{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.\" This guidance represents FDA's current thinking on the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the- counter (OTC) monograph.","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/2019/05/10/2019-09692.html","cfr_references":[],"citation":"84 FR 20633","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 10, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-1798"],"dockets":[],"document_number":"2019-09692","effective_on":null,"end_page":20634,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/05/10/2019-09692.xml","html_url":"https://www.federalregister.gov/documents/2019/05/10/2019-09692/maximal-usage-trials-for-topically-applied-active-ingredients-being-considered-for-inclusion-in-an","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-09692?publication_date=2019-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-05-10/2019-09692/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":668,"last_updated":"2026-06-24 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-05-10/pdf/2019-09692.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-09692.pdf?1557405921","publication_date":"2019-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/05/10/2019-09692.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-2018-D-1456","supporting_documents_count":0,"docket_id":"FDA-2018-D-1456","regulation_id_number":null,"title":"Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph:  Study Elements and Considerations; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2019-09-05T02:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20633,"subtype":null,"title":"Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability","toc_doc":"Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph:  Study Elements and Considerations","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}