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193 rows where docket_id = "FDA-2016-N-1111" and posted_year = 2016 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-1111-1651 | FDA | None FDA-2016-N-1111 | Attachment 7. Patient behavior tracking charts_Part 3 of 4 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:13Z | 0 | 0 | 0900006482181809 | |||
| FDA-2016-N-1111-1652 | FDA | None FDA-2016-N-1111 | Attachment 7. Patient behavior tracking charts_Part 4 of 4 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:35:09Z | 0 | 0 | 090000648218180a | |||
| FDA-2016-N-1111-1655 | FDA | None FDA-2016-N-1111 | Attachment 10. LaVigna documents re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:36:12Z | 0 | 0 | 090000648218181d | |||
| FDA-2016-N-1111-1654 | FDA | None FDA-2016-N-1111 | Attachment 9. Published literature discussing use of skin shock re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:35:57Z | 0 | 0 | 090000648218181c | |||
| FDA-2016-N-1111-1644 | FDA | None FDA-2016-N-1111 | Attachment 3c. ESD stimulation data re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:49Z | 0 | 0 | 0900006482181802 | |||
| FDA-2016-N-1111-1661 | FDA | None FDA-2016-N-1111 | Attachment 16.. November 17, 2005 NYSED Report re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:42:45Z | 0 | 0 | 0900006482181823 | |||
| FDA-2016-N-1111-1669 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 7 of 7 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:52:52Z | 0 | 0 | 0900006482181841 | |||
| FDA-2016-N-1111-1665 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 3 of 7 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:51:16Z | 0 | 0 | 090000648218183d | |||
| FDA-2016-N-1111-1670 | FDA | None FDA-2016-N-1111 | Authorization Release Letter and List of Trial Exhibits In Attachment 18-2 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:28Z | 0 | 0 | 0900006482181845 | |||
| FDA-2016-N-1111-1660 | FDA | None FDA-2016-N-1111 | Attachment 15. October 28, 2011 Flammia Letter to DOJ re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:42:17Z | 0 | 0 | 0900006482181822 | |||
| FDA-2016-N-1111-1673 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 358 - 499 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:57:56Z | 0 | 0 | 0900006482181856 | |||
| FDA-2016-N-1111-1643 | FDA | None FDA-2016-N-1111 | Attachment 3b. Data on patients sucessfully transitioned from ESD therapy re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:07Z | 0 | 0 | 09000064821814d2 | |||
| FDA-2016-N-1111-1653 | FDA | None FDA-2016-N-1111 | Attachment 8. Analysis of FDA Cited References re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:35:35Z | 0 | 0 | 090000648218180b | |||
| FDA-2016-N-1111-1674 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 500 - 599 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:58:19Z | 0 | 0 | 0900006482181857 | |||
| FDA-2016-N-1111-1649 | FDA | None FDA-2016-N-1111 | Attachment 7. Patient behavior tracking charts_Part 1 of 4 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:46Z | 0 | 0 | 0900006482181807 | |||
| FDA-2016-N-1111-1668 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 6 of 7 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:52:19Z | 0 | 0 | 0900006482181840 | |||
| FDA-2016-N-1111-1678 | FDA | None FDA-2016-N-1111 | Attachment 19 Former patient emails re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:59:59Z | 0 | 0 | 0900006482181842 | |||
| FDA-2016-N-1111-1658 | FDA | None FDA-2016-N-1111 | Attachment 13. State Waiver of Laws against Aversives re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:40:06Z | 0 | 0 | 0900006482181820 | |||
| FDA-2016-N-1111-1639 | FDA | None FDA-2016-N-1111 | Attachment 1 - JRC Protocol for utilizing the least restrictive most effective interventions re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:25Z | 0 | 0 | 09000064821814ce | |||
| FDA-2016-N-1111-1671 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 70 -310 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:31Z | 0 | 0 | 0900006482181854 | |||
| FDA-2016-N-1111-1675 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 600 - 661 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:58:30Z | 0 | 0 | 0900006482181858 | |||
| FDA-2016-N-1111-1667 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 5 of 7 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:51:50Z | 0 | 0 | 090000648218183f | |||
