{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled \"Forms FDA 3542a and FDA 3542: Questions and Answers.\" This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.","action":"Notice of availability.","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/2026/06/15/2026-11966.html","cfr_references":[],"citation":"91 FR 35985","comment_url":null,"comments_close_on":"2026-08-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-D-2698"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-06-15T09:55:48.730-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-2698-0001","allow_late_comments":false,"id":"FDA-2026-D-2698-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-D-2698","title":"Forms FDA 3542a and FDA 3542:  Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2026-11966","effective_on":null,"end_page":35987,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/15/2026-11966.xml","html_url":"https://www.federalregister.gov/documents/2026/06/15/2026-11966/forms-fda-3542a-and-fda-3542-questions-and-answers-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11966?publication_date=2026-06-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-15/2026-11966/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":509,"last_updated":"2026-10-22 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-15/pdf/2026-11966.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11966.pdf?1781268314","publication_date":"2026-06-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/15/2026-11966.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2026-D-2698","supporting_documents_count":0,"docket_id":"FDA-2026-D-2698","document_id":"FDA-2026-D-2698-0001","regulation_id_number":null,"title":"Forms FDA 3542a and FDA 3542:  Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-06-16T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35985,"subtype":null,"title":"Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability","toc_doc":"Forms FDA 3542a and FDA 3542: Questions and Answers","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}