{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Guidance on Qualification of Biomarker--Galactomannan in Studies of Treatments of Invasive Aspergillosis.\" This guidance provides a qualified context of use (COU) for Galactomannan detection in serum and/or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.","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/2015/11/13/2015-28804.html","cfr_references":[],"citation":"80 FR 70235","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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the guidance by January 12, 2016","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1630"],"dockets":[],"document_number":"2015-28804","effective_on":null,"end_page":70236,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/13/2015-28804.xml","html_url":"https://www.federalregister.gov/documents/2015/11/13/2015-28804/guidance-on-qualification-of-biomarker-galactomannan-in-studies-of-treatments-of-invasive","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-28804?publication_date=2015-11-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-13/2015-28804/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":301,"last_updated":"2026-10-22 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-13/pdf/2015-28804.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-28804.pdf?1447335952","publication_date":"2015-11-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/13/2015-28804.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-2013-D-1630","supporting_documents_count":0,"docket_id":"FDA-2013-D-1630","regulation_id_number":null,"title":"Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease; Availability","checked_regulationsdotgov_at":"2016-01-13T05:00:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70235,"subtype":null,"title":"Guidance on Qualification of Biomarker-Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability","toc_doc":"Qualification of BiomarkerGalactomannan in Studies of Treatments of Invasive Aspergillosis","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}