| FDA-2016-N-1111-1679 | FDA | None FDA-2016-N-1111 | Attachment 20 Deposition Transcript of Dr. Alfred Bacotti (April 30, 2015) re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T15:00:15Z | 0 | 0 | 0900006482181843 | |||
| FDA-2016-N-1111-1650 | FDA | None FDA-2016-N-1111 | Attachment 7. Patient behavior tracking charts_Part 2 of 4 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:10Z | 0 | 0 | 0900006482181808 | |||
| FDA-2016-N-1111-1641 | FDA | None FDA-2016-N-1111 | Attachment 2-2. JRC Consent Form for GED 4_v01-15-2014 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:01Z | 0 | 0 | 09000064821814d0 | |||
| FDA-2016-N-1111-1677 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 731-788 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:59:28Z | 0 | 0 | 090000648218185a | |||
| FDA-2016-N-1111-1672 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 311 - 357 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:57:42Z | 0 | 0 | 0900006482181855 | |||
| FDA-2016-N-1111-1664 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 2 of 7 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:51:03Z | 0 | 0 | 090000648218183c | |||
| FDA-2016-N-1111-1659 | FDA | None FDA-2016-N-1111 | Attachment 14. Letter from FDA to JRC that ESD use is within Practice of Medicine re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:41:59Z | 0 | 0 | 0900006482181821 | |||
| FDA-2016-N-1111-1640 | FDA | None FDA-2016-N-1111 | Attachment 2-1. GED CONSENT FORM (K0644122xA35AD) re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:58Z | 0 | 0 | 09000064821814cf | |||
| FDA-2016-N-1111-1646 | FDA | None FDA-2016-N-1111 | Attachment 5 Patient summaries re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:52Z | 0 | 0 | 0900006482181804 | |||
| FDA-2016-N-1111-1648 | FDA | None FDA-2016-N-1111 | Attachment 6b. Data on 189 JRC patients who have received ESD therapy 7-21-2016 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:43Z | 0 | 0 | 0900006482181806 | |||
| FDA-2016-N-1111-1642 | FDA | None FDA-2016-N-1111 | Attachment 3a. Summary of patients at JRC with court-approved plans for ESD therapy re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:29:04Z | 0 | 0 | 09000064821814d1 | |||
| FDA-2016-N-1111-1680 | FDA | None FDA-2016-N-1111 | Attachment 21 Deposition Transcript of Dr. Lewis B. Klebanoff (April 9, 2015) re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T15:00:32Z | 0 | 0 | 0900006482181844 | |||
| FDA-2016-N-1111-1662 | FDA | None FDA-2016-N-1111 | Attachment 17. JRC Response to NYSED June 9, 2006 Report re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:43:13Z | 0 | 0 | 0900006482181824 | |||
| FDA-2016-N-1111-1656 | FDA | None FDA-2016-N-1111 | Attachment 11. Fredda Brown Documents re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:37:09Z | 0 | 0 | 090000648218181e | |||
| FDA-2016-N-1111-1647 | FDA | None FDA-2016-N-1111 | Attachment 6a. Summary of Experience of JRC Client Group Receiving GEDGED-4 Treatment One Page Su re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:55Z | 0 | 0 | 0900006482181805 | |||
| FDA-2016-N-1111-1666 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 4 of 7 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:51:28Z | 0 | 0 | 090000648218183e | |||
| FDA-2016-N-1111-1645 | FDA | None FDA-2016-N-1111 | Attachment 4. Case conference reports re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2017-11-17T07:28:40Z | 0 | 0 | 0900006482181803 | |||
| FDA-2016-N-1111-1676 | FDA | None FDA-2016-N-1111 | Attachment 18-2_Exhibits 667 - 730 re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:59:07Z | 0 | 0 | 0900006482181859 | |||
| FDA-2016-N-1111-1657 | FDA | None FDA-2016-N-1111 | Attachment 12. Drug side effects re: Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:37:24Z | 0 | 0 | 090000648218181f | |||
| FDA-2016-N-1111-1663 | FDA | None FDA-2016-N-1111 | Attachment 18-1_Transcripts_Part 1 of 7 re Comment from Judge Rotenberg Educational Center (JRC) | Supporting & Related Material | Background Material | 2016-08-23T04:00:00Z | 2016 | 8 | 2016-08-23T14:50:48Z | 0 | 0 | 0900006482181825 | |||
| FDA-2016-N-1111-0395 | FDA | None FDA-2016-N-1111 | Memo from FDA to Hogan Lovells US LLP | Other | Memo | 2016-06-17T04:00:00Z | 2016 | 6 | 2016-06-17T04:00:00Z | 2016-06-17T20:22:37Z | 0 | 0 | 090000648204cf88 | ||
