other · Food and Drug Administration · Rule · Published 2011-09-19 · Effective 2011-09-19 · 76 FR 57906
Document
Document number
2011-23874
Federal Register citation
76 FR 57906
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-09-19
Effective date
2011-09-19
HHS docket
Docket No. FDA-2011-N-0003
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for the veterinary prescription use of gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending the regulations to add the established tolerances for residues of gamithromycin in edible tissues of cattle.