{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.\" The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled \"Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.\"","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/2009/12/22/E9-30326.html","cfr_references":[],"citation":"74 FR 68068","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidance at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0013"],"dockets":[],"document_number":"E9-30326","effective_on":null,"end_page":68069,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/12/22/E9-30326.xml","html_url":"https://www.federalregister.gov/documents/2009/12/22/E9-30326/international-conference-on-harmonisation-guidance-on-q4b-evaluation-and-recommendation-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-30326?publication_date=2009-12-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-12-22/E9-30326/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":68,"last_updated":"2026-07-28 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-12-22/pdf/E9-30326.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-12-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/12/22/E9-30326.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2009-12-22T20:58:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":68068,"subtype":null,"title":"International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8 on Sterility Test General Chapter; Availability","toc_doc":"Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions","toc_subject":"International Conference on Harmonisation:","topics":[],"type":"Notice","volume":74}