{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled \"Conducting Remote Regulatory Assessments--Question and Answers.\" FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/01/26/2024-01589.html","cfr_references":[],"citation":"89 FR 5244","comment_url":null,"comments_close_on":"2024-03-26","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 26, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0810"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-01-26","updated_at":"2024-01-26T09:57:01.032-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0810-0031","allow_late_comments":null,"id":"FDA-2022-D-0810-0031","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0810","title":"Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2024-01589","effective_on":null,"end_page":5246,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/01/26/2024-01589.xml","html_url":"https://www.federalregister.gov/documents/2024/01/26/2024-01589/conducting-remote-regulatory-assessments-questions-and-answers-revised-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-01589?publication_date=2024-01-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-01-26/2024-01589/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2427,"last_updated":"2026-10-24 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-26/pdf/2024-01589.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-01589.pdf?1706190329","publication_date":"2024-01-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/01/26/2024-01589.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-2022-D-0810","supporting_documents_count":0,"docket_id":"FDA-2022-D-0810","document_id":"FDA-2022-D-0810-0031","regulation_id_number":null,"title":"Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-01-27T14:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5244,"subtype":null,"title":"Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability","toc_doc":"Conducting Remote Regulatory AssessmentsQuestions and Answers","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}