{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.\" This guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled \"Draft Interim Guidance Document for Waivers of and Reductions in User Fees,\" issued July 16, 1993.","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/2011/09/27/2011-24739.html","cfr_references":[],"citation":"76 FR 59705","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0108"],"dockets":[],"document_number":"2011-24739","effective_on":null,"end_page":59706,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/09/27/2011-24739.xml","html_url":"https://www.federalregister.gov/documents/2011/09/27/2011-24739/guidance-for-industry-on-user-fee-waivers-reductions-and-refunds-for-drug-and-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-24739?publication_date=2011-09-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-09-27/2011-24739/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":106,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-09-27/pdf/2011-24739.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-09-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/09/27/2011-24739.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-D-0108","supporting_documents_count":0,"docket_id":"FDA-2011-D-0108","regulation_id_number":null,"title":"Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability","checked_regulationsdotgov_at":"2011-10-15T18:52:02Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59705,"subtype":null,"title":"Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability","toc_doc":"User Fee Waivers, Reductions, and Refunds for Drug and Biological Products","toc_subject":"Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":76}