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Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment

The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) ``lookback'' requirements regarding review of historical tes...

The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) ``lookback'' requirements regarding review of historical testing records. FDA is taking this action because the HCV ``lookback'' regulations based on review of historical testing records expired on August 24, 2015, due to the sunset provision provided under the regulation.

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80 FR 80650

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“Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment,” thefederalregister.org (December 28, 2015), https://thefederalregister.org/documents/2015-32477/hepatitis-c-virus-lookback-requirements-based-on-review-of-historical-testing-records-technical-amendment.