{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for a limited number of establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a prototype assessment protocol to evaluate quality management maturity (QMM). The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain experience with the prototype assessment protocol and to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment's quality management practices while providing useful feedback for the establishment. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.","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/2024/01/25/2024-01423.html","cfr_references":[],"citation":"89 FR 4950","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA intends to accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through March 25, 2024. See the \"Participation\" section of this document for instructions on submitting a request to participate and the selection process.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-5706"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-01-25T10:56:19.329-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-5706-0001","allow_late_comments":null,"id":"FDA-2023-N-5706-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-5706","title":"Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program"}],"document_number":"2024-01423","effective_on":null,"end_page":4952,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/01/25/2024-01423.xml","html_url":"https://www.federalregister.gov/documents/2024/01/25/2024-01423/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-01423?publication_date=2024-01-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-01-25/2024-01423/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":4131,"last_updated":"2026-08-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-25/pdf/2024-01423.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-01423.pdf?1706103929","publication_date":"2024-01-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/01/25/2024-01423.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2023-N-5706","supporting_documents_count":0,"docket_id":"FDA-2023-N-5706","document_id":"FDA-2023-N-5706-0001","regulation_id_number":null,"title":"Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program","checked_regulationsdotgov_at":"2024-01-26T15:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4950,"subtype":null,"title":"Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program","toc_doc":"Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program","toc_subject":null,"topics":[],"type":"Notice","volume":89}