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withdrawn,object_id FDA-1980-N-0049-0067,FDA,FDA-1980-N-0049,Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf,Supporting & Related Material,Background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