Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal
other · Food and Drug Administration · Rule · Published 2018-05-07 · Effective 2018-05-07 · 83 FR 19936
Document
Document number
2018-09589
Federal Register citation
83 FR 19936
CFR reference
21 CFR 600
Type
Rule
Action
Direct final rule; withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2018-05-07
Effective date
2018-05-07
HHS docket
Docket No. FDA-2017-N-7007
Abstract
The Food and Drug Administration (FDA) published in the Federal Register of January 26, 2018, a direct final rule to amend the general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.