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We refer readers to the remainder of ASM's section of this final rule for detailed discussion on comments we received on specific proposals, our responses to those comments, and our finalized provisions and policies for ASM

(2) Full and Simplified Self-Nomination for Qualified Clinical Data Registries and Qualified Registries In section IV.A.4.a.(3) of this final rule, we are finalizing our proposal to provide additional flexibilities to allow third party intermediaries additional time to fully support finalized MVPs

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