; citizen petitions (A) In general Except as provided in paragraph (5), in issuing an administrative order under paragraph (1) on the initiative of the Secretary, the Secretary shall— (i) not later than 2 business days before issuance of the proposed order, informally communicate the pending issuance of the order to sponsors of drugs that will be subject to such order; (ii) after making any such informal communication— (I) issue such a proposed administrative order by publishing it on the internet website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and (II) publish notice of availability of such proposed order in the Federal Register; (iii) except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and (iv) if, after satisfying the requirements of clauses (i) through (iii), the Secretary determines that it is appropriate to issue a final administrative order— (I) issue the final administrative order, together with a detailed statement of reasons, but such order shall not take effect until the time for requesting judicial review under paragraph (4)(D)(ii) has expired; (II) publish a notice of availability of such final administrative order in the Federal Register; (III) afford requestors of products that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially shall be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision