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306 rows where docket_id = "FDA-2016-N-1111" sorted by posted_date descending
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| id | agency_id | docket_id | title | document_type | subtype | posted_date ▲ | posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2016-N-1111-1838 | FDA | None FDA-2016-N-1111 | Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Rule | Final Rule | 2020-08-19T04:00:00Z | 2020 | 8 | 2020-08-19T04:00:00Z | 2020-08-19T12:54:34Z | 2020-16595 | 0 | 0 | 09000064848104bf | |
| FDA-2016-N-1111-1762 | FDA | None FDA-2016-N-1111 | Reference 21 - Investigation Report re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:22:15Z | 0 | 0 | 09000064843fd66e | |||
| FDA-2016-N-1111-1754 | FDA | None FDA-2016-N-1111 | Reference 11 - A review of behavioral treatments for self-injurious behaviors of persons with autism spectrum disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:19:42Z | 0 | 0 | 09000064843fd571 | |||
| FDA-2016-N-1111-1822 | FDA | None FDA-2016-N-1111 | Reference 86 - DOJ Letter to Neurological Devices Panel re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:58:53Z | 0 | 0 | 09000064843fd4d2 | |||
| FDA-2016-N-1111-1758 | FDA | None FDA-2016-N-1111 | Reference 17 - A quasi-experimental study on the effect of electrical aversion treatment on imposed mechanical restraint for self-injurious behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:20:55Z | 0 | 0 | 09000064843fd575 | |||
| FDA-2016-N-1111-1749 | FDA | None FDA-2016-N-1111 | Reference 6 - FDA Aversive Conditioning Panel Presentation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:18:22Z | 0 | 0 | 09000064843fcb87 | |||
| FDA-2016-N-1111-1759 | FDA | None FDA-2016-N-1111 | Reference 18 - Therapeutic shock device - Clinical evaluation with SIBs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:21:09Z | 0 | 0 | 09000064843fd576 | |||
| FDA-2016-N-1111-1778 | FDA | None FDA-2016-N-1111 | Reference 39 - Developing function-based punishment procedures for problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:26:46Z | 0 | 0 | 09000064843fd680 | |||
| FDA-2016-N-1111-1792 | FDA | None FDA-2016-N-1111 | Reference 55 - Remotely applied punishment vs avoidance conditioning in the treatment of SIBs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:31:33Z | 0 | 0 | 09000064843fd698 | |||
| FDA-2016-N-1111-1783 | FDA | None FDA-2016-N-1111 | Reference 46 - Social policy on the use of aversive interventions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:28:22Z | 0 | 0 | 09000064843fd68f | |||
| FDA-2016-N-1111-1776 | FDA | None FDA-2016-N-1111 | Reference 37 - Elimination of Chronic Cough by Response Suppression Shaping re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:26:15Z | 0 | 0 | 09000064843fd67e | |||
| FDA-2016-N-1111-1763 | FDA | None FDA-2016-N-1111 | Reference 22 - Observations and Findings of Out-of-State Program Visitation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:22:30Z | 0 | 0 | 09000064843fd66f | |||
| FDA-2016-N-1111-1777 | FDA | None FDA-2016-N-1111 | Reference 38 - Punishment in behavior modification - Practical, ethical, and legal issues re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:26:31Z | 0 | 0 | 09000064843fd67f | |||
| FDA-2016-N-1111-1786 | FDA | None FDA-2016-N-1111 | Reference 49 - Behavioral contingencies, self-mutilation in Lesch-Nyhan disease re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:29:31Z | 0 | 0 | 09000064843fd692 | |||
| FDA-2016-N-1111-1815 | FDA | None FDA-2016-N-1111 | Reference 79 - ECT for self-injury in an autistic boy re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:38:59Z | 0 | 0 | 09000064843fd4b8 | |||
| FDA-2016-N-1111-1798 | FDA | None FDA-2016-N-1111 | Reference 61 - Long-term use of electrical aversion treatment with SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:33:26Z | 0 | 0 | 09000064843fd69e | |||
