{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a concept paper entitled \"PDUFA Pilot Project Proprietary Name Review.\" The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review under an anticipated pilot program. FDA plans to begin enrollment in the pilot program in fiscal year (FY) 2009.","action":"Notice; 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/2008/10/07/E8-23715.html","cfr_references":[],"citation":"73 FR 58604","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the pilot program at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0281"],"dockets":[],"document_number":"E8-23715","effective_on":null,"end_page":58605,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/10/07/E8-23715.xml","html_url":"https://www.federalregister.gov/documents/2008/10/07/E8-23715/pilot-program-to-evaluate-proposed-name-submissions-concept-paper","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-23715?publication_date=2008-10-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-10-07/E8-23715/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":60,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/E8-23715.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-10-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/10/07/E8-23715.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"PDUFA Pilot Project - Proprietary Name Review - Concept Paper - September 2008","document_id":"FDA-2008-N-0281-0027"},{"title":"Office of Surveillance and Epidemiology [CDER and CBER] - Slide Presentation","document_id":"FDA-2008-N-0281-0005"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-N-0281","supporting_documents_count":2,"docket_id":"FDA-2008-N-0281","regulation_id_number":null,"title":"Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Public Meeting,","checked_regulationsdotgov_at":"2011-11-14T23:02:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":58604,"subtype":null,"title":"Pilot Program To Evaluate Proposed Name Submissions; Concept Paper","toc_doc":"Pilot Program To Evaluate Proposed Name Submissions; Concept Paper","toc_subject":null,"topics":[],"type":"Notice","volume":73}