New Animal Drugs; Change of Sponsor's Name and Address; Corrections
fda-drug · Food and Drug Administration · Rule · Published 2011-03-24 · Effective 2011-03-24 · 76 FR 16532
Document
Document number
2011-6795
Federal Register citation
76 FR 16532
CFR reference
21 CFR 510
Type
Rule
Action
Correcting amendments.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2011-03-24
Effective date
2011-03-24
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) published a document in the Federal Register of April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document contained errors in the regulatory text. FDA is correcting the tables listing sponsors of approved animal drug applications (NADAs) by adding a change to the sponsor's drug labeler code (DLC). Cross-references to the sponsor's DLC are amended in two sections of the Code of Federal Regulations (CFR) containing the conditions of use approved animal drug products. These corrections are being made to improve the accuracy of the animal drug regulations.