{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.\" This guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. This guidance is finalizing FDA's draft guidance for industry \"Assessing User Fees Under the Generic Drug User Fee Amendments of 2017,\" published in November 2019.","action":"Notice of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/2022/05/18/2022-10702.html","cfr_references":[],"citation":"87 FR 30229","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 18, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0880"],"dockets":[],"document_number":"2022-10702","effective_on":null,"end_page":30230,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/18/2022-10702.xml","html_url":"https://www.federalregister.gov/documents/2022/05/18/2022-10702/assessing-user-fees-under-the-generic-drug-user-fee-amendments-of-2017-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-10702?publication_date=2022-05-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-18/2022-10702/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":358,"last_updated":"2026-08-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-18/pdf/2022-10702.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10702.pdf?1652791535","publication_date":"2022-05-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/18/2022-10702.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_count":0,"agency_id":"FDA","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","document_id":"FDA-2012-D-0880-0034","regulation_id_number":null,"title":"Generic Drug User Fee Act: Questions and Answers","checked_regulationsdotgov_at":"2022-05-19T03:30:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30229,"subtype":null,"title":"Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Guidance for Industry; Availability","toc_doc":"Assessing User Fees under the Generic Drug User Fee Amendments of 2017","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}