; (ii) a permanent discontinuance in the manufacture of an active pharmaceutical ingredient of such drug, or an interruption in the manufacture of an active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug; or (iii) any other circumstance, such as an increase in demand or export restriction, that is likely to leave the manufacturer unable to meet demand for the drug without a meaningful shortfall or delay; and (B) the reasons for such discontinuance, interruption, or other circumstance, if known. (2) Contents Notification under this subsection with respect to a covered drug shall include— (A) with respect to the reasons for the discontinuation, interruption, or other circumstance described in paragraph (1)(A)(iii), if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation, interruption, or other circumstance, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known to 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 other circumstance described in paragraph (1)(A)(iii); (C) the expected duration of the interruption; and (D) such other information as the Secretary may require. (b) Timing A notice required under subsection (a) shall be submitted to the Secretary— (1) at least 6 months prior to the date of the discontinuance or interruption; (2) in the case of such a notice with respect to a circumstance described in subsection (a)(1)(A)(iii), as soon as practicable, or not later than 10 business days after the onset of the circumstance