{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner) or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee may consider topics such as Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device- related quality of life or health status issues, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics.","action":"Notice; establishment of public docket; request for comments.","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/2015/09/21/2015-23521.html","cfr_references":[],"citation":"80 FR 57007","comment_url":null,"comments_close_on":"2015-11-20","correction_of":null,"corrections":[],"dates":"Comments received by November 20, 2015, will be provided to the Agency.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-3166"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":15,"comment_start_date":"2015-09-21","updated_at":"2023-02-28T23:56:48.982-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-3166-0001","allow_late_comments":null,"id":"FDA-2015-N-3166-0001","comment_end_date":"2015-11-21","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-N-3166","title":"Patient Engagement Advisory Committee"}],"document_number":"2015-23521","effective_on":null,"end_page":57008,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/09/21/2015-23521.xml","html_url":"https://www.federalregister.gov/documents/2015/09/21/2015-23521/establishment-of-the-patient-engagement-advisory-committee-establishment-of-a-public-docket-request","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-23521?publication_date=2015-09-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-09-21/2015-23521/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3721,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-09-21/pdf/2015-23521.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-23521.pdf?1442580338","publication_date":"2015-09-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/09/21/2015-23521.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":15,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-3166","supporting_documents_count":0,"docket_id":"FDA-2015-N-3166","document_id":"FDA-2015-N-3166-0001","regulation_id_number":null,"title":"Patient Engagement Advisory Committee","checked_regulationsdotgov_at":"2023-03-01T04:56:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57007,"subtype":null,"title":"Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments","toc_doc":"Establishment of the Patient Engagement Advisory Committee","toc_subject":null,"topics":[],"type":"Notice","volume":80}