{"abstract":"The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2017 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities 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, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2017 rates for the small business establishment fee ($5,279), the non-small business establishment fee ($16,852), and the re-inspection fee ($15,837) for outsourcing facilities; provides information on how the fees for FY 2017 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2016, and will remain in effect through September 30, 2017.","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/2016/08/01/2016-18093.html","cfr_references":[],"citation":"81 FR 50528","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0007"],"dockets":[],"document_number":"2016-18093","effective_on":null,"end_page":50531,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/01/2016-18093.xml","html_url":"https://www.federalregister.gov/documents/2016/08/01/2016-18093/outsourcing-facility-fee-rates-for-fiscal-year-2017","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-18093?publication_date=2016-08-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-01/2016-18093/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":742,"last_updated":"2026-10-24 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-01/pdf/2016-18093.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-18093.pdf?1469796476","publication_date":"2016-08-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/01/2016-18093.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-2016-N-0007","supporting_documents_count":0,"docket_id":"FDA-2016-N-0007","regulation_id_number":null,"title":"Prescription Drug User Fee Act IV-Drug Safety","checked_regulationsdotgov_at":"2016-08-21T06:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50528,"subtype":null,"title":"Outsourcing Facility Fee Rates for Fiscal Year 2017","toc_doc":"Outsourcing Facility Fee Rates for Fiscal Year 2017","toc_subject":null,"topics":[],"type":"Notice","volume":81}