{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled \"Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.\" This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.","action":"Notice of availability.","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/2016/11/18/2016-27761.html","cfr_references":[],"citation":"81 FR 81774","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-2012-D-0880"],"dockets":[],"document_number":"2016-27761","effective_on":null,"end_page":81776,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/18/2016-27761.xml","html_url":"https://www.federalregister.gov/documents/2016/11/18/2016-27761/generic-drug-user-fee-amendments-of-2012-questions-and-answers-related-to-user-fee-assessments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-27761?publication_date=2016-11-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-18/2016-27761/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":434,"last_updated":"2026-08-25 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27761.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-27761.pdf?1479390365","publication_date":"2016-11-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/18/2016-27761.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Final Guidance for Industry - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017","document_id":"FDA-2012-D-0880-0035"},{"title":"Assessing User Fees Under the\nGeneric Drug User Fee Amendments of\n2017; Guidance for Industry;\nAvailability","document_id":"FDA-2012-D-0880-0034"},{"title":"Draft Guidance for Industry - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017","document_id":"FDA-2012-D-0880-0030"},{"title":"Assessing User Fees Under the Generic Drug User Fee Amendments of\n2017; Draft Guidance for Industry; Availability","document_id":"FDA-2012-D-0880-0029"},{"title":"Draft Guidance for Industry on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017","document_id":"FDA-2012-D-0880-0024"},{"title":"Assessing User Fees Under the Generic Drug User Fee Amendments of \n2017; Draft Guidance for Industry; Availability","document_id":"FDA-2012-D-0880-0023"},{"title":"Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments Guidance for Industry","document_id":"FDA-2012-D-0880-0022"},{"title":"Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability","document_id":"FDA-2012-D-0880-0021"},{"title":"Final Guidance for Industry Generic Drug User Fee Amendments of 2012 - Questions and Answers Related t User Fee Assessments","document_id":"FDA-2012-D-0880-0020"},{"title":"Draft Guidance for Generic Drug User Fee Amendments of 2012 Questions and Answers","document_id":"FDA-2012-D-0880-0019"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0880","supporting_documents_count":16,"docket_id":"FDA-2012-D-0880","regulation_id_number":null,"title":"Generic Drug User Fee Act: Questions and Answers","checked_regulationsdotgov_at":"2016-12-08T06:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":81774,"subtype":null,"title":"Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability","toc_doc":"Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}