| FDA-2016-N-1111-1820 | FDA | None FDA-2016-N-1111 | Reference 84 - Response to Testimony and Written Comments re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:58:08Z | 0 | 0 | 09000064843fd4d0 | |||
| FDA-2016-N-1111-1752 | FDA | None FDA-2016-N-1111 | Reference 9 - Toward a technology of 'nonaversive' behavioral support re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:19:09Z | 0 | 0 | 09000064843fcb8a | |||
| FDA-2016-N-1111-1775 | FDA | None FDA-2016-N-1111 | Reference 36 - Common behavioral decelerators (aversives) and their efficacy re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:25:53Z | 0 | 0 | 09000064843fd67d | |||
| FDA-2016-N-1111-1790 | FDA | None FDA-2016-N-1111 | Reference 53 - The right to aversive treatment including aversive stimuli re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:31:00Z | 0 | 0 | 09000064843fd696 | |||
| FDA-2016-N-1111-1828 | FDA | None FDA-2016-N-1111 | Reference 93 - A quantitative examination of punishment research re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:01:06Z | 0 | 0 | 09000064843fd4d9 | |||
| FDA-2016-N-1111-1832 | FDA | None FDA-2016-N-1111 | Reference 98 - Psychiatric and cognitive aspects of PKU - The limitations and promise of new treatments re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:02:39Z | 0 | 0 | 09000064843fd4dd | |||
| FDA-2016-N-1111-1811 | FDA | None FDA-2016-N-1111 | Reference 75 - 30 years of research on functional analysis of problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:37:44Z | 0 | 0 | 09000064843fd4b4 | |||
| FDA-2016-N-1111-1814 | FDA | None FDA-2016-N-1111 | Reference 78 - SIB in neurodevelopmental disorders - Relevance of nociceptive and immune mechanisms re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:38:38Z | 0 | 0 | 09000064843fd4b7 | |||
| FDA-2016-N-1111-1816 | FDA | None FDA-2016-N-1111 | Reference 80 - Adapted Dialectical Behavior Therapy for Adolescents with Self-Injurious Thoughts and Behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:39:25Z | 0 | 0 | 09000064843fd4b9 | |||
| FDA-2016-N-1111-1779 | FDA | None FDA-2016-N-1111 | Reference 40 - Use of punishment procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:27:10Z | 0 | 0 | 09000064843fd681 | |||
| FDA-2016-N-1111-1747 | FDA | None FDA-2016-N-1111 | Reference 4 - Panel Meeting Roster re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:17:47Z | 0 | 0 | 09000064843fc934 | |||
| FDA-2016-N-1111-1750 | FDA | None FDA-2016-N-1111 | Reference 7 - Side effects of contingent shock treatment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:18:39Z | 0 | 0 | 09000064843fcb88 | |||
| FDA-2016-N-1111-1756 | FDA | None FDA-2016-N-1111 | Reference 15 - Panel Meeting Transcript re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:20:16Z | 0 | 0 | 09000064843fd573 | |||
| FDA-2016-N-1111-1810 | FDA | None FDA-2016-N-1111 | Reference 74 - Functional analysis of problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:37:20Z | 0 | 0 | 09000064843fd4b3 | |||
| FDA-2016-N-1111-1812 | FDA | None FDA-2016-N-1111 | Reference 76 - View on the efficacy and ethics of punishment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:38:00Z | 0 | 0 | 09000064843fd4b5 | |||
| FDA-2016-N-1111-1793 | FDA | None FDA-2016-N-1111 | Reference 56 - Punishment as a therapeutic method with institutionalized persons re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:31:49Z | 0 | 0 | 09000064843fd699 | |||
| FDA-2016-N-1111-1831 | FDA | None FDA-2016-N-1111 | Reference 97 - Pharmacological treatment of severe irritability and problem behaviors in autism re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:02:14Z | 0 | 0 | 09000064843fd4dc | |||
| FDA-2016-N-1111-1772 | FDA | None FDA-2016-N-1111 | Reference 33 - Use of aversive stimulation in behavior modification re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:25:05Z | 0 | 0 | 09000064843fd67a | |||
