The purpose of this website is to provide information related to this transition, which will be updated on a regular basis (see "Status Update").

The migration will use a phased approach. Due to the tremendous amount of data to be transferred, the migration will cover a 3-month period, beginning January 15, 2008. 

Migrated FDA Dockets with Open Comment Periods will be available in FDMS beginning January 15, 2008. During the migration period, a docket (see attachment) will remain in DMS for searching, viewing, and downloading documents until it is migrated.

Also beginning January 15, 2008, electronic submissions will only be accepted by FDA through FDMS.  Please note that the process for submitting written submissions to the DMS will remain the same.

Docket ID Numbers: Any Docket opened after January 15, 2008, will receive a docket ID in FDMS format. For example: FDA-2008-P-0001.

Through dockets migrated to FDMS will recieve a new FDMS docket ID number, the original docket ID numbers that were assigned in DMS will be migrated as legacy numbers.  FDMS will provide searching capability on legacy ID numbers.

Additional details about FDMS, as well as detailed instructions and assistance for using the system, are available at regulations.gov.

Status Update

The proposed stages for a complete FDA data migration are:

  • January 15, 2008: Go-Live at Regulations.gov with specified Dockets with Open Comment Periods
  • January to beginning of April (dates TBD): Continued Migration until all Dockets open for comments, Dockets accepting late comments and Closed Dockets are migrated.

Thank you for your patience and cooperation during this migration period.


Page last updated January 31, 2008