The Food and Drug Administration (FDA) has issued a direct final rule clarifying the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. The FDA also issued a companion proposed rule to provide a procedural framework to finalize the regulation in the event that the agency receives any significant adverse comments on the direct final rule. The final rule is effective September 17, 2009, unless FDA receives any significant adverse comments. Comments will be accepted until July 20, 2009. If FDA receives no significant adverse comments within the comment period, it will publish a document confirming the effective date of the final rule; if timely significant adverse comments are received, the FDA will publish a document withdrawing the direct final rule.