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We proposed at 428.302(c)(4) to grant a reduction in the rebate amount owed if a manufacturer of an eligible drug submits to CMS a request in writing demonstrating that (1) a severe supply chain disruption has occurred during the applicable period, (2) the severe supply chain disruption directly affects the manufacturer itself, a supplier of an ingredient or packaging, a contract manufacturer, [703] or a method of shipping or distribution that the manufacturer uses in a significant capacity to make or distribute the generic Part D rebatable drug or biosimilar, and (3) the severe supply chain disruption was caused by a natural disaster or other unique or unexpected event

and (3) the interface between knowledge and action

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VallejoCordoba, A