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-2008-N-0334" sorted by posted_date descending

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Suggested facets: title, 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 5

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0334-0017 FDA None FDA-2008-N-0334 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements Notice 30 Day Proposed Information Collection 2018-02-09T05:00:00Z 2018 2 2018-02-09T05:00:00Z 2018-03-13T03:59:59Z 2018-02-12T17:10:31Z 2018-02589 0 0 0900006482f06070
FDA-2008-N-0334-0016 FDA None FDA-2008-N-0334 Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements Notice 60 Day Proposed Information Collection 2017-10-30T04:00:00Z 2017 10 2017-10-30T04:00:00Z 2017-12-30T04:59:59Z 2017-10-30T15:50:49Z 2017-23518 0 0 0900006482c21dfe
FDA-2008-N-0334-0015 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products Rule Final Rule 2015-05-27T04:00:00Z 2015 5 2015-05-27T04:00:00Z   2015-05-27T14:01:38Z 2015-12753 0 0 0900006481b04f02
FDA-2008-N-0334-0014 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections Rule Correction 2014-09-08T04:00:00Z 2014 9 2014-09-08T04:00:00Z   2015-03-08T17:22:10Z 2014-21267 0 0 090000648186336a
FDA-2008-N-0334-0013 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction Rule Correction 2014-09-08T04:00:00Z 2014 9 2014-09-08T04:00:00Z   2015-03-08T17:22:21Z 2014-21266 0 0 09000064818633f4
FDA-2008-N-0334-0012 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction Notice Correction 2014-08-14T04:00:00Z 2014 8 2014-08-14T04:00:00Z   2014-08-14T20:10:01Z 2014-19255 0 0 0900006481822218
FDA-2008-N-0334-0010 FDA None FDA-2008-N-0334 Guidance for Industry Providing Submissions in Electronic Format - Postmarketing Safety Reports-Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements Other Guidance 2014-06-10T04:00:00Z 2014 6 2014-06-10T04:00:00Z   2024-11-11T20:50:51Z   1 0 09000064817358ac
FDA-2008-N-0334-0011 FDA None FDA-2008-N-0334 Reference 1 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Final Rule - Administrative Practices and Procedures; Drugs; Labeling; Medical Devices; Reporting and Recordkeeping Requirements; Confidential Business Information; Over-the-counter Drugs; Biologics Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T15:58:32Z   0 0 09000064817358ae
FDA-2008-N-0334-0009 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements Rule Final Rule 2014-06-10T04:00:00Z 2014 6 2014-06-10T04:00:00Z   2014-06-10T15:52:19Z 2014-13480 0 0 0900006481734bb1
FDA-2008-N-0334-0001 FDA None FDA-2008-N-0334 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements Proposed Rule NPR-Notice of Proposed Rule-Making 2009-08-21T04:00:00Z 2009 8 2009-08-21T04:00:00Z 2009-11-20T04:59:59Z 2011-06-11T16:27:45Z E9-19682 0 0 0900006480a0f0ed

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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;