{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM).","action":"Notice of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/2023/02/01/2023-02103.html","cfr_references":[],"citation":"88 FR 6759","comment_url":null,"comments_close_on":"2023-04-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 3, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2315"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-02-01","updated_at":"2023-02-24T21:49:08.112-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2315-0001","allow_late_comments":null,"id":"FDA-2022-D-2315-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2315","title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2023-02103","effective_on":null,"end_page":6760,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/02/01/2023-02103.xml","html_url":"https://www.federalregister.gov/documents/2023/02/01/2023-02103/early-lyme-disease-as-manifested-by-erythema-migrans-developing-drugs-for-treatment-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-02103?publication_date=2023-02-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-02-01/2023-02103/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":235,"last_updated":"2026-07-27 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-02-01/pdf/2023-02103.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-02103.pdf?1675172731","publication_date":"2023-02-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/02/01/2023-02103.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-2315","supporting_documents_count":0,"docket_id":"FDA-2022-D-2315","document_id":"FDA-2022-D-2315-0001","regulation_id_number":null,"title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T19:12:51Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6759,"subtype":null,"title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Early Lyme Disease as Manifested by Erythema Migrans:  Developing Drugs for Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}