{"abstract":"The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.","action":"Notice of public meeting; 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/2008/05/12/E8-10513.html","cfr_references":[],"citation":"73 FR 27001","comment_url":null,"comments_close_on":"2008-07-07","correction_of":null,"corrections":[],"dates":"The public meeting will be held on June 5 and 6, 2008, from 8:30 a.m. to 5 p.m. each day. Register to make a presentation at the meeting by May 23, 2008. See section III of this document for information on how to attend or present at the meeting. Submit any written or electronic comments regarding the concept paper and pilot program by July 7, 2008.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0281"],"dockets":[],"document_number":"E8-10513","effective_on":null,"end_page":27002,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/05/12/E8-10513.xml","html_url":"https://www.federalregister.gov/documents/2008/05/12/E8-10513/pilot-program-to-evaluate-proposed-name-submissions-concept-paper-public-meeting","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-10513?publication_date=2008-05-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-05-12/E8-10513/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":26,"last_updated":"2026-08-25 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-05-12/pdf/E8-10513.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-05-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/05/12/E8-10513.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,"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27001,"subtype":null,"title":"Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting","toc_doc":"Pilot Program to Evaluate Proposed Name Submissions; Concept Paper","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":73}