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Fda is not questioning the validity or relevance of authorized consent, but alternatively pointing out that authorized consent does not remove fears linked to the shock recipients' communication issues and lack of handle about use of the product on them. The comment highlights an person who seasoned suicidal ideation but later on credited use of the ESD for saving her existence by changing what the commenter describes as "ineffective and dangerous psychotropic medicine." To support this danger of ESDs for SIB or AB, we discussed in the proposed rule that gurus in the industry of behavioral science (like members of the Panel) and State organizations that control ESDs show that the products have been Start Printed Page 13319associated with quick- and very long-expression trauma, such as suicidal ideation (81 FR 24386 at 24399). Given that ESDs can also contribute to worry, panic, realized helplessness, and posttraumatic reactions, amongst other results, we do not consider that it is acceptable to conclude that the dangers offered by ESDs are unrelated to suicidal ideation. We viewed as the viewpoints of Panel customers and other authorities, some of whom help the use of ESDs for SIB or AB and some of whom do not. However, Fda did not dismiss evidence that supports the use of ESDs for SIB or AB

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