Dockets Comments No Longer Accepted Through FDA Website

January 17, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s website will no longer allow the public to electronically submit comments to its dockets.

Rockville, MD (Jan. 11)-The US Food and Drug Administration’s website (www.fda.gov) will no longer allow the public to electronically submit comments to its dockets. Electronic submissions will now only be accepted through the Federal Dockets Management System (FDMS). The process for submitting written comments to agency dockets remains the same.

As part of the federal eRulemaking Initiative, FDMS is “designed so that the public has a single point of access to the public dockets across the Federal government” (Federal Register Notice, Jan. 14, 2008). The system is accessible at www.Regulations.gov.

Any docket created after Jan. 15, 2008, will receive a docket ID, established by the FDMS system. Those dockets created on or before Jan. 15, 2008, also will receive a docket ID established by FDMS and will include a reference to its original docket identification number previously assigned by FDA (legacy numbers).

The complete announcement regarding FDMS can be found here.