federal_register: 2012-27783
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-27783 | Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, To Reduce the Risk of Transmission of Hepatitis B Virus; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus," dated October 2012. The guidance document provides recommendations on the use of FDA- licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the guidance provides notification that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. The guidance announced in this notice finalizes the draft guidance of the same title, dated November 2011. The guidance also supplements previous memoranda and guidance from FDA concerning the testing of donations for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) and the management of donors and donations mentioned in those documents. | 2012-11-15 | 2012 | 11 | https://www.federalregister.gov/documents/2012/11/15/2012-27783/guidance-for-industry-use-of-nucleic-acid-tests-on-pooled-and-individual-samples-from-donors-of | https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-27783.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to... |