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

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13 rows where docket_id = "FDA-2017-N-6381" sorted by posted_date descending

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posted_year 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-N-6381-0008 FDA None FDA-2017-N-6381 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements - FRIA Other Assessment Document or Analysis 2020-10-01T04:00:00Z 2020 10 2020-10-01T04:00:00Z   2020-10-01T15:59:41Z   0 0 09000064847c5f5d
FDA-2017-N-6381-0013 FDA None FDA-2017-N-6381 FDA tab B - Postmarket Safety Reports for NAD - RIA (OMB redline compare 3-18-20 to 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Background Material 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:19:41Z   0 0 09000064848af132
FDA-2017-N-6381-0011 FDA None FDA-2017-N-6381 FDA tab A - Postmarket Safety Reports for NAD - RIA (OMB preliminary 3-18-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Background Material 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:19:22Z   0 0 09000064848ae7c8
FDA-2017-N-6381-0009 FDA None FDA-2017-N-6381 Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Other Memorandum 2020-10-01T04:00:00Z 2020 10 2020-10-01T04:00:00Z   2020-10-01T18:10:24Z   0 0 09000064848ae7c5
FDA-2017-N-6381-0010 FDA None FDA-2017-N-6381 FDA tab A - Postmarket Safety Reports for NAD - Final Rule (2018-333) (OMB preliminary 3-18-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Background Material 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:19:12Z   0 0 09000064848ae7c7
FDA-2017-N-6381-0015 FDA None FDA-2017-N-6381 FDA tab C - Postmarket Safety Reports for NAD - RIA (OMB final 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Letter 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:20:15Z   0 0 09000064848af134
FDA-2017-N-6381-0012 FDA None FDA-2017-N-6381 FDA tab B - Postmarket Safety Reports for NAD - Final Rule (OMB redline compare 3-18-20 and 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Background Material 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:19:30Z   0 0 09000064848af131
FDA-2017-N-6381-0014 FDA None FDA-2017-N-6381 FDA tab C - Postmarket Safety Reports for NAD - Final Rule (2018-333) (OMB final 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) Supporting & Related Material Background Material 2020-10-01T04:00:00Z 2020 10     2020-10-01T18:19:56Z   0 0 09000064848af133
FDA-2017-N-6381-0007 FDA None FDA-2017-N-6381 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction Rule Correction 2020-09-22T04:00:00Z 2020 9 2020-09-22T04:00:00Z   2020-09-22T12:37:08Z 2020-18263 0 0 090000648486e736
FDA-2017-N-6381-0006 FDA None FDA-2017-N-6381 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-08-31T04:00:00Z 2020 8 2020-08-31T04:00:00Z   2020-08-31T12:51:51Z 2020-19092 0 0 090000648482d0bc
FDA-2017-N-6381-0005 FDA None FDA-2017-N-6381 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements Rule Final Rule 2020-07-29T04:00:00Z 2020 7 2020-07-29T04:00:00Z   2020-08-31T17:18:31Z 2020-15441 0 0 09000064847b35cc
FDA-2017-N-6381-0002 FDA None FDA-2017-N-6381 Docket No FDA-2017-N-6381 PRIA - ADE Mandatory Electronic Submission NPRM - Feb 14 2018 Other Report 2018-02-14T05:00:00Z 2018 2 2018-02-14T05:00:00Z   2018-02-14T16:00:16Z   0 0 0900006482f31359
FDA-2017-N-6381-0001 FDA None FDA-2017-N-6381 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-02-14T05:00:00Z 2018 2 2018-02-14T05:00:00Z 2018-05-01T03:59:59Z 2018-04-26T01:05:34Z 2018-02757 0 0 0900006482f30507

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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;