{"abstract":"The Food and Drug Administration (FDA) is requesting comment on issues relating to the agency's development and use of guidance documents. These issues were raised in a citizen petition submitted by the Indiana Medical Devices Manufacturers Council, Inc. (IMDMC). (See Docket No. 95P-0110). The petition requested that FDA control the initiation, development, and issuance of guidance documents by written procedures that assure the appropriate level of meaningful public participation. In its response to the petition, FDA agreed that public participation generally benefits the guidance document development process. FDA also stated the importance of communicating more clearly to its employees and to the public the nonbinding nature of guidance documents. Therefore, FDA agreed to take steps to improve its guidance document procedures. FDA is seeking an approach that addresses concerns regarding adequate public participation but does not make it impractical for the agency to continue making guidance available in a timely fashion. Some suggestions for improving FDA's guidance document procedures are set forth in this document. FDA is soliciting comment on these suggestions and is soliciting additional recommendations for improving its guidance document procedures. A public meeting on these issues will be held at least 30 days before the end of the comment period. The agency will announce the details of that meeting in a future issue of the Federal Register.","action":"Notice; 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/1996/03/07/96-5344.html","cfr_references":[],"citation":"61 FR 9181","comment_url":null,"comments_close_on":"1996-06-05","correction_of":null,"corrections":[],"dates":"Written comments by June 5, 1996.","disposition_notes":null,"docket_ids":["Docket No. 95P-0110"],"dockets":[],"document_number":"96-5344","effective_on":null,"end_page":9185,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/03/07/96-5344/guidance-documents-the-food-and-drug-administrations-development-and-use-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-5344?publication_date=1996-03-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-03-07/96-5344/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":48,"last_updated":"2026-04-15 14:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-03-07/pdf/96-5344.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-03-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/03/07/96-5344.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T01:05:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9181,"subtype":null,"title":"Guidance Documents; The Food and Drug Administration's Development and Use; Request for Comments","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":61}