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

7 rows where docket_id = "FDA-2013-D-0349" 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 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-D-0349-0014 FDA None FDA-2013-D-0349 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-02-15T05:00:00Z 2018 2 2018-02-15T05:00:00Z   2018-02-15T18:00:59Z 2018-03128 0 0 0900006482f35a7e
FDA-2013-D-0349-0013 FDA None FDA-2013-D-0349 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Waiver- Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format Notice 30 Day Proposed Information Collection 2017-08-08T04:00:00Z 2017 8 2017-08-08T04:00:00Z 2017-09-08T03:59:59Z 2017-08-08T13:39:53Z 2017-16647 0 0 09000064829d67e3
FDA-2013-D-0349-0012 FDA None FDA-2013-D-0349 Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format Notice 60 Day Proposed Information Collection 2017-05-23T04:00:00Z 2017 5 2017-05-23T04:00:00Z 2017-07-25T03:59:59Z 2017-05-23T12:28:00Z 2017-10537 0 0 090000648260032f
FDA-2013-D-0349-0011 FDA None FDA-2013-D-0349 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry Other Guidance 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2024-12-20T19:47:11Z   1 0 09000064823c72be
FDA-2013-D-0349-0010 FDA None FDA-2013-D-0349 Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; Availability Notice Notice of Availability 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T15:53:39Z 2016-28606 0 0 09000064823c5f73
FDA-2013-D-0349-0002 FDA None FDA-2013-D-0349 Draft Guidance for Industry; Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format Other Guidance 2013-04-08T04:00:00Z 2013 4 2013-04-08T04:00:00Z   2020-01-08T20:09:47Z   0 0 090000648127fb4e
FDA-2013-D-0349-0001 FDA None FDA-2013-D-0349 Draft Guidance for Industry; Availability: Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format Notice Notice of Availability 2013-04-08T04:00:00Z 2013 4 2013-04-08T04:00:00Z 2013-05-09T03:59:59Z 2013-05-10T01:06:27Z 2013-08014 0 0 090000648127ff9c

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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;