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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

6 rows where docket_id = "FDA-2011-N-0915" sorted by posted_date descending

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

posted_year 5

  • 2015 2
  • 2011 1
  • 2012 1
  • 2016 1
  • 2018 1

document_type 1

  • Notice 6

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0915-0007 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Notice 60 Day Proposed Information Collection 2018-08-15T04:00:00Z 2018 8 2018-08-15T04:00:00Z 2018-10-16T03:59:59Z 2018-10-17T01:01:01Z 2018-17526 0 0 090000648362232f
FDA-2011-N-0915-0006 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Notice Notice of Approval 2016-02-03T05:00:00Z 2016 2 2016-02-03T05:00:00Z   2016-02-03T15:15:15Z 2016-01885 0 0 0900006481e49f43
FDA-2011-N-0915-0004 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Notice 30 Day Proposed Information Collection 2015-06-25T04:00:00Z 2015 6 2015-06-25T04:00:00Z 2015-07-28T03:59:59Z 2015-06-25T13:48:52Z 2015-15638 0 0 0900006481b54bc8
FDA-2011-N-0915-0003 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Notice 60 Day Proposed Information Collection 2015-01-23T05:00:00Z 2015 1 2015-01-23T05:00:00Z 2015-03-25T03:59:59Z 2015-03-24T02:04:49Z 2015-01111 0 0 09000064819db747
FDA-2011-N-0915-0002 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Submissions for Office Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Notice General Notice 2012-05-24T04:00:00Z 2012 5     2012-05-24T15:47:25Z 2012-12589 0 0 090000648101b320
FDA-2011-N-0915-0001 FDA None FDA-2011-N-0915 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products, etc. Notice General Notice 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z 2012-02-28T04:59:59Z 2011-12-27T16:45:58Z 2011-33140 0 0 0900006480f89156

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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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