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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

4 rows where docket_id = "FDA-2015-D-4386" sorted by posted_date descending

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Suggested facets: 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 2

  • 2015 2
  • 2017 2

document_type 2

  • Notice 2
  • Other 2

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-4386-0010 FDA None FDA-2015-D-4386 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability Notice Notice of Availability 2017-09-07T04:00:00Z 2017 9 2017-09-07T04:00:00Z   2017-09-07T13:48:59Z 2017-18737 0 0 0900006482b131fd
FDA-2015-D-4386-0011 FDA None FDA-2015-D-4386 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Guidance for Industry Other Guidance 2017-09-07T04:00:00Z 2017 9 2017-09-07T04:00:00Z   2024-11-07T01:11:02Z   1 0 0900006482b13dfd
FDA-2015-D-4386-0002 FDA None FDA-2015-D-4386 Draft Guidance for Industry Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Other Guidance 2015-12-24T05:00:00Z 2015 12 2015-12-24T05:00:00Z   2024-11-11T21:17:36Z   1 0 0900006481dd0460
FDA-2015-D-4386-0001 FDA None FDA-2015-D-4386 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-24T05:00:00Z 2015 12 2015-12-24T05:00:00Z 2016-03-24T03:59:59Z 2016-03-22T18:00:26Z 2015-32323 0 0 0900006481dd00d7

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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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