{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry.\" The draft guidance document addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the draft guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain requirements in the biologics regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the draft guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components.","action":"Notice of availability, draft compliance policy.","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/2022/05/24/2022-11120.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"630","title":21},{"chapter":null,"citation_url":null,"part":"640","title":21}],"citation":"87 FR 31440","comment_url":null,"comments_close_on":"2022-07-25","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 25, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by July 25, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0588"],"dockets":[{"supporting_documents":[{"title":"Reference 1 Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency","document_id":"FDA-2022-D-0588-0003"}],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2022-05-24","updated_at":"2023-02-28T17:12:33.528-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0588-0001","allow_late_comments":null,"id":"FDA-2022-D-0588-0001","comment_end_date":"2022-07-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2022-D-0588","title":"Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry; Availability"}],"document_number":"2022-11120","effective_on":null,"end_page":31442,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/24/2022-11120.xml","html_url":"https://www.federalregister.gov/documents/2022/05/24/2022-11120/compliance-policy-regarding-blood-and-blood-component-donation-suitability-donor-eligibility-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-11120?publication_date=2022-05-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-24/2022-11120/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":686,"last_updated":"2026-10-23 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-24/pdf/2022-11120.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-11120.pdf?1653309924","publication_date":"2022-05-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/24/2022-11120.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency","document_id":"FDA-2022-D-0588-0003"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-0588","supporting_documents_count":1,"docket_id":"FDA-2022-D-0588","document_id":"FDA-2022-D-0588-0001","regulation_id_number":null,"title":"Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-10-19T18:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31440,"subtype":null,"title":"Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry; Availability","toc_doc":"Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements","toc_subject":"Guidance:\n","topics":[],"type":"Proposed Rule","volume":87}