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-2011-D-0597" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

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 7

document_type 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0597-0063 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2019-09-12T04:00:00Z 2019 9 2019-09-12T04:00:00Z   2022-11-22T18:59:39Z 2019-19779 0 0 0900006483f49943
FDA-2011-D-0597-0062 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring Notice 30 Day Proposed Information Collection 2019-04-16T04:00:00Z 2019 4 2019-04-16T04:00:00Z 2019-05-17T03:59:59Z 2019-04-16T14:12:14Z 2019-07523 0 0 0900006483bac96d
FDA-2011-D-0597-0060 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring Notice 60 Day Proposed Information Collection 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2022-11-22T18:59:11Z 2018-26032 0 0 0900006483915d45
FDA-2011-D-0597-0059 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-07-11T04:00:00Z 2016 7 2016-07-11T04:00:00Z   2016-07-11T13:40:56Z 2016-16349 0 0 090000648209c0b5
FDA-2011-D-0597-0058 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring Notice 30 Day Proposed Information Collection 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-01-20T04:59:59Z 2015-12-17T14:54:03Z 2015-31695 0 0 0900006481db6a1d
FDA-2011-D-0597-0055 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring Notice 60 Day Proposed Information Collection 2015-07-14T04:00:00Z 2015 7 2015-07-14T04:00:00Z 2015-09-15T03:59:59Z 2015-09-12T01:30:55Z 2015-17318 0 0 0900006481b82f1c
FDA-2011-D-0597-0053 FDA None FDA-2011-D-0597 Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring Other Guidance 2013-08-07T04:00:00Z 2013 8 2013-08-07T04:00:00Z   2024-11-07T22:58:12Z   1 0 0900006481395793
FDA-2011-D-0597-0052 FDA None FDA-2011-D-0597 Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring; Availability Notice Notice of Availability 2013-08-07T04:00:00Z 2013 8 2013-08-07T04:00:00Z   2015-07-07T16:52:03Z 2013-19004 0 0 0900006481394d5e
FDA-2011-D-0597-0050 FDA None FDA-2011-D-0597 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance for Industry; Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring Notice 30 Day Proposed Information Collection 2012-09-25T04:00:00Z 2012 9 2012-09-25T04:00:00Z 2012-10-26T03:59:59Z 2015-07-07T16:54:15Z 2012-23545 0 0 090000648112654c
FDA-2011-D-0597-0001 FDA None FDA-2011-D-0597 Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring Notice Notice of Availability 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z 2011-11-29T04:59:59Z 2011-08-29T14:24:36Z 2011-21972 0 0 0900006480f07901
FDA-2011-D-0597-0002 FDA None FDA-2011-D-0597 Draft Guidance for Industry; Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring Other Guidance 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2019-10-21T13:49:09Z   0 0 0900006480f07410

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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;