{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Nonprescription Sunscreen Drug Products--Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act\". This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.","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/2015/11/23/2015-29637.html","cfr_references":[],"citation":"80 FR 72973","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.","disposition_notes":null,"docket_ids":["Docket No.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-4033"],"dockets":[],"document_number":"2015-29637","effective_on":null,"end_page":72975,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/23/2015-29637.xml","html_url":"https://www.federalregister.gov/documents/2015/11/23/2015-29637/sunscreen-innovation-act-nonprescription-sunscreen-drug-products-content-and-format-of-data","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-29637?publication_date=2015-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-23/2015-29637/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":795,"last_updated":"2026-10-23 16:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29637.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-29637.pdf?1448027126","publication_date":"2015-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/23/2015-29637.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-4033","supporting_documents_count":0,"docket_id":"FDA-2015-D-4033","regulation_id_number":null,"title":"Sunscreen Innovation Act:  Nonprescription Sunscreen Drug Products Content and Format of Data Submissions","checked_regulationsdotgov_at":"2019-06-21T03:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72973,"subtype":null,"title":"Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability","toc_doc":"Sunscreen Innovation Act; Nonprescription Sunscreen Drug ProductsContent and Format of Data Submissions","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}