{"abstract":"The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the United States District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004. The purpose of this final order is to categorize AVA according to the evidence of its safety and effectiveness, thereby determining if it may remain licensed and on the market; issue a final response to recommendations made in the Panel's report, and; respond to comments on the previously published proposed order. The final rule and final order concerning bacterial vaccines and toxoids other than AVA is published elsewhere in this issue of the Federal Register.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2005/12/19/05-24223.html","cfr_references":[],"citation":"70 FR 75180","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The final order on categorization of AVA is effective December 19, 2005.","disposition_notes":null,"docket_ids":["Docket No. 1980N-0208"],"dockets":[],"document_number":"05-24223","effective_on":"2005-12-19","end_page":75198,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/12/19/05-24223.xml","html_url":"https://www.federalregister.gov/documents/2005/12/19/05-24223/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review-anthrax-vaccine","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-24223?publication_date=2005-12-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-12-19/05-24223/mods.xml","not_received_for_publication":null,"page_length":19,"page_views":{"count":559,"last_updated":"2026-09-21 02:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-12-19/pdf/05-24223.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-12-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/12/19/05-24223.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"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","document_id":"FDA-1980-N-0049-0167"},{"title":"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 ","document_id":"FDA-1980-N-0049-0165"},{"title":"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.","document_id":"FDA-1980-N-0049-0084"},{"title":"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","document_id":"FDA-1980-N-0049-0080"},{"title":"Reference List","document_id":"FDA-1980-N-0049-0079"},{"title":"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","document_id":"FDA-1980-N-0049-0077"},{"title":"Reference 6: Anthrax Vaccine Adsorbed (BIOTHRAX) Package Insert (January 31, 2002)","document_id":"FDA-1980-N-0049-0074"},{"title":"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","document_id":"FDA-1980-N-0049-0070"},{"title":"Reference 16: http://www.fda. gov/ohrms/dockets/ac/01/transcripts/3805t2_01 .pdf","document_id":"FDA-1980-N-0049-0068"},{"title":"Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf","document_id":"FDA-1980-N-0049-0067"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1980-N-0049","supporting_documents_count":117,"docket_id":"FDA-1980-N-0049","document_id":"FDA-1980-N-0049-0162","regulation_id_number":null,"title":"Biological Products; Bacterial Vaccines & Toxiods","checked_regulationsdotgov_at":"2020-09-28T02:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":75180,"subtype":null,"title":"Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order","toc_doc":"Anthrax vaccine absorbed","toc_subject":"Biological products:","topics":[],"type":"Notice","volume":70}