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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

7 rows where docket_id = "FDA-2011-N-0015" sorted by posted_date descending

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

posted_year 3

  • 2011 3
  • 2017 2
  • 2018 2

document_type 1

  • Notice 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0015-0007 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals; Correction Notice Correction 2018-05-04T04:00:00Z 2018 5 2018-05-04T04:00:00Z   2018-05-04T15:22:09Z 2018-09437 0 0 090000648322b662
FDA-2011-N-0015-0006 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2018-04-09T04:00:00Z 2018 4 2018-04-09T04:00:00Z   2018-04-09T15:53:41Z 2018-07146 0 0 09000064830e0589
FDA-2011-N-0015-0005 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/ Food and Drug Administration Form for Orphan Medicinal Product Designation Notice 30 Day Proposed Information Collection 2017-12-12T05:00:00Z 2017 12 2017-12-12T05:00:00Z 2018-01-12T04:59:59Z 2017-12-12T17:22:33Z 2017-26669 0 0 0900006482cfd0ff
FDA-2011-N-0015-0004 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation Notice 60 Day Proposed Information Collection 2017-06-19T04:00:00Z 2017 6 2017-06-19T04:00:00Z 2017-08-19T03:59:59Z 2017-06-19T13:34:46Z 2017-12620 0 0 09000064826ece9f
FDA-2011-N-0015-0003 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application Form for Orphan Medicinal Product Designation Notice General Notice 2011-11-14T05:00:00Z 2011 11 2011-11-14T05:00:00Z   2011-11-14T14:46:40Z 2011-29296 0 0 0900006480f6bb8e
FDA-2011-N-0015-0002 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Orphan Drugs; Common EMA/FDA Application formfor Orphan Medicinal Product Designation Notice N-Notice 2011-05-13T04:00:00Z 2011 5 2011-05-13T04:00:00Z 2011-06-14T03:59:59Z 2011-05-13T13:18:38Z 2011-11744 0 0 0900006480c79eda
FDA-2011-N-0015-0001 FDA None FDA-2011-N-0015 Agency Information Collection Activities; Proposals, Submissions, and Approvals Form for Orphan Medicinal Product Designation (Form FDA 3671) Notice N-Notice 2011-01-21T05:00:00Z 2011 1 2011-01-21T05:00:00Z 2011-03-23T03:59:59Z 2011-01-21T14:28:36Z 2011-1270 0 0 0900006480bcfb66

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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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