Department of Health and Human Services October 3, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 4, 2019. That notice, withdrawing approval of five abbreviated new drug applications for pemoline products, contained an incorrect website address for an archived web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that FDA issued on October 24, 2005, stating its conclusion that the overall liver toxicity risk of CYLERT (new drug applications 016832 and 017703) and generic pemoline products outweighed the benefits of these products. This document corrects that error.

The National Eye Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Opsis Therapeutics, LLC, (``Opsis'') located in Madison Wisconsin and its affiliate, FUJIFILM Cellular Dynamics, Inc.

The ACF, ORR, Division of Refugee Health announces the intent to award three OPDIV-Initiated Supplements in the amount of $67,724 to each of three current grantees providing direct services funded through the Services for Survivors of Torture (SOT) Program.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The guidance updates the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2018.