{"abstract":"The Food and Drug Administration (FDA) is announcing the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation. A public hearing in September 2014 provided an opportunity for public input on future policy priorities. FDA is seeking additional written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups.","action":"Notice; reopening of docket; request for comments.","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/2015/02/06/2015-02401.html","cfr_references":[],"citation":"80 FR 6729","comment_url":null,"comments_close_on":"2015-03-09","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by March 9, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1168"],"dockets":[{"supporting_documents":[{"title":"Transcript  Text Version re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014, FDA-2014-N-1168-0026 and FDA-2014-N-1168-0027","document_id":"FDA-2014-N-1168-0028"},{"title":"Testimony from Marcie Coates re Comment from Mylan Inc.","document_id":"FDA-2014-N-1168-0025"}],"agency_name":null,"documents":[{"comment_count":5,"comment_start_date":"2015-02-06","updated_at":"2023-02-28T17:06:30.124-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-1168-0029","allow_late_comments":null,"id":"FDA-2014-N-1168-0029","comment_end_date":"2015-03-10","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2014-N-1168","title":"Generic Drug User Fee Amendments of 2012"}],"document_number":"2015-02401","effective_on":null,"end_page":6731,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/06/2015-02401.xml","html_url":"https://www.federalregister.gov/documents/2015/02/06/2015-02401/generic-drug-user-fee-amendments-of-2012-september-2014-public-hearing-on-policy-development","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-02401?publication_date=2015-02-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-06/2015-02401/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":654,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-06/pdf/2015-02401.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-02401.pdf?1423144491","publication_date":"2015-02-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/06/2015-02401.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Transcript  Text Version re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014, FDA-2014-N-1168-0026 and FDA-2014-N-1168-0027","document_id":"FDA-2014-N-1168-0028"},{"title":"Testimony from Marcie Coates re Comment from Mylan Inc.","document_id":"FDA-2014-N-1168-0025"}],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1168","supporting_documents_count":2,"docket_id":"FDA-2014-N-1168","document_id":"FDA-2014-N-1168-0029","regulation_id_number":null,"title":"Generic Drug User Fee Amendments of 2012","checked_regulationsdotgov_at":"2023-02-28T22:06:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6729,"subtype":null,"title":"Generic Drug User Fee Amendments of 2012; September 2014 Public Hearing on Policy Development; Reopening of Docket; Request for Comments","toc_doc":"Public Hearing on Policy Development; Reopening of Docket","toc_subject":"Generic Drug User Fee Amendments:","topics":[],"type":"Notice","volume":80}