U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Dockets Management
  4. Posting of Comments
  1. Dockets Management

Posting of Comments

Comments submitted electronically through http://www.regulations.gov to any FDA docket, existing or new, on or after October 15, 2015, will be posted to the applicable docket and publicly viewable on http://www.regulations.gov. All comments submitted by mail or delivery to the Docket Management Staff in written/paper format to any FDA docket, existing or new, on or after October 15, 2015, will be posted to the applicable docket and publicly viewable on http://www.regulations.gov

On September 18, 2015, the Food and Drug Administration published a notice in the Federal Register informing the public that the Agency is changing the Agency's long standing practice of not publicly posting on http://www.regulations.gov comments submitted by individuals in their individual capacity. These are generally comments from people who self-identify as an “individual consumer” under the field titled “Category (Required)” on the “Your Information” page on http://www.regulations.gov. This notice can be seen at https://www.federalregister.gov/articles/2015/09/18/2015-23389/consumer-comments-public-posting-and-availability-of-comments-submitted-to-food-and-drug#furinf.

The commenter is solely responsible for ensuring that the submitted comment does not include any confidential information that the commenter or a third party may not wish to be posted, such as private medical information, the commenter's or anyone else's Social Security number, or confidential business information, such as a manufacturing process. If a name, contact information, or other information that identifies the commenter is included in the body of the submitted comment, that information will be posted on http://www.regulations.gov. FDA will post comments, as well as any attachments submitted electronically, on http://www.regulations.gov, along with the State/Province and country (if provided), the name of the commenter's representative (if any), and the category selected to identify the commenter (e.g., individual, consumer, academic, industry).

Exception: FDA will take the following steps when a submitter mails or delivers a paper comment with the intent that the comment or portions thereof shall remain confidential: (1) The written/paper submission is marked as confidential, and (2) the submitter provides an unredacted and a redacted version; the redacted version must have the information claimed as confidential redacted/blacked out. If submitted under these conditions, only the redacted/blacked out written/paper submission will be posted publicly on http://www.regulations.gov, except as otherwise provided by 21 CFR 10.20 or other law.

Back to Top