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withdrawn,object_id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-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,,,2016-02-08T16:27:09Z,,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,,,2016-02-08T16:28:40Z,,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,,,2016-02-08T16:26:32Z,,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,,,2016-02-08T16:28:03Z,,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,,,2016-02-05T18:06:29Z,,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,,,2016-02-05T17:35:09Z,,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,
November 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,,,2016-02-05T18:09:06Z,,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,,,2016-02-05T18:09:28Z,,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
Statistics, 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,,,2016-02-05T18:06:58Z,,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,,,2016-02-05T18:06:45Z,,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,,,2016-02-05T18:07:35Z,,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,,,2016-02-05T17:35:39Z,,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,,,2016-02-05T18:07:54Z,,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,,,2016-02-05T18:08:51Z,,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,,,2016-02-05T18:06:00Z,,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,,,2016-02-05T18:05:42Z,,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,Supporting & Related Material,Background Material,2008-10-28T04:00:00Z,2008,10,,,2016-02-05T18:05:05Z,,0,0,090000648078103d
FDA-2003-N-0313-0008,FDA,FDA-2003-N-0313,Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Final Rule,Rule,Final Rule,2008-10-28T04:00:00Z,2008,10,2008-10-28T04:00:00Z,,2016-02-09T17:49:24Z,E8-25670,0,0,0900006480780764
FDA-2003-N-0313-0007,FDA,FDA-2003-N-0313,Outreach Letter from FDA (Office of Federal State Relations),Other,Letter(s),2008-07-31T04:00:00Z,2008,7,2008-07-31T04:00:00Z,,2016-02-09T17:48:29Z,,0,0,09000064806a4e29
FDA-2003-N-0313-0006,FDA,FDA-2003-N-0313,Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Interim Final Rule,Rule,Interim Final Rule,2008-01-03T05:00:00Z,2008,1,2008-01-02T05:00:00Z,,2016-02-09T17:44:40Z,,0,0,0900006480494f76
FDA-2003-N-0313-0002,FDA,FDA-2003-N-0313,Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Correction,Notice,Correction,2004-06-09T04:00:00Z,2004,6,2004-06-04T04:00:00Z,,2016-02-09T17:41:55Z,,0,0,0900006480494efa
FDA-2003-N-0313-0001,FDA,FDA-2003-N-0313,Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2004-04-23T04:00:00Z,2004,4,2004-04-21T04:00:00Z,2004-07-22T03:59:59Z,2016-02-09T22:01:05Z,,0,0,0900006480494e6b