{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a public workshop and an opportunity for public comment on Erythropoietic Protoporphyria (EPP). The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for, and gain perspective from, patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion.","action":"Notice of public workshop; 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/2016/07/01/2016-15662.html","cfr_references":[],"citation":"81 FR 43207","comment_url":null,"comments_close_on":"2016-12-24","correction_of":null,"corrections":[],"dates":"The public workshop will be held on October 24, 2016, from 10 a.m. to 4 p.m. Submit electronic or written comments to the public docket by December 24, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-N-2016-1493"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":31,"comment_start_date":"2016-07-01","updated_at":"2023-03-01T01:01:43.790-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-1493-0001","allow_late_comments":null,"id":"FDA-2016-N-1493-0001","comment_end_date":"2016-12-25","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-N-1493","title":"Scientific Workshop on Erythropoietic Protoporphyria (EPP)."}],"document_number":"2016-15662","effective_on":null,"end_page":43209,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15662.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15662/erythropoietic-protoporphyria-scientific-workshop","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15662?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15662/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":103,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15662.pdf?1467290953","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15662.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":31,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1493","supporting_documents_count":0,"docket_id":"FDA-2016-N-1493","document_id":"FDA-2016-N-1493-0001","regulation_id_number":null,"title":"Scientific Workshop on Erythropoietic Protoporphyria (EPP).","checked_regulationsdotgov_at":"2023-03-01T06:01:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43207,"subtype":null,"title":"Erythropoietic Protoporphyria; Scientific Workshop","toc_doc":"Erythropoietic Protoporphyria; Scientific Workshop","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":81}