Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Confirmation of Effective Date
other · Food and Drug Administration · Rule · Published 2001-04-23 · Effective 2001-06-11 · 66 FR 20402
Document
Document number
01-9873
Federal Register citation
66 FR 20402
CFR reference
21 CFR 660
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-04-23
Effective date
2001-06-11
HHS docket
Docket No. 00N-1586
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of June 11, 2001, for the direct final rule that appeared in the Federal Register of December 12, 2000 (65 FR 77497). The direct final rule rule amends the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin and Blood Grouping Reagents by removing the requirement that these products be sterile. This document confirms the effective date of the direct final rule.