{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Completeness Assessments for Type II API DMFs Under GDUFA\". It finalizes the draft guidance entitled \"Initial Completeness Assessments for Type II API DMFs Under GDUFA\", which published on October 2, 2012. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).","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/2016/02/16/2016-02969.html","cfr_references":[],"citation":"81 FR 7815","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-1010"],"dockets":[],"document_number":"2016-02969","effective_on":null,"end_page":7816,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/02/16/2016-02969.xml","html_url":"https://www.federalregister.gov/documents/2016/02/16/2016-02969/completeness-assessments-for-type-ii-active-pharmaceutical-ingredient-drug-master-files-under-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-02969?publication_date=2016-02-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-02-16/2016-02969/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":559,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-02-16/pdf/2016-02969.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-02969.pdf?1455284739","publication_date":"2016-02-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/02/16/2016-02969.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-1010","supporting_documents_count":0,"docket_id":"FDA-2012-D-1010","regulation_id_number":null,"title":"Completeness Assessments for Type II API DMFs Under GDUFA","checked_regulationsdotgov_at":"2016-03-07T06:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7815,"subtype":null,"title":"Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability","toc_doc":"Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files under the Generic Drug User Fee Amendments","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}