Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment
other · Food and Drug Administration · Rule · Published 2008-02-08 · Effective 2008-02-19 · 73 FR 7463
Document
Document number
E8-2322
Federal Register citation
73 FR 7463
CFR reference
21 CFR 606
Type
Rule
Action
Direct final rule; confirmation of effective date and technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-02-08
Effective date
2008-02-19
HHS docket
Docket No. FDA-2008-N-0067
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.