| FDA-2016-N-1111-1753 | FDA | None FDA-2016-N-1111 | Reference 10 - Efficacy of behavioral interventions for reducing problem behavior in persons with autism re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:19:24Z | 0 | 0 | 09000064843fd570 | |||
| FDA-2016-N-1111-1796 | FDA | None FDA-2016-N-1111 | Reference 59 - Punishment (Positive Punishment) re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:32:51Z | 0 | 0 | 09000064843fd69c | |||
| FDA-2016-N-1111-1746 | FDA | None FDA-2016-N-1111 | Reference 3 - Self-injury among a community cohort of young children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:17:29Z | 0 | 0 | 09000064843fc933 | |||
| FDA-2016-N-1111-1768 | FDA | None FDA-2016-N-1111 | Reference 28 - DSM-5 - PTSD re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:23:54Z | 0 | 0 | 09000064843fd674 | |||
| FDA-2016-N-1111-1785 | FDA | None FDA-2016-N-1111 | Reference 48 - Modification of schizophrenic behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:29:08Z | 0 | 0 | 09000064843fd691 | |||
| FDA-2016-N-1111-1782 | FDA | None FDA-2016-N-1111 | Reference 45 - On the importance of reliable equipment in the shock punishment of SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:27:57Z | 0 | 0 | 09000064843fd68e | |||
| FDA-2016-N-1111-1835 | FDA | None FDA-2016-N-1111 | RIA Reference 1-3 - NAICS 623220 wages (May 2018) re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:04:20Z | 0 | 0 | 09000064843fd4e0 | |||
| FDA-2016-N-1111-1802 | FDA | None FDA-2016-N-1111 | Reference 65 - Positive behavioral support of adults with developmental disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:34:41Z | 0 | 0 | 09000064843fd6a3 | |||
| FDA-2016-N-1111-1803 | FDA | None FDA-2016-N-1111 | Reference 66 - Manipulation of self-destruction in three children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:34:58Z | 0 | 0 | 09000064843fd6a4 | |||
| FDA-2016-N-1111-1799 | FDA | None FDA-2016-N-1111 | Reference 62 - A maintenance strategy for discontinuing aversive procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:33:47Z | 0 | 0 | 09000064843fd69f | |||
| FDA-2016-N-1111-1801 | FDA | None FDA-2016-N-1111 | Reference 64 - Are aversive procedures durable re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:34:22Z | 0 | 0 | 09000064843fd6a2 | |||
| FDA-2016-N-1111-1821 | FDA | None FDA-2016-N-1111 | Reference 85 - Ellen Howe affidavit re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:58:28Z | 0 | 0 | 09000064843fd4d1 | |||
| FDA-2016-N-1111-1780 | FDA | None FDA-2016-N-1111 | Reference 42 - Aversion for the treatment of SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:27:25Z | 0 | 0 | 09000064843fd682 | |||
| FDA-2016-N-1111-1787 | FDA | None FDA-2016-N-1111 | Reference 50 - Control of chronic SIB by conditioning procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:29:48Z | 0 | 0 | 09000064843fd693 | |||
| FDA-2016-N-1111-1761 | FDA | None FDA-2016-N-1111 | Reference 20 - A 4-year follow-up of treatment of self-injury re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:21:43Z | 0 | 0 | 09000064843fd66d | |||
| FDA-2016-N-1111-1817 | FDA | None FDA-2016-N-1111 | Reference 81 - Do improvements after inpatient dialectical behavioral therapy persist in the long term re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:39:46Z | 0 | 0 | 09000064843fd4ba | |||
| FDA-2016-N-1111-1788 | FDA | None FDA-2016-N-1111 | Reference 51 - Remission of chronic ruminative vomiting through a reversal of social contingencies re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:30:06Z | 0 | 0 | 09000064843fd694 | |||
| FDA-2016-N-1111-1833 | FDA | None FDA-2016-N-1111 | RIA Reference 1-1 - NAICS 623000 wages (May 2018) re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:03:15Z | 0 | 0 | 09000064843fd4de | |||
