{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled \"Potency Assessment of Active Immunotherapy Products.\" The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on \"Potency Assurance for Cellular and Gene Therapy Products\" with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.","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/2026/08/20/2026-16960.html","cfr_references":[],"citation":"91 FR 53880","comment_url":"http://www.regulations.gov/commenton/FDA-2026-D-8561-0001","comments_close_on":"2026-11-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 18, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2026-D-8561"],"dockets":[{"supporting_documents":[{"title":"NOA Reference 2 - FR Application of Current Statutory Authorities to Human Somatic Cell-Therapy Products and Gene Therapy Products","document_id":"FDA-2026-D-8561-0015"},{"title":"NOA Reference 1 - Potency Assurance for Cellular and Gene Therapy Products Draft Guidance for Industry","document_id":"FDA-2026-D-8561-0014"},{"title":"Guidance Reference 11 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry","document_id":"FDA-2026-D-8561-0013"},{"title":"Guidance Reference 10 - Current Good Manufacturing Practice for Phase 1 Investigational Drugs Guidance for Industry","document_id":"FDA-2026-D-8561-0012"},{"title":"Guidance Reference 9 - Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy","document_id":"FDA-2026-D-8561-0011"},{"title":"Guidance Reference 8 - Chemistry Manufacturing and Control Information for Human Gene Therapy Investigational New Drug Applications Guidance for Industry","document_id":"FDA-2026-D-8561-0010"},{"title":"Guidance Reference 7 - Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological Biological Products","document_id":"FDA-2026-D-8561-0009"},{"title":"Guidance Reference 6 - Quality of Biotechnological Products Stability Testing of Biotechnological Biological Products Guidance for Industry","document_id":"FDA-2026-D-8561-0008"},{"title":"Guidance Reference 5 - Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products Draft Guidance for Industry","document_id":"FDA-2026-D-8561-0007"},{"title":"Guidance Reference 4 - Q5E Comparability of Biotechnological Biological Products Subject to Changes in Their Manufacturing Process Guidance for Industry","document_id":"FDA-2026-D-8561-0006"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-20","updated_at":"2026-08-20T10:57:53.151-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-8561-0001","allow_late_comments":false,"id":"FDA-2026-D-8561-0001","comment_end_date":"2026-11-19","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":13,"id":"FDA-2026-D-8561","title":"Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability"}],"document_number":"2026-16960","effective_on":null,"end_page":53881,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/20/2026-16960.xml","html_url":"https://www.federalregister.gov/documents/2026/08/20/2026-16960/potency-assessment-of-active-immunotherapy-products-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16960?publication_date=2026-08-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-20/2026-16960/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":687,"last_updated":"2026-10-24 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-20/pdf/2026-16960.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16960.pdf?1787143517","publication_date":"2026-08-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/20/2026-16960.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"NOA Reference 2 - FR Application of Current Statutory Authorities to Human Somatic Cell-Therapy Products and Gene Therapy Products","document_id":"FDA-2026-D-8561-0015"},{"title":"NOA Reference 1 - Potency Assurance for Cellular and Gene Therapy Products Draft Guidance for Industry","document_id":"FDA-2026-D-8561-0014"},{"title":"Guidance Reference 11 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry","document_id":"FDA-2026-D-8561-0013"},{"title":"Guidance Reference 10 - Current Good Manufacturing Practice for Phase 1 Investigational Drugs Guidance for Industry","document_id":"FDA-2026-D-8561-0012"},{"title":"Guidance Reference 9 - Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy","document_id":"FDA-2026-D-8561-0011"},{"title":"Guidance Reference 8 - Chemistry Manufacturing and Control Information for Human Gene Therapy Investigational New Drug Applications Guidance for Industry","document_id":"FDA-2026-D-8561-0010"},{"title":"Guidance Reference 7 - Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological Biological Products","document_id":"FDA-2026-D-8561-0009"},{"title":"Guidance Reference 6 - Quality of Biotechnological Products Stability Testing of Biotechnological Biological Products Guidance for Industry","document_id":"FDA-2026-D-8561-0008"},{"title":"Guidance Reference 5 - Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products Draft Guidance for Industry","document_id":"FDA-2026-D-8561-0007"},{"title":"Guidance Reference 4 - Q5E Comparability of Biotechnological Biological Products Subject to Changes in Their Manufacturing Process Guidance for Industry","document_id":"FDA-2026-D-8561-0006"}],"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-2026-D-8561","supporting_documents_count":13,"docket_id":"FDA-2026-D-8561","document_id":"FDA-2026-D-8561-0001","regulation_id_number":null,"title":"Potency Assessment of Active Immunotherapy Products; 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