; (ii) an interruption in the manufacture of the device that is likely to lead to a shortage or meaningful disruption in the supply of that device in the United States; or (iii) any other situation or circumstance that is likely to lead to a shortage or meaningful disruption in the supply of that device in the United States; and (B) in accordance with paragraph (2)(C), of the reason for such discontinuance, interruption, or other situation or circumstance. (2) Required inclusions A notification under paragraph (1) shall include each of the following: (A) The name of the device, including the Device Identifier or National Product Code for the device, if applicable. (B) The name of the manufacturer of the device. (C) The reason for the notification, including whether any of the following reasons apply: (i) Requirements related to complying with quality system regulations. (ii) Shortage of a material used in the manufacture of the device. (iii) Shortage of a component, part, or accessory of the device. (iv) Delay in shipping of the device. (v) Increased demand for the device. (vi) Natural disaster. (vii) Cyber security. (viii) Facility closure. (ix) Other reasons as the Secretary deems appropriate. (D) The estimated duration of the discontinuance, interruption, or other situation or circumstance. (E) Any other information the manufacturer deems relevant. (3) Timing The notification required under paragraph (1) shall be submitted, in a manner prescribed by the Secretary— (A) no later than 6 months prior to the date of the discontinuance, interruption, or other situation or circumstance