{"abstract":"Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA or Agency) announces its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS.","action":"Notice of intent.","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/2021/05/13/2021-10091.html","cfr_references":[],"citation":"86 FR 26224","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This notice initiates the public scoping process that will close on June 14, 2021. FDA will consider comments in response to this notice to determine the need for any public scoping meetings prior to the preparation of a draft EIS. In order to be considered during the preparation of the draft EIS, all comments must be received prior to the close of the public scoping period. FDA anticipates that if any public scoping meetings are necessary, due to the impact of this COVID- 19 pandemic, such meetings will be held virtually via a live webcast. See FDA's website for periodic updates, available at https:// www.fda.gov/drugs/guidance-compliance-regulatory-information and search for Environmental Impact Statement. FDA will provide additional opportunities for public participation upon publication of the draft EIS.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0352"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":22,"comment_start_date":"2021-05-13","updated_at":"2023-03-01T14:10:23.150-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0352-0001","allow_late_comments":null,"id":"FDA-2021-N-0352-0001","comment_end_date":"2021-09-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-N-0352","title":"Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use CLOSED 09/27/2021"}],"document_number":"2021-10091","effective_on":null,"end_page":26225,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/13/2021-10091.xml","html_url":"https://www.federalregister.gov/documents/2021/05/13/2021-10091/intent-to-prepare-an-environmental-impact-statement-for-certain-sunscreen-drug-products-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10091?publication_date=2021-05-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-13/2021-10091/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2031,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-13/pdf/2021-10091.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10091.pdf?1620823522","publication_date":"2021-05-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/13/2021-10091.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":22,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0352","supporting_documents_count":0,"docket_id":"FDA-2021-N-0352","document_id":"FDA-2021-N-0352-0001","regulation_id_number":null,"title":"Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use CLOSED 09/27/2021","checked_regulationsdotgov_at":"2023-03-01T19:10:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26224,"subtype":null,"title":"Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use","toc_doc":"Certain Sunscreen Drug Products for Over-The-Counter Use","toc_subject":"Environmental Impact Statements; Availability, etc.:\n","topics":[],"type":"Notice","volume":86}