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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-2020-N-1082" sorted by posted_date descending

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

document_type 3

  • Supporting & Related Material 3
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2020 4
  • 2021 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2020-N-1082-0018 FDA None FDA-2020-N-1082 Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests Rule Final Rule 2021-11-22T05:00:00Z 2021 11 2021-11-22T05:00:00Z   2021-11-22T15:48:14Z 2021-25374 0 0 0900006484e71277
FDA-2020-N-1082-0002 FDA None FDA-2020-N-1082 Reference 5 - Aisyah et al Journal Viral Hep 2018 re Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests Supporting & Related Material Background Material 2020-04-02T04:00:00Z 2020 4     2020-04-02T13:16:28Z   0 0 090000648447e9b0
FDA-2020-N-1082-0003 FDA None FDA-2020-N-1082 Reference 6 - Moorman et al Heptaology 2015 re Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests Supporting & Related Material Background Material 2020-04-02T04:00:00Z 2020 4     2020-04-02T13:17:48Z   0 0 090000648447e9b1
FDA-2020-N-1082-0004 FDA None FDA-2020-N-1082 Reference 7 - Ioannou et al Journal of Hepatology 2018 re Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests Supporting & Related Material Background Material 2020-04-02T04:00:00Z 2020 4     2020-04-02T13:19:37Z   0 0 090000648447e9b2
FDA-2020-N-1082-0001 FDA None FDA-2020-N-1082 Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests Proposed Rule Amendment 2020-04-02T04:00:00Z 2020 4 2020-04-02T04:00:00Z 2020-06-02T03:59:59Z 2020-06-03T01:03:28Z 2020-06821 0 0 090000648448123d

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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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