{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the over-the-counter (OTC) monograph order request (OMOR) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OMORs. This notice publishes the OMOR fee rates under OMUFA for FY 2025. FDA plans to publish the FY 2025 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of OMUFA facility fee rate publication for prior fiscal years).","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/2024/07/31/2024-16878.html","cfr_references":[],"citation":"89 FR 61455","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These OTC OMORs fees are effective on October 1, 2024, and will remain in effect through September 30, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3001"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-07-31T11:56:28.396-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3001-0001","allow_late_comments":null,"id":"FDA-2024-N-3001-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-3001","title":"Over-the-Counter Monograph Drug User Fee Program--OTC Monograph Order Request Fee Rates for Fiscal Year 2025"}],"document_number":"2024-16878","effective_on":"2024-10-01","end_page":61457,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/07/31/2024-16878.xml","html_url":"https://www.federalregister.gov/documents/2024/07/31/2024-16878/over-the-counter-monograph-drug-user-fee-program-otc-monograph-order-request-fee-rates-for-fiscal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-16878?publication_date=2024-07-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-07-31/2024-16878/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2183,"last_updated":"2026-10-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-31/pdf/2024-16878.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16878.pdf?1722343536","publication_date":"2024-07-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/07/31/2024-16878.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-2024-N-3001","supporting_documents_count":0,"docket_id":"FDA-2024-N-3001","document_id":"FDA-2024-N-3001-0001","regulation_id_number":null,"title":"Over-the-Counter Monograph Drug User Fee Program--OTC Monograph Order Request Fee Rates for Fiscal Year 2025","checked_regulationsdotgov_at":"2024-08-01T15:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61455,"subtype":null,"title":"Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025","toc_doc":"Over-the-Counter Monograph Order Requests Fee Rates for Fiscal Year 2025","toc_subject":"Over-the-Counter Monograph Drug User Fee Program:\n","topics":[],"type":"Notice","volume":89}