; and (ii) with respect to which no data relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug (or, as applicable, since the deeming of such tentative final monograph as a final administrative order under paragraph (7)). (C) Hearing procedures (i) Denial of request for hearing If the Secretary determines that a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (3)(A)(iv), does not establish the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies. (ii) Single hearing for multiple related requests If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate. (iii) Presiding officer The Secretary shall appoint a presiding officer of a hearing requested under subparagraph (A) who— (I) is not an employee of the Center for Drug Evaluation and Research