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As reviewed in depth in the comment responses in section V, while we uncovered that specific risks experienced weaker guidance than we asserted in the proposed rule, other information submitted in remarks presented larger assistance for other challenges. The extra references cited in the reviews on the proposed rule undergo from the same methodological and other constraints as people Fda regarded as previously, and the documents and summaries JRC submitted about its inhabitants constitute an even weaker source of proof pertaining to the performance of ESDs for SIB or AB. For this rulemaking, we also connected the Panel Meeting docket with this motion (Docket No. Fda-2014-N-0238) and regarded as the roughly three hundred remarks submitted to the Panel Meeting docket. See Judge Rotenberg Center, Inc., et al., v. Comm'r of the Dep't of Developmental Servs., et al., Docket No. 86E-0018-GI (Bristol, Mass. In its opinions on the proposed rule, JRC incorporated the hearing transcripts and displays from a recent Massachusetts court proceeding that regarded as the use of ESDs, in certain the Judge Rotenberg Center's (JRC's) graduated electronic decelerator (GED) units. The healthcare local community now broadly recognizes that conducting thorough functional assessments and addressing the fundamental leads to of SIB and AB somewhat than suppressing behaviors with shocks not only avoids the challenges posed by ESDs, but can obtain durable, prolonged-phrase positive aspects

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