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Comment 25) One comment objects to FDA's reliance on JRC's coverage document listing achievable collateral consequences of ESDs since this document was designed in reaction to a necessity from the NYSED by Corrective Action Requests to contain a discussion of the collateral outcomes of aversive interventions in its guidelines, and there is no evidence ESDs prompted any of these collateral outcomes. Specifically, NYSED obtained experiences of AEs, which NYSED refers to as collateral effects, from the use of these equipment, these as boosts in aggression and increases in escape behaviors or psychological reactions. However, the scientific studies conducted for approval of the medicine supply a superior baseline to recognize their pitfalls than that available for ESDs, and the scientific studies dietary supplement our comprehension from spontaneous postmarket experiences of AEs. Dr. McCracken testified that in the literature about the use of ESDs, "there has been pretty much no endeavor to identify or analyze side effects" (Ref. Fda disagrees. As discussed in the proposed rule, Fda believes that the scientific literature suffers from a variety of restrictions and has likely underreported AEs involved with ESDs for a selection of good reasons (see eighty one FR 24386 at 24935). Perhaps most importantly, the products have been analyzed only on a pretty tiny range of topics, a lot of of whom would have issues speaking or usually demonstrating AEs, which includes accidents

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