{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document entitled \"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.\" The guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The guidance announced in this notice finalizes the draft guidance, \"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products,\" dated December 2017 and supersedes the document entitled \"Guidance for Industry: Changes to an Approved Application: Biological Products,\" dated July 1997 (July 1997 guidance).","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/2021/06/24/2021-13392.html","cfr_references":[],"citation":"86 FR 33310","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 24, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-1995-D-0288 (Formerly Docket No. 95D-0052)"],"dockets":[],"document_number":"2021-13392","effective_on":null,"end_page":33312,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/06/24/2021-13392.xml","html_url":"https://www.federalregister.gov/documents/2021/06/24/2021-13392/chemistry-manufacturing-and-controls-changes-to-an-approved-application-certain-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-13392?publication_date=2021-06-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-06-24/2021-13392/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":788,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-06-24/pdf/2021-13392.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-13392.pdf?1624452363","publication_date":"2021-06-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/06/24/2021-13392.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Ref. 23 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research March 2019 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry","document_id":"FDA-1995-D-0288-0055"},{"title":"Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry","document_id":"FDA-1995-D-0288-0054"},{"title":"Ref. 9 - Comparability Protocols for Human Drugs and Biologics April 2016 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry","document_id":"FDA-1995-D-0288-0053"},{"title":"Ref. 7 - ICH Q 12 Annex RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry","document_id":"FDA-1995-D-0288-0052"},{"title":"Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry","document_id":"FDA-1995-D-0288-0051"},{"title":"26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry","document_id":"FDA-1995-D-0288-0031"},{"title":"25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Dra","document_id":"FDA-1995-D-0288-0030"},{"title":"23 Reference 22 - Guidance Document Post-Notice of Compliance (NOC) Changes Quality Document - Canada_ca re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry","document_id":"FDA-1995-D-0288-0026"},{"title":"22 Reference 21 - Guidance for Industry Qualtiy Systems Approach to Pharamceutical CGMP Regulations re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry","document_id":"FDA-1995-D-0288-0025"},{"title":"21 Reference 20 -Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingrediants re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry","document_id":"FDA-1995-D-0288-0024"}],"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-1995-D-0288","supporting_documents_count":34,"docket_id":"FDA-1995-D-0288","document_id":"FDA-1995-D-0288-0048","regulation_id_number":null,"title":"Changes to be Reported for Product and Establishment License Application; Guidance","checked_regulationsdotgov_at":"2021-06-25T03:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33310,"subtype":null,"title":"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability","toc_doc":"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}