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Such information and supporting documentation include the following: (i) Evidence that the severe supply chain disruption directly affects the manufacturer itself, a supplier of an ingredient or packaging, a contract manufacturer, or a method of shipping or distribution that the manufacturer uses to make or distribute the generic Part D rebatable drug(s) or biosimilar(s), such as a change in the production or distribution of the generic Part D ( rebatable drug(s) or biosimilar(s) that is reasonably likely to lead to a significant reduction in the U.S

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