{"abstract":"The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled \"Investigational New Drug Applications (INDs)--Determining whether Human Research Studies can be Conducted without an IND,\" published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).","action":"Notice; reopening of the 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/2014/02/06/2014-02550.html","cfr_references":[],"citation":"79 FR 7204","comment_url":null,"comments_close_on":"2014-04-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by April 7, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0503"],"dockets":[],"document_number":"2014-02550","effective_on":null,"end_page":7204,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/06/2014-02550.xml","html_url":"https://www.federalregister.gov/documents/2014/02/06/2014-02550/guidance-for-clinical-investigators-sponsors-and-institutional-review-boards-on-investigational-new","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-02550?publication_date=2014-02-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-06/2014-02550/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1127,"last_updated":"2026-07-28 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02550.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-02550.pdf?1391608465","publication_date":"2014-02-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/06/2014-02550.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-11T05:03:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7204,"subtype":null,"title":"Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period","toc_doc":"Determining whether Human Research Studies can be Conducted without an Investigational New Drug Application; Reopening of the Comment Period","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":79}