; (ii) a permanent discontinuance in the manufacture of an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug or an interruption in the manufacture of the active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug; (iii) an increased demand (other than an anticipated seasonal surge) for such drug or an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug that is likely to lead to a shortage of the drug or the active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug; and (B) the reasons for such discontinuance, interruption, or increased demand. (2) Contents Notification under this subsection with respect to a critical essential medicine shall include— (A) with respect to the reasons for the discontinuation, interruption, or increased demand referred to in paragraph (1)(C), if an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug is a reason for, or risk factor in, such discontinuation, interruption, or increased demand, the source of the active pharmaceutical ingredient, excipient, or other input and any alternative sources for the an active pharmaceutical ingredient, an excipient, or any other input by the manufacturer; (B) whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation, interruption, or increased demand; (C) the expected duration of the interruption or increased demand; and (D) such other information as the Secretary may require. (b) Timing (1) In general A notice required under subsection (a) shall be submitted to the Secretary— (A) at least 6 months prior to the date of the discontinuance or interruption