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

12 rows where docket_id = "FDA-2013-N-0093" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0093-0016 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2022-10-28T04:00:00Z 2022 10 2022-10-28T04:00:00Z   2022-10-28T18:57:11Z 2022-23510 0 0 0900006485462fa0
FDA-2013-N-0093-0015 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Submissions Notice 30 Day Proposed Information Collection 2022-08-29T04:00:00Z 2022 8 2022-08-29T04:00:00Z 2022-09-29T03:59:59Z 2022-08-29T19:29:38Z 2022-18546 0 0 09000064852853f4
FDA-2013-N-0093-0014 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Proposed Collection; Comment Request; New Molecular Entity New Drug Applications and Original Biologics License Applications Notice 60 Day Proposed Information Collection 2022-03-21T04:00:00Z 2022 3 2022-03-21T04:00:00Z 2022-05-21T03:59:59Z 2022-08-29T19:25:19Z 2022-05814 0 0 0900006484fd6a0a
FDA-2013-N-0093-0013 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Information Collection Request (ICR) 2019-11-07T05:00:00Z 2019 11 2019-11-07T05:00:00Z   2019-11-07T15:05:12Z 2019-24263 0 0 090000648412882c
FDA-2013-N-0093-0012 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act Notice 30 Day Proposed Information Collection 2019-08-19T04:00:00Z 2019 8 2019-08-19T04:00:00Z 2019-09-19T03:59:59Z 2019-08-19T12:57:43Z 2019-17713 0 0 0900006483e6b73f
FDA-2013-N-0093-0011 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Proposed Collection; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act Notice 60 Day Proposed Information Collection 2019-03-12T04:00:00Z 2019 3 2019-03-12T04:00:00Z 2019-05-14T03:59:59Z 2019-07-29T17:42:10Z 2019-04429 0 0 0900006483ad6852
FDA-2013-N-0093-0010 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:47:08Z 2016-30351 0 0 09000064824264d4
FDA-2013-N-0093-0007 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts Notice 30 Day Proposed Information Collection 2016-07-21T04:00:00Z 2016 7 2016-07-21T04:00:00Z 2016-08-23T03:59:59Z 2016-08-23T01:02:01Z 2016-17185 0 0 09000064820db4f9
FDA-2013-N-0093-0006 FDA None FDA-2013-N-0093 Agency Information Collection Activities: Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts Notice 60 Day Proposed Information Collection 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T17:15:29Z 2015-31100 0 0 0900006481d9ab7a
FDA-2013-N-0093-0004 FDA None FDA-2013-N-0093 Meetings: Interim Assessment of the Program for Enhanced Review Transparency and Communication Notice Meeting 2015-04-22T04:00:00Z 2015 4 2015-04-22T04:00:00Z 2015-07-01T03:59:59Z 2015-06-25T01:30:38Z 2015-09300 0 0 0900006481ab3685
FDA-2013-N-0093-0002 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act Notice 30 Day Proposed Information Collection 2013-05-08T04:00:00Z 2013 5 2013-05-08T04:00:00Z   2015-11-19T19:44:10Z 2013-10898 0 0 09000064812c4599
FDA-2013-N-0093-0001 FDA None FDA-2013-N-0093 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act Notice 60 Day Proposed Information Collection 2013-02-19T05:00:00Z 2013 2 2013-02-19T05:00:00Z 2013-04-23T03:59:59Z 2024-11-07T22:49:06Z 2013-03705 1 0 09000064811fd0b1

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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;