{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Generic Drug User Fee Amendments of 2012: Questions and Answers.\" The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires that generic drug facilities, sites, and organizations located around the world provide identification information annually to FDA. This guidance is intended to provide 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 the requirements and commitments of GDUFA.","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/2012/08/27/2012-20944.html","cfr_references":[],"citation":"77 FR 51814","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 26, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0880"],"dockets":[],"document_number":"2012-20944","effective_on":null,"end_page":51814,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/08/27/2012-20944.xml","html_url":"https://www.federalregister.gov/documents/2012/08/27/2012-20944/draft-guidance-for-industry-on-generic-drug-user-fee-amendments-of-2012-questions-and-answers","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-20944?publication_date=2012-08-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-08-27/2012-20944/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":965,"last_updated":"2026-07-28 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-08-27/pdf/2012-20944.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-20944.pdf?1345648928","publication_date":"2012-08-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/08/27/2012-20944.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":"2012-10-29T05:01:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51814,"subtype":null,"title":"Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability","toc_doc":"Generic Drug User Fee Amendments of 2012, Questions and Answers","toc_subject":"Draft Guidances for Industry:","topics":[],"type":"Notice","volume":77}