; (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; or (3) if compliance with paragraph (1) or (2) is not possible, as soon as practicable. (c) Distribution To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of, or other circumstance described in subsection (a)(1)(A)(iii) that is likely to lead to a shortage or meaningful disruption in the supply of, covered drugs to appropriate organizations, including physician, health provider, and patient organizations, as described in section 506E. ; (3) in subsection (g), in the matter preceding paragraph (1), by striking drug described in subsection (a) and inserting covered drug ; and (4) in subsection (j), by striking drug described in subsection (a) and inserting covered drug . (b) Definitions Paragraph (1) of section 506C(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(h) ) is amended to read as follows: (1) the term covered drug means a drug that is intended for human use and that— (A) is— (i) life-supporting; (ii) life-sustaining