{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled \"Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.\" The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.","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/2009/07/14/E9-16702.html","cfr_references":[],"citation":"74 FR 34024","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the guidance at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0372"],"dockets":[],"document_number":"E9-16702","effective_on":null,"end_page":34025,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/07/14/E9-16702.xml","html_url":"https://www.federalregister.gov/documents/2009/07/14/E9-16702/guidance-for-industry-questions-and-answers-regarding-adverse-event-reporting-and-recordkeeping-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-16702?publication_date=2009-07-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-07-14/E9-16702/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":335,"last_updated":"2026-07-27 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-07-14/pdf/E9-16702.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-07-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/07/14/E9-16702.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Suporting Statement","document_id":"FDA-2007-D-0372-0011"},{"title":"References","document_id":"FDA-2007-D-0372-0003"},{"title":"Guidance","document_id":"FDA-2007-D-0372-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-D-0372","supporting_documents_count":3,"docket_id":"FDA-2007-D-0372","regulation_id_number":null,"title":"Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34024,"subtype":null,"title":"Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability","toc_doc":"Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":74}