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

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33 rows where docket_id = "FDA-2008-N-0326" sorted by posted_date descending

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document_type 3

posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0326-0348 FDA None FDA-2008-N-0326 Reference 12 - New England Journal of Medicine, Mechanism of Disease The New B-Lactamases re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2012-07-04T04:00:00Z 2012 7     2012-07-04T16:54:14Z   0 0 090000648064e653
FDA-2008-N-0326-0346 FDA None FDA-2008-N-0326 References (Pfizer - Comment) re FDA-2008-N-0326-0165 - Background Supporting & Related Material Background Material 2012-07-04T04:00:00Z 2012 7     2012-07-04T15:15:48Z   0 0 0900006480788190
FDA-2008-N-0326-0345 FDA None FDA-2008-N-0326 Office of the Executive Secretariat (OES) Response to Council of State Territorial Epidemiologists (CSTE) - Letter re FDA-2008-N-0326-0333 Other Letter(s) 2012-07-03T04:00:00Z 2012 7     2012-07-04T15:49:08Z   0 0 09000064810121c1
FDA-2008-N-0326-0338 FDA None FDA-2008-N-0326 See FDA-2008-N-0326-0302 Supporting & Related Material Reference (external attachments) 2012-04-18T04:00:00Z 2012 4     2012-04-24T21:16:10Z   0 0 0900006480fd8b41
FDA-2008-N-0326-0333 FDA None FDA-2008-N-0326 See FDA-2008-N-0326-0344 Supporting & Related Material Background Material 2012-03-29T04:00:00Z 2012 3     2012-07-04T15:53:44Z   0 0 0900006480fe3bfb
FDA-2008-N-0326-0269 FDA None FDA-2008-N-0326 American Academy of Pediatrics re FDA-2008-N-0326-0268 Supporting & Related Material Reference (external attachments) 2012-03-06T05:00:00Z 2012 3     2012-03-06T16:28:40Z   0 0 0900006480fcb04e
FDA-2008-N-0326-0283 FDA None FDA-2008-N-0326 The Veterinary Pharmacy (TVP), Inc. - Request for Extension Other Request for Extension 2012-03-06T05:00:00Z 2012 3 2012-01-06T05:00:00Z 2012-03-07T04:59:59Z 2012-03-08T20:13:45Z   0 0 0900006480fcf456
FDA-2008-N-0326-0177 FDA None FDA-2008-N-0326 New Animal Drugs; Orders of Prohibition: Cephalosporin Drugs; Extralabel Animal Drug Use Rule Final Rule 2012-01-06T05:00:00Z 2012 1 2012-01-06T05:00:00Z 2012-03-07T04:59:59Z 2012-07-05T02:01:56Z 2012-00035 0 0 0900006480f8ecbc
FDA-2008-N-0326-0176 FDA None FDA-2008-N-0326 New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal Rule NWL-Notice of Withdrawl 2008-11-26T05:00:00Z 2008 11 2008-11-26T05:00:00Z   2008-12-20T16:26:21Z E8-28093 0 0 09000064807c1087
FDA-2008-N-0326-0172 FDA None FDA-2008-N-0326 Attachment 2 - Executive Summary and Reference List 1-16, 8-41 (Pfizer - Comment) re FDA-2008-N-0326-0165 and FDA-2008-N-0326-0346 Supporting & Related Material Background Material 2008-11-04T05:00:00Z 2008 11     2012-07-04T15:30:52Z   0 0 09000064807940aa
FDA-2008-N-0326-0173 FDA None FDA-2008-N-0326 See FDA-2008-N-0326-0116 (American College of Poultry Veterinarians - Comment) Supporting & Related Material Background Material 2008-11-04T05:00:00Z 2008 11     2012-07-04T17:00:54Z   0 0 0900006480794057
FDA-2008-N-0326-0051 FDA None FDA-2008-N-0326 Sample Write-In Campaign 1 [Multiple Submitters=6] - Form Letter Comment Other FL-Form Letter 2008-08-18T04:00:00Z 2008 8 2008-08-18T04:00:00Z   2012-03-07T17:19:37Z   0 0 09000064806caf24
FDA-2008-N-0326-0049 FDA None FDA-2008-N-0326 New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition; Extension of Comment Period; Delay of Effective Date of Final Rule Rule Delay of Effective Date 2008-08-18T04:00:00Z 2008 8 2008-08-18T04:00:00Z 2008-11-04T04:59:59Z 2012-01-27T23:43:15Z E8-18967 0 0 09000064806ca625
FDA-2008-N-0326-0036 FDA None FDA-2008-N-0326 American Association of Small Ruminant Practitioner - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-08-10T04:00:00Z 2008 8 2008-08-10T04:00:00Z   2008-08-10T22:23:19Z   0 0 09000064806b7ab7
FDA-2008-N-0326-0029 FDA None FDA-2008-N-0326 American Association of Bovine Practitioners - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-08-05T04:00:00Z 2008 8 2008-08-05T04:00:00Z   2013-07-27T22:19:07Z   0 0 090000648068cb7f
FDA-2008-N-0326-0025 FDA None FDA-2008-N-0326 American Association of Bovine Practitioners - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-07-22T04:00:00Z 2008 7 2008-07-22T04:00:00Z   2013-08-11T04:27:03Z   0 0 090000648068d52e