| FDA-2016-N-1111-0382 | FDA | None FDA-2016-N-1111 | Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period | Proposed Rule | Extension of Comment Period | 2016-05-23T04:00:00Z | 2016 | 5 | 2016-05-23T04:00:00Z | 2016-07-26T03:59:59Z | 2018-07-11T01:05:15Z | 2016-12026 | 0 | 0 | 0900006481fe7441 |
| FDA-2016-N-1111-0065 | FDA | None FDA-2016-N-1111 | Reference 63 - Understanding implantable cardioverter defibrillator shocks and storms re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:45:20Z | 0 | 0 | 0900006481f8aabd | |||
| FDA-2016-N-1111-0076 | FDA | None FDA-2016-N-1111 | Reference 73 - CONFIDENTIAL JRC Public Docket Comment (Jun 23, 2014) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:01:47Z | 0 | 0 | 0900006481f8aacb | |||
| FDA-2016-N-1111-0077 | FDA | None FDA-2016-N-1111 | Reference 74 - MJ Cameron Public Docket Comment (Apr 14, 2014) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:03:05Z | 0 | 0 | 0900006481f8aacc | |||
| FDA-2016-N-1111-0078 | FDA | None FDA-2016-N-1111 | Reference 75 - BRI Parents and Friends Public Docket Comment (Apr 14, 2014) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:04:10Z | 0 | 0 | 0900006481f8aacd | |||
| FDA-2016-N-1111-0090 | FDA | None FDA-2016-N-1111 | Reference 86 - Manipulation of potential punishment parameters in the treatment of self-injury re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:30:26Z | 0 | 0 | 0900006481f8aada | |||
| FDA-2016-N-1111-0103 | FDA | None FDA-2016-N-1111 | Reference 99 - Positive Behavior Support for People with Developmental Disabilities re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:56:39Z | 0 | 0 | 0900006481f8aae8 | |||
| FDA-2016-N-1111-0104 | FDA | None FDA-2016-N-1111 | Reference 100 - Anatomy of self-injurious, stereotypic, and aggressive movements re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:58:05Z | 0 | 0 | 0900006481f8aae9 | |||
| FDA-2016-N-1111-0119 | FDA | None FDA-2016-N-1111 | Reference 114 - An evaluation of an intervention sequence outline in PBS for people with autism etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:31:30Z | 0 | 0 | 0900006481f8aaf6 | |||
| FDA-2016-N-1111-0123 | FDA | None FDA-2016-N-1111 | Reference 118 - The effects of extinction, noncontingent reinforcement, and differential reinforcement etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:36:23Z | 0 | 0 | 0900006481f8aafa | |||
| FDA-2016-N-1111-0143 | FDA | None FDA-2016-N-1111 | Reference 138 - SA Gant, Gant Yackel & Assocs, letter re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T22:00:36Z | 0 | 0 | 0900006481f8ab06 | |||
| FDA-2016-N-1111-0015 | FDA | None FDA-2016-N-1111 | Reference 13 - Pain Sensations Associated with Electrocutaneous Stimulation re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:38:11Z | 0 | 0 | 0900006481f8a6da | |||
| FDA-2016-N-1111-0026 | FDA | None FDA-2016-N-1111 | Reference 24 - Painfulness decreases the discriminability of electric shock re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:58:10Z | 0 | 0 | 0900006481f8a6ea | |||
| FDA-2016-N-1111-0027 | FDA | None FDA-2016-N-1111 | Reference 25 - The detectability, discriminability, and perceived magnitude of painful electrical shock re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:59:32Z | 0 | 0 | 0900006481f8a6eb | |||
| FDA-2016-N-1111-0071 | FDA | None FDA-2016-N-1111 | Reference 69 - CONFIDENTIAL DLC Comment Attachment re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:54:58Z | 0 | 0 | 0900006481f8a739 | |||
| FDA-2016-N-1111-0073 | FDA | None FDA-2016-N-1111 | Reference 71 - Observations and Findings of Out-of-State Program Visitation, JRC Inc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:58:17Z | 0 | 0 | 0900006481f8a73b | |||
| FDA-2016-N-1111-0074 | FDA | None FDA-2016-N-1111 | Reference 72 - NYSED Public Docket Comment (Apr 14, 2014) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:59:21Z | 0 | 0 | 0900006481f8a73c | |||
| FDA-2016-N-1111-0106 | FDA | None FDA-2016-N-1111 | Reference 102 - Fifteen years later, Has positive programming become the expected tech for addressing etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:00:53Z | 0 | 0 | 0900006481f8a758 | |||
| FDA-2016-N-1111-0084 | FDA | None FDA-2016-N-1111 | Reference 80 - Self-injurious behavior in schizophrenic and retarded children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:13:51Z | 0 | 0 | 0900006481f8aad3 | |||
