Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
other · Food and Drug Administration · Rule · Published 2015-12-28 · 80 FR 80650
Document
Document number
2015-32477
Federal Register citation
80 FR 80650
CFR reference
21 CFR 606
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-12-28
HHS docket
Docket No. FDA-1999-N-0114 (formerly 1999N-2337)
Abstract
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.