Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
other · Food and Drug Administration · Rule · Published 2016-07-21 · Effective 2016-04-04 · 81 FR 47288
Document
Document number
2016-17186
Federal Register citation
81 FR 47288
CFR reference
21 CFR 56
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-07-21
Effective date
2016-04-04
HHS docket
Docket No. FDA-2015-N-5052
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.