| FDA-2016-N-1111-1836 | FDA | None FDA-2016-N-1111 | RIA Reference 3 - Treating Challenging Behaviors with DBT re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:05:10Z | 0 | 0 | 09000064843fd4e1 | |||
| FDA-2016-N-1111-1800 | FDA | None FDA-2016-N-1111 | Reference 63 - A comparison of shock intensity in the treatment of longstanding and severe SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:34:05Z | 0 | 0 | 09000064843fd6a0 | |||
| FDA-2016-N-1111-1809 | FDA | None FDA-2016-N-1111 | Reference 73 - Punishment by Stimulus Presentation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:36:54Z | 0 | 0 | 09000064843fd6aa | |||
| FDA-2016-N-1111-1804 | FDA | None FDA-2016-N-1111 | Reference 67 - Seven case studies of individuals expelled from positive-only programs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:35:19Z | 0 | 0 | 09000064843fd6a5 | |||
| FDA-2016-N-1111-1823 | FDA | None FDA-2016-N-1111 | Reference 87 - Positive Behavior Support for People with Developmental Disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:59:16Z | 0 | 0 | 09000064843fd4d3 | |||
| FDA-2016-N-1111-1824 | FDA | None FDA-2016-N-1111 | Reference 88 - Positive behavior support and applied behavior analysis - A familial alliance re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:59:34Z | 0 | 0 | 09000064843fd4d4 | |||
| FDA-2016-N-1111-1789 | FDA | None FDA-2016-N-1111 | Reference 52 - Extinction procedure for eliminating SIB in a 9-year old autistic girl re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:30:33Z | 0 | 0 | 09000064843fd695 | |||
| FDA-2016-N-1111-1834 | FDA | None FDA-2016-N-1111 | RIA Reference 1-2 - NAICS 623210 wages (May 2018) PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:03:41Z | 0 | 0 | 09000064843fd4df | |||
| FDA-2016-N-1111-1784 | FDA | None FDA-2016-N-1111 | Reference 47 - Treatment of aggression with behavioral programming that includes supplementary contingent skin shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:28:49Z | 0 | 0 | 09000064843fd690 | |||
| FDA-2016-N-1111-1744 | FDA | None FDA-2016-N-1111 | List of References re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:15:57Z | 0 | 0 | 09000064843fc931 | |||
| FDA-2016-N-1111-1751 | FDA | None FDA-2016-N-1111 | Reference 8 - The efficacy of positive behavioural support with the most challenging behaviour re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:18:53Z | 0 | 0 | 09000064843fcb89 | |||
| FDA-2016-N-1111-1795 | FDA | None FDA-2016-N-1111 | Reference 58 - The successful treatment of a dually-diagnosed deaf man's aggression with a program that included contingent electric shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:32:33Z | 0 | 0 | 09000064843fd69b | |||
| FDA-2016-N-1111-1813 | FDA | None FDA-2016-N-1111 | Reference 77 - SIB in children with developmental disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:38:20Z | 0 | 0 | 09000064843fd4b6 | |||
| FDA-2016-N-1111-1826 | FDA | None FDA-2016-N-1111 | Reference 91 - Personal Paradigm Shifts Among ABA and PBS Experts re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:00:25Z | 0 | 0 | 09000064843fd4d6 | |||
| FDA-2016-N-1111-1760 | FDA | None FDA-2016-N-1111 | Reference 19 - A long-term follow-up of treatment for severe self-injury re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:21:22Z | 0 | 0 | 09000064843fd577 | |||
| FDA-2016-N-1111-1748 | FDA | None FDA-2016-N-1111 | Reference 5 - Panel Meeting Executive Summary re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:18:04Z | 0 | 0 | 09000064843fc935 | |||
| FDA-2016-N-1111-1755 | FDA | None FDA-2016-N-1111 | Reference 12 - Patients Exhibiting Self-Injurious and Aggressive Behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:20:00Z | 0 | 0 | 09000064843fd572 | |||
