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

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37 rows where docket_id = "FDA-2010-N-0548" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-N-0548-0200 FDA None FDA-2010-N-0548 Attachment 1 Summary of Recommendations re: Comment from Boehringer Ingelheim Supporting & Related Material Background Material 2017-01-27T05:00:00Z 2017 1     2017-01-27T16:56:28Z   0 0 0900006482499243
FDA-2010-N-0548-0124 FDA None FDA-2010-N-0548 Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period Proposed Rule Extension of Comment Period 2016-10-31T04:00:00Z 2016 10 2016-10-31T04:00:00Z 2017-01-22T04:59:59Z 2017-01-28T02:02:11Z 2016-26244 0 0 090000648235e57d
FDA-2010-N-0548-0122 FDA None FDA-2010-N-0548 Request for Extension from Merck & Co, Inc Other Request for Extension 2016-10-25T04:00:00Z 2016 10 2016-10-25T04:00:00Z   2016-10-25T20:57:02Z   0 0 0900006482345518
FDA-2010-N-0548-0121 FDA None FDA-2010-N-0548 Request for Extension from The International Consortium for Innovation and Quality in Pharmaceutical Development Other Request for Extension 2016-10-25T04:00:00Z 2016 10 2016-10-25T04:00:00Z   2016-10-25T20:49:41Z   0 0 090000648232566a
FDA-2010-N-0548-0118 FDA None FDA-2010-N-0548 Request for extension from Society of Quality Assurance Other Electronic Regulation from Form 2016-10-12T04:00:00Z 2016 10 2016-10-12T04:00:00Z   2016-10-12T17:44:46Z   0 0 090000648229ba88
FDA-2010-N-0548-0119 FDA None FDA-2010-N-0548 Request for extension from PhRMA Other Electronic Regulation from Form 2016-10-12T04:00:00Z 2016 10 2016-10-12T04:00:00Z   2016-10-12T17:47:09Z   0 0 09000064822ecfc6
FDA-2010-N-0548-0116 FDA None FDA-2010-N-0548 Attachment 1 US Census Bureau 2012 Economic Census NAICS Code 541711 re: Comment from Litron Laboratories Supporting & Related Material Background Material 2016-09-28T04:00:00Z 2016 9     2016-09-28T18:25:57Z   0 0 090000648227d131
FDA-2010-N-0548-0117 FDA None FDA-2010-N-0548 Attachment 1 US Census Bureau 2012 Economic Census NAICS Code 541380 re: Comment from Litron Laboratories Supporting & Related Material Background Material 2016-09-28T04:00:00Z 2016 9     2016-09-28T18:27:15Z   0 0 090000648227d132
FDA-2010-N-0548-0090 FDA None FDA-2010-N-0548 Reference 1 - OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:05Z   0 0 090000648219db1c
FDA-2010-N-0548-0113 FDA None FDA-2010-N-0548 PRIA Reference 5 - SBA Table of Small Business Size Standards Matched to North American Industry Classification System Codes, March 26, 2012 re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:32Z   0 0 090000648219db86
FDA-2010-N-0548-0103 FDA None FDA-2010-N-0548 Reference 14 - OECD Series on Principles of GLP and Compliance Monitoring Number 8 (Revised), The Role and Responsibilities of the Study Director in GLP Studies re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:52Z   0 0 090000648219db61
FDA-2010-N-0548-0101 FDA None FDA-2010-N-0548 Reference 12 - Nonclinical Laboratory Studies, Good Laboratory Practice Regulations, Final Rule re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:44Z   0 0 090000648219db5f
FDA-2010-N-0548-0098 FDA None FDA-2010-N-0548 Reference 9 - OECD Series on Principles of GLP and Compliance Monitoring Number 11, The Role and Responsibilities of the Sponsor in the Application of Principles of GLP re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:33Z   0 0 090000648219db5c
FDA-2010-N-0548-0109 FDA None FDA-2010-N-0548 PRIA Reference 1 - EPA Good Laboratory Practice Standards re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:16Z   0 0 090000648219db82
FDA-2010-N-0548-0111 FDA None FDA-2010-N-0548 PRIA Reference 3 - BLS May 2014 National Occupational Employment and Wage Estimates, May 2014 Occupational Employment Statistics re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:24Z   0 0 090000648219db84
FDA-2010-N-0548-0114 FDA None FDA-2010-N-0548 PRIA Reference 6 - U.S. Census Bureau, Industry Statistics for Subsectors and Industries by Employment Size 2007 Economic Census, American FactFinder re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:36Z   0 0 090000648219db87
FDA-2010-N-0548-0093 FDA None FDA-2010-N-0548 Reference 4 - Nonclinical Laboratory Studies; Proposed Regulations for Good Laboratory Practice Regulations re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:16Z   0 0 090000648219db1f
FDA-2010-N-0548-0097 FDA None FDA-2010-N-0548 Reference 8- OECD Series on Principles of GLP and Compliance Monitoring Number 1, The OECD Principles on Good Laboratory Practice re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:29Z   0 0 090000648219db5b
