{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of Guidance for Industry and FDA Staff entitled \"Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.\" The document finalizes the draft guidance entitled \"Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.\" The guidance clarifies the circumstances under which FDA may access and copy records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. (\"Bioterrorism Act\"), and describes the procedure that FDA intends to follow to exercise its authority to inspect records under the Federal Food, Drug, and Cosmetic Act (the act).","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/2005/11/30/05-23504.html","cfr_references":[],"citation":"70 FR 71858","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidance documents at any time.","disposition_notes":null,"docket_ids":["Docket No. 2004G-0381"],"dockets":[{"supporting_documents":[{"title":"Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002","document_id":"FDA-2004-G-0002-0003"},{"title":"Guideline","document_id":"FDA-2004-G-0002-0002"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2005-11-30","updated_at":"2025-11-13T10:55:40.667-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-G-0002-0004","allow_late_comments":false,"id":"FDA-2004-G-0002-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2004-G-0002","title":"Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002"}],"document_number":"05-23504","effective_on":null,"end_page":71859,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/11/30/05-23504.xml","html_url":"https://www.federalregister.gov/documents/2005/11/30/05-23504/guidance-for-industry-and-food-and-drug-administration-staff-guidance-for-records-access-authority","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-23504?publication_date=2005-11-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-11-30/05-23504/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":358,"last_updated":"2026-05-11 10:15:15 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-11-30/pdf/05-23504.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-11-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/11/30/05-23504.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002","document_id":"FDA-2004-G-0002-0003"},{"title":"Guideline","document_id":"FDA-2004-G-0002-0002"}],"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-2004-G-0002","supporting_documents_count":2,"docket_id":"FDA-2004-G-0002","document_id":"FDA-2004-G-0002-0004","regulation_id_number":null,"title":"Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002","checked_regulationsdotgov_at":"2025-11-14T19:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71858,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff, Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability","toc_doc":"Records access authority; industry and staff guidance","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":70}