On November 12, 2008, the Food and Drug Administration (FDA) issued a direct final rule to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities under FDA jurisdiction, as required by the Federal Civil Penalties Inflation Adjustment Act. The rule does not adjust new CMPs enacted by the Food and Drug Administration Amendments Act of 2007. The FDA is using direct final rulemaking for this action because the agency expects no significant adverse comment on the rule. However, the agency also is concurrently issuing the rule in proposed form and soliciting comments on the direct rule. If significant adverse comments are received, the FDA will withdraw the final rule and address the comments in a subsequent rulemaking. The rule is effective March 27, 2009, unless the FDA receives significant adverse comment by January 26, 2009. Comments will be accepted on the proposed rule until December 26, 2008.