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The US Food and Drug Administration says that by participating in its comment process the public can help shape the agency’s decisions. Such participation is, it says, an important part of the ‘notice-and-comment rulemaking and guidance development processes’.
The FDA was spotlighting public comments as part of its series of notices about Understanding Tobacco Regulation and Guidance.
‘Public participation in the rulemaking process is an essential function of good governance,’ the agency said in a statement. ‘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.’
The FDA suggested ways of submitting effective comments that included providing a clear statement of whether the participant supported or oppose the proposed rule or guidance, and any comments or data that supported her position. Other tips for submitting effective comments are here.
The FDA said that it solicited 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.
It said it would 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. Comments may be submitted:
- 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.