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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-2012-D-0880" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 7

document_type 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2012-D-0880-0036 FDA None FDA-2012-D-0880 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Final Guidance Other Guidance 2023-06-08T04:00:00Z 2023 6 2023-06-08T04:00:00Z   2024-11-11T21:23:32Z   1 0 0900006485ae0c44
FDA-2012-D-0880-0035 FDA None FDA-2012-D-0880 Final Guidance for Industry - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Other Guidance 2022-05-18T04:00:00Z 2022 5 2022-05-18T04:00:00Z   2024-11-07T00:38:54Z   1 0 09000064850894ca
FDA-2012-D-0880-0034 FDA None FDA-2012-D-0880 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Guidance for Industry; Availability Notice Notice of Availability 2022-05-18T04:00:00Z 2022 5 2022-05-18T04:00:00Z   2022-05-18T19:49:37Z 2022-10702 0 0 090000648508897a
FDA-2012-D-0880-0030 FDA None FDA-2012-D-0880 Draft Guidance for Industry - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Other Guidance 2019-11-01T04:00:00Z 2019 11 2019-11-01T04:00:00Z   2024-11-12T23:11:37Z   1 0 09000064841152bd
FDA-2012-D-0880-0029 FDA None FDA-2012-D-0880 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability Notice Notice of Availability 2019-11-01T04:00:00Z 2019 11 2019-11-01T04:00:00Z 2020-01-01T04:59:59Z 2019-12-21T02:01:25Z 2019-23875 0 0 0900006484113ec1
FDA-2012-D-0880-0024 FDA None FDA-2012-D-0880 Draft Guidance for Industry on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Other Guidance 2017-10-30T04:00:00Z 2017 10 2017-10-30T04:00:00Z   2022-05-19T15:23:06Z   0 0 0900006482c22925
FDA-2012-D-0880-0023 FDA None FDA-2012-D-0880 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-10-30T04:00:00Z 2017 10 2017-10-30T04:00:00Z 2017-12-30T04:59:59Z 2017-12-29T02:00:42Z 2017-23526 0 0 0900006482c21d18
FDA-2012-D-0880-0021 FDA None FDA-2012-D-0880 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability Notice Notice of Availability 2017-07-26T04:00:00Z 2017 7 2017-07-26T04:00:00Z   2017-07-26T13:59:13Z 2017-15654 0 0 090000648296a012
FDA-2012-D-0880-0022 FDA None FDA-2012-D-0880 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments Guidance for Industry Other Guidance 2017-07-26T04:00:00Z 2017 7 2017-07-26T04:00:00Z   2024-11-07T01:03:50Z   1 0 090000648296d644
FDA-2012-D-0880-0020 FDA None FDA-2012-D-0880 Final Guidance for Industry Generic Drug User Fee Amendments of 2012 - Questions and Answers Related t User Fee Assessments Other Guidance 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2024-11-07T23:53:21Z   1 0 0900006482409ef4
FDA-2012-D-0880-0018 FDA None FDA-2012-D-0880 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability Notice Notice of Availability 2016-11-18T05:00:00Z 2016 11 2016-11-18T05:00:00Z   2016-11-18T17:35:39Z 2016-27761 0 0 09000064823a05f3
FDA-2012-D-0880-0019 FDA None FDA-2012-D-0880 Draft Guidance for Generic Drug User Fee Amendments of 2012 Questions and Answers Other Guidance 2016-11-18T05:00:00Z 2016 11 2016-11-18T05:00:00Z   2024-11-12T06:16:24Z   1 0 09000064823a0ef6
FDA-2012-D-0880-0009 FDA None FDA-2012-D-0880 Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period Notice General Notice 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2013-12-12T04:59:59Z 2016-11-18T14:46:02Z 2013-28392 0 0 090000648149c2b6
FDA-2012-D-0880-0006 FDA None FDA-2012-D-0880 Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Availability Notice Notice of Availability 2013-09-10T04:00:00Z 2013 9 2013-09-10T04:00:00Z 2013-11-27T04:59:59Z 2016-11-18T14:44:33Z 2013-21891 0 0 09000064813ebe4c
FDA-2012-D-0880-0007 FDA None FDA-2012-D-0880 Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) Other Guidance 2013-09-10T04:00:00Z 2013 9 2013-09-10T04:00:00Z   2024-11-07T22:57:45Z   1 0 09000064813eca54
FDA-2012-D-0880-0001 FDA None FDA-2012-D-0880 Draft Guidances for Industry: Generic Drug User Fee Amendments of 2012, Questions and Answers Notice Notice of Availability 2012-08-27T04:00:00Z 2012 8 2012-08-27T04:00:00Z 2012-10-27T03:59:59Z 2012-10-02T02:01:15Z 2012-20944 0 0 09000064810f2477
FDA-2012-D-0880-0002 FDA None FDA-2012-D-0880 Draft Guidances for Industry: Generic Drug User Fee Amendments of 2012, Questions and Answers Other Guidance 2012-08-27T04:00:00Z 2012 8 2012-08-27T04:00:00Z   2024-11-12T04:51:37Z   1 0 09000064810f272a

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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;