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

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11 rows where agency_id = "FDA" and docket_id = "FDA-2013-N-1428" sorted by posted_date descending

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Suggested facets: 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 6

document_type 2

agency_id 1

  • FDA · 11 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-1428-0023 FDA None FDA-2013-N-1428 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-04-08T04:00:00Z 2020 4 2020-04-08T04:00:00Z   2020-04-08T17:11:50Z 2020-01655 0 0 090000648430cc83
FDA-2013-N-1428-0022 FDA None FDA-2013-N-1428 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2019-10-10T04:00:00Z 2019 10 2019-10-10T04:00:00Z 2019-11-13T04:59:59Z 2019-10-10T14:02:43Z 2019-22189 0 0 090000648407778c
FDA-2013-N-1428-0021 FDA None FDA-2013-N-1428 Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2019-07-17T04:00:00Z 2019 7 2019-07-17T04:00:00Z 2019-09-17T03:59:59Z 2019-07-17T12:25:22Z 2019-15124 0 0 0900006483d98dc0
FDA-2013-N-1428-0020 FDA None FDA-2013-N-1428 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Publication 2017-05-25T04:00:00Z 2017 5 2017-05-25T04:00:00Z   2017-05-25T15:14:06Z 2017-10711 0 0 09000064826103b1
FDA-2013-N-1428-0019 FDA None FDA-2013-N-1428 Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Other Guidance 2017-01-03T05:00:00Z 2017 1 2017-01-03T05:00:00Z   2024-11-12T06:16:20Z   1 0 0900006482446bec
FDA-2013-N-1428-0018 FDA None FDA-2013-N-1428 Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice Notice of Availability 2017-01-03T05:00:00Z 2017 1 2017-01-03T05:00:00Z   2017-01-03T15:18:44Z 2016-31789 0 0 0900006482445e5f
FDA-2013-N-1428-0016 FDA None FDA-2013-N-1428 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Electronic Drug Product Reporting of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2016-08-01T04:00:00Z 2016 8 2016-08-01T04:00:00Z 2016-09-01T03:59:59Z 2016-08-30T01:00:19Z 2016-18048 0 0 0900006482145578
FDA-2013-N-1428-0011 FDA None FDA-2013-N-1428 Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Revised Draft Guidance Other Guidance 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z   2024-11-11T20:55:17Z   1 0 0900006481941993
FDA-2013-N-1428-0010 FDA None FDA-2013-N-1428 Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance Notice Notice of Availability 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z 2015-01-24T04:59:59Z 2019-07-17T12:23:03Z 2014-27691 0 0 09000064819413b6
FDA-2013-N-1428-0002 FDA None FDA-2013-N-1428 Guidance for Industry Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Other Guidance 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z   2024-11-12T05:23:40Z   1 0 09000064814a6674
FDA-2013-N-1428-0001 FDA None FDA-2013-N-1428 Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability Notice Notice of Availability 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-02-04T04:59:59Z 2019-07-17T12:21:27Z 2013-28960 0 0 09000064814a6172

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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;