{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.\" This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures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.","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/2017/10/30/2017-23526.html","cfr_references":[],"citation":"82 FR 50142","comment_url":null,"comments_close_on":"2017-12-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the guidance December 29, 2017 to ensure that the Agency considers your comment on this draft guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0880"],"dockets":[{"supporting_documents":[{"title":"Final Guidance for Industry - Assessing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; 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