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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

8 rows where docket_id = "FDA-2013-N-0579" sorted by posted_date descending

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

posted_year 5

  • 2013 2
  • 2016 2
  • 2019 2
  • 2017 1
  • 2020 1

document_type 1

  • Notice 8

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0579-0010 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-03-17T04:00:00Z 2020 3 2020-03-17T04:00:00Z   2020-03-17T14:24:04Z 2020-05354 0 0 090000648444cc69
FDA-2013-N-0579-0009 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing Notice 30 Day Proposed Information Collection 2019-12-26T05:00:00Z 2019 12 2019-12-26T05:00:00Z 2020-01-28T04:59:59Z 2019-12-26T15:03:34Z 2019-27791 0 0 090000648424ffef
FDA-2013-N-0579-0007 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and TissueBased Deviations in Manufacturing Notice 60 Day Proposed Information Collection 2019-07-31T04:00:00Z 2019 7 2019-07-31T04:00:00Z 2019-10-01T03:59:59Z 2019-12-02T19:43:49Z 2019-16243 0 0 0900006483dd472a
FDA-2013-N-0579-0006 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Publication 2017-05-25T04:00:00Z 2017 5 2017-05-25T04:00:00Z   2017-05-25T15:25:47Z 2017-10736 0 0 0900006482611b62
FDA-2013-N-0579-0005 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing Notice 30 Day Proposed Information Collection 2016-11-14T05:00:00Z 2016 11 2016-11-14T05:00:00Z 2016-12-15T04:59:59Z 2016-11-14T18:27:00Z 2016-27259 0 0 09000064823935bf
FDA-2013-N-0579-0003 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and 3486A Notice 60 Day Proposed Information Collection 2016-06-07T04:00:00Z 2016 6 2016-06-07T04:00:00Z 2016-08-09T03:59:59Z 2016-08-09T01:00:14Z 2016-13366 0 0 0900006482018b27
FDA-2013-N-0579-0002 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Notice 30 Day Proposed Information Collection 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-01-04T04:59:59Z 2013-12-30T02:01:45Z 2013-28990 0 0 09000064814a61ed
FDA-2013-N-0579-0001 FDA None FDA-2013-N-0579 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Notice General Notice 2013-06-05T04:00:00Z 2013 6 2013-06-05T04:00:00Z 2013-08-06T03:59:59Z 2013-06-05T14:27:01Z 2013-13279 0 0 090000648130b88c

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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;
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