FDA-2010-N-0548-0099 FDA None FDA-2010-N-0548 Reference 10 - International Guiding Principles for Biomedical Research Involving Animals re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:37Z   0 0 090000648219db5d
FDA-2010-N-0548-0095 FDA None FDA-2010-N-0548 Reference 6 - OECD Series on GLP and Compliance Monitoring Number 13, The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:23Z   0 0 090000648219db21
FDA-2010-N-0548-0112 FDA None FDA-2010-N-0548 PRIA Reference 4 - FDA Guidance for Industry GLP Questions and Answers July 2007 re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:29Z   0 0 090000648219db85
FDA-2010-N-0548-0091 FDA None FDA-2010-N-0548 Reference 2 - Mutual Acceptance of Data (MAD) re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:09Z   0 0 090000648219db1d
FDA-2010-N-0548-0094 FDA None FDA-2010-N-0548 Reference 5 - MOU 225-06-4000 MOU Among USDA FDA NIH Concerning Laboratory Animal Welfare re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:20Z   0 0 090000648219db20
FDA-2010-N-0548-0104 FDA None FDA-2010-N-0548 Reference 15 - OECD Series on Principles of GLP and Compliance Monitoring Number 7 (Revised),The Application of the GLP Principles to Short Term Studies re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:56Z   0 0 090000648219db62
FDA-2010-N-0548-0106 FDA None FDA-2010-N-0548 Reference 17-1 - Pesticide Registration Notice 2011-3 - Standard Format for Data Submitted Under FIFRA and Certain Provisions of the FFDCA re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:03Z   0 0 090000648219db7f
FDA-2010-N-0548-0115 FDA None FDA-2010-N-0548 PRIA Reference 7 - Eastern Research Group, Inc., Evaluation of Recordkeeping Costs for Food Manufacturers re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:40Z   0 0 090000648219db88
FDA-2010-N-0548-0102 FDA None FDA-2010-N-0548 Reference 13 - Compliance Policy Guide (CPG 7151.02), Sec. 130.300--FDA Access to Results of Quality Assurance Program Audits and Inspections re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:48Z   0 0 090000648219db60
FDA-2010-N-0548-0108 FDA None FDA-2010-N-0548 Reference 18 - Full Analysis of Economic Impacts (Docket Number FDA-2010-N-0548), Preliminary Regulatory Impact Analysis re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:12Z   0 0 090000648219db81
FDA-2010-N-0548-0110 FDA None FDA-2010-N-0548 PRIA Reference 2 - Organisation for Economic Co-operation and Development (OECD) re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:20Z   0 0 090000648219db83
FDA-2010-N-0548-0096 FDA None FDA-2010-N-0548 Reference 7 - OECD Series on Principles of GLP and Compliance Monitoring Number 4 (Revised), Quality Assurance and GLP re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-30T17:30:34Z   0 0 090000648219db5a
FDA-2010-N-0548-0100 FDA None FDA-2010-N-0548 Reference 11 - Institute for Laboratory Animal Research, Guide for the Care and Use of Laboratory Animals, Eighth Edition re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:41Z   0 0 090000648219db5e
FDA-2010-N-0548-0107 FDA None FDA-2010-N-0548 Reference 17-2 - Study Profile Templates re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:13:08Z   0 0 090000648219db80
FDA-2010-N-0548-0092 FDA None FDA-2010-N-0548 Reference 3 - FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:13Z   0 0 090000648219db1e
FDA-2010-N-0548-0105 FDA None FDA-2010-N-0548 Reference 16 - Bioanalytical Method Validation Draft Guidance for Industry re Good Laboratory Practice for Nonclinical Laboratory Studies Supporting & Related Material Background Material 2016-08-25T04:00:00Z 2016 8     2016-08-25T20:12:59Z   0 0 090000648219db63
FDA-2010-N-0548-0088 FDA None FDA-2010-N-0548 Good Laboratory Practice for Nonclinical Laboratory Studies Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z 2016-11-23T04:59:59Z 2016-11-12T02:00:31Z 2016-19875 0 0 09000064821977f2
FDA-2010-N-0548-0009 FDA None FDA-2010-N-0548 Society of Quality Assurance (SQA) - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2011-02-09T05:00:00Z 2011 2 2011-02-09T05:00:00Z   2013-07-27T23:42:08Z   0 0 0900006480bc902a
FDA-2010-N-0548-0001 FDA None FDA-2010-N-0548 Good Laboratory Practice for Nonclinical Laboratory Studies Proposed Rule NPR-Notice of Proposed Rule-Making 2010-12-21T05:00:00Z 2010 12 2010-12-21T05:00:00Z 2011-02-23T04:59:59Z 2010-12-21T14:18:06Z 2010-31888 0 0 0900006480bbcc10

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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;