{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2000-N-0108\" sorted by posted_date descending", "rows": [["FDA-2000-N-0108-0071", "FDA", "FDA-2000-N-0108", "Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products: Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans", "Rule", "Final Rule", "2010-09-29T04:00:00Z", 2010, 9, "2010-09-29T04:00:00Z", null, "2016-02-24T19:19:31Z", "2010-24296", 0, 0, "0900006480b63055"], ["FDA-2000-N-0108-0075", "FDA", "FDA-2000-N-0108", "Reference 5.  U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]", "Supporting & Related Material", "BKG-Background Material", "2010-09-29T04:00:00Z", 2010, 9, null, null, "2010-09-29T15:15:36Z", null, 0, 0, "0900006480b627cb"], ["FDA-2000-N-0108-0074", "FDA", "FDA-2000-N-0108", "Reference 4.  Occupational Employment and Wage Estimates  May 2008  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]", "Supporting & Related Material", "BKG-Background Material", "2010-09-29T04:00:00Z", 2010, 9, null, null, "2010-09-29T15:13:46Z", null, 0, 0, "0900006480b627c7"], ["FDA-2000-N-0108-0072", "FDA", "FDA-2000-N-0108", "List of References re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule", "Supporting & Related Material", "List", "2010-09-29T04:00:00Z", 2010, 9, null, null, "2016-02-25T15:38:49Z", null, 0, 0, "0900006480b62025"], ["FDA-2000-N-0108-0073", "FDA", "FDA-2000-N-0108", "Reference 1.  \"Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising From Clinical Trials on Medicinal Products for Human Use\" [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]", "Supporting & Related Material", "BKG-Background Material", "2010-09-29T04:00:00Z", 2010, 9, null, null, "2010-09-29T15:03:54Z", null, 0, 0, "0900006480b62574"], ["FDA-2000-N-0108-0076", "FDA", "FDA-2000-N-0108", "Reference 6.  U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series, Biological Product Manufacturing, Table 4  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]", "Supporting & Related Material", "BKG-Background Material", "2010-09-29T04:00:00Z", 2010, 9, null, null, "2010-09-29T15:16:51Z", null, 0, 0, "0900006480b62859"], ["FDA-2000-N-0108-0054", "FDA", "FDA-2000-N-0108", "Shipping Label re Comment from Teva Pharmaceutical Industries Ltd", "Supporting & Related Material", "Transmittals", "2010-02-27T05:00:00Z", 2010, 2, null, null, "2017-08-04T14:14:47Z", null, 0, 0, "09000064804c2776"], ["FDA-2000-N-0108-0021", "FDA", "FDA-2000-N-0108", "Reference List - \"V.G. References\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2017-08-11T13:34:03Z", null, 0, 0, "09000064804c26ba"], ["FDA-2000-N-0108-0025", "FDA", "FDA-2000-N-0108", "Reference 15  - \"Agency for Health Care Policy and Research, \u201cNational Medical Expenditure Survey: Annual Expenses and Sources of Payment for Health Care Services, Research Findings 14,\u201d p.7, 1995\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2016-02-25T16:25:24Z", null, 0, 0, "09000064804c26ad"], ["FDA-2000-N-0108-0024", "FDA", "FDA-2000-N-0108", "Reference 14 -\"Statistical Abstract of the United States: The National Data Book, p.137-138, 1999\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2017-08-11T15:01:33Z", null, 0, 0, "09000064804c26f5"], ["FDA-2000-N-0108-0026", "FDA", "FDA-2000-N-0108", "Reference 17 - \"General Accounting Office, Adverse Drug Events The Magnitude of Health Risk Is Uncertain Because of Limited Incidence Data, GAO/HEHS-00-21, January, 2000\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2016-02-25T16:29:36Z", null, 0, 0, "09000064804c26d1"], ["FDA-2000-N-0108-0022", "FDA", "FDA-2000-N-0108", "Reference 10 - \"Institute of Medicine, edited by Kohn et al., To Err is Human: Building a Safer Health System, National Academy Press, 1999 \" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2016-02-25T16:35:18Z", null, 0, 0, "09000064804c26ed"], ["FDA-2000-N-0108-0023", "FDA", "FDA-2000-N-0108", "Reference 12 - \"Department of Health and Human Services, Office of the Inspector General, Review of the Food and Drug Administration\u2019s Handling of Adverse Drug Reaction Reports, Report No. A-15-98-50001, 1999\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2016-02-25T16:35:47Z", null, 0, 0, "09000064804c26f1"], ["FDA-2000-N-0108-0027", "FDA", "FDA-2000-N-0108", "Reference 25 - \"Eastern Research Group, Inc., \u201cCost of Implementing MedDRA Terminology for Pharmaceutical and Biologics Companies,\u201d2000\" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006", "Supporting & Related Material", "Background Material", "2010-02-26T05:00:00Z", 2010, 2, null, null, "2016-02-25T16:54:58Z", null, 0, 0, "09000064804c26bc"], ["FDA-2000-N-0108-0028", "FDA", "FDA-2000-N-0108", "Comment from Bristol-Myers Squibb Pharmaceutical Research Institute", "Other", "Letter(s)", "2010-02-26T05:00:00Z", 2010, 2, "2010-02-26T05:00:00Z", null, "2016-02-23T19:11:22Z", null, 0, 0, "09000064804c28fe"], ["FDA-2000-N-0108-0008", "FDA", "FDA-2000-N-0108", "Tab B - \"OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA\" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 79-174)", "Supporting & Related Material", "REF-Reference (internal unless indicated)", "2003-11-03T05:00:00Z", 2003, 11, null, null, "2010-02-26T21:17:41Z", null, 0, 0, "09000064804c2946"], ["FDA-2000-N-0108-0012", "FDA", "FDA-2000-N-0108", "Tab A - \"OMB Review March 14, 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- \"OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA\" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 377-464)", "Supporting & Related Material", "REF-Reference (internal unless indicated)", "2003-11-03T05:00:00Z", 2003, 11, null, null, "2010-02-26T21:27:30Z", null, 0, 0, "09000064804c2954"], ["FDA-2000-N-0108-0017", "FDA", "FDA-2000-N-0108", "Tab B - \"OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA\" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 278-376)", "Supporting & Related Material", "REF-Reference (internal unless indicated)", "2003-11-03T05:00:00Z", 2003, 11, null, null, "2010-02-26T21:21:09Z", null, 0, 0, "09000064804c2964"], ["FDA-2000-N-0108-0015", "FDA", "FDA-2000-N-0108", "Tab B - \"OMB Review March 14, 2003, Executive Order 12866, Changes 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