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The Appeals Court ruled that Congressional delegations of authority are constitutional if Congress "lay[s] down by legislative act an intelligible principle to which the person or body authorized [to exercise the authority] is directed to conform." It is "constitutionally sufficient if Congress clearly delineates the general policy, the public agency which is to apply it, and the boundaries of th[e] delegated authority." Specifically, the Circuit Court determined the TCA established detailed regulatory frameworks for the FDA to follow and the TCA automatically applied to certain classes of products

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Therefore, the MVP Participant would not know whether they would meet the case minimum requirement for the selected population health measure at the time of data submission

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