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withdrawn,object_id FDA-1980-N-0049-0165,FDA,FDA-1980-N-0049,"Background Information for Notice of Withdrawal of 12/29/04 - Tab 2: January 8, 2004, January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction",Supporting & Related Material,Background Material,2008-10-02T04:00:00Z,2008,10,,,2020-05-22T16:57:55Z,,0,0,09000064805b9ac3 FDA-1980-N-0049-0167,FDA,FDA-1980-N-0049,"Background Information for Notice of Withdrawal of 12/29/04 - Tab 3: February 13, 2004, Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction",Supporting & Related Material,Background Material,2008-10-02T04:00:00Z,2008,10,,,2020-05-22T17:18:00Z,,0,0,09000064805b9ac5 FDA-1980-N-0049-0166,FDA,FDA-1980-N-0049,"Background Information for Notice of Withdrawal of 12/29/04 - Tab 1: January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Final rule and final order",Supporting & Related Material,Background Material,2008-10-02T04:00:00Z,2008,10,,,2020-05-22T17:01:18Z,,0,0,09000064805b9ac4 FDA-1980-N-0049-0164,FDA,FDA-1980-N-0049,"Background Information for Notice of Withdrawal of 12/29/04 - Tab 4: October 27, 2004, Court issued a memorandum opinion vacating and remanding the January 2004 final rule and final order to FDA for reconsideration",Supporting & Related Material,Background Material,2008-10-02T04:00:00Z,2008,10,,,2020-05-22T16:55:09Z,,0,0,09000064805b9ac2 FDA-1980-N-0049-0163,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Notice,Notice of Final Rule,2005-12-21T05:00:00Z,2005,12,2005-12-15T05:00:00Z,,2020-09-25T13:40:57Z,05-24224,0,0,09000064805ba0aa FDA-1980-N-0049-0162,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Notice,General Notice,2005-12-21T05:00:00Z,2005,12,2005-12-15T05:00:00Z,,2020-09-25T13:43:01Z,05-24223,0,0,09000064805ba0a9 FDA-1980-N-0049-0124,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T17:26:17Z,,0,0,09000064805ba082 FDA-1980-N-0049-0142,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:47:53Z,,0,0,09000064805ba095 FDA-1980-N-0049-0144,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:18:41Z,,0,0,09000064805ba097 FDA-1980-N-0049-0146,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:08:05Z,,0,0,09000064805ba099 FDA-1980-N-0049-0156,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T19:47:03Z,,0,0,09000064805ba0a3 FDA-1980-N-0049-0137,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:46:44Z,,0,0,09000064805ba08f FDA-1980-N-0049-0155,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:24:38Z,,0,0,09000064805ba0a2 FDA-1980-N-0049-0157,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:45:00Z,,0,0,09000064805ba0a4 FDA-1980-N-0049-0127,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T17:41:35Z,,0,0,09000064805ba085 FDA-1980-N-0049-0154,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:21:37Z,,0,0,09000064805ba0a1 FDA-1980-N-0049-0141,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T21:02:42Z,,0,0,09000064805ba093 FDA-1980-N-0049-0139,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:47:11Z,,0,0,09000064805ba091 FDA-1980-N-0049-0149,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:37:37Z,,0,0,09000064805ba09c FDA-1980-N-0049-0159,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:49:10Z,,0,0,09000064805ba0a6 FDA-1980-N-0049-0126,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T17:37:32Z,,0,0,09000064805ba084 FDA-1980-N-0049-0130,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:44:46Z,,0,0,09000064805ba088 FDA-1980-N-0049-0132,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T19:44:09Z,,0,0,09000064805ba08a FDA-1980-N-0049-0134,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T20:02:28Z,,0,0,09000064805ba08c FDA-1980-N-0049-0138,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:46:59Z,,0,0,09000064805ba090 FDA-1980-N-0049-0148,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:31:39Z,,0,0,09000064805ba09b