{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.\" This guidance provides answers to common questions regarding the communication of health care economic information (d) about approved prescription drugs and approved or cleared medical devices by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also provides answers to common questions about both firms' dissemination of information to payors about medical products that are not yet approved or cleared for any use and firms' dissemination of information to payors about unapproved uses of approved or cleared medical products. The Agency is issuing this guidance to explain FDA's current thinking on frequently asked questions regarding these topics in order to provide clarity for firms and payors. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","action":"Notice of 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/2018/06/13/2018-12632.html","cfr_references":[],"citation":"83 FR 27605","comment_url":null,"comments_close_on":"2018-07-13","correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 13, 2018. Submit written comments on the collection of information by July 13, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1307"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2018-06-13","updated_at":"2023-03-01T01:42:21.286-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-D-1307-0028","allow_late_comments":null,"id":"FDA-2016-D-1307-0028","comment_end_date":"2018-07-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-D-1307","title":"Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; Availability"}],"document_number":"2018-12632","effective_on":null,"end_page":27609,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/13/2018-12632.xml","html_url":"https://www.federalregister.gov/documents/2018/06/13/2018-12632/drug-and-device-manufacturer-communications-with-payors-formulary-committees-and-similar","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-12632?publication_date=2018-06-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-13/2018-12632/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":2163,"last_updated":"2026-10-25 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-13/pdf/2018-12632.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-12632.pdf?1528807515","publication_date":"2018-06-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/13/2018-12632.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-1307","supporting_documents_count":0,"docket_id":"FDA-2016-D-1307","document_id":"FDA-2016-D-1307-0028","regulation_id_number":null,"title":"Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T06:42:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27605,"subtype":null,"title":"Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability","toc_doc":"Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar EntitiesQuestions and Answers","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}