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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

8 rows where docket_id = "FDA-2011-N-0085" sorted by posted_date descending

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

posted_year 5

  • 2011 2
  • 2014 2
  • 2018 2
  • 2012 1
  • 2017 1

document_type 1

  • Notice 8

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0085-0009 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-06-08T04:00:00Z 2018 6 2018-06-08T04:00:00Z   2018-06-08T12:41:35Z 2018-12338 0 0 090000648337b834
FDA-2011-N-0085-0007 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice 30 Day Proposed Information Collection 2018-01-10T05:00:00Z 2018 1 2018-01-10T05:00:00Z 2018-02-10T04:59:59Z 2018-02-10T02:01:14Z 2018-00238 0 0 0900006482dd3829
FDA-2011-N-0085-0006 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice 60 Day Proposed Information Collection 2017-08-07T04:00:00Z 2017 8 2017-08-07T04:00:00Z 2017-10-07T03:59:59Z 2017-08-07T14:40:35Z 2017-16564 0 0 09000064829c55ff
FDA-2011-N-0085-0005 FDA None FDA-2011-N-0085 Agency Information Collection Activities Submission for Office of Management and Budget Review Comment Request Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Notice 30 Day Proposed Information Collection 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z 2015-01-21T04:59:59Z 2014-12-18T16:15:06Z 2014-29611 0 0 0900006481982302
FDA-2011-N-0085-0004 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice General Notice 2014-07-07T04:00:00Z 2014 7 2014-07-07T04:00:00Z 2014-09-06T03:59:59Z 2014-07-07T14:31:08Z 2014-15810 0 0 090000648179245b
FDA-2011-N-0085-0003 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cooperative Manufacturing Arrangements for Licensed Biologics Notice Notice of Approval 2012-03-13T04:00:00Z 2012 3 2012-03-13T04:00:00Z   2012-03-13T14:14:35Z 2012-06021 0 0 0900006480fd5dfe
FDA-2011-N-0085-0002 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cooperative Manufacturing Arrangements for Licensed Biologics Notice General Notice 2011-08-08T04:00:00Z 2011 8 2011-08-08T04:00:00Z 2011-09-08T03:59:59Z 2012-03-24T19:28:44Z 2011-19958 0 0 0900006480ed9ec2
FDA-2011-N-0085-0001 FDA None FDA-2011-N-0085 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics Notice N-Notice 2011-03-16T04:00:00Z 2011 3 2011-03-16T04:00:00Z 2011-05-17T03:59:59Z 2011-03-16T15:50:51Z 2011-06055 0 0 0900006480c08d42

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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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