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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

5 rows where docket_id = "FDA-2009-N-0545" 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 4

  • 2023 2
  • 2009 1
  • 2010 1
  • 2022 1

document_type 1

  • Notice 5

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-N-0545-0005 FDA None FDA-2009-N-0545 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Publication 2023-05-04T04:00:00Z 2023 5 2023-05-04T04:00:00Z   2023-05-04T13:46:01Z 2023-09401 0 0 09000064859cab3c
FDA-2009-N-0545-0004 FDA None FDA-2009-N-0545 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing Notice 30 Day Proposed Information Collection 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T14:57:53Z 2023-00013 0 0 090000648559b211
FDA-2009-N-0545-0003 FDA None FDA-2009-N-0545 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing Notice 60 Day Proposed Information Collection 2022-06-17T04:00:00Z 2022 6 2022-06-17T04:00:00Z 2022-08-17T03:59:59Z 2023-01-06T13:44:13Z 2022-13086 0 0 0900006485178d42
FDA-2009-N-0545-0002 FDA None FDA-2009-N-0545 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2010-05-14T04:00:00Z 2010 5     2010-05-14T15:22:56Z 2010-11541 0 0 0900006480aed928
FDA-2009-N-0545-0001 FDA None FDA-2009-N-0545 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2010-01-20T04:59:59Z 2009-11-18T19:42:09Z E9-27716 0 0 0900006480a58fc5

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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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