Revision of the Requirements for Spore-Forming Microorganisms; Confirmation of Effective Date
other · Food and Drug Administration · Rule · Published 2004-05-14 · Effective 2004-06-01 · 69 FR 26768
Document
Document number
04-11027
Federal Register citation
69 FR 26768
CFR reference
21 CFR 600
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-05-14
Effective date
2004-06-01
HHS docket
Docket No. 2003N-0528
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of June 1, 2004, for the direct final rule that appeared in the Federal Register of December 30, 2003 (68 FR 75116). The direct final rule amends the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore-forming microorganisms. This document confirms the effective date of the direct final rule.