{"abstract":"The Food and Drug Administration (FDA) is announcing the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled \"PDUFA Pilot Project Proprietary Name Review.\" This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.","action":"Notice.","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/2009/10/01/E9-23620.html","cfr_references":[],"citation":"74 FR 50806","comment_url":"https://www.regulations.gov/commenton/FDA-2008-N-0281-0029","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA will begin accepting requests to register for the voluntary pilot program on October 1, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0281"],"dockets":[{"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"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2009-10-01","updated_at":"2024-11-08T17:28:33.929-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2008-N-0281-0029","allow_late_comments":true,"id":"FDA-2008-N-0281-0029","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2008-N-0281","title":"Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Public Meeting,"}],"document_number":"E9-23620","effective_on":null,"end_page":50809,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/01/E9-23620.xml","html_url":"https://www.federalregister.gov/documents/2009/10/01/E9-23620/pilot-program-to-evaluate-proposed-proprietary-name-submissions-procedures-to-register-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-23620?publication_date=2009-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-01/E9-23620/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":143,"last_updated":"2026-08-25 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-01/pdf/E9-23620.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/10/01/E9-23620.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_count":0,"agency_id":"FDA","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","document_id":"FDA-2008-N-0281-0029","regulation_id_number":null,"title":"Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Public Meeting,","checked_regulationsdotgov_at":"2024-11-08T22:23:14Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2008-N-0281-0029","significant":null,"signing_date":null,"start_page":50806,"subtype":null,"title":"Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data","toc_doc":"Procedures to Register for Participation and Submit Data","toc_subject":"Pilot Program to Evaluate Proposed Proprietary Name Submissions:","topics":[],"type":"Notice","volume":74}