{"abstract":"The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled \"Regulation of Intentionally Altered Genomic DNA in Animals\" that was announced in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.","action":"Notice of availability; extension of comment period.","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/2017/04/13/2017-07470.html","cfr_references":[],"citation":"82 FR 17844","comment_url":null,"comments_close_on":"2017-06-19","correction_of":null,"corrections":[],"dates":"We are extending the comment period on the draft guidance published January 19, 2017 (82 FR 6561). Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance, submit either electronic or written comments on the draft guidance by June 19, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-D-0394"],"dockets":[{"supporting_documents":[{"title":"See FDA-2008-D-0394-0186 ","document_id":"FDA-2008-D-0394-0262"},{"title":"Guidance document was replaced by an updated version (guide 187(2) \r\nDoc id FDA-2008-D-00394-0012","document_id":"FDA-2008-D-0394-0003"},{"title":"posted without the content file, please see FDA-2008-D-0394-0003","document_id":"FDA-2008-D-0394-0002"}],"agency_name":"FDA","documents":[{"comment_count":29,"comment_start_date":"2017-04-13","updated_at":"2023-02-28T19:15:40.849-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2008-D-0394-0325","allow_late_comments":null,"id":"FDA-2008-D-0394-0325","comment_end_date":"2017-06-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2008-D-0394","title":"Guidance for Industry; Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability\" \r\n\r\n"}],"document_number":"2017-07470","effective_on":null,"end_page":17845,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/04/13/2017-07470.xml","html_url":"https://www.federalregister.gov/documents/2017/04/13/2017-07470/regulation-of-intentionally-altered-genomic-dna-in-animals-extension-of-comment-period","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-07470?publication_date=2017-04-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-04-13/2017-07470/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":702,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-04-13/pdf/2017-07470.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-07470.pdf?1492001147","publication_date":"2017-04-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/04/13/2017-07470.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"See FDA-2008-D-0394-0186 ","document_id":"FDA-2008-D-0394-0262"},{"title":"Guidance document was replaced by an updated version (guide 187(2) \r\nDoc id FDA-2008-D-00394-0012","document_id":"FDA-2008-D-0394-0003"},{"title":"posted without the content file, please see FDA-2008-D-0394-0003","document_id":"FDA-2008-D-0394-0002"}],"comments_count":29,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-D-0394","supporting_documents_count":3,"docket_id":"FDA-2008-D-0394","document_id":"FDA-2008-D-0394-0325","regulation_id_number":null,"title":"Guidance for Industry; Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability\" \r\n\r\n","checked_regulationsdotgov_at":"2023-03-01T00:15:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17844,"subtype":null,"title":"Regulation of Intentionally Altered Genomic DNA in Animals; Extension of Comment Period","toc_doc":"Regulation of Intentionally Altered Genomic DNA in Animals","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}