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FDA staff scientists had unanimously opposed every peptide being added to the list, citing a lack of solid clinical trial data, inconsistent recipes from batch to batch and the risk the compounds could trigger harmful immune reactions

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Therefore, we believe the one-time burden estimate to be 88,992 hours for all hospitals (12 hours 7,416 hospitals) at a cost of $10,840,708.80 (7,416 hospitals [($87.52 8 hours) + ($128.00 2 hours) + ($252.82 2 hours])