FDA Dockets Transparency To Be Enhanced

FDA has published a Federal Register Notice announcing a significant change in how it prospectively will handle public comments submitted on rulemakings and other docketed matters by individuals in their individual capacity.

Since the adoption of the government-wide electronic portal system for submitting and posting comments, FDA generally has not posted public comments submitted by individuals in their individual capacity at Regulations.gov. Instead, such individuals’ comments have been made available only in the public reading room at the Agency’s dockets branch, or through submission of a FOIA request. FDA developed the practice largely because of concerns about disclosing personal information of individuals who may not have realized, when submitting their comments, that their names, addresses, and other identifying information would be publicly viewable. That practice is changing.

After October 15, 2015, all comments to any FDA docket, existing or new, submitted electronically through Regulations.gov, or submitted by mail or delivery to the Division of Dockets Management in written/paper format, generally will be posted to the applicable docket and publicly viewable on Regulations.gov. However, an exception will apply to comments submitted in written/paper format under the following conditions:

  1. The written/paper submission is marked as confidential, and
  2. The submitter provides an unredacted and a redacted version (i.e., the redacted version must have the information claimed as confidential redacted/blacked out).

If submitted under these conditions, only the redacted written/paper submission would be posted publicly on Regulations.gov (except as otherwise provided by 21 C.F.R. § 10.20 or other law).

This change in practice is intended to increase the transparency and utility of FDA’s public dockets. Moreover, the change fulfills a recommendation from the 2010 FDA Transparency Initiative aligns with Recommendation No. 2013-4 from the Administrative Conference of the United States, and furthers an objective in Executive Order 13563, which directs agencies to base their regulations on “public participation and an open exchange of ideas.”

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