{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Providing Regulatory Submissions in Electronic and Non-Electronic Format-- Promotional Labeling and Advertising Materials for Human Prescription Drugs.\" This draft guidance explains how manufacturers, packers, and distributors (firms) that may either be the applicant or acting on behalf of the applicant, should make submissions pertaining to promotional materials for human prescription drugs and biologic products (\"drugs\") to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This draft guidance describes the various types of submissions of promotional materials and general considerations for submissions. In addition, this draft guidance discusses the specific aspects of submission of promotional materials using module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file. This guidance does not address the more general requirements for a valid electronic submission using eCTD or the specifications for module 1 of the eCTD. This guidance contains both binding and nonbinding provisions.","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/2015/04/22/2015-09297.html","cfr_references":[],"citation":"80 FR 22529","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 21, 2015. Submit either electronic or written comments on the proposed collection of information by June 22, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-1163"],"dockets":[],"document_number":"2015-09297","effective_on":null,"end_page":22532,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/04/22/2015-09297.xml","html_url":"https://www.federalregister.gov/documents/2015/04/22/2015-09297/providing-regulatory-submissions-in-electronic-and-non-electronic-format-promotional-labeling-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-09297?publication_date=2015-04-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-04-22/2015-09297/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":952,"last_updated":"2026-07-28 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-04-22/pdf/2015-09297.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-09297.pdf?1429620363","publication_date":"2015-04-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/04/22/2015-09297.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-1163","supporting_documents_count":0,"docket_id":"FDA-2015-D-1163","regulation_id_number":null,"title":"Providing Regulatory Submissions in Electronic and Non-Electronic Format--Promotional Labeling and Advertising Materials for Human Prescription Drugs","checked_regulationsdotgov_at":"2015-06-23T05:00:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22529,"subtype":null,"title":"Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs, Draft Guidance for Industry; Availability","toc_doc":"Providing Regulatory Submissions in Electronic and Non-Electronic FormatPromotional Labeling and Advertising Materials for Human Prescription Drugs","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}