{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"User Fees and Refunds for Premarket Approval Applications.\" This guidance outlines the types of premarket approval applications (PMAs), including supplements and other submissions, that are subject to user fees as well as those that do not have an associated fee. The guidance also identifies industry and FDA actions on these submissions that may result in a partial refund of the fee. The guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).","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/2003/11/24/03-29196.html","cfr_references":[],"citation":"68 FR 65940","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2003D-0512"],"dockets":[],"document_number":"03-29196","effective_on":null,"end_page":65941,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/11/24/03-29196.xml","html_url":"https://www.federalregister.gov/documents/2003/11/24/03-29196/guidance-for-industry-and-food-and-drug-administration-staff-user-fees-and-refunds-for-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-29196?publication_date=2003-11-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-11-24/03-29196/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-11-24/pdf/03-29196.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-11-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/11/24/03-29196.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-02-27T18:27:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65940,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff; User Fees and Refunds for Premarket Approval Applications; Availability","toc_doc":"Premarket approval applications user fees and refunds","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}