{"abstract":"The Food and Drug Administration (FDA) is announcing that a collection of information entitled \"Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (FDA Form 3671)\" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.","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/2011/11/14/2011-29296.html","cfr_references":[],"citation":"76 FR 70461","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0015"],"dockets":[],"document_number":"2011-29296","effective_on":null,"end_page":70462,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/11/14/2011-29296.xml","html_url":"https://www.federalregister.gov/documents/2011/11/14/2011-29296/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approval","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-29296?publication_date=2011-11-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-11-14/2011-29296/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":32,"last_updated":"2026-10-24 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-11-14/pdf/2011-29296.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2011-29296.pdf?1320933187","publication_date":"2011-11-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/11/14/2011-29296.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-2011-N-0015","supporting_documents_count":0,"docket_id":"FDA-2011-N-0015","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671) ","checked_regulationsdotgov_at":"2011-12-04T16:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70461,"subtype":null,"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form 3671)","toc_doc":"Application Form for Orphan Medicinal Product Designation","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":76}