{"abstract":"The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled \"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products,\" published in the Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.","action":"Notice; reopening of the comment period.","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/2024/12/31/2024-31365.html","cfr_references":[],"citation":"89 FR 107147","comment_url":null,"comments_close_on":"2025-03-03","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period on the request for information and comments notice published July 25, 2024 (89 FR 60436). Either electronic or written comments must be submitted by March 3, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-2980"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-12-31","updated_at":"2024-12-31T11:01:15.938-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-2980-0006","allow_late_comments":false,"id":"FDA-2024-N-2980-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-2980","title":"Evaluating the immunogenicity risk of host cell proteins in follow-on recombinant peptide products; Establishment of a public docket; Request for information and comments"}],"document_number":"2024-31365","effective_on":null,"end_page":107148,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/12/31/2024-31365.xml","html_url":"https://www.federalregister.gov/documents/2024/12/31/2024-31365/evaluating-the-immunogenicity-risk-of-host-cell-proteins-in-follow-on-recombinant-peptide-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31365?publication_date=2024-12-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-12-31/2024-31365/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2465,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-31/pdf/2024-31365.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31365.pdf?1735566318","publication_date":"2024-12-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/12/31/2024-31365.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-2980","supporting_documents_count":0,"docket_id":"FDA-2024-N-2980","document_id":"FDA-2024-N-2980-0006","regulation_id_number":null,"title":"Evaluating the immunogenicity risk of host cell proteins in follow-on recombinant peptide products; Establishment of a public docket; Request for information and comments","checked_regulationsdotgov_at":"2025-01-01T14:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":107147,"subtype":null,"title":"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period","toc_doc":"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products","toc_subject":null,"topics":[],"type":"Notice","volume":89}