{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.\" This draft guidance provides a statement of qualification for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome instrument and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation and Research's (CDER's) drug development tool (DDT) qualification program. Qualification of the EXACT represents a conclusion that, within the stated COU, the instrument can be relied on to have a specific interpretation and application in drug development and regulatory review. This draft guidance is an attachment to the guidance for industry entitled \"Qualification Process for Drug Development Tools.\"","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/2014/01/10/2014-00259.html","cfr_references":[],"citation":"79 FR 1873","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 10, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1630"],"dockets":[],"document_number":"2014-00259","effective_on":null,"end_page":1874,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/01/10/2014-00259.xml","html_url":"https://www.federalregister.gov/documents/2014/01/10/2014-00259/draft-guidance-for-industry-on-qualification-of-exacerbations-of-chronic-pulmonary-disease-tool-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-00259?publication_date=2014-01-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-01-10/2014-00259/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":293,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-10/pdf/2014-00259.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-00259.pdf?1389302983","publication_date":"2014-01-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/01/10/2014-00259.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":"2020-04-29T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1873,"subtype":null,"title":"Draft Guidance for Industry on 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","toc_doc":"Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis, etc.","toc_subject":"Draft Guidances for Industry; Availability:","topics":[],"type":"Notice","volume":79}