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  1. Regulatory Information

Posting of Comments

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 Division of Dockets Management 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.