{"abstract":"The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.","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/2011/06/21/2011-15346.html","cfr_references":[{"chapter":null,"citation_url":null,"part":600,"title":21},{"chapter":null,"citation_url":null,"part":610,"title":21},{"chapter":null,"citation_url":null,"part":680,"title":21}],"citation":"76 FR 36019","comment_url":null,"comments_close_on":"2011-09-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed rule by September 19, 2011. See section X of this document for the proposed effective date of any final rule that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0080"],"dockets":[],"document_number":"2011-15346","effective_on":null,"end_page":36027,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/06/21/2011-15346.xml","html_url":"https://www.federalregister.gov/documents/2011/06/21/2011-15346/amendments-to-sterility-test-requirements-for-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-15346?publication_date=2011-06-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-06-21/2011-15346/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":3481,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-06-21/pdf/2011-15346.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-06-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/06/21/2011-15346.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-0080","supporting_documents_count":0,"docket_id":"FDA-2011-N-0080","regulation_id_number":null,"title":"Amendments to Sterility Test Requirements for Biological Products","checked_regulationsdotgov_at":"2011-07-09T08:11:02Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36019,"subtype":null,"title":"Amendments to Sterility Test Requirements for Biological Products","toc_doc":"Sterility Test Requirements for Biological Products","toc_subject":null,"topics":["Biologics","Blood","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":76}