{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2024 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs, and for certain submissions related to generic investigational new animal drug (JINAD) files. This notice establishes the fee rates for FY 2024.","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/2023/10/23/2023-23374.html","cfr_references":[],"citation":"88 FR 72767","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2023, and will remain in effect through September 30, 2024. The fee rates for requests to establish a JINAD file, and for certain submissions to JINAD files established prior to October 1, 2023, are effective on October 1, 2023, and will remain in effect through September 30, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-4468"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-10-23","updated_at":"2023-10-23T16:56:06.728-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-4468-0001","allow_late_comments":null,"id":"FDA-2023-N-4468-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-4468","title":"Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024"}],"document_number":"2023-23374","effective_on":null,"end_page":72771,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/10/23/2023-23374.xml","html_url":"https://www.federalregister.gov/documents/2023/10/23/2023-23374/animal-generic-drug-user-fee-program-rates-and-payment-procedures-for-fiscal-year-2024","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-23374?publication_date=2023-10-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-10-23/2023-23374/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":584,"last_updated":"2026-10-23 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-23/pdf/2023-23374.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23374.pdf?1697806038","publication_date":"2023-10-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/10/23/2023-23374.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-4468","supporting_documents_count":0,"docket_id":"FDA-2023-N-4468","document_id":"FDA-2023-N-4468-0001","regulation_id_number":null,"title":"Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024","checked_regulationsdotgov_at":"2023-10-24T19:55:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72767,"subtype":null,"title":"Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024","toc_doc":"Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024","toc_subject":null,"topics":[],"type":"Notice","volume":88}