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Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction", "Notice", "Correction", "2004-02-20T05:00:00Z", 2004, 2, "2004-02-13T05:00:00Z", null, "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", null, "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", null, "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", null, "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, null, null, "2020-05-19T17:42:07Z", null, 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, null, null, "2020-05-19T18:58:35Z", null, 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, null, null, "2020-05-19T17:53:55Z", null, 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, null, null, "2020-05-19T17:31:09Z", null, 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, null, null, "2020-05-19T16:51:25Z", null, 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, null, null, "2020-05-19T16:09:59Z", null, 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, null, null, "2020-05-19T18:49:26Z", null, 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, null, null, "2020-05-19T17:17:27Z", null, 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, null, null, "2020-05-19T19:30:18Z", null, 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, null, null, "2020-05-19T19:21:05Z", null, 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, null, null, "2020-05-19T16:40:29Z", null, 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, null, null, "2020-05-19T18:23:42Z", null, 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, null, null, "2020-05-19T16:41:44Z", null, 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, null, null, "2020-05-19T18:30:13Z", null, 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, null, null, "2020-05-19T16:57:23Z", null, 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, null, null, "2020-05-19T16:42:28Z", null, 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, null, null, "2020-05-19T19:11:53Z", null, 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, null, null, "2020-05-19T17:09:06Z", null, 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, null, null, "2020-05-20T16:17:24Z", null, 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, null, null, "2020-05-19T17:26:38Z", null, 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, null, null, "2020-05-19T18:42:51Z", null, 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, null, null, "2020-05-19T17:01:43Z", null, 0, 0, "09000064805b99d0"]], "truncated": false, "filtered_table_rows_count": 88, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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", 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