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

11 rows where docket_id = "FDA-2016-N-0543" sorted by posted_date descending

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

posted_year 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0543-0013 FDA None FDA-2016-N-0543 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Rule Direct Final Rule 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z   2016-11-23T14:57:20Z 2016-28120 0 0 09000064823b9aa7
FDA-2016-N-0543-0014 FDA None FDA-2016-N-0543 Nonprescription Sunscreen Drug Products  Format and Content of Data Submissions Guidance for Industry Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:35:30Z   0 0 09000064823ba8d7
FDA-2016-N-0543-0006 FDA None FDA-2016-N-0543 Reference 4 Content and Format of Sunscreen Data Submissions Draft Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:46:52Z   0 0 0900006481f0eaca
FDA-2016-N-0543-0007 FDA None FDA-2016-N-0543 Reference 5 - A FDA Track re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:48:38Z   0 0 0900006481f0eacb
FDA-2016-N-0543-0005 FDA None FDA-2016-N-0543 Reference 3 2009 GAO Report on Federal Rulemaking re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:43:10Z   0 0 0900006481f0eac9
FDA-2016-N-0543-0004 FDA None FDA-2016-N-0543 Reference 2 OFR Guide to the Rulemaking Process re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:41:15Z   0 0 0900006481f0eac8
FDA-2016-N-0543-0008 FDA None FDA-2016-N-0543 Reference 5B Sunscreen Innovation Act (SIA) Website re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:53:11Z   0 0 0900006481f0eacc
FDA-2016-N-0543-0001 FDA None FDA-2016-N-0543 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Proposed Rule Amendment 2016-04-04T04:00:00Z 2016 4 2016-04-04T04:00:00Z 2016-06-04T03:59:59Z 2016-05-28T20:55:03Z 2016-07612 0 0 0900006481f2331f
FDA-2016-N-0543-0002 FDA None FDA-2016-N-0543 References List for Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:32:46Z   0 0 0900006481f24068
FDA-2016-N-0543-0003 FDA None FDA-2016-N-0543 Reference 1 TEA Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:41:41Z   0 0 0900006481f0eac7
FDA-2016-N-0543-0009 FDA None FDA-2016-N-0543 Reference 5C - Rulemaking History for OTC Time and Extent Applications re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Supporting & Related Material Background Material 2016-04-04T04:00:00Z 2016 4     2016-04-04T14:57:06Z   0 0 0900006481f0eacd

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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;