{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Handling and Retention of BA and BE Testing Samples.\" This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations (CROs), regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, and recommendations regarding responsibilities of each party involved in the study pertaining to reserve samples. Additionally, this guidance describes the conditions under which the Agency generally does not intend to take enforcement action against an applicant or CRO that retains less than the quantity of reserve samples specified in the regulation.","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/2024/03/27/2024-06500.html","cfr_references":[],"citation":"89 FR 21255","comment_url":null,"comments_close_on":"2024-05-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft portion of this guidance by May 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Comments on the final portion of this guidance may be submitted at any time for Agency consideration.","disposition_notes":null,"docket_ids":["Docket No. FDA-2002-D-0176 (Formerly Docket No. 2002D-0350)"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-03-27","updated_at":"2024-09-03T16:49:48.446-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2002-D-0176-0004","allow_late_comments":false,"id":"FDA-2002-D-0176-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2002-D-0176","title":"Handling and Retention of Bioavailability and Bioequivalence"}],"document_number":"2024-06500","effective_on":null,"end_page":21257,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/27/2024-06500.xml","html_url":"https://www.federalregister.gov/documents/2024/03/27/2024-06500/handling-and-retention-of-bioavailability-and-bioequivalence-testing-samples-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-06500?publication_date=2024-03-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-27/2024-06500/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":806,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-27/pdf/2024-06500.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-06500.pdf?1711457126","publication_date":"2024-03-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/27/2024-06500.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-2002-D-0176","supporting_documents_count":0,"docket_id":"FDA-2002-D-0176","document_id":"FDA-2002-D-0176-0004","regulation_id_number":null,"title":"Handling and Retention of Bioavailability and Bioequivalence","checked_regulationsdotgov_at":"2024-03-28T13:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":21255,"subtype":null,"title":"Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Guidance for Industry (Part Draft, Part Final); Availability","toc_doc":"Handling and Retention of Bioavailability and Bioequivalence Testing Samples","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}