{"abstract":"The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information and to allow 60 days for public comment. This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).","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/2015/10/21/2015-26673.html","cfr_references":[],"citation":"80 FR 63797","comment_url":null,"comments_close_on":"2015-12-21","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by December 21, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0372"],"dockets":[{"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"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2015-10-21","updated_at":"2023-02-28T23:52:32.252-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2007-D-0372-0014","allow_late_comments":null,"id":"FDA-2007-D-0372-0014","comment_end_date":"2015-12-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2007-D-0372","title":"Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act"}],"document_number":"2015-26673","effective_on":null,"end_page":63799,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/21/2015-26673.xml","html_url":"https://www.federalregister.gov/documents/2015/10/21/2015-26673/agency-information-collection-activities-proposed-collection-comment-request-adverse-event-reporting","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-26673?publication_date=2015-10-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-21/2015-26673/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":937,"last_updated":"2026-08-25 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-21/pdf/2015-26673.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-26673.pdf?1445345155","publication_date":"2015-10-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/21/2015-26673.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_count":0,"agency_id":"FDA","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","document_id":"FDA-2007-D-0372-0014","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","checked_regulationsdotgov_at":"2023-03-01T04:52:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63797,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act","toc_doc":"Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":80}