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E., Rius-Prez, S., Brittes, P

The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as for low-volume items and services (but the Secretary may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act)

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of this final rule with comment period, we discuss the finalized requirements for the ASCQR Program