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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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17 rows where docket_id = "FDA-2016-N-1111" and posted_year = 2017 sorted by posted_date descending

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document_type 2

posted_year 1

  • 2017 · 17 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1111-1709 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
FDA-2016-N-1111-1705 FDA None FDA-2016-N-1111 Attachment 2 Letter from Hogan Lovells to FDA CDRH January 16, 2013 re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:01:56Z   0 0 090000648254a521
FDA-2016-N-1111-1712 FDA None FDA-2016-N-1111 Attachment 9 Police Report Canton Police Department re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:11:59Z   0 0 090000648254a539
FDA-2016-N-1111-1710 FDA None FDA-2016-N-1111 Attachment 7 Letter from Hogan Lovells to FDA CDRH February 1, 2013 re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:00:21Z   0 0 090000648254a526
FDA-2016-N-1111-1708 FDA None FDA-2016-N-1111 Attachment 5 Article from Silence Breaking Sound "Tell the FDA: Stop the Shock!" re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T13:53:24Z   0 0 090000648254a524
FDA-2016-N-1111-1713 FDA None FDA-2016-N-1111 Attachment 10 Letter from Judge Rotenberg Center December 21, 2016 re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:18:08Z   0 0 090000648254a53a
FDA-2016-N-1111-1715 FDA None FDA-2016-N-1111 Attachment 12 Letter from FDA CDRH to St. Jude Medical, Inc. re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:37:10Z   0 0 090000648254a53c
FDA-2016-N-1111-1719 FDA None FDA-2016-N-1111 Attachment 16 Letter from FDA CDRH to Micro Interventional Devices, Inc. re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T15:08:33Z   0 0 090000648254a540
FDA-2016-N-1111-1714 FDA None FDA-2016-N-1111 Attachment 11 JRC Policy Procedures and Rules for GED Applications and Approvals re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:20:55Z   0 0 090000648254a53b
FDA-2016-N-1111-1703 FDA None FDA-2016-N-1111 Supplemental Comment from Eckert Seamans re: Judge Rotenberg Educational Center, Inc. Other Supplemental Comment 2017-04-11T04:00:00Z 2017 4 2017-04-11T04:00:00Z   2017-04-11T12:42:09Z   0 0 0900006482549ba0
FDA-2016-N-1111-1711 FDA None FDA-2016-N-1111 Attachment 8 Product Description of Antabuse Disulfran Tablet re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:12:15Z   0 0 090000648254a538
FDA-2016-N-1111-1717 FDA None FDA-2016-N-1111 Attachment 14 Letter from FDA CDRH to Edwards Lifesciences, LLC August 12, 2016 re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T14:50:34Z   0 0 090000648254a53e
FDA-2016-N-1111-1718 FDA None FDA-2016-N-1111 Attachment 15 Edwards Intuity Elite Valve System re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T15:11:28Z   0 0 090000648254a53f
FDA-2016-N-1111-1704 FDA None FDA-2016-N-1111 Attachment 1 Linked Profile of James Eason re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc. Supporting & Related Material Background Material 2017-04-11T04:00:00Z 2017 4     2017-04-11T13:42:05Z   0 0 090000648254a520

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;