{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products under an investigational new drug (IND) application, where warranted, based upon the anticipated clinical benefit of earlier patient access to the products. FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.","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/2022/10/31/2022-23575.html","cfr_references":[],"citation":"87 FR 65596","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Starting April 1, 2023, FDA will accept requests to participate in the CDRP program. See the \"Participation\" section of this document for eligibility criteria, instructions on how to submit a request to participate, and selection criteria and process.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-2396"],"dockets":[{"supporting_documents":[{"title":"SOPP-8212-Breakthrough-Therapy-Products-V6","document_id":"FDA-2022-N-2396-0007"},{"title":"SOPP-8101.1-Regulatory-Meetings-Sponsors-Applicants-Drugs-Biological-Products_V14","document_id":"FDA-2022-N-2396-0006"},{"title":"SOPP 8212: Breakthrough Therapy Products - Designation and Management RE Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement","document_id":"FDA-2022-N-2396-0003"},{"title":"MAPP 6025.6 Good Review Practice: Management of Breakthrough Therapy Designated Drugs and Biologics RE Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement","document_id":"FDA-2022-N-2396-0002"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-10-31","updated_at":"2023-02-27T21:04:30.252-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-2396-0001","allow_late_comments":null,"id":"FDA-2022-N-2396-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2022-N-2396","title":"Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement."}],"document_number":"2022-23575","effective_on":null,"end_page":65598,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/10/31/2022-23575.xml","html_url":"https://www.federalregister.gov/documents/2022/10/31/2022-23575/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-23575?publication_date=2022-10-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-10-31/2022-23575/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":11943,"last_updated":"2026-09-21 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-31/pdf/2022-23575.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-23575.pdf?1666961118","publication_date":"2022-10-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/10/31/2022-23575.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"SOPP-8212-Breakthrough-Therapy-Products-V6","document_id":"FDA-2022-N-2396-0007"},{"title":"SOPP-8101.1-Regulatory-Meetings-Sponsors-Applicants-Drugs-Biological-Products_V14","document_id":"FDA-2022-N-2396-0006"},{"title":"SOPP 8212: Breakthrough Therapy Products - Designation and Management RE Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement","document_id":"FDA-2022-N-2396-0003"},{"title":"MAPP 6025.6 Good Review Practice: Management of Breakthrough Therapy Designated Drugs and Biologics RE Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement","document_id":"FDA-2022-N-2396-0002"}],"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-2022-N-2396","supporting_documents_count":4,"docket_id":"FDA-2022-N-2396","document_id":"FDA-2022-N-2396-0001","regulation_id_number":null,"title":"Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement.","checked_regulationsdotgov_at":"2023-02-28T02:04:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65596,"subtype":null,"title":"Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement","toc_doc":"Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program","toc_subject":null,"topics":[],"type":"Notice","volume":87}