Revision of the Requirements for Publication of License Revocation

The Food and Drug Administration (FDA) is clarifying the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. FDA is amending the regulations in accordance with the agency's direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.