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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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21 rows where docket_id = "FDA-2012-D-0530" sorted by posted_date descending

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posted_year 9

document_type 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-D-0530-0039 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Publication 2023-05-04T04:00:00Z 2023 5 2023-05-04T04:00:00Z   2023-05-04T13:44:30Z 2023-09401 0 0 09000064859ca72a
FDA-2012-D-0530-0038 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices Notice 30 Day Proposed Information Collection 2022-12-22T05:00:00Z 2022 12 2022-12-22T05:00:00Z 2023-01-24T04:59:59Z 2022-12-22T14:51:41Z 2022-27815 0 0 090000648554d616
FDA-2012-D-0530-0037 FDA None FDA-2012-D-0530 EPFP OverviewDocument Template Supporting & Related Material Background Material 2022-08-09T04:00:00Z 2022 8     2022-08-09T20:33:26Z   0 0 090000648522a964
FDA-2012-D-0530-0036 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission Program for Medical Devices Notice 60 Day Proposed Information Collection 2022-08-09T04:00:00Z 2022 8 2022-08-09T04:00:00Z 2022-10-12T03:59:59Z 2022-12-22T14:51:20Z 2022-17058 0 0 09000064852266f0
FDA-2012-D-0530-0035 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-01-30T05:00:00Z 2020 1 2020-01-30T05:00:00Z   2020-01-30T17:36:40Z 2020-01655 0 0 090000648430cf52
FDA-2012-D-0530-0033 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices Notice 30 Day Proposed Information Collection 2019-11-15T05:00:00Z 2019 11 2019-11-15T05:00:00Z 2019-12-17T04:59:59Z 2019-11-16T02:03:08Z 2019-24803 0 0 0900006484161392
FDA-2012-D-0530-0032 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission Program for Medical Devices Notice 60 Day Proposed Information Collection 2019-08-13T04:00:00Z 2019 8 2019-08-13T04:00:00Z 2019-10-12T03:59:59Z 2019-08-20T13:06:32Z 2019-17345 0 0 0900006483e3c11b
FDA-2012-D-0530-0031 FDA None FDA-2012-D-0530 Guidance for Industry on Requests for Feedback on Medical Device Submissions The Pre-Submission Program and Meetings with Food and Drug Administration Staff Other Guidance 2017-10-03T04:00:00Z 2017 10 2017-10-03T04:00:00Z   2024-11-07T01:17:02Z   1 0 0900006482b95aad
FDA-2012-D-0530-0030 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2017-05-30T04:00:00Z 2017 5 2017-05-30T04:00:00Z   2017-05-30T14:41:21Z 2017-11011 0 0 09000064826680d8
FDA-2012-D-0530-0029 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pre-Submission Program for Medical Devices Notice 30 Day Proposed Information Collection 2016-10-20T04:00:00Z 2016 10 2016-10-20T04:00:00Z 2016-11-22T04:59:59Z 2016-10-20T13:15:20Z 2016-25359 0 0 090000648232063e
FDA-2012-D-0530-0028 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices Notice 60 Day Proposed Information Collection 2016-07-28T04:00:00Z 2016 7 2016-07-28T04:00:00Z 2016-09-27T03:59:59Z 2016-07-28T13:45:00Z 2016-17802 0 0 09000064821349fc
FDA-2012-D-0530-0026 FDA None FDA-2012-D-0530 Request for Expressions of Interest From Coverage Organizations; Coverage Organizations Interested in Providing Input Regarding Private Payer Coverage to Medical Device Sponsors Who Request Their Participation in a Pre-Submission Meeting With the Food and Drug Administration Notice General Notice 2016-02-24T05:00:00Z 2016 2 2016-02-24T05:00:00Z   2016-02-24T17:16:45Z 2016-03909 0 0 0900006481e837da
FDA-2012-D-0530-0027 FDA None FDA-2012-D-0530 Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff Other Guidance 2016-02-24T05:00:00Z 2016 2 2016-02-24T05:00:00Z   2016-03-01T14:57:32Z   0 0 0900006481e84b42
FDA-2012-D-0530-0025 FDA None FDA-2012-D-0530 Requests for Feedback on Medical Device Submissions: The Pre- Submission Program and Meetings With Food and Drug Administration Staff; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2014-02-18T05:00:00Z 2014 2 2014-02-18T05:00:00Z   2024-11-11T20:49:10Z   1 0 0900006481578a5a
FDA-2012-D-0530-0024 FDA None FDA-2012-D-0530 Requests for Feedback on Medical Device Submissions: The Pre- Submission Program and Meetings With Food and Drug Administration Staff; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-02-18T05:00:00Z 2014 2 2014-02-18T05:00:00Z   2015-11-12T13:09:11Z 2014-03453 0 0 0900006481576953
FDA-2012-D-0530-0023 FDA None FDA-2012-D-0530 Agency Information Collection ctivities; Announcement of Office of Management and Budget Approval; equests for Feedback on Medical Device Submissions Notice Notice of Approval 2014-01-23T05:00:00Z 2014 1 2014-01-23T05:00:00Z   2015-11-12T13:07:43Z 2014-01311 0 0 090000648151ce06
FDA-2012-D-0530-0022 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings with FDA Staff Notice 60 Day Proposed Information Collection 2013-10-31T04:00:00Z 2013 10 2013-10-31T04:00:00Z   2015-11-12T13:06:43Z 2013-25964 0 0 090000648146a1b7
FDA-2012-D-0530-0021 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Submission for Office of Management and Budge Review; Comment Request; Guidance on Medical Devices; Pre-Submission Program and Meetings with FDA Staff; Withdrawal Notice Withdrawal 2013-01-07T05:00:00Z 2013 1 2013-01-07T05:00:00Z   2015-11-12T13:05:14Z 2013-00009 0 0 09000064811aa8e8
FDA-2012-D-0530-0019 FDA None FDA-2012-D-0530 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on Medical Devices; Pre-Submission Program and Meetings with FDA Staff Notice 30 Day Proposed Information Collection 2012-12-11T05:00:00Z 2012 12 2012-12-11T05:00:00Z 2013-01-11T04:59:59Z 2015-11-12T13:04:02Z 2012-29788 0 0 090000648118589b
FDA-2012-D-0530-0001 FDA None FDA-2012-D-0530 Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability Notice Notice of Availability 2012-07-13T04:00:00Z 2012 7 2012-07-13T04:00:00Z 2012-10-12T03:59:59Z 2012-11-30T21:20:01Z 2012-17078 0 0 09000064810934d0
FDA-2012-D-0530-0002 FDA None FDA-2012-D-0530 Draft Guidance for Industry and Food and Drug Administration Staff Medical Devices The Pre-Submission Program and Meetings with FDA Staff Other Guidance 2012-07-13T04:00:00Z 2012 7 2012-07-13T04:00:00Z 2012-10-12T03:59:59Z 2012-10-12T02:02:03Z   0 0 0900006481094e0c

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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;