| FDA-2016-N-1111-1757 | FDA | None FDA-2016-N-1111 | Reference 16 - An accelerometer-activated device to control assaultive and self-destructive behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:20:32Z | 0 | 0 | 09000064843fd574 | |||
| FDA-2016-N-1111-1766 | FDA | None FDA-2016-N-1111 | Reference 26 - Posttraumatic stress disorder - An empirical evaluation of core assumptions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:23:21Z | 0 | 0 | 09000064843fd672 | |||
| FDA-2016-N-1111-1770 | FDA | None FDA-2016-N-1111 | Reference 31 - The control of violent behavior through faradic shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:24:31Z | 0 | 0 | 09000064843fd676 | |||
| FDA-2016-N-1111-1805 | FDA | None FDA-2016-N-1111 | Reference 68 - A component analysis of positive behaviour support plans re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:35:45Z | 0 | 0 | 09000064843fd6a6 | |||
| FDA-2016-N-1111-1774 | FDA | None FDA-2016-N-1111 | Reference 35 - Behavior Modification Techniques in the Treatment of SIB in Institutionalized Persons re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:25:38Z | 0 | 0 | 09000064843fd67c | |||
| FDA-2016-N-1111-1765 | FDA | None FDA-2016-N-1111 | Reference 25 - Building social behavior in autistic children by use of electric shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:23:06Z | 0 | 0 | 09000064843fd671 | |||
| FDA-2016-N-1111-1794 | FDA | None FDA-2016-N-1111 | Reference 57 - Life threatening behavior - Analysis and intervention re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:32:08Z | 0 | 0 | 09000064843fd69a | |||
| FDA-2016-N-1111-1827 | FDA | None FDA-2016-N-1111 | Reference 92 - The path to aversive interventions - Four mothers' perceptions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:00:47Z | 0 | 0 | 09000064843fd4d7 | |||
| FDA-2016-N-1111-1829 | FDA | None FDA-2016-N-1111 | Reference 95 - Assessment and treatment of challenging behaviour for individuals with intellectual disability re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:01:28Z | 0 | 0 | 09000064843fd4da | |||
| FDA-2016-N-1111-1830 | FDA | None FDA-2016-N-1111 | Reference 96 - Association Between SIB and Autism Spectrum Disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:01:51Z | 0 | 0 | 09000064843fd4db | |||
| FDA-2016-N-1111-1797 | FDA | None FDA-2016-N-1111 | Reference 60 - On the status of knowledge for using punishment - Implications for treating behavior disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:33:07Z | 0 | 0 | 09000064843fd69d | |||
| FDA-2016-N-1111-1825 | FDA | None FDA-2016-N-1111 | Reference 89 - Positive behaviour support for a child with severe learning disability re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:59:58Z | 0 | 0 | 09000064843fd4d5 | |||
| FDA-2016-N-1111-1818 | FDA | None FDA-2016-N-1111 | Reference 82 - Report on the Use and Effects of ESDs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:57:04Z | 0 | 0 | 09000064843fd4ce | |||
| FDA-2016-N-1111-1745 | FDA | None FDA-2016-N-1111 | Reference 2 - Should the FDA Ban Aversive Conditioning Devices re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:17:09Z | 0 | 0 | 09000064843fc932 | |||
| FDA-2016-N-1111-1806 | FDA | None FDA-2016-N-1111 | Reference 69 - Fifteen years later - Has positive programming become the expected technology for addressing problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:36:02Z | 0 | 0 | 09000064843fd6a7 | |||
| FDA-2016-N-1111-1807 | FDA | None FDA-2016-N-1111 | Reference 70 - The role of positive programming in behavioral treatment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:36:20Z | 0 | 0 | 09000064843fd6a8 | |||
| FDA-2016-N-1111-1791 | FDA | None FDA-2016-N-1111 | Reference 54 - Effectiveness of several suppression procedures in eliminating high-probability response in a severely brain-damaged child re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:31:16Z | 0 | 0 | 09000064843fd697 | |||
