Public Hearing Before a Public Advisory Committee; Examination of Administrative Record and Other Advisory Committee Records

The Food and Drug Administration (FDA) is amending its administrative regulations governing the public disclosure of written information for consideration by an advisory committee at an advisory committee meeting. This action amends the regulations to state that the written information for consideration by an advisory committee at a committee meeting is available for public disclosure, whenever practicable, before or at the time of the meeting. FDA is taking this action to reflect current FDA policy in conformance with applicable law. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.