{"abstract":"The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2016 rates for the small business establishment fee ($5,203), the non-small business establishment fee ($16,465), and the reinspection fee ($15,610) for outsourcing facilities; provides information on how the fees for FY 2016 were determined; and describes the payment procedures outsourcing facilities should follow.","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/2015/08/03/2015-18916.html","cfr_references":[],"citation":"80 FR 46007","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0007"],"dockets":[],"document_number":"2015-18916","effective_on":null,"end_page":46010,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/03/2015-18916.xml","html_url":"https://www.federalregister.gov/documents/2015/08/03/2015-18916/outsourcing-facility-fee-rates-for-fiscal-year-2016","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-18916?publication_date=2015-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-03/2015-18916/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1441,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18916.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-18916.pdf?1438346776","publication_date":"2015-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/03/2015-18916.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-2015-N-0007","supporting_documents_count":0,"docket_id":"FDA-2015-N-0007","regulation_id_number":null,"title":"Prescription Drug User Fee Act IV-Drug Safety","checked_regulationsdotgov_at":"2015-08-23T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46007,"subtype":null,"title":"Outsourcing Facility Fee Rates for Fiscal Year 2016","toc_doc":"Outsourcing Facility Fee Rates for Fiscal Year 2016","toc_subject":null,"topics":[],"type":"Notice","volume":80}