{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.","action":"Final rule.","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/2005/11/23/05-23120.html","cfr_references":[{"chapter":null,"citation_url":null,"part":312,"title":21}],"citation":"70 FR 70720","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 23, 2005.","disposition_notes":null,"docket_ids":["Docket No. 2000N-1663"],"dockets":[],"document_number":"05-23120","effective_on":"2005-12-23","end_page":70730,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/11/23/05-23120.xml","html_url":"https://www.federalregister.gov/documents/2005/11/23/05-23120/investigational-new-drugs-export-requirements-for-unapproved-new-drug-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-23120?publication_date=2005-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-11-23/05-23120/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":2168,"last_updated":"2026-08-24 22:15:11 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-11-23/pdf/05-23120.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/11/23/05-23120.txt","regulation_id_number_info":{"0910-AA61":{"issue":"200410","html_url":"https://www.federalregister.gov/regulations/0910-AA61/investigational-new-drugs-export-requirements-for-unapproved-new-drug-products","title":"Investigational New Drugs: Export Requirements for Unapproved New Drug Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200410&RIN=0910-AA61&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AA61"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T17:34:15Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":70720,"subtype":null,"title":"Investigational New Drugs: Export Requirements for Unapproved New Drug Products","toc_doc":"Unapproved new investigational drug products; export requirements","toc_subject":"Human drugs:","topics":["Drugs","Exports","Imports","Investigations","Labeling","Medical research","Reporting and recordkeeping requirements","Safety"],"type":"Rule","volume":70}