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-2012-N-0129" sorted by posted_date descending

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

posted_year 5

document_type 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-N-0129-0014 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants Notice 60 Day Proposed Information Collection 2019-11-22T05:00:00Z 2019 11 2019-11-22T05:00:00Z 2020-01-22T04:59:59Z 2019-11-22T14:28:29Z 2019-25328 0 0 0900006484197e92
FDA-2012-N-0129-0015 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2019-11-22T05:00:00Z 2019 11 2019-11-22T05:00:00Z   2019-11-22T16:45:10Z 2019-07467 0 0 0900006483bad4d0
FDA-2012-N-0129-0013 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 30 Day Proposed Information Collection 2018-11-20T05:00:00Z 2018 11 2018-11-20T05:00:00Z 2018-12-21T04:59:59Z 2018-11-20T14:24:41Z 2018-25232 0 0 09000064838ec50e
FDA-2012-N-0129-0012 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 60 Day Proposed Information Collection 2018-07-03T04:00:00Z 2018 7 2018-07-03T04:00:00Z 2018-09-05T03:59:59Z 2018-07-03T13:13:34Z 2018-14265 0 0 09000064834948fb
FDA-2012-N-0129-0011 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice Notice of Approval 2016-02-02T05:00:00Z 2016 2 2016-02-02T05:00:00Z   2016-02-02T20:22:59Z 2016-01783 0 0 0900006481e44e4f
FDA-2012-N-0129-0010 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 30 Day Proposed Information Collection 2015-07-01T04:00:00Z 2015 7 2015-07-01T04:00:00Z 2015-08-01T03:59:59Z 2015-07-01T14:17:59Z 2015-16128 0 0 0900006481b61af0
FDA-2012-N-0129-0006 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 60 Day Proposed Information Collection 2015-02-03T05:00:00Z 2015 2 2015-02-03T05:00:00Z 2015-04-07T03:59:59Z 2015-04-23T02:01:59Z 2015-02025 0 0 09000064819ef83e
FDA-2012-N-0129-0005 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Submissions for Office of Management and Budget Review, Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 30 Day Proposed Information Collection 2012-05-24T04:00:00Z 2012 5 2012-05-24T04:00:00Z 2012-06-26T03:59:59Z 2015-01-21T17:13:12Z 2012-12591 0 0 090000648101b461
FDA-2012-N-0129-0002 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Correction Notice Correction 2012-02-23T05:00:00Z 2012 2 2012-02-23T05:00:00Z   2015-01-21T17:11:14Z 2012-04168 0 0 0900006480fbeaab
FDA-2012-N-0129-0001 FDA None FDA-2012-N-0129 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 60 Day Proposed Information Collection 2012-02-15T05:00:00Z 2012 2 2012-02-15T05:00:00Z 2012-04-17T03:59:59Z 2015-01-21T17:10:49Z 2012-03548 0 0 0900006480fb7292

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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;