{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2003-N-0313\" sorted by posted_date descending", "rows": [["FDA-2003-N-0313-0023", "FDA", "FDA-2003-N-0313", "Tab A Initial Draft (FRN) Submitted to OMB and OIRA for Review re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-08T05:00:00Z", 2016, 2, null, null, "2016-02-08T16:27:09Z", null, 0, 0, "0900006480494f03"], ["FDA-2003-N-0313-0025", "FDA", "FDA-2003-N-0313", "Tab C Recommendations of from OIRA for Review and Action re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-08T05:00:00Z", 2016, 2, null, null, "2016-02-08T16:28:40Z", null, 0, 0, "0900006480494f0b"], ["FDA-2003-N-0313-0022", "FDA", "FDA-2003-N-0313", "Regulations Policy and Management Staff re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products  OMB and OIRA Review", "Supporting & Related Material", "Background Material", "2016-02-08T05:00:00Z", 2016, 2, null, null, "2016-02-08T16:26:32Z", null, 0, 0, "0900006480494f08"], ["FDA-2003-N-0313-0024", "FDA", "FDA-2003-N-0313", "Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-08T05:00:00Z", 2016, 2, null, null, "2016-02-08T16:28:03Z", null, 0, 0, "0900006480494efe"], ["FDA-2003-N-0313-0014", "FDA", "FDA-2003-N-0313", "Reference 3 \"Sources of Receipts or Revenue, 1997 Economic Census, Health Care and Social Assistance, Subject Series,\" U.S. Dept of Commerce Publication No. EC97S62S-LS, August 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:06:29Z", null, 0, 0, "0900006480494ede"], ["FDA-2003-N-0313-0012", "FDA", "FDA-2003-N-0313", "Reference 1 \"2001 Industry Facts-at-a-Glance,\" National Association of Chain Drug Stores, http://www.nacds.org re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T17:35:09Z", null, 0, 0, "0900006480494ed6"], ["FDA-2003-N-0313-0020", "FDA", "FDA-2003-N-0313", "Reference 13 Pharmaceutical Preparation Manufacturing, 1997 Economic Census, Manufacturing, Industry Series,\" U.S. Dept of Commerce, Publication No. EC97M-3254B,\nNovember 1999 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:09:06Z", null, 0, 0, "0900006480494ecc"], ["FDA-2003-N-0313-0021", "FDA", "FDA-2003-N-0313", "Reference 14 Statistics of U.S. Businesses: 1999, Pharmaceutical Preparation Manufacturing, U.S. Dept of Commerce, www.census.gov/epcd/susb/1999/us/US325412.htm  re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:09:28Z", null, 0, 0, "0900006480494ed9"], ["FDA-2003-N-0313-0016", "FDA", "FDA-2003-N-0313", "Reference 5 \"2000 National Occupational Employment and Wage Estimates,\" U.S. Dept of Labor, Bureau of Labor\nStatistics, http://www.bls.gov.oes/2OOO/oes292O52.htm re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:06:58Z", null, 0, 0, "0900006480494ee4"], ["FDA-2003-N-0313-0015", "FDA", "FDA-2003-N-0313", "Reference 4 Svarstad, B. et al., \"Evaluation of Written Prescription Information Provided in Community Pharmacies 2001,\" Final report to FDA, December 21, 2001 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:06:45Z", null, 0, 0, "0900006480494ee1"], ["FDA-2003-N-0313-0017", "FDA", "FDA-2003-N-0313", "Reference 7 GAO Adverse Drug Events The Magnitude of Health Risk is Uncertain Because of Limited Incidence Data January 2000  re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:07:35Z", null, 0, 0, "0900006480494eea"], ["FDA-2003-N-0313-0013", "FDA", "FDA-2003-N-0313", "Reference 2 \"'Summary 1997 Economic Census, Retail Trade,\" U.S. Dept of Commerce Publication No. EC97R44S-SM, January 2001 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T17:35:39Z", null, 0, 0, "0900006480494eb9"], ["FDA-2003-N-0313-0018", "FDA", "FDA-2003-N-0313", "Reference 11 Establishment and Firm Size, 1997 Economic Census, Retail Trade,\" U.S. Dept of Commerce Publication No. EC97R44S-SZ October 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:07:54Z", null, 0, 0, "0900006480494edb"], ["FDA-2003-N-0313-0019", "FDA", "FDA-2003-N-0313", "Reference 12 Establishment and Firm Size, 1997 Economic Census, Health Care and Social Assistance, Subject Series,\" Dept of Commerce, Publication EC97S62S-SZ, October 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:08:51Z", null, 0, 0, "0900006480494ecf"], ["FDA-2003-N-0313-0011", "FDA", "FDA-2003-N-0313", "List of References - Table of Contents re: Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-05T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:06:00Z", null, 0, 0, "0900006480494ed4"], ["FDA-2003-N-0313-0010", "FDA", "FDA-2003-N-0313", "References for Proposed Rule: Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products", "Supporting & Related Material", "Background Material", "2016-02-04T05:00:00Z", 2016, 2, null, null, "2016-02-05T18:05:42Z", null, 0, 0, "0900006480494ed1"], ["FDA-2003-N-0313-0009", "FDA", "FDA-2003-N-0313", "Labeling Comprehension Study Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products", 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