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

9 rows where docket_id = "FDA-2009-N-0458" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-N-0458-0017 FDA None FDA-2009-N-0458 Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-05-01T04:00:00Z 2014 5 2014-05-01T04:00:00Z   2014-05-01T16:06:14Z 2014-09897 0 0 09000064816da467
FDA-2009-N-0458-0018 FDA None FDA-2009-N-0458 Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2014-05-01T04:00:00Z 2014 5 2014-05-01T04:00:00Z   2024-11-07T23:06:35Z   1 0 09000064816dabbc
FDA-2009-N-0458-0016 FDA None FDA-2009-N-0458 Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure. - CLOSED Rule Final Rule 2014-01-10T05:00:00Z 2014 1 2014-01-10T05:00:00Z   2014-01-13T15:21:29Z 2014-00267 0 0 09000064814fa981
FDA-2009-N-0458-0011 FDA None FDA-2009-N-0458 Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure Proposed Rule Supplemental Notice of Proposed Rulemaking (SNPRM) 2013-02-19T05:00:00Z 2013 2 2013-02-19T05:00:00Z 2013-04-23T03:59:59Z 2014-01-13T19:10:40Z 2013-03647 0 0 09000064811fced6
FDA-2009-N-0458-0010 FDA None FDA-2009-N-0458 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information, etc.: Withdrawal Rule NWL-Notice of Withdrawl 2010-07-20T04:00:00Z 2010 7     2011-06-11T16:28:04Z 2010-17617 0 0 0900006480b1cf7d
FDA-2009-N-0458-0004 FDA None FDA-2009-N-0458 Tab A - "Draft Regulatory Action, April 1, 2010" - [OMB Review, Executive Order12866, RPMS Note to the Division of Docket Management, April 19, 2010" - (Medical Device; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure; Direct Final Rule, April 1, 2010) - Reference] Supporting & Related Material REF-Reference (internal unless indicated) 2010-04-30T04:00:00Z 2010 4     2010-04-30T19:27:49Z   0 0 0900006480adc3b1
FDA-2009-N-0458-0003 FDA None FDA-2009-N-0458 OMB Review, Executive Order12866, Regulatory Policy and Management Staff Note to the Division of Docket Management, April 19, 2010" - [Medical Device; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure; Directfinal Rule, April 1, 2010] - Reference Other REF-Reference 2010-04-30T04:00:00Z 2010 4 2010-04-30T04:00:00Z   2010-04-30T19:27:47Z   0 0 0900006480adc3af
FDA-2009-N-0458-0002 FDA None FDA-2009-N-0458 Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease, et al. Rule NFR-Notice of Final Rule 2010-04-01T04:00:00Z 2010 4 2010-04-01T04:00:00Z 2010-06-16T03:59:59Z 2011-06-11T16:28:04Z 2010-07193 0 0 0900006480ace1bb
FDA-2009-N-0458-0001 FDA None FDA-2009-N-0458 Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease, etc. Proposed Rule NPR-Notice of Proposed Rule-Making 2010-04-01T04:00:00Z 2010 4 2010-04-01T04:00:00Z 2010-06-16T03:59:59Z 2011-06-11T16:28:05Z 2010-07192 0 0 0900006480ace1b9

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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;