{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Self- Identification of Generic Drug Facilities, Sites, and Organizations.\" On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry as it prepares to meet the self- identification requirement. It explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.","action":"Notice.","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/2012/08/27/2012-20946.html","cfr_references":[],"citation":"77 FR 51811","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments concerning the proposed collection of information by October 26, 2012. Submit either electronic or written comments on the draft guidance by October 26, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0881"],"dockets":[],"document_number":"2012-20946","effective_on":null,"end_page":51814,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/08/27/2012-20946.xml","html_url":"https://www.federalregister.gov/documents/2012/08/27/2012-20946/draft-guidance-for-industry-on-self-identification-of-generic-drug-facilities-sites-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-20946?publication_date=2012-08-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-08-27/2012-20946/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":874,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-08-27/pdf/2012-20946.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-20946.pdf?1345648933","publication_date":"2012-08-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/08/27/2012-20946.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-0881","supporting_documents_count":0,"docket_id":"FDA-2012-D-0881","regulation_id_number":null,"title":"Self-Identification of Generic Drug Facilities, Sites, and Organizations","checked_regulationsdotgov_at":"2012-10-29T05:01:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51811,"subtype":null,"title":"Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability","toc_doc":"Self-Identification of Generic Drug Facilities, Sites, and Organizations","toc_subject":"Draft Guidances for Industry:","topics":[],"type":"Notice","volume":77}