{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.\" This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is \"not\" required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2015/11/23/2015-29635.html","cfr_references":[],"citation":"80 FR 72972","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.","disposition_notes":null,"docket_ids":["Docket No.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-3990"],"dockets":[],"document_number":"2015-29635","effective_on":null,"end_page":72973,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/23/2015-29635.xml","html_url":"https://www.federalregister.gov/documents/2015/11/23/2015-29635/sunscreen-innovation-act-section-586cc-advisory-committee-process-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-29635?publication_date=2015-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-23/2015-29635/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":381,"last_updated":"2026-10-23 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29635.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-29635.pdf?1448027120","publication_date":"2015-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/23/2015-29635.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-3990","supporting_documents_count":0,"docket_id":"FDA-2015-D-3990","regulation_id_number":null,"title":"Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process","checked_regulationsdotgov_at":"2016-01-23T05:01:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72972,"subtype":null,"title":"Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability","toc_doc":"Sunscreen Innovation Act; Section 586C(c) Advisory Committee Process","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}