documents

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-2022-D-3054" sorted by posted_date descending

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

posted_year 2

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-D-3054-0032 FDA None FDA-2022-D-3054 M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP) - Draft Guidance Other Guidance 2025-06-06T04:00:00Z 2025 6 2025-06-06T04:00:00Z 2025-07-08T03:59:59Z 2025-07-08T09:00:22Z   1 0 09000064b8dda25b
FDA-2022-D-3054-0033 FDA None FDA-2022-D-3054 M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) - Draft Guidance Other Guidance 2025-06-06T04:00:00Z 2025 6 2025-06-06T04:00:00Z 2025-07-08T03:59:59Z 2025-06-06T16:59:36Z   1 0 09000064b8dddc34
FDA-2022-D-3054-0031 FDA None FDA-2022-D-3054 M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability Notice Notice of Availability 2025-06-06T04:00:00Z 2025 6 2025-06-06T04:00:00Z   2025-06-06T16:41:44Z 2025-10359 0 0 09000064b8dddb6a
FDA-2022-D-3054-0001 FDA None FDA-2022-D-3054 M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability Notice Notice of Availability 2022-12-22T05:00:00Z 2022 12     2022-12-22T14:20:38Z 2022-27832 0 0 090000648554d5cb
FDA-2022-D-3054-0004 FDA None FDA-2022-D-3054 M11 TEMPLATE: CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP); Draft Guidance Other Guidance 2022-12-22T05:00:00Z 2022 12 2022-12-22T05:00:00Z 2023-02-22T04:59:59Z 2025-07-09T09:00:26Z   0 0 090000648554d81b
FDA-2022-D-3054-0002 FDA None FDA-2022-D-3054 M11 CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL; (CESHARP); Draft Guidance Other Guidance 2022-12-22T05:00:00Z 2022 12 2022-12-22T05:00:00Z 2023-02-22T04:59:59Z 2025-07-09T09:00:26Z   1 0 090000648554d819
FDA-2022-D-3054-0003 FDA None FDA-2022-D-3054 M11 TECHNICAL SPRECIFICATION: CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP); Draft Guidance Other Guidance 2022-12-22T05:00:00Z 2022 12 2022-12-22T05:00:00Z 2023-02-22T04:59:59Z 2025-07-09T09:00:26Z   0 0 090000648554cffe

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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;