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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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