Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints

The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities within our jurisdiction and to amend the process for initiating certain CMP administrative actions. We are taking these actions to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended, and to streamline our internal processes. The last CMP adjustment was published in the Federal Register of November 12, 2008, and the FCPIAA requires Federal Agencies to adjust their CMPs at least once every 4 years. We are using direct final rulemaking for these actions because the Agency expects that there will be no significant adverse comment on the rule. We are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.