FDA-1980-N-0049-0129,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T18:54:03Z,,0,0,09000064805ba087 FDA-1980-N-0049-0143,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:14:43Z,,0,0,09000064805ba096 FDA-1980-N-0049-0151,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T19:51:46Z,,0,0,09000064805ba09e FDA-1980-N-0049-0153,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:17:12Z,,0,0,09000064805ba0a0 FDA-1980-N-0049-0136,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T20:14:58Z,,0,0,09000064805ba08e FDA-1980-N-0049-0150,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T19:50:51Z,,0,0,09000064805ba09d FDA-1980-N-0049-0125,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T17:32:47Z,,0,0,09000064805ba083 FDA-1980-N-0049-0152,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T19:52:41Z,,0,0,09000064805ba09f FDA-1980-N-0049-0158,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:33:57Z,,0,0,09000064805ba0a5 FDA-1980-N-0049-0160,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:52:22Z,,0,0,09000064805ba0a7 FDA-1980-N-0049-0131,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:45:11Z,,0,0,09000064805ba089 FDA-1980-N-0049-0133,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T19:47:40Z,,0,0,09000064805ba08b FDA-1980-N-0049-0147,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:28:39Z,,0,0,09000064805ba09a FDA-1980-N-0049-0135,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T20:10:43Z,,0,0,09000064805ba08d FDA-1980-N-0049-0145,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T13:24:03Z,,0,0,09000064805ba098 FDA-1980-N-0049-0161,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-09T20:55:12Z,,0,0,09000064805ba0a8 FDA-1980-N-0049-0128,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-10T18:38:53Z,,0,0,09000064805ba086 FDA-1980-N-0049-0140,FDA,FDA-1980-N-0049,Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order,Supporting & Related Material,Background Material,2005-12-15T05:00:00Z,2005,12,,,2020-09-15T14:47:29Z,,0,0,09000064805ba092 FDA-1980-N-0049-0116,FDA,FDA-1980-N-0049,Letter from Russell E. Dingle and Thomas L. Rempfer to FDA re: Electronic Comment from Mr. Lawrence Rizzo,Supporting & Related Material,Background Material,2005-04-13T04:00:00Z,2005,4,,,2020-05-27T13:02:20Z,,0,0,09000064805b9bf0 FDA-1980-N-0049-0118,FDA,FDA-1980-N-0049,Letter from Russell E. Dingle and Thomas L. Rempfer to FDA re: Electronic Comment from Mr. Lawrence Rizzo,Supporting & Related Material,Background Material,2005-04-13T04:00:00Z,2005,4,,,2020-05-27T13:02:11Z,,0,0,09000064805b9bf2 FDA-1980-N-0049-0120,FDA,FDA-1980-N-0049,Letter from David Panzera to FDA/DDM re: Electronic Comment from Mr. David Panzera,Supporting & Related Material,Background Material,2005-04-13T04:00:00Z,2005,4,,,2020-05-27T13:12:21Z,,0,0,09000064805b9bf5 FDA-1980-N-0049-0119,FDA,FDA-1980-N-0049,Letter from David Panzera to FDA/DDM re: Electronic Comment from Mr. David Panzera,Supporting & Related Material,Background Material,2005-04-13T04:00:00Z,2005,4,,,2020-05-27T13:12:31Z,,0,0,09000064805b9bf4 FDA-1980-N-0049-0115,FDA,FDA-1980-N-0049,Letter from US Army Medical Research Institute of Infectious Disease to FDA/DDM re: Electronic Comment from US Army Medical Research Institute of Infectious Disease,Supporting & Related Material,Background Material,2005-04-13T04:00:00Z,2005,4,,,2020-05-27T12:51:31Z,,0,0,09000064805b9bef FDA-1980-N-0049-0106,FDA,FDA-1980-N-0049,HFM-17,Other,CR-Correction,2005-03-04T05:00:00Z,2005,3,,,2008-05-30T22:52:24Z,,0,0,09000064805b9aee FDA-1980-N-0049-0105,FDA,FDA-1980-N-0049,HFM-17,Other,CR-Correction,2005-03-04T05:00:00Z,2005,3,,,2008-05-30T22:53:08Z,,0,0,09000064805b9aed FDA-1980-N-0049-0096,FDA,FDA-1980-N-0049,Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2005-01-06T05:00:00Z,2005,1,2004-12-23T05:00:00Z,2005-03-30T04:59:59Z,2020-05-11T14:23:43Z,04-28322,0,0,09000064805b99fc