{"abstract":"The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled \"Labeling for Biosimilar Products; Draft Guidance for Industry; Availability\" that appeared in the Federal Register of April 4, 2016. The Agency is taking this action 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/2016/06/06/2016-13223.html","cfr_references":[],"citation":"81 FR 36313","comment_url":null,"comments_close_on":"2016-08-02","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-0643"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":11354,"comment_start_date":"2016-06-06","updated_at":"2023-03-01T01:05:09.414-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-D-0643-0003","allow_late_comments":null,"id":"FDA-2016-D-0643-0003","comment_end_date":"2016-08-03","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-D-0643","title":"Labeling for Biosimilar Products"}],"document_number":"2016-13223","effective_on":null,"end_page":36314,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/06/2016-13223.xml","html_url":"https://www.federalregister.gov/documents/2016/06/06/2016-13223/labeling-for-biosimilar-products-draft-guidance-for-industry-availability-extension-of-comment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-13223?publication_date=2016-06-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-06/2016-13223/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":653,"last_updated":"2026-09-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-06/pdf/2016-13223.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-13223.pdf?1464958078","publication_date":"2016-06-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/06/2016-13223.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":11354,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-0643","supporting_documents_count":0,"docket_id":"FDA-2016-D-0643","document_id":"FDA-2016-D-0643-0003","regulation_id_number":null,"title":"Labeling for Biosimilar Products","checked_regulationsdotgov_at":"2023-03-01T06:05:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36313,"subtype":null,"title":"Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period","toc_doc":"Labeling for Biosimilar Products; Extension of Comment Period","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}