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In light of this prior burden estimate revision to account for the additional effort that commenters stated would be necessary to crosswalk discharges to an MS-DRG, and since hospitals are already required to publicly report the payer-specific negotiated charge information which they will use to calculate these medians, in accordance with the Hospital Price Transparency requirements in effect at the time that this data collection requirement goes into effect, we continue to believe that the burden estimate is reasonable

Research institutions must ensure thorough documentation, including approvals from oversight committees, detailed standard operating procedures, and robust safety measures for all dosing experiments

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