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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

22 rows where docket_id = "FDA-1980-N-0049" and posted_year = 2003 sorted by posted_date descending

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  • 2003 · 22 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 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);