{"abstract":"The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled \"Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use\" (Proposed Order), which was issued on September 24, 2021. A notice of availability for the Proposed Order appeared in the Federal Register of September 27, 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order in response to a request for an extension to allow interested persons additional time to submit comments.","action":"Proposed order; extension of comment period.","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/2021/11/22/2021-25371.html","cfr_references":[],"citation":"86 FR 66318","comment_url":null,"comments_close_on":"2021-12-27","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the Proposed Order issued on September 24, 2021 (86 FR 53322). Submit electronic comments on the Proposed Order by 11:59 p.m. Eastern Time at the end of December 27, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-1978-N-0018"],"dockets":[{"supporting_documents":[{"title":"Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen","document_id":"FDA-1978-N-0018-1051"},{"title":"Reference 190 - EPA_Using Insect Repellents Safely and Effectively","document_id":"FDA-1978-N-0018-1031"},{"title":"Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels","document_id":"FDA-1978-N-0018-1026"},{"title":"Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens","document_id":"FDA-1978-N-0018-1021"},{"title":"Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure","document_id":"FDA-1978-N-0018-1020"},{"title":"Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans","document_id":"FDA-1978-N-0018-1010"},{"title":"Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure","document_id":"FDA-1978-N-0018-1004"},{"title":"Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers","document_id":"FDA-1978-N-0018-0994"},{"title":"Reference 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment","document_id":"FDA-1978-N-0018-0993"},{"title":"Reference 148 - Stuart_1984_Deposition and Clearance of Inhaled Particles","document_id":"FDA-1978-N-0018-0989"}],"agency_name":"FDA","documents":[{"comment_count":9,"comment_start_date":"2021-11-22","updated_at":"2023-02-28T12:37:55.383-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-1978-N-0018-15847","allow_late_comments":null,"id":"FDA-1978-N-0018-15847","comment_end_date":"2021-12-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":325,"id":"FDA-1978-N-0018","title":"Sunscreen Drug Products -OPEN"}],"document_number":"2021-25371","effective_on":null,"end_page":66319,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/11/22/2021-25371.xml","html_url":"https://www.federalregister.gov/documents/2021/11/22/2021-25371/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-25371?publication_date=2021-11-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-11-22/2021-25371/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":976,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25371.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-25371.pdf?1637329530","publication_date":"2021-11-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/11/22/2021-25371.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen","document_id":"FDA-1978-N-0018-1051"},{"title":"Reference 190 - EPA_Using Insect Repellents Safely and Effectively","document_id":"FDA-1978-N-0018-1031"},{"title":"Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels","document_id":"FDA-1978-N-0018-1026"},{"title":"Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens","document_id":"FDA-1978-N-0018-1021"},{"title":"Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure","document_id":"FDA-1978-N-0018-1020"},{"title":"Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans","document_id":"FDA-1978-N-0018-1010"},{"title":"Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure","document_id":"FDA-1978-N-0018-1004"},{"title":"Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers","document_id":"FDA-1978-N-0018-0994"},{"title":"Reference 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment","document_id":"FDA-1978-N-0018-0993"},{"title":"Reference 148 - Stuart_1984_Deposition and Clearance of Inhaled Particles","document_id":"FDA-1978-N-0018-0989"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AF43/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph-","title":"Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph\n"},"comments_count":9,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1978-N-0018","supporting_documents_count":325,"docket_id":"FDA-1978-N-0018","document_id":"FDA-1978-N-0018-15847","regulation_id_number":"0910-AF43","title":"Sunscreen Drug Products -OPEN","checked_regulationsdotgov_at":"2023-02-28T17:37:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66318,"subtype":null,"title":"Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period","toc_doc":"Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order; Extension of Comment Period","toc_subject":"Amending Over-the-Counter Monograph M020:\n","topics":[],"type":"Notice","volume":86}