federal_register: 2010-30405
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-30405 | Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion" dated December 2010. The guidance document notifies establishments that manufacture whole blood and blood components intended for transfusion about FDA approvals of biologics license applications for serological test systems for the detection of antibodies to Trypanosoma cruzi. These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. The guidance document does not apply to the collection of source plasma. Also, the guidance does not apply to establishments that make eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/ Ps). The guidance announced in this document finalizes the draft guidance entitled "Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated March 2009. The recommendations for HCT/P donor screening and testing for T. cruzi antibodies contained in the draft guidance are not being finalized at this time because FDA believes additional discussion is warranted. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that the proposed collection of information for the guidance has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. | 2010-12-06 | 2010 | 12 | https://www.federalregister.gov/documents/2010/12/06/2010-30405/guidance-for-industry-use-of-serological-tests-to-reduce-the-risk-of-transmission-of-trypanosoma | https://www.govinfo.gov/content/pkg/FR-2010-12-06/pdf/2010-30405.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 Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended... |