{"abstract":"The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current \"Good Guidance Practices\" (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.","action":"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/2000/09/19/00-23887.html","cfr_references":[{"chapter":null,"citation_url":null,"part":7,"title":21},{"chapter":null,"citation_url":null,"part":10,"title":21},{"chapter":null,"citation_url":null,"part":14,"title":21},{"chapter":null,"citation_url":null,"part":19,"title":21},{"chapter":null,"citation_url":null,"part":25,"title":21},{"chapter":null,"citation_url":null,"part":101,"title":21},{"chapter":null,"citation_url":null,"part":107,"title":21},{"chapter":null,"citation_url":null,"part":110,"title":21},{"chapter":null,"citation_url":null,"part":114,"title":21},{"chapter":null,"citation_url":null,"part":170,"title":21},{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":312,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":316,"title":21},{"chapter":null,"citation_url":null,"part":500,"title":21},{"chapter":null,"citation_url":null,"part":514,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21},{"chapter":null,"citation_url":null,"part":803,"title":21},{"chapter":null,"citation_url":null,"part":814,"title":21},{"chapter":null,"citation_url":null,"part":860,"title":21}],"citation":"65 FR 56468","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective October 19, 2000.","disposition_notes":null,"docket_ids":["Docket No. 99N-4783"],"dockets":[],"document_number":"00-23887","effective_on":"2000-10-19","end_page":56480,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/09/19/00-23887.xml","html_url":"https://www.federalregister.gov/documents/2000/09/19/00-23887/administrative-practices-and-procedures-good-guidance-practices","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-23887?publication_date=2000-09-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-09-19/00-23887/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":1756,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-09-19/pdf/00-23887.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-09-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/09/19/00-23887.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T03:15:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56468,"subtype":null,"title":"Administrative Practices and Procedures; Good Guidance Practices","toc_doc":"Good guidance practices","toc_subject":"Administrative practice and procedure:","topics":["Administrative practice and procedure","Advisory committees","Animal drugs","Biologics","Cancer","Color additives","Confidential business information","Consumer protection","Drugs","Environmental impact statements","Exports","Food additives","Food labeling","Food packaging","Foods","Foreign relations","Imports","Infants and children","Investigations","Labeling","Medical devices","Medical research","News media","Nutrition","Packaging and containers","Polychlorinated biphenyls (PCB's)","Radiation protection","Reporting and recordkeeping requirements","Safety","Signs and symbols"],"type":"Rule","volume":65}