{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #227) entitled \"Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.\" The purpose of this document is to provide recommendations to sponsors submitting CMC data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process.","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/2014/10/20/2014-24796.html","cfr_references":[],"citation":"79 FR 62635","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 19, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1492"],"dockets":[],"document_number":"2014-24796","effective_on":null,"end_page":62636,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/20/2014-24796.xml","html_url":"https://www.federalregister.gov/documents/2014/10/20/2014-24796/two-phased-chemistry-manufacturing-and-controls-technical-sections-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-24796?publication_date=2014-10-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-20/2014-24796/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":359,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-20/pdf/2014-24796.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-24796.pdf?1413550206","publication_date":"2014-10-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/20/2014-24796.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-1492","supporting_documents_count":0,"docket_id":"FDA-2014-D-1492","regulation_id_number":null,"title":"Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections","checked_regulationsdotgov_at":"2015-01-12T19:45:58Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":62635,"subtype":null,"title":"Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Availability","toc_doc":"Two-Phased Chemistry, Manufacturing, and Controls Technical Sections","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}