Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
other · Food and Drug Administration · Rule · Published 2009-08-21 · Effective 2009-09-17 · 74 FR 42175
Document
Document number
E9-20119
Federal Register citation
74 FR 42175
CFR reference
21 CFR 601
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-08-21
Effective date
2009-09-17
HHS docket
Docket No. FDA-2009-N-0100
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule.