Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment
other · Food and Drug Administration · Rule · Published 2001-01-10 · Effective 1999-08-19 · 66 FR 1834
Document
Document number
01-533
Federal Register citation
66 FR 1834
CFR reference
21 CFR 606
Type
Rule
Action
Direct final rule; confirmation in part and technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-01-10
Effective date
1999-08-19
HHS docket
Docket No. 98N-0673
Abstract
The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. 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and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.