{"abstract":"The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2013 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2013.","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/2012/08/01/2012-18710.html","cfr_references":[],"citation":"77 FR 45629","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0807"],"dockets":[],"document_number":"2012-18710","effective_on":null,"end_page":45634,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/08/01/2012-18710.xml","html_url":"https://www.federalregister.gov/documents/2012/08/01/2012-18710/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2013","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-18710?publication_date=2012-08-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-08-01/2012-18710/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":174,"last_updated":"2026-10-23 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-08-01/pdf/2012-18710.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-18710.pdf?1343739079","publication_date":"2012-08-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/08/01/2012-18710.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-2012-N-0807","supporting_documents_count":0,"docket_id":"FDA-2012-N-0807","regulation_id_number":null,"title":"Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013","checked_regulationsdotgov_at":"2012-08-21T08:25:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45629,"subtype":null,"title":"Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013","toc_doc":"Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013","toc_subject":null,"topics":[],"type":"Notice","volume":77}