{"abstract":"The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a \"changes being effected\" (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the \"Highlights of Prescribing Information\" for drug products with labeling in the \"Physician Labeling Rule\" (PLR) format.","action":"Proposed rule.","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/2013/11/13/2013-26799.html","cfr_references":[{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"78 FR 67985","comment_url":null,"comments_close_on":"2014-01-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by January 13, 2014. See section VII for the proposed effective date of a final rule based on this proposed rule. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by December 13, 2013, (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0500"],"dockets":[],"document_number":"2013-26799","effective_on":null,"end_page":67999,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/13/2013-26799.xml","html_url":"https://www.federalregister.gov/documents/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products","images":{"EP13NO13.029":{"large":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_large.png","medium":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_medium.png","original_size":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_original_size.png"}},"images_metadata":{"EP13NO13.029":{"large":{"identifier":"EP13NO13.029","content_type":"image/png","size":133855,"width":823,"sha":"b1978504b183f8e467fa81a1c7884fca","url":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_large.png","height":1068},"medium":{"identifier":"EP13NO13.029","content_type":"image/png","size":35277,"width":407,"sha":"844fcae6ec4e70ff474b318d2b586865","url":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_medium.png","height":528},"original_size":{"identifier":"EP13NO13.029","content_type":"image/png","size":365835,"width":3075,"sha":"6faaf384872ca206e3717d76406acce1","url":"https://img.federalregister.gov/EP13NO13.029/EP13NO13.029_original_size.png","height":3991}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-26799?publication_date=2013-11-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-13/2013-26799/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":19621,"last_updated":"2026-06-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/2013-26799.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-26799.pdf?1383927140","publication_date":"2013-11-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/13/2013-26799.txt","regulation_id_number_info":{"0910-AG94":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AG94/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products","title":"Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AG94&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG94"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-12-22T05:01:10Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":67985,"subtype":null,"title":"Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products","toc_doc":"Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":78}