{"abstract":"The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements 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). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.","action":"Final 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/2016/11/23/2016-28120.html","cfr_references":[{"chapter":null,"citation_url":null,"part":330,"title":21}],"citation":"81 FR 84465","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 23, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0543"],"dockets":[],"document_number":"2016-28120","effective_on":"2016-12-23","end_page":84477,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/23/2016-28120.xml","html_url":"https://www.federalregister.gov/documents/2016/11/23/2016-28120/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications","images":{"ER23NO16.004":{"large":"https://img.federalregister.gov/ER23NO16.004/ER23NO16.004_large.png","original_size":"https://img.federalregister.gov/ER23NO16.004/ER23NO16.004_original_size.png"}},"images_metadata":{"ER23NO16.004":{"large":{"identifier":"ER23NO16.004","content_type":"image/png","size":53396,"width":821,"sha":"f5fddc4c9a4fc6b92cdfa3de3f18cfed","url":"https://img.federalregister.gov/ER23NO16.004/ER23NO16.004_large.png","height":728},"original_size":{"identifier":"ER23NO16.004","content_type":"image/png","size":71064,"width":3905,"sha":"dab9363b9901107d0291bde0751a672d","url":"https://img.federalregister.gov/ER23NO16.004/ER23NO16.004_original_size.png","height":3461}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-28120?publication_date=2016-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-23/2016-28120/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":1561,"last_updated":"2026-10-23 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28120.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-28120.pdf?1479822333","publication_date":"2016-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/23/2016-28120.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_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","regulation_id_number":"0910-AH30","title":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","checked_regulationsdotgov_at":"2016-12-13T06:00:19Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":84465,"subtype":null,"title":"Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications","toc_doc":"Review and Action on Over-the-Counter Time and Extent Applications","toc_subject":null,"topics":["Over-the-counter drugs"],"type":"Rule","volume":81}