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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

6 rows where docket_id = "FDA-2003-N-0096" sorted by posted_date descending

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

posted_year 3

  • 2003 2
  • 2005 2
  • 2007 2

document_type 2

  • Notice 4
  • Supporting & Related Material 2

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-N-0096-0005 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Guidance for Industry; Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms Supporting & Related Material Guidance 2007-09-07T04:00:00Z 2007 9     2025-06-18T19:52:56Z   0 0 0900006480483927
FDA-2003-N-0096-0006 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 "Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms"; Availability Notice Notice of Data Availability 2007-09-07T04:00:00Z 2007 9 2007-09-07T04:00:00Z   2025-06-18T19:32:10Z E7-17709 0 0 090000648048392a
FDA-2003-N-0096-0004 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability Notice Notice of Data Availability 2005-03-03T05:00:00Z 2005 3 2005-02-24T05:00:00Z 2005-05-26T03:59:59Z 2025-06-18T19:26:25Z 05-3593 0 0 090000648048390b
FDA-2003-N-0096-0003 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Guidance for Industry; Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Draft Guidance Supporting & Related Material Background Material 2005-03-03T05:00:00Z 2005 3     2025-06-18T19:48:43Z   0 0 0900006480483907
FDA-2003-N-0096-0001 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements for Spore-Forming Microorganisms Notice NPR-Notice of Proposed Rule-Making 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-19T09:00:11Z 03-31919 0 0 09000064804838aa
FDA-2003-N-0096-0002 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule Notice Notice of Final Rule 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-18T19:14:55Z 03-31918 0 0 09000064804838f1

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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);
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