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Docket Management Process - Background

View PDF of the Docket Management Process Section (31 KB)


Transparency Report Arrow Background

Summary of Public Comments

Considerations

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Background

FDA maintains various dockets—each docket is a repository of information related to an FDA rulemaking or other matter.  Dockets facilitate public participation in FDA rule making and in other matters by allowing the public to view information about these matters and submit comments on them.  Comments can be submitted to the docket electronically, or in writing to FDA’s Division of Docket’s Management. 

 

Most information in FDA’s dockets is available on www.regulations.gov.  When FDA creates a docket for a rulemaking or other matter, the public can find, read, and comment on the matter on this site.  FDA also has a docket reading room that contains most comments (confidential material is not available).

 

Due to concerns raised by some individuals about disclosing the personal information of individuals who submit comments to the docket, as a matter of Agency practice, FDA generally does not post on www.regulations.gov comments from people who identify themselves as an “individual consumer” when submitting a comment to www.regulations.gov.  All comments, however, are considered by FDA, irrespective of whether the comment is posted online.  FDA regulations set forth procedures for submitting comments to the Agency.