{"abstract":"The Food and Drug Administration (FDA) is amending its regulations to remove references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDA is also removing references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.","action":"Direct final rule.","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/1999/01/05/99-140.html","cfr_references":[{"chapter":null,"citation_url":null,"part":2,"title":21},{"chapter":null,"citation_url":null,"part":3,"title":21},{"chapter":null,"citation_url":null,"part":5,"title":21},{"chapter":null,"citation_url":null,"part":10,"title":21},{"chapter":null,"citation_url":null,"part":12,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":20,"title":21},{"chapter":null,"citation_url":null,"part":25,"title":21},{"chapter":null,"citation_url":null,"part":50,"title":21},{"chapter":null,"citation_url":null,"part":54,"title":21},{"chapter":null,"citation_url":null,"part":56,"title":21},{"chapter":null,"citation_url":null,"part":58,"title":21},{"chapter":null,"citation_url":null,"part":60,"title":21},{"chapter":null,"citation_url":null,"part":70,"title":21}],"citation":"64 FR 396","comment_url":null,"comments_close_on":"1999-04-20","correction_of":null,"corrections":[],"dates":"This rule is effective May 20, 1999. Submit written comments on or before March 22, 1999. If no timely significant adverse comments are received, the agency will publish a document in the Federal Register before April 20, 1999, confirming the effective date of the direct final rule. The agency intends to make the direct final rule effective 30 days after publication of the confirmation document in the Federal Register. If timely significant adverse comments are received, the agency will publish a document of significant adverse comment in the Federal Register withdrawing this direct final rule before April 20, 1999.","disposition_notes":null,"docket_ids":["Docket No. 98N-0720"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"1999-01-05","updated_at":"2024-08-22T16:57:14.807-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1998-N-1172-0002","allow_late_comments":null,"id":"FDA-1998-N-1172-0002","comment_end_date":"1999-03-23","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-1998-N-1172","title":"Conforming Regulations Regarding Removal of Section 507"}],"document_number":"99-140","effective_on":"1999-05-20","end_page":404,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/01/05/99-140/conforming-regulations-regarding-removal-of-section-507-of-the-federal-food-drug-and-cosmetic-act","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-140?publication_date=1999-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-01-05/99-140/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1338,"last_updated":"2026-08-24 06:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-01-05/pdf/99-140.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/01/05/99-140.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-1998-N-1172","supporting_documents_count":0,"docket_id":"FDA-1998-N-1172","document_id":"FDA-1998-N-1172-0002","regulation_id_number":null,"title":"Conforming Regulations Regarding Removal of Section 507","checked_regulationsdotgov_at":"2024-08-23T20:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":396,"subtype":null,"title":"Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":64}