| FDA-2016-N-1111-0088 | FDA | None FDA-2016-N-1111 | Reference 84 - The treatment of dangerous behavior re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:18:02Z | 0 | 0 | 0900006481f8aad8 | |||
| FDA-2016-N-1111-0140 | FDA | None FDA-2016-N-1111 | Reference 135 - Unparalleled Positive Programming (Apr 20, 2016) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:57:44Z | 0 | 0 | 0900006481f8ab03 | |||
| FDA-2016-N-1111-0128 | FDA | None FDA-2016-N-1111 | Reference 123 - A review of behavioral treatments for SIBs of persons with ASDs re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:42:04Z | 0 | 0 | 0900006481f8a76e | |||
| FDA-2016-N-1111-0040 | FDA | None FDA-2016-N-1111 | Reference 38 - The use of aversive stimulation in the treatment of chronic SIB re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:32:26Z | 0 | 0 | 0900006481f8aa96 | |||
| FDA-2016-N-1111-0004 | FDA | None FDA-2016-N-1111 | Reference 2 - A Survey of the Prevalence of Stereotypy, Self-Injury and Aggression in Children and Young Adults with Cri du Chat Syndrome re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:14:29Z | 0 | 0 | 0900006481f8a69d | |||
| FDA-2016-N-1111-0025 | FDA | None FDA-2016-N-1111 | Reference 23 - A study of discomfort with electrical stimulation re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:56:58Z | 0 | 0 | 0900006481f8a6e9 | |||
| FDA-2016-N-1111-0029 | FDA | None FDA-2016-N-1111 | Reference 27 - FDA Panel Meeting Roster re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:12:45Z | 0 | 0 | 0900006481f8a6ed | |||
| FDA-2016-N-1111-0044 | FDA | None FDA-2016-N-1111 | Reference 42 - Building social behavior in autistic children by use of electric shock re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:37:43Z | 0 | 0 | 0900006481f8a712 | |||
| FDA-2016-N-1111-0001 | FDA | None FDA-2016-N-1111 | Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T04:00:00Z | 2016-05-26T03:59:59Z | 2016-05-28T20:58:34Z | 2016-09433 | 0 | 0 | 0900006481f88fd3 |
| FDA-2016-N-1111-0056 | FDA | None FDA-2016-N-1111 | Reference 54 - The negative side effects of reward re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:53:58Z | 0 | 0 | 0900006481f8aab4 | |||
| FDA-2016-N-1111-0058 | FDA | None FDA-2016-N-1111 | Reference 56 - Aversion for the treatment of self-injurious behaviour re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:34:22Z | 0 | 0 | 0900006481f8aab6 | |||
| FDA-2016-N-1111-0059 | FDA | None FDA-2016-N-1111 | Reference 57 - Employing electric shock with autistic children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:35:27Z | 0 | 0 | 0900006481f8aab7 | |||
| FDA-2016-N-1111-0086 | FDA | None FDA-2016-N-1111 | Reference 82 - Use of behaviour modification techniques in a community service for mentally handicapped children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:15:59Z | 0 | 0 | 0900006481f8aad6 | |||
| FDA-2016-N-1111-0099 | FDA | None FDA-2016-N-1111 | Reference 95 - Positive behavioral support of adults with developmental disabilities re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:43:41Z | 0 | 0 | 0900006481f8aae4 | |||
| FDA-2016-N-1111-0136 | FDA | None FDA-2016-N-1111 | Reference 131 - Response to Testimony and Written Comments to Proposed Amendments re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:53:25Z | 0 | 0 | 0900006481f8aaff | |||
| FDA-2016-N-1111-0138 | FDA | None FDA-2016-N-1111 | Reference 133 - The path to aversive interventions re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:55:26Z | 0 | 0 | 0900006481f8ab01 | |||
| FDA-2016-N-1111-0009 | FDA | None FDA-2016-N-1111 | Reference 7 - A community survey of self-injurious behavior re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:25:00Z | 0 | 0 | 0900006481f8aa81 | |||
| FDA-2016-N-1111-0010 | FDA | None FDA-2016-N-1111 | Reference 8 - Should the FDA Ban Aversive Conditioning Devices? re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:26:24Z | 0 | 0 | 0900006481f8aa82 | |||
| FDA-2016-N-1111-0033 | FDA | None FDA-2016-N-1111 | Reference 31 - PTSD, Empirical Evaluation of Core Assumptions re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:19:33Z | 0 | 0 | 0900006481f8aa8f | |||
| FDA-2016-N-1111-0038 | FDA | None FDA-2016-N-1111 | Reference 36 - Manipulation of self-destruction in three retarded children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:28:28Z | 0 | 0 | 0900006481f8aa94 | |||
