federal_register: 2023-10252
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-10252 | Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry." The guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance announced in this notice finalizes the draft guidance of the same title issued January 2023. This guidance also supersedes the guidance entitled "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry" dated April 2020 and updated August 2020. | 2023-05-12 | 2023 | 5 | https://www.federalregister.gov/documents/2023/05/12/2023-10252/recommendations-for-evaluating-donor-eligibility-using-individual-risk-based-questions-to-reduce-the | https://www.govinfo.gov/content/pkg/FR-2023-05-12/pdf/2023-10252.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus... |