{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Q3D(R2) Guideline for Elemental Impurities.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance revises the guidance for industry \"Q3D(R1) Elemental Impurities\" issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. The guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.","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/2022/09/15/2022-19997.html","cfr_references":[],"citation":"87 FR 56683","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 15, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1156"],"dockets":[{"supporting_documents":[{"title":"Q3D(R2) ELEMENTAL IMPURITIES Guidance for Industry","document_id":"FDA-2013-D-1156-0033"},{"title":"Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0032"},{"title":"Q3D(R2) Elemental Impurities; Draft Guidance for Industry","document_id":"FDA-2013-D-1156-0030"},{"title":"Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0029"},{"title":"Q3D(R1) Elemental Impurities; Guidance for Industry","document_id":"FDA-2013-D-1156-0027"},{"title":"Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0026"},{"title":"01-Draft Guidance for Industry ICH Q3D Elemental Impurities","document_id":"FDA-2013-D-1156-0022"},{"title":"Q3D(R1) Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0021"},{"title":"Q3D Elemental Impurities Guidance for Industry","document_id":"FDA-2013-D-1156-0019"},{"title":"International Conference on Harmonisation; Guidance on Q3D\nElemental Impurities; Availability","document_id":"FDA-2013-D-1156-0018"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-09-15","updated_at":"2023-02-27T20:19:01.343-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-1156-0032","allow_late_comments":null,"id":"FDA-2013-D-1156-0032","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":12,"id":"FDA-2013-D-1156","title":"International Conference on Harmonisation; On Elemental Impurities"}],"document_number":"2022-19997","effective_on":null,"end_page":56684,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/15/2022-19997.xml","html_url":"https://www.federalregister.gov/documents/2022/09/15/2022-19997/q3dr2-guideline-for-elemental-impurities-international-council-for-harmonisation-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-19997?publication_date=2022-09-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-15/2022-19997/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1181,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-15/pdf/2022-19997.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-19997.pdf?1663159536","publication_date":"2022-09-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/15/2022-19997.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Q3D(R2) ELEMENTAL IMPURITIES Guidance for Industry","document_id":"FDA-2013-D-1156-0033"},{"title":"Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0032"},{"title":"Q3D(R2) Elemental Impurities; Draft Guidance for Industry","document_id":"FDA-2013-D-1156-0030"},{"title":"Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0029"},{"title":"Q3D(R1) Elemental Impurities; Guidance for Industry","document_id":"FDA-2013-D-1156-0027"},{"title":"Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0026"},{"title":"01-Draft Guidance for Industry ICH Q3D Elemental Impurities","document_id":"FDA-2013-D-1156-0022"},{"title":"Q3D(R1) Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability","document_id":"FDA-2013-D-1156-0021"},{"title":"Q3D Elemental Impurities Guidance for Industry","document_id":"FDA-2013-D-1156-0019"},{"title":"International Conference on Harmonisation; Guidance on Q3D\nElemental Impurities; Availability","document_id":"FDA-2013-D-1156-0018"}],"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-2013-D-1156","supporting_documents_count":12,"docket_id":"FDA-2013-D-1156","document_id":"FDA-2013-D-1156-0032","regulation_id_number":null,"title":"International Conference on Harmonisation; On Elemental Impurities","checked_regulationsdotgov_at":"2023-02-28T01:19:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56683,"subtype":null,"title":"Q3D(R2)-Guideline for Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"Elemental Impurities; International Council for Harmonisation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}