{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled \"Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.\" This draft guidance is intended to revise and replace the current draft guidance for industry entitled \"Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment\" issued on December 5, 2019. This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).","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/2023/06/05/2023-11899.html","cfr_references":[],"citation":"88 FR 36590","comment_url":null,"comments_close_on":"2023-08-04","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 4, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-4656"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-06-05","updated_at":"2023-06-05T12:56:24.363-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-4656-0017","allow_late_comments":null,"id":"FDA-2019-D-4656-0017","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-4656","title":"Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability "}],"document_number":"2023-11899","effective_on":null,"end_page":36592,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/06/05/2023-11899.xml","html_url":"https://www.federalregister.gov/documents/2023/06/05/2023-11899/interstitial-cystitisbladder-pain-syndrome-establishing-drug-development-programs-for-treatment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-11899?publication_date=2023-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-06-05/2023-11899/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":483,"last_updated":"2026-10-25 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-05/pdf/2023-11899.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11899.pdf?1685709931","publication_date":"2023-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/06/05/2023-11899.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-4656","supporting_documents_count":0,"docket_id":"FDA-2019-D-4656","document_id":"FDA-2019-D-4656-0017","regulation_id_number":null,"title":"Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-06-06T15:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36590,"subtype":null,"title":"Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised Draft Guidance for Industry; Availability","toc_doc":"Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}