{"abstract":"The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient.","action":"Proposed rule.","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/2016/04/04/2016-07612.html","cfr_references":[{"chapter":null,"citation_url":null,"part":330,"title":21}],"citation":"81 FR 19069","comment_url":null,"comments_close_on":"2016-06-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by June 3, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 3, 2016, (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0543"],"dockets":[{"supporting_documents":[{"title":"Nonprescription Sunscreen Drug Products ? Format and Content of Data Submissions Guidance for Industry","document_id":"FDA-2016-N-0543-0014"},{"title":"Reference 5C - Rulemaking History for OTC Time and Extent Applications re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0009"},{"title":"Reference 5B Sunscreen Innovation Act (SIA) Website re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0008"},{"title":"Reference 5 - A FDA Track re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0007"},{"title":"Reference 4 Content and Format of Sunscreen Data Submissions Draft Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0006"},{"title":"Reference 3 2009 GAO Report on Federal Rulemaking re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0005"},{"title":"Reference 2 OFR Guide to the Rulemaking Process re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0004"},{"title":"Reference 1 TEA Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0003"},{"title":"References List for Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0002"}],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2016-04-04","updated_at":"2023-02-28T16:18:35.073-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-0543-0001","allow_late_comments":null,"id":"FDA-2016-N-0543-0001","comment_end_date":"2016-06-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":9,"id":"FDA-2016-N-0543","title":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications"}],"document_number":"2016-07612","effective_on":null,"end_page":19086,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/04/04/2016-07612.xml","html_url":"https://www.federalregister.gov/documents/2016/04/04/2016-07612/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-07612?publication_date=2016-04-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-04-04/2016-07612/mods.xml","not_received_for_publication":null,"page_length":18,"page_views":{"count":1434,"last_updated":"2026-10-23 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-04-04/pdf/2016-07612.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-07612.pdf?1459514865","publication_date":"2016-04-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/04/04/2016-07612.txt","regulation_id_number_info":{"0910-AH30":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AH30/fda-review-and-action-on-over-the-counter-time-and-extent-applications","title":"FDA Review and Action on Over-the-Counter Time and Extent Applications","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AH30&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH30"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Nonprescription Sunscreen Drug Products ? Format and Content of Data Submissions Guidance for Industry","document_id":"FDA-2016-N-0543-0014"},{"title":"Reference 5C - Rulemaking History for OTC Time and Extent Applications re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0009"},{"title":"Reference 5B Sunscreen Innovation Act (SIA) Website re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0008"},{"title":"Reference 5 - A FDA Track re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0007"},{"title":"Reference 4 Content and Format of Sunscreen Data Submissions Draft Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0006"},{"title":"Reference 3 2009 GAO Report on Federal Rulemaking re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0005"},{"title":"Reference 2 OFR Guide to the Rulemaking Process re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0004"},{"title":"Reference 1 TEA Guidance re Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0003"},{"title":"References List for Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","document_id":"FDA-2016-N-0543-0002"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AH30/fda-review-and-action-on-over-the-counter-time-and-extent-applications","title":"FDA Review and Action on Over-the-Counter Time and Extent Applications"},"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0543","supporting_documents_count":9,"docket_id":"FDA-2016-N-0543","document_id":"FDA-2016-N-0543-0001","regulation_id_number":"0910-AH30","title":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","checked_regulationsdotgov_at":"2023-02-28T21:18:34Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":19069,"subtype":null,"title":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","toc_doc":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","toc_subject":null,"topics":["Over-the-counter drugs"],"type":"Proposed Rule","volume":81}