| FDA-2016-N-1111-0042 | FDA | None FDA-2016-N-1111 | Reference 40 - Generalization of punishment effects in the deviant behavior of a psychotic child re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:34:31Z | 0 | 0 | 0900006481f8a70a | |||
| FDA-2016-N-1111-0072 | FDA | None FDA-2016-N-1111 | Reference 70 - Mass DEEC Investigation Report re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:55:58Z | 0 | 0 | 0900006481f8a73a | |||
| FDA-2016-N-1111-0109 | FDA | None FDA-2016-N-1111 | Reference 106 - Positive behavior support and applied behavior analysis re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:16:24Z | 0 | 0 | 0900006481f8a75c | |||
| FDA-2016-N-1111-0113 | FDA | None FDA-2016-N-1111 | Reference 110 - Practice Guideline for the Treatment of Patients with Borderline Personality Disorder re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:23:15Z | 0 | 0 | 0900006481f8a760 | |||
| FDA-2016-N-1111-0110 | FDA | None FDA-2016-N-1111 | Reference 107 - Patients Exhibiting Self-Injurious and Aggressive Behavior re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:17:39Z | 0 | 0 | 0900006481f8a75d | |||
| FDA-2016-N-1111-0112 | FDA | None FDA-2016-N-1111 | Reference 109 - An analysis of functional communication training as an empirically supported treatment etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:21:49Z | 0 | 0 | 0900006481f8a75f | |||
| FDA-2016-N-1111-0132 | FDA | None FDA-2016-N-1111 | Reference 127 - L Brown Public Docket Comment (Apr 14, 2014) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:48:59Z | 0 | 0 | 0900006481f8a772 | |||
| FDA-2016-N-1111-0054 | FDA | None FDA-2016-N-1111 | References 52 - Short-term effects of behaviour therapy and hospital treatment of chronic alcoholics re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:51:30Z | 0 | 0 | 0900006481f8aab0 | |||
| FDA-2016-N-1111-0055 | FDA | None FDA-2016-N-1111 | Reference 53 - Effect of electric aversion on cigarette smoking re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:52:57Z | 0 | 0 | 0900006481f8aab1 | |||
| FDA-2016-N-1111-0098 | FDA | None FDA-2016-N-1111 | Reference 94 - Seven case studies of individuals expelled from positive-only programs re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T20:42:34Z | 0 | 0 | 0900006481f8aae3 | |||
| FDA-2016-N-1111-0121 | FDA | None FDA-2016-N-1111 | Reference 116 - Adapted Dialectical Behavior Therapy for Adolescents with Self-Injurious Thoughts and Behaviors re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:34:18Z | 0 | 0 | 0900006481f8aaf8 | |||
| FDA-2016-N-1111-0125 | FDA | None FDA-2016-N-1111 | Reference 120 - Side effects of extinction re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:38:33Z | 0 | 0 | 0900006481f8aafc | |||
| FDA-2016-N-1111-0134 | FDA | None FDA-2016-N-1111 | Reference 129 - Effects of within-activity choices on the challenging behavior of children with severe DDs re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T21:51:06Z | 0 | 0 | 0900006481f8a774 | |||
| FDA-2016-N-1111-0011 | FDA | None FDA-2016-N-1111 | Reference 9 - Self-injury among a community cohort of young children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:28:03Z | 0 | 0 | 0900006481f8aa83 | |||
| FDA-2016-N-1111-0041 | FDA | None FDA-2016-N-1111 | Reference 39 - A long-term follow-up of treatment for severe self-injury re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T18:33:27Z | 0 | 0 | 0900006481f8aa97 | |||
| FDA-2016-N-1111-0012 | FDA | None FDA-2016-N-1111 | Reference 10 - Conduction of electrical current to and through the human body re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:29:48Z | 0 | 0 | 0900006481f8a6d7 | |||
| FDA-2016-N-1111-0017 | FDA | None FDA-2016-N-1111 | Reference 15 - Factors that can affect the use of electric shock in behavior therapy re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T16:41:01Z | 0 | 0 | 0900006481f8a6dc | |||
| FDA-2016-N-1111-0068 | FDA | None FDA-2016-N-1111 | Reference 67 - Contingent Electric Shock as a Treatment for Severe Behavior Problems re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior | Supporting & Related Material | Background Material | 2016-04-25T04:00:00Z | 2016 | 4 | 2016-04-25T19:50:17Z | 0 | 0 | 0900006481f8a736 |
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