{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Providing Regulatory Submissions in Electronic Format--Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions.\" This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of orphan-drug and humanitarian use device (HUD) designation requests and related submissions to the Office of Orphan Products Development (OPD). The submission of these documents in electronic format should improve the agency's efficiency in processing, archiving, and reviewing them.","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/2006/03/31/E6-4709.html","cfr_references":[],"citation":"71 FR 16317","comment_url":null,"comments_close_on":"2006-05-30","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by May 30, 2006. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 2006D-0128"],"dockets":[],"document_number":"E6-4709","effective_on":null,"end_page":16318,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/03/31/E6-4709.xml","html_url":"https://www.federalregister.gov/documents/2006/03/31/E6-4709/draft-guidance-for-industry-on-providing-regulatory-submissions-in-electronic-format-orphan-drug-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E6-4709?publication_date=2006-03-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-03-31/E6-4709/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":60,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-03-31/pdf/E6-4709.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-03-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/03/31/E6-4709.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T19:02:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16317,"subtype":null,"title":"Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions; Availability","toc_doc":"Orphan-drug and humanitarian use device designation requests and related submissions; providing regulatory submissions in electronic format","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":71}