Department of Health and Human Services December 6, 2017 – Federal Register Recent Federal Regulation Documents
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Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document provides recommendations to blood collection establishments regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance announced in this notice supersedes the 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Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) and finalizes the draft guidance entitled ``Amendment to `Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'; Draft Guidance for Industry'' dated November 2016 (2016 Draft Chagas Guidance). The guidance incorporates recommendations for blood donor testing, deferral, and donor reentry from the 2016 Draft Chagas Guidance.
Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the Requests for Comments and Information that appeared in the Federal Register of September 8, 2017. In the Requests for Comments and Information, FDA requested comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
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