{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.'' The draft guidance document is intended to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.","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/1999/07/26/99-18928.html","cfr_references":[],"citation":"64 FR 40381","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Written comments may be submitted at any time, however, comments should be submitted by October 25, 1999, to ensure their adequate consideration in preparation of the final document.","disposition_notes":null,"docket_ids":["Docket No. 99D-2096"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2011-04-06","updated_at":"2025-06-10T08:57:20.521-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0178-0001","allow_late_comments":false,"id":"FDA-1999-D-0178-0001","comment_end_date":"1999-10-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-1999-D-0178","title":"Interpreting Sameness of Monoclonal Antibody Products"}],"document_number":"99-18928","effective_on":null,"end_page":40382,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/07/26/99-18928/draft-guidance-for-industry-interpreting-sameness-of-monoclonal-antibody-products-under-the-orphan","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-18928?publication_date=1999-07-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-07-26/99-18928/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":46,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-07-26/pdf/99-18928.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-07-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/07/26/99-18928.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1999-D-0178","supporting_documents_count":0,"docket_id":"FDA-1999-D-0178","document_id":"FDA-1999-D-0178-0001","regulation_id_number":null,"title":"Interpreting Sameness of Monoclonal Antibody Products","checked_regulationsdotgov_at":"2025-06-11T15:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40381,"subtype":null,"title":"Draft ``Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations;'' Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":64}