{"abstract":"The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is establishing a public docket entitled \"Use of a Type V Drug Master File (DMF) for Model Master File (MMF) Submissions to Support Abbreviated New Drug Applications (ANDAs).\" The purpose of this docket to solicit input from interested parties on this topic.","action":"Notice; establishment of a public docket; request for comments.","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/2025/01/17/2025-01182.html","cfr_references":[],"citation":"90 FR 5892","comment_url":null,"comments_close_on":"2025-04-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the notice by April 17, 2025 to ensure that the Agency considers your comment. The docket number is FDA-2024-N-5975.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-5975"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2025-01-17","updated_at":"2025-04-18T01:56:38.364-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-5975-0001","allow_late_comments":false,"id":"FDA-2024-N-5975-0001","comment_end_date":"2025-04-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-5975","title":"Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications"}],"document_number":"2025-01182","effective_on":null,"end_page":5893,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/17/2025-01182.xml","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01182/use-of-a-type-v-drug-master-file-for-model-master-file-submissions-to-support-abbreviated-new-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-01182?publication_date=2025-01-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-17/2025-01182/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1242,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01182.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01182.pdf?1737035134","publication_date":"2025-01-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/17/2025-01182.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-5975","supporting_documents_count":0,"docket_id":"FDA-2024-N-5975","document_id":"FDA-2024-N-5975-0001","regulation_id_number":null,"title":"Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications","checked_regulationsdotgov_at":"2025-04-19T00:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5892,"subtype":null,"title":"Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments","toc_doc":"Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications","toc_subject":"Establishment of a Public Docket","topics":[],"type":"Notice","volume":90}