{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #227 entitled \"Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.\" This draft guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications. This guidance describes the options for soliciting early input from the Center for Veterinary Medicine (CVM) and the process for submission of components of the CMC technical section.","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/2024/09/17/2024-20924.html","cfr_references":[],"citation":"89 FR 76117","comment_url":null,"comments_close_on":"2024-11-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 18, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2014-D-1492"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-09-17","updated_at":"2024-09-17T10:56:45.063-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-1492-0008","allow_late_comments":false,"id":"FDA-2014-D-1492-0008","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-D-1492","title":"Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections"}],"document_number":"2024-20924","effective_on":null,"end_page":76119,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/17/2024-20924.xml","html_url":"https://www.federalregister.gov/documents/2024/09/17/2024-20924/chemistry-manufacturing-and-controls-technical-section-filing-strategies-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-20924?publication_date=2024-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-17/2024-20924/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":398,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-17/pdf/2024-20924.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20924.pdf?1726490716","publication_date":"2024-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/17/2024-20924.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-2014-D-1492","supporting_documents_count":0,"docket_id":"FDA-2014-D-1492","document_id":"FDA-2014-D-1492-0008","regulation_id_number":null,"title":"Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections","checked_regulationsdotgov_at":"2024-09-18T14:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":76117,"subtype":null,"title":"Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability","toc_doc":"Chemistry, Manufacturing, and Controls Technical Section Filing Strategies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}