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

5 rows where docket_id = "FDA-2019-N-5192" sorted by posted_date descending

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posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-N-5192-0014 FDA None FDA-2019-N-5192 Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests Rule Final Rule 2022-05-16T04:00:00Z 2022 5 2022-05-16T04:00:00Z   2022-05-16T14:35:27Z 2022-10461 0 0 090000648507f151
FDA-2019-N-5192-0003 FDA None FDA-2019-N-5192 Reference 2 - Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies re: Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests Supporting & Related Material Background Material 2020-02-21T05:00:00Z 2020 2     2020-02-24T00:07:58Z   0 0 0900006484399ccf
FDA-2019-N-5192-0004 FDA None FDA-2019-N-5192 Reference 3 - BPAC-07.18.18-07.19.18-Meeting-Issue-Summary-Reclassification-of-HIV-Point-of-Care-and-Laboratory-based-serological-and-NAT-diagnostic-devices re: Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests Supporting & Related Material Background Material 2020-02-21T05:00:00Z 2020 2     2020-02-24T00:10:37Z   0 0 0900006484399cd0
FDA-2019-N-5192-0001 FDA None FDA-2019-N-5192 Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests Proposed Rule Notice of Proposed Rulemaking (NPRM) 2020-02-21T05:00:00Z 2020 2 2020-02-21T05:00:00Z 2020-04-22T03:59:59Z 2020-04-22T01:00:35Z 2020-03515 0 0 0900006484397dd6
FDA-2019-N-5192-0002 FDA None FDA-2019-N-5192 Reference 1 - Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings re: Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests Supporting & Related Material Background Material 2020-02-21T05:00:00Z 2020 2     2020-02-24T00:05:31Z   0 0 0900006484399cce

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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;