FDA-1980-N-0049-0095,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal,Notice,Withdrawal,2005-01-06T05:00:00Z,2005,1,2004-12-23T05:00:00Z,,2020-05-11T14:00:29Z,04-28459,0,0,09000064805b99fb FDA-1980-N-0049-0093,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal,Notice,Withdrawal,2005-01-06T05:00:00Z,2005,1,2004-12-23T05:00:00Z,,2020-05-11T13:58:41Z,04-28459,0,0,09000064805b99f9 FDA-1980-N-0049-0094,FDA,FDA-1980-N-0049,Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal,Notice,Withdrawal,2005-01-06T05:00:00Z,2005,1,2004-12-23T05:00:00Z,,2020-05-11T13:58:58Z,04-28459,0,0,09000064805b99fa FDA-1980-N-0049-0088,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:41:00Z,,0,0,09000064805b99f4 FDA-1980-N-0049-0091,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:51:32Z,,0,0,09000064805b99f7 FDA-1980-N-0049-0089,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:44:51Z,,0,0,09000064805b99f5 FDA-1980-N-0049-0087,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:27:53Z,,0,0,09000064805b99f3 FDA-1980-N-0049-0092,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:56:57Z,,0,0,09000064805b99f8 FDA-1980-N-0049-0090,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:47:47Z,,0,0,09000064805b99f6 FDA-1980-N-0049-0086,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction,Notice,Correction,2004-02-20T05:00:00Z,2004,2,2004-02-13T05:00:00Z,,2020-05-12T12:44:15Z,04-3135,0,0,09000064805b99de FDA-1980-N-0049-0085,FDA,FDA-1980-N-0049,Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction,Notice,Correction,2004-02-20T05:00:00Z,2004,2,2004-02-13T05:00:00Z,,2020-05-11T13:47:13Z,04-3135,0,0,09000064805b99dd FDA-1980-N-0049-0062,FDA,FDA-1980-N-0049,Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Notice,Notice of Final Rule,2004-01-17T05:00:00Z,2004,1,2003-12-30T05:00:00Z,,2020-05-11T13:30:40Z,03-32255,0,0,09000064805b99c6 FDA-1980-N-0049-0061,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Notice,Notice of Final Rule,2004-01-17T05:00:00Z,2004,1,2003-12-30T05:00:00Z,,2020-05-11T13:28:17Z,03-32255,0,0,09000064805b99c5 FDA-1980-N-0049-0060,FDA,FDA-1980-N-0049,Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Notice,Notice of Final Rule,2004-01-17T05:00:00Z,2004,1,2003-12-30T05:00:00Z,,2020-05-12T12:38:34Z,03-32255,0,0,09000064805b99c4 FDA-1980-N-0049-0067,FDA,FDA-1980-N-0049,Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:42:07Z,,0,0,09000064805b99cb FDA-1980-N-0049-0077,FDA,FDA-1980-N-0049,"Reference 12: ""Protecting our Kids: What is causing the current shortage in childhood vaccines? Testimony Before the Committee on Governmental Affairs, United States Senate,"" June 12, 2002,"" http://www. cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002. htm",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T18:58:35Z,,0,0,09000064805b99d5 FDA-1980-N-0049-0065,FDA,FDA-1980-N-0049,Reference 18: http://www.fda.gov/ohrms//dockets/ac/02/transcripts/3842t1.pdf,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:53:55Z,,0,0,09000064805b99c9 FDA-1980-N-0049-0068,FDA,FDA-1980-N-0049,Reference 16: http://www.fda. gov/ohrms/dockets/ac/01/transcripts/3805t2_01 .pdf,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:31:09Z,,0,0,09000064805b99cc FDA-1980-N-0049-0074,FDA,FDA-1980-N-0049,"Reference 6: Anthrax Vaccine Adsorbed (BIOTHRAX) Package Insert (January 31, 2002)",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:51:25Z,,0,0,09000064805b99d2 FDA-1980-N-0049-0079,FDA,FDA-1980-N-0049,Reference List,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:09:59Z,,0,0,09000064805b99d7 FDA-1980-N-0049-0080,FDA,FDA-1980-N-0049,"Reference 14: Centers for Disease Control and Prevention,""Prevention of Plague: Recommendations of the Advisory Committee on Immunization Practices (ACIP),"" Morbidity and Mortality Weekly Report, 45 (No. RR-14), 1996",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T18:49:26Z,,0,0,09000064805b99d8 FDA-1980-N-0049-0070,FDA,FDA-1980-N-0049,"Reference 10: ""Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1),"" September 1998, http://www.fda.gov/cber/gdlns/vaers-1.pdf",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:17:27Z,,0,0,09000064805b99ce FDA-1980-N-0049-0084,FDA,FDA-1980-N-0049,"Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T19:30:18Z,,0,0,09000064805b99dc FDA-1980-N-0049-0063,FDA,FDA-1980-N-0049,"Reference 11: ""Estimated Vaccination Coverage with 3+DTP Among Children 19-35 Months of Age by Race/Ethnicity, and by State and Immunization Action Plan Area - U.S., National Immunization Survey, Q3/2000 - Q2/2001,"" http://www.cdc.gov/nip/coverage/NlS/00-01/tab19- 3dpt_race_iap. htm.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T19:21:05Z,,0,0,09000064805b99c7 FDA-1980-N-0049-0076,FDA,FDA-1980-N-0049,"Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:40:29Z,,0,0,09000064805b99d4 FDA-1980-N-0049-0083,FDA,FDA-1980-N-0049,"Reference 3: Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. M. Pitt, C. A. Rossi, P. H. Gibbs, and A. M. Friedlander, ""Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin,"" Vaccine, 19(23-24):3241-3247, 2001",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T18:23:42Z,,0,0,09000064805b99db FDA-1980-N-0049-0081,FDA,FDA-1980-N-0049,"Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:41:44Z,,0,0,09000064805b99d9 FDA-1980-N-0049-0082,FDA,FDA-1980-N-0049,"Reference 4: Ivins, B. E., P. F. Fellows, M. L. M. Pitt, J. E. Estep, S. L. Welkos, P. L.Worsham and A. M. Friedlander, ""Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys,"" Salisbury Medical Bulletin 87(Suppl.):125-126, 1996",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T18:30:13Z,,0,0,09000064805b99da FDA-1980-N-0049-0073,FDA,FDA-1980-N-0049,"Reference 7: Wright, G. G., Green, T. W, and Kanode, Jr., R. G., ""Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-Precipitated Protective Antigen,"" Journal of Immunology, 73:387- 391, 1954",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:57:23Z,,0,0,09000064805b99d1 FDA-1980-N-0049-0075,FDA,FDA-1980-N-0049,"Reference 1: Brachman, P. S., H. Gold, S. Plotkin, F. R. Fekety, M. Werrin, and N. R. Ingraham, ""Field Evaluation of a Human Anthrax Vaccine,"" American Journal of Public Health, 52:632-645, 1962.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T16:42:28Z,,0,0,09000064805b99d3 FDA-1980-N-0049-0064,FDA,FDA-1980-N-0049,"Reference 9: ""Table of Reportable Events Following Vaccination,"" http://www.vaers.org/reportable.htm.",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T19:11:53Z,,0,0,09000064805b99c8 FDA-1980-N-0049-0071,FDA,FDA-1980-N-0049,"Reference 13: Colditz, et al., ""Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Meta Analysis of the Published Literature,"" Journal of the American Medical Association, 271:698-702, 1994",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:09:06Z,,0,0,09000064805b99cf FDA-1980-N-0049-0066,FDA,FDA-1980-N-0049,Transcript in the matter of Vaccines and Related Biological Products Advisory Committee,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-20T16:17:24Z,,0,0,09000064805b99ca FDA-1980-N-0049-0069,FDA,FDA-1980-N-0049,Reference 15: http://Mrww.fda.gov/ohrms/dockets/ac/01/transcripts/3755t1.pdf,Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:26:38Z,,0,0,09000064805b99cd FDA-1980-N-0049-0078,FDA,FDA-1980-N-0049,"Reference 5: Ivins, B. E., M. L. M. Pitt, P. F. Fellows, J. W. Farchaus, B. E. Benner, D. M. Waag, S. F. Little, G. W. Anderson, P. H. Gibbs, and A. M. Friedlander, ""Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques,"" Vaccine, 16(11-12):1141-1148,1998",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T18:42:51Z,,0,0,09000064805b99d6 FDA-1980-N-0049-0072,FDA,FDA-1980-N-0049,"Reference 8: 61 FR 40153, August 1, 1996",Supporting & Related Material,Background Material,2003-12-29T05:00:00Z,2003,12,,,2020-05-19T17:01:43Z,,0,0,09000064805b99d0