{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Head Lice Infestation: Developing Drugs for Topical Treatment.\" The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This draft guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials.","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/2015/12/15/2015-31406.html","cfr_references":[],"citation":"80 FR 77636","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 14, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4561"],"dockets":[],"document_number":"2015-31406","effective_on":null,"end_page":77637,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/12/15/2015-31406.xml","html_url":"https://www.federalregister.gov/documents/2015/12/15/2015-31406/head-lice-infestation-developing-drugs-for-topical-treatment-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-31406?publication_date=2015-12-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-12-15/2015-31406/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":192,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-12-15/pdf/2015-31406.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-31406.pdf?1450100753","publication_date":"2015-12-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/12/15/2015-31406.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-2015-D-4561","supporting_documents_count":0,"docket_id":"FDA-2015-D-4561","regulation_id_number":null,"title":"Head Lice Infestation:  Developing Drugs for Topical Treatment","checked_regulationsdotgov_at":"2016-03-15T05:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":77636,"subtype":null,"title":"Head Lice Infestation: Developing Drugs for Topical Treatment; Draft Guidance for Industry; Availability","toc_doc":"Head Lice InfestationDeveloping Drugs for Topical Treatment","toc_subject":"Draft Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}