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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

88 rows where docket_id = "FDA-1980-N-0049" sorted by posted_date descending

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posted_year 4

  • 2005 51
  • 2003 22
  • 2004 11
  • 2008 4

document_type 4

  • Supporting & Related Material 69
  • Notice 10
  • Other 8
  • Proposed Rule 1

agency_id 1

  • FDA 88
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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 Biological Products; Bacterial Vaccines & Toxiods 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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