{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.\" This draft guidance provides a statement of qualification for exploratory use for the evaluating respiratory symptoms in chronic obstructive pulmonary disease (E-RS: COPD), a 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 for exploratory use of the E-RS: COPD 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 This draft guidance is an attachment to the guidance for industry entitled \"Qualification Process for Drug Development Tools.\"","action":"Notice of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/2016/03/09/2016-05224.html","cfr_references":[],"citation":"81 FR 12506","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 7, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-0712"],"dockets":[],"document_number":"2016-05224","effective_on":null,"end_page":12508,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/09/2016-05224.xml","html_url":"https://www.federalregister.gov/documents/2016/03/09/2016-05224/evaluating-respiratory-symptoms-in-chronic-obstructive-pulmonary-disease-a-patient-reported-outcome","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-05224?publication_date=2016-03-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-09/2016-05224/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":384,"last_updated":"2026-10-24 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-09/pdf/2016-05224.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-05224.pdf?1457444772","publication_date":"2016-03-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/09/2016-05224.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-0712","supporting_documents_count":0,"docket_id":"FDA-2016-D-0712","regulation_id_number":null,"title":"Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidanc","checked_regulationsdotgov_at":"2020-04-23T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12506,"subtype":null,"title":"Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability","toc_doc":"Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary DiseaseQualification for Exploratory Use","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}