documents

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

10 rows where docket_id = "FDA-2011-D-0164" sorted by posted_date descending

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posted_year 6

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0164-0014 FDA None FDA-2011-D-0164 Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-09-19T04:00:00Z 2025 9 2025-09-19T04:00:00Z   2025-09-19T17:40:44Z 2025-18152 0 0 09000064b8fba49d
FDA-2011-D-0164-0015 FDA None FDA-2011-D-0164 Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Other Guidance 2025-09-19T04:00:00Z 2025 9 2025-09-19T04:00:00Z 2025-11-19T04:59:59Z 2025-11-19T10:00:08Z   1 0 09000064b8fbdd94
FDA-2011-D-0164-0013 FDA None FDA-2011-D-0164 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-07-11T04:00:00Z 2016 7 2016-07-11T04:00:00Z   2016-07-11T13:45:57Z 2016-16349 0 0 090000648209c0b6
FDA-2011-D-0164-0011 FDA None FDA-2011-D-0164 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-01-20T04:59:59Z 2015-12-18T22:00:50Z 2015-31696 0 0 0900006481db6b0a
FDA-2011-D-0164-0010 FDA None FDA-2011-D-0164 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Safety Labeling Changes— Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2015-09-02T04:00:00Z 2015 9 2015-09-02T04:00:00Z 2015-11-03T04:59:59Z 2015-09-02T13:46:56Z 2015-21645 0 0 0900006481c4f38c
FDA-2011-D-0164-0008 FDA None FDA-2011-D-0164 Guidance for Industry: Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability Notice Notice of Availability 2013-07-30T04:00:00Z 2013 7 2013-07-30T04:00:00Z   2015-08-25T11:00:35Z 2013-18236 0 0 0900006481384e2d
FDA-2011-D-0164-0009 FDA None FDA-2011-D-0164 Guidance for Industry: Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Other Guidance 2013-07-30T04:00:00Z 2013 7 2013-07-30T04:00:00Z   2024-11-07T22:55:35Z   1 0 0900006481385154
FDA-2011-D-0164-0007 FDA None FDA-2011-D-0164 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2012-11-16T05:00:00Z 2012 11 2012-11-16T05:00:00Z 2012-12-18T04:59:59Z 2015-08-25T11:02:16Z 2012-27881 0 0 0900006481169eb1
FDA-2011-D-0164-0002 FDA None FDA-2011-D-0164 Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry Other Guidance 2011-04-13T04:00:00Z 2011 4 2011-04-13T04:00:00Z   2019-10-21T13:35:42Z   0 0 0900006480c2788c
FDA-2011-D-0164-0001 FDA None FDA-2011-D-0164 Draft Guidance for Industry on Safety Labeling Changes; Availability: Implementation of the Federal Food, Drug, and Cosmetic Act Notice Notice of Availability 2011-04-13T04:00:00Z 2011 4 2011-04-13T04:00:00Z 2011-07-13T03:59:59Z 2015-08-25T10:56:27Z 2011-08895 0 0 0900006480c25f86

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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;