FDA-2008-N-0326-0026 FDA None FDA-2008-N-0326 Pfizer, Inc. - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-07-22T04:00:00Z 2008 7 2008-07-22T04:00:00Z   2013-07-27T22:19:18Z   0 0 090000648068d596
FDA-2008-N-0326-0024 FDA None FDA-2008-N-0326 Animal Health Institute - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-07-22T04:00:00Z 2008 7 2008-07-22T04:00:00Z   2013-07-27T22:18:59Z   0 0 0900006480685084
FDA-2008-N-0326-0023 FDA None FDA-2008-N-0326 American Veterinary Medical Association - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-07-18T04:00:00Z 2008 7 2008-07-18T04:00:00Z   2013-07-27T22:18:53Z   0 0 090000648067ffa0
FDA-2008-N-0326-0001 FDA None FDA-2008-N-0326 New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition Rule NFR-Notice of Final Rule 2008-07-03T04:00:00Z 2008 7 2008-07-03T04:00:00Z 2008-09-04T03:59:59Z 2012-07-05T02:02:01Z E8-15052 0 0 0900006480653961
FDA-2008-N-0326-0008 FDA None FDA-2008-N-0326 Reference 7 - CDC, National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS): Human Isolates Final Report, 2004 re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:56:03Z   0 0 090000648064e468
FDA-2008-N-0326-0011 FDA None FDA-2008-N-0326 Reference 10 - Clinical & Laboratory Standards Institute, Performance Standards for Antimicrobial Susceptibility Testing re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:56:46Z   0 0 090000648064e62b
FDA-2008-N-0326-0004 FDA None FDA-2008-N-0326 Reference 3 - B-Lactam Resistance & B-lactamases in Bacteria of Animal Origin re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:55:08Z   0 0 090000648064e439
FDA-2008-N-0326-0005 FDA None FDA-2008-N-0326 Reference 4 - EARSS Annual Report 2005 Pages 1-147 2006 Bilthoven, The Netherlands, European Antimicrobial Resistance Surveillance System re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:55:22Z   0 0 090000648064e441
FDA-2008-N-0326-0010 FDA None FDA-2008-N-0326 Reference 9 - American Society for Microbiology, B-Lactamaces in Laboratory & Clinical Resistance re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:56:34Z   0 0 090000648064e61f
FDA-2008-N-0326-0014 FDA None FDA-2008-N-0326 List of References re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:57:28Z   0 0 0900006480654597
FDA-2008-N-0326-0009 FDA None FDA-2008-N-0326 Reference 8 - American Society for Microbiology, DNA Sequence Analysis of Regions Surrounding blacmy-2 from Multiple Salmonella Plasmid Backbones re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:56:13Z   0 0 090000648064e603
FDA-2008-N-0326-0002 FDA None FDA-2008-N-0326 Reference 1 - Williams et al Antibiotics in Laboratory Medicine re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:54:43Z   0 0 090000648064e32d
FDA-2008-N-0326-0007 FDA None FDA-2008-N-0326 Reference 6 - CDC Enteric Disease Branch, Animal-to-man Transmission of Antimicrobial-resistant Salmonella: Investigations of United States Outbreaks, 1971-1983 re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:55:50Z   0 0 090000648064e45d
FDA-2008-N-0326-0003 FDA None FDA-2008-N-0326 Reference 2 - US Food & Drug Administration, Maxipime (Cefepime Hydrochloride) for Injection, Powder, For Solution (Bristol-Myers Squibb) re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:54:56Z   0 0 090000648064e42a
FDA-2008-N-0326-0006 FDA None FDA-2008-N-0326 Reference 5 - USDA/ARS National Antimicrobial Resistance Montoring System, Veterinary Isolates Data re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:55:34Z   0 0 090000648064e44b
FDA-2008-N-0326-0012 FDA None FDA-2008-N-0326 Reference 11 - J. of Antimicrobial Chemotherapy, CTX-M: Changing the Face of ESBLs In Europe re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:56:59Z   0 0 090000648064e63a
FDA-2008-N-0326-0013 FDA None FDA-2008-N-0326 Reference 13 - Summary of Data from Hatchery Inspections Conducted September-October, 2001 re New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition, FDA-2008-N-0326-0001 - Background Supporting & Related Material Background Material 2008-07-03T04:00:00Z 2008 7     2012-07-04T16:57:14Z   0 0 090000648064e666

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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;