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Response: We appreciate commenters' concerns but forcefully reiterate, as stated in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82086, 82116), that this final rule with comment period falls outside the scope of the FCA

At research doses of 0.252mg daily, AHK-Cu delivers approximately 0.050.4mg elemental copper per day well below the tolerable upper intake level of 10mg daily established by the NIH

The applicant asserted that the Axoguard HA+ Nerve Protector TM does not fit any existing mesh or patch category used for general surgical repair because it is a specialized nerve protector and stands apart from surgical meshes used in abdominal or orthopedic procedures

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