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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

9 rows where agency_id = "FDA" and docket_id = "FDA-2011-N-0908" 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

  • 2018 4
  • 2015 2
  • 2011 1
  • 2012 1
  • 2016 1

document_type 2

  • Notice 8
  • Other 1

agency_id 1

  • FDA · 9 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0908-0009 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-11-13T05:00:00Z 2018 11 2018-11-13T05:00:00Z   2018-11-13T21:20:00Z 2018-24609 0 0 09000064838cf565
FDA-2011-N-0908-0007 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice 30 Day Proposed Information Collection 2018-09-12T04:00:00Z 2018 9 2018-09-12T04:00:00Z 2018-10-13T03:59:59Z 2018-09-12T13:24:03Z 2018-19799 0 0 09000064836df350
FDA-2011-N-0908-0008 FDA None FDA-2011-N-0908 0581 GFI for Clinical Trial Sponsors Other Guidance 2018-09-12T04:00:00Z 2018 9 2018-09-12T04:00:00Z   2024-11-07T01:37:49Z   1 0 09000064836e3e05
FDA-2011-N-0908-0006 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice 60 Day Proposed Information Collection 2018-05-31T04:00:00Z 2018 5 2018-05-31T04:00:00Z 2018-07-31T03:59:59Z 2018-05-31T14:59:03Z 2018-11647 0 0 0900006483315f9e
FDA-2011-N-0908-0005 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice Notice of Approval 2016-02-02T05:00:00Z 2016 2 2016-02-02T05:00:00Z   2016-02-02T15:17:57Z 2016-01781 0 0 0900006481e44e57
FDA-2011-N-0908-0004 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice 30 Day Proposed Information Collection 2015-09-09T04:00:00Z 2015 9 2015-09-09T04:00:00Z 2015-10-10T03:59:59Z 2015-09-09T14:53:20Z 2015-22680 0 0 0900006481c61b0b
FDA-2011-N-0908-0003 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice 60 Day Proposed Information Collection 2015-03-27T04:00:00Z 2015 3 2015-03-27T04:00:00Z 2015-05-27T03:59:59Z 2015-03-27T15:36:51Z 2015-07009 0 0 0900006481a6c227
FDA-2011-N-0908-0002 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clincal Trail Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice General Notice 2012-04-20T04:00:00Z 2012 4     2012-04-20T13:09:41Z 2012-09533 0 0 0900006480ff4c12
FDA-2011-N-0908-0001 FDA None FDA-2011-N-0908 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice General Notice 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z 2012-02-22T04:59:59Z 2011-12-22T17:04:41Z 2011-32776 0 0 0900006480f87d15

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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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