{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271\" dated February 2015. The draft guidance document is intended to provide manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/ Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The draft guidance, when finalized, is intended to supplement section XXII of FDA's guidance entitled \"Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)\" dated December 2011 and supersede the guidance entitled \"Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)\" dated November 2005.","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/2015/02/20/2015-03490.html","cfr_references":[],"citation":"80 FR 9267","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 21, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-0349"],"dockets":[],"document_number":"2015-03490","effective_on":null,"end_page":9268,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/20/2015-03490.xml","html_url":"https://www.federalregister.gov/documents/2015/02/20/2015-03490/investigating-and-reporting-adverse-reactions-related-to-human-cells-tissues-and-cellular-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-03490?publication_date=2015-02-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-20/2015-03490/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":422,"last_updated":"2026-07-27 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-20/pdf/2015-03490.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-03490.pdf?1424353977","publication_date":"2015-02-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/20/2015-03490.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2 Guidance for Industry Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)  re Investigating and Reporting Adverse Reactions Related to Human","document_id":"FDA-2015-D-0349-0017"},{"title":"Reference 1 Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) re Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based","document_id":"FDA-2015-D-0349-0016"},{"title":"List of References - Guidance - Draft - Investigating and Reporting Adverse Reactions","document_id":"FDA-2015-D-0349-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-0349","supporting_documents_count":3,"docket_id":"FDA-2015-D-0349","regulation_id_number":null,"title":"Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2015-03-12T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9267,"subtype":null,"title":"Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability","toc_doc":"Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}