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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

12 rows where docket_id = "FDA-2009-D-0052" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, comment_end_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2018 5
  • 2009 3
  • 2010 2
  • 2020 2

document_type 3

  • Other 6
  • Notice 5
  • Supporting & Related Material 1

agency_id 1

  • FDA 12
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-D-0052-0016 FDA None FDA-2009-D-0052 Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability Notice Notice of Availability 2020-11-13T05:00:00Z 2020 11 2020-11-13T05:00:00Z   2020-11-13T15:21:33Z 2020-25131 0 0 090000648495bcbe
FDA-2009-D-0052-0017 FDA None FDA-2009-D-0052 Documenting Electronic Data Files and Statistical Analysis Programs Guidance for Industry Other Guidance 2020-11-13T05:00:00Z 2020 11 2020-11-13T05:00:00Z   2024-11-06T23:42:31Z   1 0 090000648495cea6
FDA-2009-D-0052-0012 FDA None FDA-2009-D-0052 Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period Notice Extension of Comment Period 2018-07-20T04:00:00Z 2018 7 2018-07-20T04:00:00Z 2018-10-19T03:59:59Z 2018-10-19T01:04:26Z 2018-15568 0 0 09000064835262a7
FDA-2009-D-0052-0011 FDA None FDA-2009-D-0052 Request for Extension from Animal Health Institute Other Request for Extension 2018-07-11T04:00:00Z 2018 7 2018-07-11T04:00:00Z   2018-07-11T20:06:36Z   0 0 09000064834d345c
FDA-2009-D-0052-0010 FDA None FDA-2009-D-0052 Request for Extension from Animal Health Institute (AHI) Other Request for Extension 2018-07-06T04:00:00Z 2018 7 2018-07-06T04:00:00Z   2018-07-06T15:45:08Z   0 0 09000064834b606e
FDA-2009-D-0052-0006 FDA None FDA-2009-D-0052 Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-05-21T04:00:00Z 2018 5 2018-05-21T04:00:00Z 2018-10-19T03:59:59Z 2018-07-20T16:08:50Z 2018-10722 0 0 09000064832a0d5f
FDA-2009-D-0052-0007 FDA None FDA-2009-D-0052 CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs Other Guidance 2018-05-21T04:00:00Z 2018 5 2018-05-21T04:00:00Z   2024-11-07T01:26:25Z   1 0 09000064832a2f35
FDA-2009-D-0052-0005 FDA None FDA-2009-D-0052 Guidance for Industry Documenting Statistical Analysis Programs and Data Files Other Guidance 2010-05-05T04:00:00Z 2010 5 2010-05-05T04:00:00Z   2024-11-12T04:51:42Z   1 0 0900006480ae69ef
FDA-2009-D-0052-0004 FDA None FDA-2009-D-0052 Guidance for Industry: Documenting Statistical Analysis Programs and Data Files; Availability Notice NAD-Notice of Availability of Data 2010-05-05T04:00:00Z 2010 5 2010-05-05T04:00:00Z   2018-03-23T12:16:53Z 2010-10582 0 0 0900006480ae7114
FDA-2009-D-0052-0003 FDA None FDA-2009-D-0052 Documenting Statistical Analysis Programs and Data Files Other GDL-Guidance (Supporting and Related Materials) 2009-04-27T04:00:00Z 2009 4 2009-04-27T04:00:00Z   2013-08-11T04:33:01Z   0 0 090000648096d40e
FDA-2009-D-0052-0001 FDA None FDA-2009-D-0052 Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability Notice Notice of Availability 2009-03-16T04:00:00Z 2009 3 2009-03-16T04:00:00Z 2009-06-02T03:59:59Z 2018-03-23T12:07:57Z E9-05650 0 0 0900006480914734
FDA-2009-D-0052-0002 FDA None FDA-2009-D-0052 See FDA-2009-D-0052-0003 Supporting & Related Material   2009-03-16T00:00:00Z 2009 3     2009-04-27T17:15:05Z   0 1 09000064809147c3

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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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