| FDA-2016-N-1111-1837 | FDA | None FDA-2016-N-1111 | RIA Reference 4 - NAICS 2017 Table of Size Standards PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T13:05:31Z | 0 | 0 | 09000064843fd4e2 | |||
| FDA-2016-N-1111-1819 | FDA | None FDA-2016-N-1111 | Reference 83 - An evaluation of positive behavioural support for people with very severe challenging behaviours in community-based settings re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:57:20Z | 0 | 0 | 09000064843fd4cf | |||
| FDA-2016-N-1111-1767 | FDA | None FDA-2016-N-1111 | Reference 27 - Post-traumatic stress disorder without the trauma re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:23:40Z | 0 | 0 | 09000064843fd673 | |||
| FDA-2016-N-1111-1769 | FDA | None FDA-2016-N-1111 | Reference 29 - The use of punishment as a treatment modality re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:24:10Z | 0 | 0 | 09000064843fd675 | |||
| FDA-2016-N-1111-1771 | FDA | None FDA-2016-N-1111 | Reference 32 - The effects of the reinforcement of compatible and incompatible alternative behaviors on self-injurious and related behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:24:49Z | 0 | 0 | 09000064843fd679 | |||
| FDA-2016-N-1111-1781 | FDA | None FDA-2016-N-1111 | Reference 43 - SIB - A behavioral analysis re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:27:42Z | 0 | 0 | 09000064843fd68d | |||
| FDA-2016-N-1111-1764 | FDA | None FDA-2016-N-1111 | Reference 24 - Stimulus fading and transfer in the treatment of self-restraint and SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:22:51Z | 0 | 0 | 09000064843fd670 | |||
| FDA-2016-N-1111-1773 | FDA | None FDA-2016-N-1111 | Reference 34 - Overcoming situation-specific problems associated with typical institutional attempts to suppress self-mutialtive behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:25:22Z | 0 | 0 | 09000064843fd67b | |||
| FDA-2016-N-1111-1808 | FDA | None FDA-2016-N-1111 | Reference 72 - Explosive, oppositional, and aggressive behavior in children with autism compared to other clinical disorders and typical children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2020-03-09T04:00:00Z | 2020 | 3 | 2020-03-23T12:36:37Z | 0 | 0 | 09000064843fd6a9 | |||
| FDA-2016-N-1111-1743 | FDA | None FDA-2016-N-1111 | Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior | Rule | Final Rule | 2020-03-06T05:00:00Z | 2020 | 3 | 2020-03-06T05:00:00Z | 2020-03-20T18:30:05Z | 2020-04328 | 0 | 0 | 09000064843f9b66 | |
| FDA-2016-N-1111-1709 | FDA | None FDA-2016-N-1111 | Attachment 6 Linked Profile of Quentin Davies re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. | Supporting & Related Material | Background Material | 2017-04-11T04:00:00Z | 2017 | 4 | 2017-04-11T13:57:54Z | 0 | 0 | 090000648254a525 | |||
| FDA-2016-N-1111-1706 | FDA | None FDA-2016-N-1111 | Attachment 3 Article from ASAN "Tell the FDA: Ban Electric Shock Torture of People with Disabilities" re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. | Supporting & Related Material | Background Material | 2017-04-11T04:00:00Z | 2017 | 4 | 2017-04-11T13:47:59Z | 0 | 0 | 090000648254a522 | |||
| FDA-2016-N-1111-1707 | FDA | None FDA-2016-N-1111 | Attachment 4 Article from Change.org "USA Today: Time to ban skin shocks to disabled" re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. | Supporting & Related Material | Background Material | 2017-04-11T04:00:00Z | 2017 | 4 | 2017-04-11T13:50:42Z | 0 | 0 | 090000648254a523 | |||
| FDA-2016-N-1111-1716 | FDA | None FDA-2016-N-1111 | Attachment 13 Instructions for Use Amplatzer PFO Occluder re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. | Supporting & Related Material | Background Material | 2017-04-11T04:00:00Z | 2017 | 4 | 2017-04-11T14:42:57Z | 0 | 0 | 090000648254a53d |
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