{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and posted_year = 2003 sorted by posted_date descending", "rows": [["FDA-2003-D-0428-0003", "FDA", "FDA-2003-D-0428", "GUIDANCE", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:55:43Z", null, 0, 0, "09000064804a21d1"], ["FDA-2003-D-0244-0001", "FDA", "FDA-2003-D-0244", "FDA", "Notice", "NAD-Notice of Availability of Data", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-30T05:00:00Z", "2004-03-02T04:59:59Z", "2008-04-12T00:55:07Z", null, 0, 0, "090000648048ecd0"], ["FDA-2003-N-0096-0001", "FDA", "FDA-2003-N-0096", "Revision of the Requirements for Spore-Forming Microorganisms", "Notice", "NPR-Notice of Proposed Rule-Making", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-30T05:00:00Z", "2004-03-16T04:59:59Z", "2025-06-19T09:00:11Z", "03-31919", 0, 0, "09000064804838aa"], ["FDA-2003-D-0428-0002", "FDA", "FDA-2003-D-0428", "GUIDANCE", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:55:43Z", null, 0, 0, "09000064804a21cf"], ["FDA-2002-D-0022-0003", "FDA", "FDA-2002-D-0022", "GUIDANCE", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T01:16:13Z", null, 0, 0, "0900006480488e12"], ["FDA-2003-D-0244-0003", "FDA", "FDA-2003-D-0244", "Guidance", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:55:07Z", null, 0, 0, "090000648048ed15"], ["FDA-2002-D-0022-0002", "FDA", "FDA-2002-D-0022", "GUIDANCE", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T01:16:13Z", null, 0, 0, "0900006480488e0f"], ["FDA-2002-D-0022-0004", "FDA", "FDA-2002-D-0022", "FDA", "Notice", "NAD-Notice of Availability of Data", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-19T05:00:00Z", "2004-12-20T04:59:59Z", "2008-04-12T01:16:13Z", null, 0, 0, "0900006480488e14"], ["FDA-2003-D-0244-0002", "FDA", "FDA-2003-D-0244", "Guidance", "Supporting & Related Material", "GDL-Guidance", "2003-12-30T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:55:07Z", null, 0, 0, "090000648048ecfe"], ["FDA-2000-N-0139-0002", "FDA", "FDA-2000-N-0139", "Agency Information Collection Activities; Comment Request; Guidance for Industry-Changes to an Approved New Drug Application or Abbreviated New Drug Application", "Notice", "General Notice", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-19T05:00:00Z", "2004-02-18T04:59:59Z", "2025-06-12T20:08:33Z", "03-31412", 0, 0, "09000064804d0bb0"], ["FDA-2003-D-0428-0001", "FDA", "FDA-2003-D-0428", "FDA", "Notice", "NAD-Notice of Availability of Data", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-19T05:00:00Z", "2004-12-20T04:59:59Z", "2008-04-12T00:55:43Z", null, 0, 0, "09000064804a21c9"], ["FDA-2003-N-0096-0002", "FDA", "FDA-2003-N-0096", "Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule", "Notice", "Notice of Final Rule", "2003-12-30T05:00:00Z", 2003, 12, "2003-12-30T05:00:00Z", "2004-03-16T04:59:59Z", "2025-06-18T19:14:55Z", "03-31918", 0, 0, "09000064804838f1"], ["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-2003-P-0177-0001", "FDA", "FDA-2003-P-0177", "Acknowledgment Letter from FDA DMB to Stockbridge Family Medicine", "Other", "Acknowledgement Letter/Receipt", "2003-12-29T05:00:00Z", 2003, 12, null, null, "2024-10-11T15:15:33Z", null, 0, 0, "0900006480489c44"], ["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"], ["FDA-2003-P-0409-0001", "FDA", "FDA-2003-P-0409", "HFA-305 to Hogan & Hartson L.L.P.", "Other", "ACK-Acknowledgement Letter", "2003-12-24T05:00:00Z", 2003, 12, null, null, "2008-04-12T01:13:30Z", null, 0, 0, "09000064804a1b19"], ["FDA-1994-P-0041-0231", "FDA", "FDA-1994-P-0041", "HFC-1 to CSPI", "Other", "PAV-Petition Approval", "2003-12-24T05:00:00Z", 2003, 12, null, null, "2008-05-16T23:19:32Z", null, 0, 0, "09000064804ff056"], ["FDA-2002-P-0082-0001", "FDA", "FDA-2002-P-0082", "Petition Denial from FDA CDER to SensorMedics Corporation", "Other", "PDN-Petition Denial", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2024-08-27T13:59:44Z", null, 0, 0, "090000648048d94e"], ["FDA-2003-P-0126-0002", "FDA", "FDA-2003-P-0126", "Petition Denial from FDA CDER to HRA Pharma", "Other", "PDN-Petition Denial", "2003-12-23T05:00:00Z", 2003, 12, "2003-12-17T05:00:00Z", null, "2024-10-17T21:12:42Z", null, 0, 0, "09000064804861cf"], ["FDA-2003-N-0161-0046", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:07Z", null, 0, 0, "090000648048819d"], ["FDA-2003-N-0161-0037", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:01Z", null, 0, 0, "0900006480488178"], ["FDA-2003-N-0161-0053", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:04Z", null, 0, 0, "09000064804881b4"], ["FDA-2003-N-0161-0041", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:07Z", null, 0, 0, "0900006480488186"], ["FDA-2003-N-0161-0040", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:07Z", null, 0, 0, "0900006480488183"], ["FDA-2003-P-0077-0004", "FDA", "FDA-2003-P-0077", "HFD-600 to The Weinberg Group Inc", "Other", "PAV-Petition Approval", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T01:10:53Z", null, 0, 0, "09000064804829c8"], ["FDA-2003-N-0161-0052", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:08Z", null, 0, 0, "09000064804881b1"], ["FDA-2003-N-0161-0035", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:01Z", null, 0, 0, "090000648048816c"], ["FDA-2003-N-0161-0048", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:00Z", null, 0, 0, "09000064804881a4"], ["FDA-2003-N-0161-0038", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:06Z", null, 0, 0, "090000648048817d"], ["FDA-2003-N-0161-0031", "FDA", "FDA-2003-N-0161", "FDA and the Office of Assistant Secretary of Planning and Evaluation - \"Exploring the Link Between Weight Management and Food Labels and Packaging, November 20, 2003\" - Supplement", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2009-11-21T23:28:52Z", null, 0, 0, "0900006480488156"], ["FDA-2003-N-0161-0034", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:58:59Z", null, 0, 0, "0900006480488168"], ["FDA-2003-N-0161-0030", "FDA", "FDA-2003-N-0161", "Shipping Label - [Bureau of Consumer Protection, Bureau of Economics, and the Office of Policy Planning, FTC - Comment] re FDA-2003-N-0161-0029", "Supporting & Related Material", "C-Comment (Supporting and Related Material)", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2012-03-24T19:28:36Z", null, 0, 0, "0900006480488152"], ["FDA-2003-N-0161-0036", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:02Z", null, 0, 0, "0900006480488170"], ["FDA-2003-N-0161-0050", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:00Z", null, 0, 0, "09000064804881ab"], ["FDA-2003-N-0161-0043", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:59:08Z", null, 0, 0, "0900006480488191"], ["FDA-2003-N-0161-0047", "FDA", "FDA-2003-N-0161", "Exploring the Link Between Food Labeling and Weight Management", "Other", "SUP-Supplement", "2003-12-23T05:00:00Z", 2003, 12, null, null, "2008-04-12T00:58:59Z", null, 0, 0, "09000064804881a1"], 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