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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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