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Use of international standard ISO 10993-1, biological evaluation of medical devices Part 1: Evaluation and testing within a risk management proces guidance for industry and Food and drug administration staff

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We proposed at 428.302(b)(1) to provide a time-limited standard reduction of 75 percent in the total rebate amount for a generic Part D rebatable drug or biosimilar when CMS determines there is a severe supply chain disruption during the applicable period, such as that caused by a natural disaster or other unique or unexpected event