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-2013-N-0080" sorted by posted_date descending

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

document_type 4

posted_year 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0080-0016 FDA None FDA-2013-N-0080 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-06-19T04:00:00Z 2018 6 2018-06-19T04:00:00Z   2018-06-19T18:42:13Z 2018-13098 0 0 090000648342fb0e
FDA-2013-N-0080-0015 FDA None FDA-2013-N-0080 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Rule Final Rule 2018-02-21T05:00:00Z 2018 2 2018-02-21T05:00:00Z   2018-02-21T14:26:29Z 2018-03244 0 0 0900006482f4ca35
FDA-2013-N-0080-0017 FDA None FDA-2013-N-0080 Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2018-02-21T05:00:00Z 2018 2 2018-02-21T05:00:00Z   2024-11-12T23:18:55Z   1 0 09000064843fe841
FDA-2013-N-0080-0014 FDA None FDA-2013-N-0080 Minutes of Meeting between FDA and AdvaMed, Marh 3, 2014 Other Minutes 2014-04-10T04:00:00Z 2014 4 2014-04-10T04:00:00Z   2014-04-10T15:55:23Z   0 0 09000064816addac
FDA-2013-N-0080-0001 FDA None FDA-2013-N-0080 Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-02-25T05:00:00Z 2013 2 2013-02-25T05:00:00Z 2013-05-29T03:59:59Z 2014-01-14T13:16:22Z 2013-04201 0 0 0900006481206965

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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;