{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.\" The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes labialis. The guidance also addresses prevention of recurrent herpes labialis. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of recurrent herpes labialis.","action":"Notice.","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/2016/07/01/2016-15698.html","cfr_references":[],"citation":"81 FR 43210","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1504"],"dockets":[],"document_number":"2016-15698","effective_on":null,"end_page":43211,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15698.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15698/recurrent-herpes-labialis-developing-drugs-for-treatment-and-prevention-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15698?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15698/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":418,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15698.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15698.pdf?1467291037","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15698.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-2016-D-1504","supporting_documents_count":0,"docket_id":"FDA-2016-D-1504","regulation_id_number":null,"title":"Recurrent Herpes Labialis:  Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2016-09-30T05:00:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43210,"subtype":null,"title":"Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability","toc_doc":"Recurrent Herpes Labialis:  Developing Drugs for Treatment and Prevention","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}