{"abstract":"The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is proposing this action in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.","action":"Proposed 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/2014/12/31/2014-30528.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"79 FR 78744","comment_url":null,"comments_close_on":"2015-03-31","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by March 31, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1484"],"dockets":[],"document_number":"2014-30528","effective_on":null,"end_page":78749,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/31/2014-30528.xml","html_url":"https://www.federalregister.gov/documents/2014/12/31/2014-30528/revisions-to-exceptions-applicable-to-certain-human-cells-tissues-and-cellular-and-tissue-based","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-30528?publication_date=2014-12-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-31/2014-30528/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":858,"last_updated":"2026-09-20 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-31/pdf/2014-30528.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-30528.pdf?1419947447","publication_date":"2014-12-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/31/2014-30528.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-2014-N-1484","supporting_documents_count":0,"docket_id":"FDA-2014-N-1484","regulation_id_number":null,"title":"Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","checked_regulationsdotgov_at":"2015-04-01T05:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78744,"subtype":null,"title":"Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_doc":"Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_subject":null,"topics":["Biologics","Drugs","Human cells and tissue-based products","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":79}