{"abstract":"The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled \"Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)\", published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.","action":"Notice; reopening of the comment period.","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/2013/11/27/2013-28392.html","cfr_references":[],"citation":"78 FR 70953","comment_url":null,"comments_close_on":"2013-12-11","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments to the docket by December 11, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0880"],"dockets":[],"document_number":"2013-28392","effective_on":null,"end_page":70953,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/27/2013-28392.xml","html_url":"https://www.federalregister.gov/documents/2013/11/27/2013-28392/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/2013-28392?publication_date=2013-11-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-27/2013-28392/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":887,"last_updated":"2026-08-26 00:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-27/pdf/2013-28392.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-28392.pdf?1385474074","publication_date":"2013-11-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/27/2013-28392.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":"2014-01-14T17:53:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70953,"subtype":null,"title":"Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period","toc_doc":"Generic Drug User Fee Amendments of 2012; Questions and Answers (Revision 1)","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":78}