As part of its “Understanding Tobacco Regulation and Guidance” series, the Food & Drug Administration’s Center for Tobacco Products is spotlighting the importance of public comments and how to submit them. The following information has been provided by the FDA:
Public participation in the rulemaking process is an essential function of good governance. By providing input, individuals and other stakeholders offer FDA a chance to actively listen to a wide-range of concerns, values, and perspectives, which in turn can inform regulatory decisions.
FDA accepts comments on documents within a defined timeframe, known as the open comment period. FDA invites public comments on Advance Notices of Proposed Rulemaking (ANPRMs), proposed rules (Notices of Proposed Rulemaking or NPRMs), and draft guidances and announces the length of the public comment period in the Federal Register. FDA reviews and considers the submitted comments in preparing the final documents. When FDA publishes a final rule, the agency describes and responds to comments received.
Participation in the comment process helps shape the agency’s decisions and is an important part of the notice-and-comment rulemaking and guidance development processes. Some suggestions for submitting effective comments include: providing a clear statement of whether you support or oppose the proposed rule or guidance and, any comments or data that support your position.
Click here for more tips on submitting effective comments.
How to Get Involved
FDA solicits information and comments, announced in the Federal Register and posted in dockets on regulations.gov, from the general public, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act. FDA will consider all comments, data, research, and other relevant information submitted to the docket to determine what regulatory next steps may be appropriate for a given issue. You may submit comments:
- Online through the Federal eRulemaking Portal at https://www.regulations.gov
- By mail, hand delivery, or courier to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.