{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.\" This draft guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2015/11/23/2015-29634.html","cfr_references":[],"citation":"80 FR 72970","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4012"],"dockets":[],"document_number":"2015-29634","effective_on":null,"end_page":72971,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/23/2015-29634.xml","html_url":"https://www.federalregister.gov/documents/2015/11/23/2015-29634/sunscreen-innovation-act-withdrawal-of-a-586a-request-or-pending-request-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-29634?publication_date=2015-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-23/2015-29634/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":289,"last_updated":"2026-10-24 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29634.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-29634.pdf?1448027120","publication_date":"2015-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/23/2015-29634.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-4012","supporting_documents_count":0,"docket_id":"FDA-2015-D-4012","regulation_id_number":null,"title":"Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request","checked_regulationsdotgov_at":"2016-01-23T05:01:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72970,"subtype":null,"title":"Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability","toc_doc":"Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}