Presiding Officers at Regulatory Hearings

The Food and Drug Administration (FDA) is amending its administrative regulations governing who may act as a presiding officer at a regulatory hearing. This action amends the regulations to permit an administrative law judge (ALJ) to act as a presiding officer and provide the appropriate delegations of authority. FDA is taking this action to increase the pool of qualified personnel available as presiding officers, thereby increasing the efficiency with which the agency conducts regulatory hearings, beginning with responding to hearing requests and continuing through issuance of written hearing reports. 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.